Linguistic Validation of the M. D. Anderson Symptom Inventory in Persian-Speaking Iranian Cancer Patients.

PubMed

Saadatpour, Leila; Hemati, Simin; Habibi, Farzaneh; Behzadi, Erfan; Hashemi-Jazi, Marsa Sadat; Kheirabadi, Gholamreza; Mirbagher, Leila; Gholamrezaei, Ali

2015-09-01

Various symptoms frequently affect cancer patients' quality of life. Appropriate assessment of these symptoms provides valuable data for cancer management. This study aimed to validate the Persian version of the M. D. Anderson Symptom Inventory (MDASI-P). This cross-sectional study was conducted at four cancer treatment centers in two cities in Iran. Breast cancer and colorectal cancer patients aged 18 years and older were consecutively included in the study. The standard forward-backward translation method was applied. Patients completed the MDASI-P along with the previously validated Persian version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Construct validity (factor analysis), criterion validity (against the EORTC QLQ-C30), and reliability (Cronbach's alpha) were analyzed. A total of 146 breast cancer and 94 colorectal cancer patients were studied. Factor analysis for the symptom severity items resulted in a three-factor solution, further reduced to a two-factor solution: general symptoms and gastrointestinal symptoms. Correlation of the MDASI-P symptom severity items with corresponding EORTC QLQ-C30 symptom items (r = 0.48-0.75) and MDASI-P interference items with corresponding EORTC QLQ-C30 functioning domains (r = -0.46 to -0.23) supported the criterion validity. Cronbach's alpha was 0.90, 0.88, and 0.77 for the total questionnaire, symptom severity items, and the interference subscale, respectively. The MDASI-P is a feasible, valid, and reliable instrument for evaluation of symptoms in Persian-speaking cancer patients and can be used to improve symptom management in these patients. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

EORTC radiation proctitis-specific quality of life module - pretesting in four European countries.

PubMed

Halkett, Georgia; Aoun, Samar; Hayne, Dickon; Lund, Jo-Asmund; Gruen, Arne; Villa, Julie; Livi, Lorenzo; Arcangeli, Stefano; Velikova, Galina; Spry, Nigel

2010-11-01

Radiation proctitis is a side effect which can occur after pelvic radiation therapy. Currently available questionnaires do not comprehensively assess the range of problems, nor impact on quality of life associated with proctitis. This article reports on the cultural testing phase of an EORTC module (QLQ-PRT21) developed to assess radiation proctitis specific issues and designed to be used in conjunction with the EORTC core quality of life questionnaire (QLQ-C30). The previously developed 21-item module, pre-tested in Australia, was translated into Norwegian, German, French and Italian. Patients completed the EORTC QLQ-C30 and module questionnaires towards the end of their radical pelvic radiation treatment to target acute side effects. Patients experiencing chronic proctitis were also surveyed. Patients also participated in structured interviews to determine issues of comprehensibility, coverage and relevance. Results were compared with Australian data. Questionnaires were completed by 64 European patients. The module was found to be relevant and culturally acceptable to participants. Feedback has led to minor translation modifications and the inclusion of two additional questions. This module is ready for Phase IV testing which will consist of large scale field testing with the aim to perform psychometric analysis and finalize a module that will be suitable in the assessment of radiation induced proctitis. Crown Copyright © 2010. Published by Elsevier Ireland Ltd. All rights reserved.

The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients.

PubMed

Hjermstad, Marianne Jensen; Bergenmar, Mia; Fisher, Sheila E; Montel, Sébastien; Nicolatou-Galitis, Ourania; Raber-Durlacher, Judith; Singer, Susanne; Verdonck-de Leeuw, Irma; Weis, Joachim; Yarom, Noam; Herlofson, Bente B

2012-09-01

Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). The aim was to develop a supplementary module to the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) focusing on oral health and related QoL issues in all cancer diagnoses. The module development followed the EORTC guidelines. Phases 1&2 were conducted in France, Germany, Greece, Netherlands, Norway and United Kingdom, while seven countries representing seven languages were included in Phase 3. Eighty-five QoL-items were identified from systematic literature searches. Semi-structured interviews with health-care professionals experienced in oncology and oral/dental care (n=18) and patients (n=133) resulted in a provisional module with 41 items. In phase 3 this was further tested in 178 European patients representing different phases of disease and treatment. Results from the interviews, clinical experiences and statistical analyses resulted in the EORTC QLQ-OH17. The module consists of 17 items conceptualised into four multi-item scales (pain/discomfort, xerostomia, eating, information) and three single items related to use of dentures and future worries. This study provides a useful tool intended for use in conjunction with the EORTC QLQ-C30 for assessment of oral and dental problems. The increased awareness may lead to proper interventions, thereby preventing more serious problems and negative impact on QoL. The reliability and validity, the cross-cultural applicability and the psychometric properties of the module will be tested in a larger international study. Copyright © 2012 Elsevier Ltd. All rights reserved.

International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases.

PubMed

Chow, Edward; Nguyen, Janet; Zhang, Liying; Tseng, Ling-Ming; Hou, Ming-Feng; Fairchild, Alysa; Vassiliou, Vassilios; Jesus-Garcia, Reynaldo; Alm El-Din, Mohamed A; Kumar, Aswin; Forges, Fabien; Chie, Wei-Chu; Bottomley, Andrew

2012-03-01

The objective of this international field study was to test the reliability, validity, and responsiveness of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 module to assess health-related quality of life (HRQOL) in patients with bone metastases. Patients undergoing a variety of bone metastases-specific treatments were accrued. The QLQ-BM22 was administered with the QLQ-C30 at baseline and at 1 follow-up time point internationally. A debriefing questionnaire was administered to determine patient acceptability and understanding. Large-scale field testing of the QLQ-BM22 in addition to the QLQ-C30 took place in 7 countries: Brazil, Canada, Cyprus, Egypt, France, India, and Taiwan. A total of 400 patients participated. Multitrait scaling analyses confirmed 4 scales in the 22-item module. The scales were able to discriminate between clinically distinct patient groups, such as between those with a poor and those with a better performance status. The QLQ-BM22 was well received in all 7 countries, and the majority of patients did not recommend any significant changes from the module in its current form. The final QLQ-BM22 module contains 22 items and 4 scales assessing Painful Sites, Painful Characteristics, Functional Interference, and Psychosocial Aspects. Results confirmed the validity, reliability, cross-cultural applicability, and sensitivity of the 22-item EORTC QLQ-BM22. It is therefore recommended that the QLQ-BM22 be used in addition to the QLQ-C30 in clinical trials to assess HRQOL in patients with bone metastases. Copyright © 2011 American Cancer Society.

Phase III development of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for women undergoing breast reconstruction.

PubMed

Winters, Z E; Balta, V; Thomson, H J; Brandberg, Y; Oberguggenberger, A; Sinove, Y; Unukovych, D; Nava, M; Sandelin, K; Johansson, H; Dobbeleir, J; Blondeel, P; Bruno, N; Catanuto, G; Llewellyn-Bennett, R

2014-03-01

Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items. The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed. Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26. The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR. © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with prostate cancer - EORTC QLQ-PR25.

PubMed

Park, Jinsung; Shin, Dong Wook; Yun, Seok Joong; Park, Sung-Woo; Jeon, Seong Soo; Kwak, Cheol; Kwon, Tae Gyun; Kim, Hyung Jin; Ahn, Hanjong

2013-01-01

We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer QLQ-PR25 when applied to Korean prostate cancer (PC) patients. A total of 172 patients who underwent curative radical prostatectomy (RP) with or without adjuvant androgen deprivation therapy were asked to complete the Korean version of the EORTC QLQ-C30 and PR25 questionnaires 3 times (before and 3 and 6 months after RP). Psychometric evaluation of the questionnaire was conducted. Multitrait scaling analysis showed satisfactory construct validity in most scales except for bowel symptoms and hormonal treatment-related symptoms. Internal consistency tested by Cronbach's α coefficient met the 0.70 criterion for the urinary symptom, sexual activity and sexual functioning scales at the all 3 time points. Known-group comparison analyses showed better quality-of-life (QOL) scores in patients with higher performance status, and higher hormonal treatment-related symptom scores in patients on hormonal treatment. Responsiveness to changes was in line with clinical implications over time after RP. Our results show that the EORTC QLQ-PR25 questionnaire has adequate levels in cross-cultural validity. The Korean version of the EORTC QLQ-PR25 is a generally reliable and robust instrument for the assessment of various QOL aspects that can be self-administered to Korean PC patients undergoing RP. © 2013 S. Karger AG, Basel.

Development of a disease-specific quality of life questionnaire for patients with aplastic anemia and/or paroxysmal nocturnal hemoglobinuria (QLQ-AA/PNH)-report on phases I and II.

PubMed

Groth, Martha; Singer, Susanne; Niedeggen, Cathrin; Petermann-Meyer, Andrea; Röth, Alexander; Schrezenmeier, Hubert; Höchsmann, Britta; Brümmendorf, Tim H; Panse, Jens

2017-02-01

Acquired aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated ultra-rare diseases. Quality of life (QoL) evaluation tools used in studies for AA and PNH are unspecific and designed for cancer patients (e.g., the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). Given the complexity of AA and PNH, variation in symptoms and treatments, younger age of many patients, and the fact that AA and PNH are not classified as malignant diseases, it is likely that cancer-specific questionnaires are inappropriate. We generate an AA/PNH-specific QoL questionnaire (QLQ-AA/PNH), performed according to EORTC guidelines. QoL issues were obtained from the literature and interviews with patients and physicians (phase I), then ranked by patients and physicians. In phase II, items were created. Patients in more than 25 German and Swiss cities were interviewed face to face. In phase I, interviews of 19 patients and 8 physicians specialized in AA/PNH treatment resulted in 649 QoL issues; these were condensed to 175 and graded according to their importance by 30 patients and 14 physicians (phase II). Five physicians took part in phases I and II. Altogether, 97 issues were rated important. Twelve EORTC QLQ-C30 items were not rated important, while several new QoL aspects were brought up. Modifications in wording and phrasing led to two questionnaires with 77 items regarding general QoL aspects and 20 items regarding medical care. Important QoL aspects of PNH/AA patients are inappropriately captured with available QoL tools. Developing a new QoL questionnaire specific for this patient group is warranted.

Validation of EORTC IN-PATSAT32 for Chinese cancer patients.

PubMed

Zhang, Lei; Dai, Zhenbo; Cheng, Siying; Xie, Shumin; Woo, Stephanie Mu-Lian; Luo, Zhiqin; Wu, Jinglian; Gao, Tianwen; Liu, Jiahao; Zhang, Kai; Zhang, Jing; Jia, Xinyu; Miller, Adam R; Wang, Changli

2015-09-01

The aim of this study is to test the psychometric properties and acceptability of the European Organization for Research and Treatment of Cancer (EORTC) inpatient satisfaction with care questionnaire 32 (IN-PATSAT32) for evaluating Chinese cancer patients and to analyze the influence of age, educational level, diagnostic time, and tumor stage on patient satisfaction. Three hundred two cancer inpatients in Tianjin Cancer Institution and Hospital from June 2013 to December 2013 were recruited for this study. All participants self-administered the EORTC IN-PATSAT32 and EORTC quality of life questionnaire-core 30 (QLQ-C30). Psychometric evaluation of the validity, reliability, acceptability, as well as the influence of age, educational level, diagnostic time, and tumor stage on patient satisfaction, was conducted. A favorable internal consistency reliability was confirmed, as the Cronbach's α coefficients were >0.80 for all scales in the EORTC IN-PATSAT32, ranging from 0.849 to 0.944. Multi-trait scaling analysis showed that all item-scale correlation coefficients met the standard of convergent validity, and 79.3 % met the standard of discriminant validity. Weak correlations were found between the scales and single items of the EORTC IN-PATSAT32 and EORTC QLQ-C30, proving the validity of EORTC IN-PATSAT32. None of the EORTC IN-PATSAT32 scales were able to discriminate between patients across age categories, while significant influences of educational level on doctors' and nurses' conduct, as well as influences of diagnostic time and tumor stage on nurses' conduct, and information provision scales were discovered. The questionnaire was easily understood with a satisfactory acceptability. The EORTC IN-PATSAT32 appears to be a reliable, valid, and acceptable instrument to use on cancer patients and is appropriate for measuring the patient satisfaction of Chinese patients.

Psychometric Validation of the Malaysian Chinese Version of the EORTC QLQ-C30 in Colorectal Cancer Patients.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Law, Chee Wei; Sagap, Ismail

2015-01-01

Colorectal cancer is the second most frequent cancer in Malaysia. We aimed to assess the validity and reliability of the Malaysian Chinese version of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire core (QLQ-C30) in patients with colorectal cancer. Translated versions of the QLQ-C30 were obtained from the EORTC. A cross sectional study design was used to obtain data from patients receiving treatment at two teaching hospitals in Kuala Lumpur, Malaysia. The Malaysian Chinese version of QLQ-C30 was self-administered in 96 patients while the Karnofsky Performance Scales (KPS) was generated by attending surgeons. Statistical analysis included reliability, convergent, discriminate validity, and known-groups comparisons. Statistical significance was based on p value ≤0.05. The internal consistencies of the Malaysian Chinese version were acceptable [Cronbach's alpha (α≥ 0.70)] in the global health status/overall quality of life (GHS/QOL), functioning scales except cognitive scale (α≤0.32) in all levels of analysis, and social/family functioning scale (α=0.63) in patients without a stoma. All questionnaire items fulfilled the criteria for convergent and discriminant validity except question number 5, with correlation with role (r = 0.62) and social/family (r = 0.41) functioning higher than with physical functioning scales (r = 0.34). The test-retest coefficients in the GHS/QOL, functioning scales and in most of the symptoms scales were moderate to high (r = 0.58 to 1.00). Patients with a stoma reported statistically significant lower physical functioning (p=0.015), social/family functioning (p=0.013), and higher constipation (p=0.010) and financial difficulty (p=0.037) compared to patients without stoma. There was no significant difference between patients with high and low KPS scores. Malaysian Chinese version of the QLQ-C30 is a valid and reliable measure of HRQOL in patients with colorectal cancer.

Quality of life in cancer patients undergoing anticoagulant treatment with LMWH for venous thromboembolism: the QUAVITEC study on behalf of the Groupe Francophone Thrombose et Cancer (GFTC).

PubMed

Farge, Dominique; Cajfinger, Francis; Falvo, Nicolas; Berremili, Toufek; Couturaud, Francis; Bensaoula, Okba; Védrine, Lionel; Bensalha, Hocine; Bonnet, Isabelle; Péré-Vergé, Denis; Coudurier, Marie; Li, Veronique; Rafii, Hanadi; Benzidia, Ilham; Connors, Jean M; Resche-Rigon, Matthieu

2018-06-05

Clinical guidelines recommend at least 3-months low molecular weight heparin (LMWH) treatment for established venous thromboembolism (VTE) in cancer patients. However, no study has analyzed the impact of 3-6 months of LMWH therapy on quality-of-life (QoL) in cancer patients. Among 400 cancer patients included at M0, 88.8% received long-term LMWH. Using a random-effects linear regression model with time as covariate, QoL scores in the MOS SF-36 (Global HRQoL, 1.3-fold per month [95% confidence interval (CI) 0.81-1.79], p < 0.0001) and EORTC QLQ-C30 (global health status/qol, 2.25-fold per month [95% CI 1.63-2.88]; p < 0.0001) questionnaires significantly improved over the 6-month study period in patients treated with LMWH, while VEINES-QOL scores did not change. In the MOS SF-36 and EORTC QLQ-C30, the following factors were associated with change in QoL: symptomatic VTE, cancer dissemination and histological type. Factors pertaining to reduced mobility were also identified as significant predictors of QoL outcomes, including being bedridden in the MOS SF-36 and ECOG score ≥ 2 in the EORTC QLQ-C30. Presence of acute infection and not undergoing anti-angiogenic therapy were additional factors associated with QoL improvement in the EORTC QLQ-C30. QUAVITEC, a prospective, longitudinal, multicenter study, recruited all consecutive eligible adult cancer patients with objectively confirmed VTE between February 2011 and 2012. Patients were asked to answer three QoL questionnaires at anticoagulant treatment initiation (M0) and at 3 (M3) and 6 (M6)-month follow-ups. QUAVITEC is the first study to show that QoL was improved in cancer patients receiving long-term LMWH treatment for established VTE.

Differences in health-related quality of life between European and Asian patients with hepatocellular carcinoma.

PubMed

Chie, Wei-Chu; Blazeby, Jane M; Hsiao, Chin-Fu; Chiu, Herng-Chia; Poon, Ronnie T; Mikoshiba, Naoko; Al-Kadhim, Gillian; Heaton, Nigel; Calara, Jozer; Collins, Peter; Caddick, Katharine; Costantini, Anna; Vilgrain, Valerie

2017-10-01

The aim of this study is to explore the possible effects of clinical and cultural characteristics of hepatocellular carcinoma on patients' health-related quality of life (HRQoL). Patients with hepatocellular carcinoma from Asian and European countries completed the EORTC QLQ-C30 and the EORTC QLQ-HCC18. Comparisons were made using Student's t-test and Wilcoxon rank-sum test with method of false discovery to correct multiple comparisons. Multiway analysis of variance and model selection were used to assess the effects of clinical characteristics and geographic areas. Two hundred and twenty-seven patients with hepatocellular carcinoma completed questionnaires. After adjusting for demographic and clinical characteristics, Asian patients still had significantly better HRQoL scores in emotional functioning, insomnia, (QLQ-C30) and in sexual interest (QLQ-HCC18). We also found an interaction in physical functioning (QLQ-C30) and fatigue (QLQ-HCC18) between geographic region and marital status, married European had worse HRQoL scores than Asian singles. Both clinical characteristics and geographic areas affected the HRQoL in with hepatocellular carcinoma. Cultural differences and clinical differences in the pattern of disease due to active surveillance of Asian countries may explain the results. © 2016 John Wiley & Sons Australia, Ltd.

Physical Distress, Emotional Status, and Quality of Life in Patients With Nasopharyngeal Cancer Complicated by Post-Radiotherapy Endocrinopathy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lue, B.-H.; Department of Social Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan

2008-01-01

Purpose: To explore factors affecting quality of life (QOL) among patients with nasopharyngeal cancer (NPC) complicated by post-radiotherapy endocrinopathy. Methods and Materials: This cross-sectional study was conducted in a tertiary medical center and involved a total of 43 post-radiotherapy, recurrence-free NPC patients with endocrinopathy. They performed self-assessment of their emotional status using the Beck Anxiety Inventory and Beck Depression Inventory-II, and their QoL with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) questionnaire and the H and N35 cancer module. Results: Emotional and cognitive functioning of EORTC QLQ-C30 were the most affected. Fatigue,more » insomnia, and pain were the main concerns. Of the patients, 22 (51.2%) had anxiety and 19 (44.2%) had depression. Both depression and anxiety were negatively correlated with functional scales and global QoL but positively correlated with symptom scales. Multiple linear regression analysis revealed that physical distress symptoms of QLQ-C30 and physical functioning were the significant predictors of global QoL. Emotional and social functioning could predict depression, whereas emotional and physical functioning were significant predictors of anxiety. Conclusions: NPC patients with post-radiotherapy endocrinopathy exhibit impaired cognitive function and negative emotions. Symptoms of physical distress play an important role in QoL perception. Measurement of EORTC QLQ-C30 can be a useful instrument for the early detection of patients' impaired cognitive function and psychological morbidity. The high psychological distress related to the endocrine disturbances or the impact of NPC itself needs further study.« less

Validation of the Mexican Spanish version of the EORTC QLQ-H&N35 instrument to measure health-related quality of life in patients with head and neck cancers.

PubMed

Carrillo, José F; Ortiz-Toledo, Miguel Angel; Salido-Noriega, Zarahi; Romero-Ventura, Norma Berenice; Ochoa-Carrillo, Francisco J; Oñate-Ocaña, Luis F

2013-05-01

Health-related quality of life (HRQL) is an important outcome measurement in oncology. Our aim was to validate the Mexican Spanish version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire to measure HRQL in patients with head and neck cancers. The QLQ-C30 and QLQ-H&N35 instruments were applied to Mexican patients with head and neck cancer at a cancer referral center. Reliability and validity tests were performed. Test-retest was carried out in selected patients. One hundred ninety-three patients were included in this cohort; tumor locations included the following: oral cavity 45 (23.3 %); larynx 35 (18.1 %); thyroid carcinoma invasive to aerodigestive tract 32 (16.6 %); oropharynx 17 (8.8 %); hypopharynx 12 (6.2 %); nasal cavity and paranasal sinuses 11 (5.7 %); salivary glands 11 (5.7 %); nasopharynx 8 (4.1 %); eye and adnexa 7 (3.6 %); cervical metastases of unknown origin 5 (2.6 %); primary sarcoma of the head and neck region 5 (2.6 %); maxillary antrum carcinoma 4 (2.1 %); and retinoblastoma 1 (0.5 %). Questionnaire compliance rates were high, and the instrument was well accepted; the internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of 8 of 9 multi-item scales of the QLQ-C30 and 6 of 8 scales of the QLQ-H&N35 instruments were >0.7 (range 0.22-0.89). Scales of the QLQ-C30 and QLQ-H&N35 instruments distinguished among clinically distinct groups of patients; some were highly sensitive to change over time. The Mexican Spanish version of the QLQ-H&N35 questionnaire is reliable and valid for the assessment of HRQL in patients with head and neck cancers and can be used in clinical trials in Mexican communities.

Psychometric Validation of the Bahasa Malaysia Version of the EORTC QLQ-CR29.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Law, Chee Wei; Raduan, Farhana; Sagap, Ismail

2015-01-01

This study examined the psychometric properties of the Bahasa Malaysia (BM) version of the European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer-specific Quality Of Life Questionnaire (QLQ-CR29). We studied 93 patients recruited from University Malaya and Universiti Kebangsaan Medical Centers, Kuala Lumpur, Malaysia using a self-administered method. Tools included QLQ-C30, QLQ-CR29 and Karnofsky Performance Scales (KPS). Statistical analyses included Cronbach's alpha, test-retest correlations, multi-traits scaling and known-groups comparisons. A p value ≤ 0.05 was considered significant. The internal consistency coefficients for body image, urinary frequency, blood and mucus and stool frequency scales were acceptable (Cronbach's alpha α ≥ 0.65). However, the coefficients were low for the blood and mucus and stool frequency scales in patients with a stoma bag (α = 0.46). Test-retest correlation coefficients were moderate to high (range: r = 0.51 to 1.00) for most of the scales except anxiety, urinary frequency, buttock pain, hair loss, stoma care related problems, and dyspareunia (r ≤ 0.49). Convergent and discriminant validities were achieved in all scales. Patients with a stoma reported significantly higher symptoms of blood and mucus in the stool, flatulence, faecal incontinence, sore skin, and embarrassment due to the frequent need to change the stoma bag (p < 0.05) compared to patients without stoma. None of the scales distinguished between patients based on the KPS scores. There were no overlaps between scales in the QLQ-C30 and QLQ-CR29 (r < 0.40). the BM version of the QLQ-CR29 indicated acceptable psychometric properties in most of the scales similar to original validation study. This questionnaire could be used to complement the QLQ-C30 in assessing HRQOL among BM speaking population with colorectal cancer.

A brief instrument to measure health-related quality of life in patients with bone metastasis: validation of the German version of Bone Metastases Quality-of-Life-10 (BOMET-QoL-10).

PubMed

Marschner, Norbert; Wilke, Jochen; Reschke, Daniel; Kaiser, Florian; Schmoor, Claudia; Grugel, Renate; Boller, Emil

2018-06-06

This prospective, epidemiologic study was designed to translate the original Spanish Bone Metastases Quality-of-Life-10 (BOMET-QoL-10) questionnaire and undertake a validation of the translated German version of BOMET-QoL-10 in Germany to assess health-related quality of life (HRQoL) in patients with bone metastases (BM). The translation process included forward and backward translations, and a linguistic validation. Patients aged ≥18 years with histological confirmation of cancer, diagnosed with BM, life expectancy ≥6 months, and fluency in German were eligible for this study (enrolled consecutively in 33 outpatient centers in Germany). Patients were given the German version of BOMET-QoL-10 together with European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and EORTC QLQ-BM22 questionnaires at inclusion, 6 weeks, 3 months, and 6 months after inclusion. A debriefing questionnaire was administered at inclusion to determine patient acceptability and understanding. Data include 364 patients with BM (median age: 68 years; female sex: 71.7%). The BOMET-QoL-10 is brief and clear (median completion time: 5 minutes; >90% of patients completed the questionnaire without assistance). The BOMET-QoL-10 forms only one overall scale. All 10 items showed a substantial correlation with the first factor (factor loading, range: 0.58 - 0.86). BOMET-QoL-10 exhibits high internal consistency and reproducibility (Cronbach's alpha: 0.91; intra-class correlation coefficient: 0.76). BOMET-QoL-10 showed significant correlations (range: 0.69 - 0.79) both with EORTC QLQ-C30 and EORTC QLQ-BM22 within the functioning (physical, social, interference) and symptom (fatigue, pain) scales, displayed significant sensitivity to change in EORTC QLQ-BM22 scores, and proved potential ability to detect change in HRQoL in patients with different disease status. There was a high proportion of females in our study which might represent a limitation. The German version of BOMET-QoL-10 is a valid, reliable, brief and clear instrument able to measure HRQoL in patients with BM.

Quality of Life in Patients With Brain Metastases Using the EORTC QLQ-BN20+2 and QLQ-C15-PAL

DOE Office of Scientific and Technical Information (OSTI.GOV)

Caissie, Amanda; Nguyen, Janet; Chen, Emily

Purpose: The 20-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Brain Neoplasm (QLQ-BN20) is a validated quality-of-life (QOL) questionnaire for patients with primary brain tumors. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15 Palliative (QLQ-C15-PAL) core palliative questionnaire is a 15-item version of the core 30-item QLQ-C30 and was developed to decrease the burden on patients with advanced cancer. The combination of the QLQ-BN20 and QLQ-C30 to assess QOL may be too burdensome for patients. The primary aim of this study was to assess QOL in patients before and aftermore » treatment for brain metastases using the QLQ-BN20+2 and QLQ-C15-PAL, a version of the QLQ-BN20 questionnaire with 2 additional questions assessing cognitive functioning that were not addressed in the QLQ-C15-PAL. Methods and Materials: Patients with brain metastases completed the QLQ-C15-PAL and QLQ-BN20+2 questionnaires to assess QOL before and 1 month after radiation. Linear regression analysis was used to assess changes in QOL scores over time, as well as to explore associations between the QLQ-BN20+2 and QLQ-C15-PAL scales, patient demographics, and clinical variables. Spearman correlation assessed associations between the QLQ-BN20+2 and QLQ-C15-PAL scales. Results: Among 108 patients, the majority (55%) received whole-brain radiotherapy only, with 65% of patients completing follow-up at 1 month after treatment. The most prominent symptoms at baseline were future uncertainty (QLQ-BN20+2) and fatigue (QLQ-C15-PAL). After treatment, significant improvement was seen for the QLQ-C15-PAL insomnia scale, as well as the QLQ-BN20+2 scales of future uncertainty, visual disorder, and concentration difficulty. Baseline Karnofsky Performance Status was negatively correlated to QLQ-BN20+2 motor dysfunction but positively related to QLQ-C15-PAL physical functioning and QLQ-BN20+2 cognitive functioning at baseline and follow-up. QLQ-BN20+2 scales of future uncertainty and motor dysfunction correlated with the most QLQ-C15-PAL scales, including overall QOL (negative association) at baseline and follow-up. Conclusion: After radiation, the questionnaires showed maintenance of QOL and improvement of QOL scores such as future uncertainty, which featured prominently in this patient population. It is proposed that the 37-item QLQ-BN20+2 and QLQ-C15-PAL, as opposed to the 50-item QLQ-BN20 and QLQ-C30, may be used together as a universal QOL assessment tool in this setting.« less

[Anxiety in women undergoing surgical treatment of breast cancer].

PubMed

Geraybeyli, G Ch; Mamedzade, G F; Gasimov, N V; Guliyeva, T S; Munir, K

To assess anxiety level and factors contributing to its development in patients undergoing surgical treatment for breast cancer. The subjects of the study were 72 women, aged 20-80 years, with the diagnosis of primary breast cancer. The Basic Psycho-Oncological Documentation Scale (PO-BADO), the European Organization for Research, and the Treatment of Cancer Quality of Life Questionnaire and its Breast Cancer Module (EORTC QLQ-C30; BR-23), the Hospital Anxiety and Depression Scale (HADS) were used. The anxiety score showed negative correlation with EORTC QLQ-C30 'physical functioning', 'cognitive functioning', 'emotional functioning', 'global health status/quality of life' subscales (p≤0,002). Anxiety is a highly prevalent in women with breast cancer and has a marked negative impact, in particular on younger patients.

Comparison of three shortened questionnaires for assessment of quality of life in advanced cancer.

PubMed

Chiu, Leonard; Chiu, Nicholas; Chow, Edward; Cella, David; Beaumont, Jennifer L; Lam, Henry; Popovic, Marko; Bedard, Gillian; Poon, Michael; Wong, Erin; Zeng, Liang; Bottomley, Andrew

2014-08-01

Quality of life (QoL) assessment questionnaires can be burdensome to advanced cancer patients, thus necessitating the need for shorter assessment instruments than traditionally available. We compare three shortened QoL questionnaires in regards to their characteristics, validity, and reliability. A literature search was conducted to identify studies that employed or discussed three abridged QoL questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Core 15-Palliative Care (EORTC QLQ-C15-PAL), the Functional Assessment of Cancer Therapy-General-7 (FACT-G7), and the Functional Assessment of Chronic Illness Therapy-Palliative Care-14 (FACIT-PAL-14). Articles that discussed questionnaire length, intended use, scoring procedure, and validation were included. The 7-item FACT-G7 is the shortest instrument, whereas the EORTC QLQ-C15-PAL and the FACIT-PAL-14 contain 14 and 15 items, respectively. All three questionnaires have similar recall period, item organization, and subscale components. Designed as core questionnaires, all three maintain content and concurrent validity of their unabridged original questionnaires. Both the EORTC QLQ-C15-PAL and the FACT-G7 demonstrate good internal consistency and reliability, with Cronbach's α ≥0.7 deemed acceptable. The developmental study for the FACIT-PAL-14 was published in 2013 and subsequent validation studies are not yet available. The EORTC QLQ-C15-PAL and the FACT-G7 were found to be reliable and appropriate for assessing health-related QoL issues-the former for palliative cancer patients and the latter for advanced cancer patients receiving chemotherapy. Conceptually, the FACIT-PAL-14 holds promise to cover social and emotional support issues that are not completely addressed by the other two questionnaires; however, further validation is needed.

Psychometric evaluation of an item bank for computerized adaptive testing of the EORTC QLQ-C30 cognitive functioning dimension in cancer patients.

PubMed

Dirven, Linda; Groenvold, Mogens; Taphoorn, Martin J B; Conroy, Thierry; Tomaszewski, Krzysztof A; Young, Teresa; Petersen, Morten Aa

2017-11-01

The European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Group is developing computerized adaptive testing (CAT) versions of all EORTC Quality of Life Questionnaire (QLQ-C30) scales with the aim to enhance measurement precision. Here we present the results on the field-testing and psychometric evaluation of the item bank for cognitive functioning (CF). In previous phases (I-III), 44 candidate items were developed measuring CF in cancer patients. In phase IV, these items were psychometrically evaluated in a large sample of international cancer patients. This evaluation included an assessment of dimensionality, fit to the item response theory (IRT) model, differential item functioning (DIF), and measurement properties. A total of 1030 cancer patients completed the 44 candidate items on CF. Of these, 34 items could be included in a unidimensional IRT model, showing an acceptable fit. Although several items showed DIF, these had a negligible impact on CF estimation. Measurement precision of the item bank was much higher than the two original QLQ-C30 CF items alone, across the whole continuum. Moreover, CAT measurement may on average reduce study sample sizes with about 35-40% compared to the original QLQ-C30 CF scale, without loss of power. A CF item bank for CAT measurement consisting of 34 items was established, applicable to various cancer patients across countries. This CAT measurement system will facilitate precise and efficient assessment of HRQOL of cancer patients, without loss of comparability of results.

Comparison of Quality of Life and Sexuality between Cervical Cancer Survivors and Healthy Women.

PubMed

Lee, Yumi; Lim, Myong Cheol; Kim, Se Ik; Joo, Jungnam; Lee, Dong Ock; Park, Sang-Yoon

2016-10-01

The purpose of this study is to compare quality of life (QoL) and sexual functioning between sexually active cervical cancer survivors and healthy women. In this cross-sectional study, propensity-score-matched cervical cancer survivors (n=104) and healthy women (n=104) were compared. All women had engaged in sexual activity within the previous 3 months, and cervical cancer survivors showed no evidence of disease after primary treatment. QoL and sexual functioning were assessed using three questionnaires; the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Cervical Cancer Module (EORTC QLQ-CX24), and the Female Sexual Function Index (FSFI). Significantly higher scores for lymphedema were observed in the cervical cancer survivors group compared with the healthy women group (mean, 20.2 vs. 12.2; p < 0.05). Sexuality, both in terms of sexual activity, sexual enjoyment, and sexual worry (EORTC QLQ-CX24), and in terms of desire, arousal, lubrication, orgasm, satisfaction, and pain (FSFI) were similar between the groups. When the scale of sexual/vaginal functioning in EORTC QLQ-CX24 was divided into individual questions, cervical cancer survivors reported shorter vaginal length than the control group, but without statistical significance (mean, 80.6 vs. 85.4; p=0.077). Compared with healthy women, sexuality was not impaired in cervical cancer survivors who showed no evidence of disease after primary treatment and engaging in sexual activity. Further prospective cohort studies are warranted to confirm this finding.

Exploratory study of long-term health-related quality of life in patients with surgically treated primary parotid gland cancer.

PubMed

Stenner, Markus; Beenen, Franziska; Hahn, Moritz; Koopmann, Mario; Weiss, Daniel; Hüttenbrink, Karl-Bernd

2016-01-01

Health-related quality of life (HRQOL) has received more and more attention as an outcome in cancer therapy. In this exploratory study, we assessed the long-term HRQOL among 77 surgically treated patients with parotid gland cancer. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions (EORTC-QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC-QLQ-C30-H&N35) questionnaires were used in a cross-sectional design. The mean time-lag between initial diagnosis and completion of the questionnaire was 89.7 months. The HRQOL significantly increased with the time-lag to surgery and decreased with the patients' age. Factors with clinically significant effects in several areas of long-term HRQOL (ie, more than 4 scores) were age, type of neck dissection, preoperative facial nerve palsy, and postoperative radiation therapy. In parotid gland cancer surgery, factors, such as sex, age, type of surgery, facial nerve palsy, and radiation therapy, seem to be associated with clinically meaningful differences in long-term HRQOL scores. © 2015 Wiley Periodicals, Inc.

Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy.

PubMed

Mesa, Ruben; Verstovsek, Srdan; Kiladjian, Jean-Jacques; Griesshammer, Martin; Masszi, Tamas; Durrant, Simon; Passamonti, Francesco; Harrison, Claire N; Pane, Fabrizio; Zachee, Pierre; Zhen, Huiling; Jones, Mark M; Parasuraman, Shreekant; Li, Jingjin; Côté, Isabelle; Habr, Dany; Vannucchi, Alessandro M

2016-08-01

Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant. © 2016 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.

Using Quality of Life Scales with Nutritional Relevance after Gastrectomy: a Challenge for Providing Personalized Treatment

PubMed Central

2017-01-01

Purpose This study evaluated the changes in nutritional status based on quality of life (QoL) item-level analysis to determine whether individual QoL responses might facilitate personal clinical impact. Materials and Methods This study retrospectively evaluated QoL data obtained by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Stomach (QLQ-STO22) as well as metabolic-nutritional data obtained by bioelectrical impedance analysis and blood tests. Patients were assessed preoperatively and at the 5-year follow-up. QoL was analyzed at the level of the constituent items. The patients were categorized into vulnerable and non-vulnerable QoL groups for each scale based on their responses to the QoL items and changes in the metabolic-nutritional indices were compared. Results Multiple shortcomings in the metabolic-nutritional indices were observed in the vulnerable groups for nausea/vomiting (waist-hip ratio, degree of obesity), dyspnea (hemoglobin, iron), constipation (body fat mass, percent body fat), dysphagia (body fat mass, percent body fat), reflux (body weight, hemoglobin), dry mouth (percent body fat, waist-hip ratio), and taste (body weight, total body water, soft lean mass, body fat mass). The shortcomings in a single index were observed in the vulnerable groups for emotional functioning and pain (EORTC QLQ-C30) and for eating restrictions (EORTC QLQ-STO22). Conclusions Long-term postoperative QoL deterioration in emotional functioning, nausea/vomiting, pain, dyspnea, constipation, dysphagia, reflux, eating restrictions, dry mouth, and taste were associated with nutritional shortcomings. QoL item-level analysis, instead of scale-level analysis, may help to facilitate personalized treatment for individual QoL respondents. PMID:29302374

Translation and validation of European organization for research and treatment of cancer quality of life Questionnaire -C30 into Moroccan version for cancer patients in Morocco

PubMed Central

2014-01-01

Background Understanding the effects of cancer on the quality of life of affected patients is critical to clinical research as well as to optimal management and care. The aim of this study was to adapt the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) questionnaire into Moroccan Arabic and to determine its psychometric properties. After translation, back translation and pretesting of the pre-final version, the translated version was submitted to a committee of professionals composed by oncologists and epidemiologists. The psychometric properties were tested in patients with cancer. Internal consistency was tested using Cronbach’s alpha and the test-retest reliability using interclass correlation coefficients. Construct validity was assessed by examining item-convergent and divergent validity. It was also tested using Spearman’s correlation between QLQ-C30 scales and EQ-5D. Results The study was conducted in 125 patients. The Moroccan version was internally reliable, Cronbach’s α was 0.87 for the total scale and ranged from 0.34 to 0.97 for the subscales. The intraclass correlation coefficient of the test-retest reliability ranged from 0.64 for “social functioning” to 0.89 for “physical activities” subscales. The instrument demonstrated a good construct and concomitant validity. Conclusions We have developed a semantically equivalent translation with cultural adaptation of EORTC QLQ-C30 questionnaire. The assessment of its measurement properties showed that it is quite reliable and a valid measure of the effect of cancer on the quality of life in Moroccan patients. PMID:24721384

Multicollinearity in prognostic factor analyses using the EORTC QLQ-C30: identification and impact on model selection.

PubMed

Van Steen, Kristel; Curran, Desmond; Kramer, Jocelyn; Molenberghs, Geert; Van Vreckem, Ann; Bottomley, Andrew; Sylvester, Richard

2002-12-30

Clinical and quality of life (QL) variables from an EORTC clinical trial of first line chemotherapy in advanced breast cancer were used in a prognostic factor analysis of survival and response to chemotherapy. For response, different final multivariate models were obtained from forward and backward selection methods, suggesting a disconcerting instability. Quality of life was measured using the EORTC QLQ-C30 questionnaire completed by patients. Subscales on the questionnaire are known to be highly correlated, and therefore it was hypothesized that multicollinearity contributed to model instability. A correlation matrix indicated that global QL was highly correlated with 7 out of 11 variables. In a first attempt to explore multicollinearity, we used global QL as dependent variable in a regression model with other QL subscales as predictors. Afterwards, standard diagnostic tests for multicollinearity were performed. An exploratory principal components analysis and factor analysis of the QL subscales identified at most three important components and indicated that inclusion of global QL made minimal difference to the loadings on each component, suggesting that it is redundant in the model. In a second approach, we advocate a bootstrap technique to assess the stability of the models. Based on these analyses and since global QL exacerbates problems of multicollinearity, we therefore recommend that global QL be excluded from prognostic factor analyses using the QLQ-C30. The prognostic factor analysis was rerun without global QL in the model, and selected the same significant prognostic factors as before. Copyright 2002 John Wiley & Sons, Ltd.

Development of an item bank for computerized adaptive test (CAT) measurement of pain.

PubMed

Petersen, Morten Aa; Aaronson, Neil K; Chie, Wei-Chu; Conroy, Thierry; Costantini, Anna; Hammerlid, Eva; Hjermstad, Marianne J; Kaasa, Stein; Loge, Jon H; Velikova, Galina; Young, Teresa; Groenvold, Mogens

2016-01-01

Patient-reported outcomes should ideally be adapted to the individual patient while maintaining comparability of scores across patients. This is achievable using computerized adaptive testing (CAT). The aim here was to develop an item bank for CAT measurement of the pain domain as measured by the EORTC QLQ-C30 questionnaire. The development process consisted of four steps: (1) literature search, (2) formulation of new items and expert evaluations, (3) pretesting and (4) field-testing and psychometric analyses for the final selection of items. In step 1, we identified 337 pain items from the literature. Twenty-nine new items fitting the QLQ-C30 item style were formulated in step 2 that were reduced to 26 items by expert evaluations. Based on interviews with 31 patients from Denmark, France and the UK, the list was further reduced to 21 items in step 3. In phase 4, responses were obtained from 1103 cancer patients from five countries. Psychometric evaluations showed that 16 items could be retained in a unidimensional item bank. Evaluations indicated that use of the CAT measure may reduce sample size requirements with 15-25% compared to using the QLQ-C30 pain scale. We have established an item bank of 16 items suitable for CAT measurement of pain. While being backward compatible with the QLQ-C30, the new item bank will significantly improve measurement precision of pain. We recommend initiating CAT measurement by screening for pain using the two original QLQ-C30 pain items. The EORTC pain CAT is currently available for "experimental" purposes.

Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events.

PubMed

Anwar, Sidra; Tan, Wei; Hong, Chi-Chen; Admane, Sonal; Dozier, Askia; Siedlecki, Francine; Whitworth, Amy; DiRaddo, Ann Marie; DePaolo, Dawn; Jacob, Sandra M; Ma, Wen Wee; Miller, Austin; Adjei, Alex A; Dy, Grace K

2017-06-26

Background : Serious adverse events (SAEs) and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL) or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods : Between 2011-2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G), Medical Outcomes Study Social Support Survey (MOSSSS), Charlson comorbidity scores (CCS) and Royal Marsden scores (RMS) were obtained at baseline. Frequency of dose limiting toxicities (DLTs), subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher's exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p -value ≤ 0.05 was considered statistically significant. Results : Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles ( p = 0.04). Conclusions : Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.

The EORTC module for quality of life in patients with thyroid cancer: phase III.

PubMed

Singer, Susanne; Jordan, Susan; Locati, Laura D; Pinto, Monica; Tomaszewska, Iwona M; Araújo, Cláudia; Hammerlid, Eva; Vidhubala, E; Husson, Olga; Kiyota, Naomi; Brannan, Christine; Salem, Dina; Gamper, Eva M; Arraras, Juan Ignacio; Ioannidis, Georgios; Andry, Guy; Inhestern, Johanna; Grégoire, Vincent; Licitra, Lisa

2017-04-01

The purpose of the study was to pilot-test a questionnaire measuring health-related quality of life (QoL) in thyroid cancer patients to be used with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire EORTC QLQ-C30. A provisional questionnaire with 47 items was administered to patients treated for thyroid cancer within the last 2 years. Patients were interviewed about time and help needed to complete the questionnaire, and whether they found the items understandable, confusing or annoying. Items were kept in the questionnaire if they fulfilled pre-defined criteria: relevant to the patients, easy to understand, not confusing, few missing values, neither floor nor ceiling effects, and high variance. A total of 182 thyroid cancer patients in 15 countries participated ( n  = 115 with papillary, n  = 31 with follicular, n  = 22 with medullary, n  = 6 with anaplastic, and n  = 8 with other types of thyroid cancer). Sixty-six percent of the patients needed 15 min or less to complete the questionnaire. Of the 47 items, 31 fulfilled the predefined criteria and were kept unchanged, 14 were removed, and 2 were changed. Shoulder dysfunction was mentioned by 5 patients as missing and an item covering this issue was added. To conclude, the EORTC quality of life module for thyroid cancer (EORTC QLQ-THY34) is ready for the final validation phase IV. © 2017 Society for Endocrinology.

Quality of life and voice assessment in patients with early-stage glottic cancer.

PubMed

Arias, Fernando; Arraras, Juan Ignacio; Asin, Gemma; Uzcanga, María Itziar; Maraví, Enrique; Chicata, Volker; Eito, Clara; Zarandona, Uxue; Mora, Itxaso; Vila, Meritxell; Domínguez, Miguel Angel

2015-03-01

The purpose of this study was to assess the quality of life (QOL) and voice handicap in a sample of disease-free patients who had been treated at our center with radiotherapy (RT) or surgery for early glottic cancer. QOL and voice handicap were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires Quality of Life Questionnaire-Core 30-questions (QLQ-C30) and Quality of Life Questionnaire-Head and Neck 35-questions (QLQ-H&N35) and the Voice Handicap Index (VHI). Ninety-one patients completed the questionnaires. Fifty-nine patients (65%) were treated with RT and 32 (35%) with surgery. QOL scores for the sample recorded, moderate limitations in 6 areas, and more than moderate limitations (>30 of 100) in 2 areas. Significant differences were found in emotional functioning (88.5 vs 76.6) and social contact (4.6 vs 12.1) on the EORTC questionnaires and on the VHI (6.1 vs 12.8), which favored the RT group. In this cross-sectional study, voice quality, emotional functioning, and social contact were better in the RT group. © 2014 Wiley Periodicals, Inc.

Reference data of the EORTC QLQ-C30 questionnaire: five consecutive annual assessments of approximately 2000 representative Dutch men and women.

PubMed

Mols, Floortje; Husson, Olga; Oudejans, Marije; Vlooswijk, Carla; Horevoorts, Nicole; van de Poll-Franse, Lonneke V

2018-06-18

Cancer and its treatment have an influence on health-related quality of life (HRQOL). Normative data could help to interpret HRQOL among cancer patients. Our aim was to generate longitudinal normative data based on sex, age and morbidity for the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. The QLQ-C30 and the Self-administered Comorbidity Questionnaire were administered to a representative panel of the Dutch-speaking population in the Netherlands in 2009 (n = 1743), 2010 (n = 2050), 2011 (n = 2040), 2012 (n = 2194) and 2013 (n = 2333). Regarding sex, at baseline, women scored statistically significant and clinically relevant worse on fatigue, pain and insomnia compared to men. Regarding age groups and sex, HRQoL was lower among the older age groups in men and women. For men, at baseline, significant and clinically relevant age differences were found on physical, role and cognitive functioning, global QOL scale, fatigue, pain and dyspnea. The change over 5 years was larger for older age groups. For women, at baseline, significant and clinically relevant age differences were found on physical functioning, role functioning, nausea/vomiting, pain, dyspnea and insomnia. Those without self-reported morbidities reported a better HRQoL compared to those with morbidities. Among those who completed five assessments, the summary scale scores were stable over time, were higher in men than in women, and higher in younger compared to older age groups. Although HRQoL remains relatively stable over time, HRQoL data needs to be interpreted with care as many confounding factors can have an impact on HRQOL. Our data (which is freely available) can aid in the interpretation of QLQ-C30 scores and can help increase our understanding of the influence of age, sex, time and morbid conditions on HRQoL among cancer patients.

Quality of Life Assessment With Orthotopic Ileal Neobladder Reconstruction After Radical Cystectomy: Results From a Prospective Italian Multicenter Observational Study.

PubMed

Imbimbo, Ciro; Mirone, Vincenzo; Siracusano, Salvatore; Niero, Mauro; Cerruto, Maria Angela; Lonardi, Cristina; Artibani, Walter; Bassi, Pierfrancesco; Iafrate, Massimo; Racioppi, Marco; Talamini, Renato; Ciciliato, Stefano; Toffoli, Laura; Visalli, Francesco; Massidda, Davide; D'Elia, Carolina; Cacciamani, Giovanni; De Marchi, Davide; Silvestri, Tommaso; Creta, Massimiliano; Belgrano, Emanuele; Verze, Paolo

2015-11-01

To assess health-related quality of life (HRQoL) parameters in patients who received radical cystectomy (RC) with ileal orthotopic neobladder (IONB) reconstruction and to identify clinic-pathologic predictors of HRQoL. From January 2010 to December 2013, a multicenter, retrospective on 174 RC-IONB patients was carried out. All patients completed the following questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the IONB-Patient Reported Outcome (IONB-PRO). Univariate and multivariate analyses were computed to identify clinic-pathologic predictors of HRQoL. Median age was 66 years (range, 31-83), and 91.4% of patients were men. Median follow-up period was 37 months (range, 3-247). The EORTC QLQ-C30 revealed that age >65 years, absence of urinary incontinence, and absence of peripheral vascular disease were independent predictors of deteriorated body image. A follow-up > 36 months and the presence of urinary incontinence were independent predictors of worsened urinary symptoms, whereas the absence of urinary incontinence was an independent predictor of a worsened body image according to EORTC QLQ-BLM30 results. A follow-up >36 months and the absence of urinary incontinence were independent predictors of better functioning in terms of relational life, emotional life, and fatigue as revealed by the IONB-PRO. Age, presence of urinary incontinence, length of follow-up, and comorbidity status may influence postoperative HRQoL and should all be taken into account when counseling RC-IONB patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Quality of life in very elderly radiotherapy patients: a prospective pilot study using the EORTC QLQ-ELD14 module.

PubMed

Kaufmann, Anne; Schmidt, Heike; Ostheimer, Christian; Ullrich, Janine; Landenberger, Margarete; Vordermark, Dirk

2015-07-01

In very elderly cancer patients, health-related quality of life (HRQOL) is a particularly important issue but has rarely been studied due to a lack of specific instruments and of reference data. We performed a prospective analysis of HRQOL in patients ≥80 years undergoing radiotherapy with the newly validated elderly-specific HRQOL module EORTC QLQ-ELD14. We prospectively assessed HRQOL in n = 50 radiotherapy patients ≥80 years (32% lung, 20% gastrointestinal, 8% each of breast, head and neck, gynecologic cancer) at the start (t1), end (t2), and 6 months after (t3) radiotherapy, using EORTC QLQ-C30 and EORTC QLQ-ELD14. Overall survival was determined in the whole cohort and subgroups. Median overall survival from the start of radiotherapy was 15 months; 1-year and 2-year overall survival rates were 57.1 and 31.0%, respectively. Eastern Cooperative Oncology Group (ECOG) performance status <2, Charlson comorbidity index ≤6, curative treatment intention, local tumor stage Union Internationale Contre le Cancer (UICC I, II), and total dose >45 Gy were associated with prolonged survival. No significant changes in any HRQOL domain were observed during the course of treatment (t1 to t2). Six months after radiotherapy (t3), a significant and clinically relevant deterioration of HRQOL was seen in EORTC QLQ-C30 for physical function and role function and in EORTC QLQ-ELD14 for future worries, burden of illness, and family support. In radiotherapy patients ≥80 years, HRQOL was maintained until the end of radiotherapy but deteriorated in general and elderly-specific areas thereafter, suggesting a need to develop specific supportive interventions for this age group.

International Psychometric Validation of an EORTC Quality of Life Module Measuring Cancer Related Fatigue (EORTC QLQ-FA12).

PubMed

Weis, Joachim; Tomaszewski, Krzysztof A; Hammerlid, Eva; Ignacio Arraras, Juan; Conroy, Thierry; Lanceley, Anne; Schmidt, Heike; Wirtz, Markus; Singer, Susanne; Pinto, Monica; Alm El-Din, Mohamed; Compter, Inge; Holzner, Bernhard; Hofmeister, Dirk; Chie, Wei-Chu; Czeladzki, Marek; Harle, Amelie; Jones, Louise; Ritter, Sabrina; Flechtner, Hans-Henning; Bottomley, Andrew

2017-05-01

The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a new multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). The module EORTC QLQ-FA13 assesses physical, cognitive, and emotional aspects of cancer-related fatigue. The methodology follows the EORTC guidelines for phase IV validation of modules. This paper focuses on the results of the psychometric validation of the factorial structure of the module. For validation and cross-validation confirmatory factor analysis (maximum likelihood estimation), intraclass correlation and Cronbach alpha for internal consistency were employed. The study involved an international multicenter collaboration of 11 European and non-European countries. A total of 946 patients with various tumor diagnoses were enrolled. Based on the confirmatory factor analysis, we could approve the three-dimensional structure of the module. Removing one item and reassigning the factorial mapping of another item resulted in the EORTC QLQ-FA12. For the revised scale, we found evidence supporting good local (indicator reliability ≥ 0.60, factor reliability ≥ 0.82) and global model fit (GFI t1|t2 = 0.965/0.957, CFI t1|t2 = 0.976/0.972, RMSEA t1|t2 = 0.060/0.069) for both measurement points. For each scale, test-retest reliability proved to be very good (intraclass correlation: R t1-t2 = 0.905-0.921) and internal consistency proved to be good to high (Cronbach alpha = .79-.90). Based on the former phase III module, the multidimensional structure was revised as a phase IV module (EORTC FA12) with an improved scale structure. For a comprehensive validation of the EORTC FA12, further aspects of convergent and divergent validity as well as sensitivity to change should be determined. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Quality-of-life impairment after endoluminal locoregional resection and laparoscopic total mesorectal excision.

PubMed

Lezoche, Emanuele; Paganini, Alessandro M; Fabiani, Bernardina; Balla, Andrea; Vestri, Annarita; Pescatori, Lorenzo; Scoglio, Daniele; D'Ambrosio, Giancarlo; Lezoche, Giovanni

2014-01-01

For selected patients with rectal cancer, endoluminal locoregional resection (ELRR) by transanal endoscopic microsurgery (TEM) may be an alternative treatment option to laparoscopic total mesorectal excision (LTME). Few data are available on quality of life (QoL) after LTME and TEM. This study aimed to compare short- and medium-term QoL for T1 rectal cancer patients undergoing LTME or ELRR by TEM. This study investigated 35 patients with T1N0 rectal cancer who underwent TEM (n = 17) or LTME (n = 18). Quality of life was evaluated by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-C38 questionnaires preoperatively and then 1, 6, and 12 months after surgery. Observation 1 month after LTME showed worsening in all items of both questionnaires. After ELRR, the QLQ-CR38 showed worsening of gastrointestinal (p = 0.005) and defecation problems (p = 0.001), and the QLQ-C30 showed worsening of global health status (p = 0.014), physical functioning (p = 0.02) role functioning (p = 0.003), fatigue (p = 0.002), and pain (p = 0.001). The QLQ-CR38 6 months after LTME showed worsening of body image (p = 0.009), micturition (p = 0.035), and gastrointestinal problems (p = 0.011), and the QLQ-C30 showed worsening of physical functioning (p = 0.003), role functioning (p = 0.002), fatigue (p = 0.004), and nausea/vomiting (p = 0.030). After ELRR, neither the QLQ-CR38 nor the QLQ-C30 questionnaire showed any worsening but demonstrated improvement in global health status and physical functioning. The QLQ-CR38 12 months after LTME showed significant improvement in defecation problems (p = 0.004) and weight loss (p = 0.003), and the QLQ-C30 showed significant improvement in global health status (p = 0.001), nausea and vomiting (p = 0.003), and pain (p = 0.005). After ELRR, the QLQ-C30 showed improvement in emotional functioning (p = 0.012), whereas no significant difference was observed by the QLQ-C38. Functional sequelae are present up to 1 month only after ELRR by TEM and up to 6 months after LTME. At 12 months, neither procedure showed a significant difference in QoL compared with preoperative status.

Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial.

PubMed

Wallwiener, Markus; Matthies, Lina; Simoes, Elisabeth; Keilmann, Lucia; Hartkopf, Andreas D; Sokolov, Alexander N; Walter, Christina B; Sickenberger, Nina; Wallwiener, Stephanie; Feisst, Manuel; Gass, Paul; Fasching, Peter A; Lux, Michael P; Wallwiener, Diethelm; Taran, Florin-Andrei; Rom, Joachim; Schneeweiss, Andreas; Graf, Joachim; Brucker, Sara Y

2017-09-14

Breast cancer represents the most common malignant disease in women worldwide. As currently systematic palliative treatment only has a limited effect on survival rates, the concept of health-related quality of life (HRQoL) is gaining more and more importance in the therapy setting of metastatic breast cancer. One of the major patient-reported outcomes (PROs) for measuring HRQoL in patients with breast cancer is provided by the European Organization for Research and Treatment of Cancer (EORTC). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. Facing the possibilities associated with evolving digitalization in medicine, validation of electronic versions of well-established PRO is essential in order to contribute to comprehensive and holistic oncological care and to ensure high quality in cancer research. The aim of this study was to analyze the reliability of a tablet-based measuring application for EORTC QLQ-C30 in German language in patients with adjuvant and (curative) metastatic breast cancer. Paper- and tablet-based questionnaires were completed by a total of 106 female patients with adjuvant and metastatic breast cancer recruited as part of the e-PROCOM study. All patients were required to complete the electronic- (e-PRO) and paper-based versions of the HRQoL EORTC QLQ-C30 questionnaire. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability [Wilcoxon test] and test of internal consistency [Spearman rho and agreement rates for single items, Pearson correlation and Kendall tau for each scale]) were analyzed. High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patient's response behavior between paper- and electronic-based questionnaires. Regarding the test of parallel forms reliability, no significant differences were found in 27 of 30 single items and in 14 of 15 scales, whereas a statistically significant correlation in the test of consistency was found in all 30 single items and all 15 scales. The evaluated e-PRO version of the EORTC QLQ-C30 is reliable for patients with both adjuvant and metastatic breast cancer, showing a high correlation in almost all questions (and in many scales). Thus, we conclude that the validated paper-based PRO assessment and the e-PRO tool are equally valid. However, the reliability should also be analyzed in other prospective trials to ensure that usability is reliable in all patient groups. ClinicalTrials.gov NCT03132506; https://clinicaltrials.gov/ct2/show/NCT03132506 (Archived by WebCite at http://www.webcitation.org/6tRcgQuou). ©Markus Wallwiener, Lina Matthies, Elisabeth Simoes, Lucia Keilmann, Andreas D Hartkopf, Alexander N Sokolov, Christina B Walter, Nina Sickenberger, Stephanie Wallwiener, Manuel Feisst, Paul Gass, Peter A Fasching, Michael P Lux, Diethelm Wallwiener, Florin-Andrei Taran, Joachim Rom, Andreas Schneeweiss, Joachim Graf, Sara Y Brucker. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.09.2017.

Randomized trial of aromatherapy versus conventional care for breast cancer patients during perioperative periods.

PubMed

Tamaki, Kentaro; Fukuyama, Akiko Komatsu; Terukina, Shigeharu; Kamada, Yoshihiko; Uehara, Kano; Arakaki, Miwa; Yamashiro, Kazuko; Miyashita, Minoru; Ishida, Takanori; McNamara, Keely May; Ohuchi, Noriaki; Tamaki, Nobumitsu; Sasano, Hironobu

2017-04-01

Several studies focused on the effect of aromatherapy on mood, quality of life (QOL), and physical symptoms in patients with cancer. We compared the effects on QOL, vital signs, and sleep quality between aromatherapy and conventional therapy during perioperative periods of the breast cancer patients in this study. Patients were randomly assigned in a 2:1 ratio to receive aromatherapy or usual care. The primary endpoint was QOL, which was assessed using the quality of life questionnaire QLQ-C30, Version 3.0 of the European Organization for Research and Treatment of Cancer (EORTC) Study Group on quality of life. Secondary endpoints included the necessity of hypnotics, vital signs including blood pressure and heart rate and adverse events. In addition, we also summarized the patients' perception of the experience from a free description-type questionnaire. A total of 249 patients had breast cancer surgery and 162 patients gave physician consent and were recruited; 110 were randomly assigned to aromatherapy group (eight patients showed incomplete EORTC QLQ-C30) and 52 to control group (one patient showed incomplete EORTC QLQ-C30). There were no statistically significant differences between the aromatherapy group and control group in the EORTC QLQ-C30 at the surgery day. As for the results of the post-operation day 1, trends for differentiations of physical functioning and role functioning were detected between aromatherapy group and control group, but the differences did not reach statistical significance (p = 0.08 and 0.09). There were no significant differences of systolic and diastolic blood pressures between aromatherapy group and control group (p = 0.82 and 0.68). There was no statistically significant difference in heart rates between aromatherapy group (70.6 ± 11.0 bpm) and control group (71.2 ± 9.8 bpm) (p = 0.73). Likewise, the rate of hypnotic use was not statistically significant (p = 0.10). No adverse events were reported after aromatherapy and all impressions from aromatherapy group were positive with descriptors such as relaxed, comfortable, and enjoyable being common. The results showed no effects of aromatherapy on QOL, sleep quality, and vital sign. However, there was not any harm or adverse event for using aromatherapy. All impressions from self-reporting were positive such as relaxed, comfortable, and enjoyable by the aromatherapy group. Therefore, we can use aromatherapy during perioperative periods in order to meet the expectations of the patients.

Longitudinal health-related quality of life analysis in oncology with time to event approaches, the STATA command qlqc30_TTD.

PubMed

Bascoul-Mollevi, C; Savina, Marion; Anota, Amélie; Barbieri, Antoine; Azria, David; Bonnetain, Franck; Gourgou, Sophie

2018-05-01

Health-related quality of life (HRQoL) has become one relevant and available alternative endpoint of clinical trials in cancer research to evaluate efficiency of care both for the patient and health system. HRQoL in oncology is mainly assessed using the 30-item European Organisation for Research and Treatment of Cancer Quality of Life-Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 questionnaire is usually assessed at different times along the clinical trials in order to analyze the kinetics of HRQoL evolution and to fully assess the impact of the treatment on the patient's HRQoL level. In this perspective, the realization of a longitudinal HRQoL analysis is essential and the time to HRQoL score deterioration approach is a method which is more and more used in clinical trials. Using the Stata software, we developed a QLQ-C30 specific command, qlqc30_TTD, which implements longitudinal strategies based on the time to event methods by considering the time to HRQoL score deterioration. This user-written command providing automatic execution of the Time To Deterioration (TTD) and Time Until Definitive Deterioration (TUDD) methods. The program implements all published definitions and provides the Kaplan-Meier curves for each dimension (by group) and a table with the Hazard Ratio and Log-Rank test. The longitudinal analysis of HRQoL data in cancer clinical trials remains complex with only few programs like ours computed. This program will be of great help and will allow a more systematic and quicker analysis of the HRQoL data in clinical trials in oncology. Copyright © 2018. Published by Elsevier B.V.

Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23).

PubMed

Yun, Young Ho; Bae, Sung Heui; Kang, Im Ok; Shin, Kyung Hwan; Lee, Ran; Kwon, So Im; Park, Young Suk; Lee, Eun Sook

2004-06-01

The aim of this study was to evaluate the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). A total of 153 patients with breast cancer and 153 normal subjects completed three questionnaires of the Korean version of the EORTC QLQ-BR23. Multitrait scaling analyses demonstrated that all scales met multidimensional conceptualization criteria in terms of convergence and discrimination validity. Cronbach's alpha coefficients for five multiple-item scales were greater than 0.70 (range, 0.72-0.91). In known-group comparisons, there were marked group differences between patients differing in disease stage. In breast cancer patients, performance on the questionnaires was in the expected direction for almost all functioning and symptom scores. In addition, comparison between the patient and control groups showed that almost all variables discriminated between patients and normal individuals. In conclusion, the Korean version of the EORTC QLQ-BR23 was found to be a reliable and valid measure of quality of life in breast cancer patients, indicating that it should be used in clinical and epidemiological cancer research.

Patient reported outcomes in head and neck cancer: selecting instruments for quality of life integration in clinical protocols.

PubMed

Silveira, Augusta P; Gonçalves, Joaquim; Sequeira, Teresa; Ribeiro, Cláudia; Lopes, Carlos; Monteiro, Eurico; Pimentel, Francisco L

2010-10-31

Health Related Quality of Life has been used in medical research for more than twenty years, being progressively accepted during the last decade as an important patient reported outcome. Considering the multidimensional approach involved in Health Related Quality of Life assessment, instrument applicability and cultural adaptation must be tested for each population. In order to select the most appropriate instrument for Head and Neck cancer patients, two major Health Related Quality of Life specific questionnaires for Head and Neck cancer patients were compared. Conceptual differences, psychometric characteristics, scores, reliability, construct validity and sensitivity to symptomatology, tumour location, tumour size were analyzed. 102 consecutive Head and Neck cancer patients completed two different Health Related Quality of Life questionnaires: EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 and the Functional Assessment of Cancer Therapy Scales (FACT-H&N). Patients completed the questionnaires, immediately before consultation as a part of the routine evaluation. A greater variability was always found in the EORTC QLC-C30 questionnaire's scores for all comparable domains. Both instruments revealed a good internal consistency and demonstrated to be good tools to distinguish symptomatic patients. The EORTC questionnaires still demonstrated sensitivity to distinguish T3 and T4 staging. Conceptual differences and the psychometric characteristics are discussed. Our results suggest that these two instruments assess different aspects of Health Related Quality of Life - the questionnaires should be used separately and chosen according to the study objectives and methodology. This study emphases the importance in selecting the appropriate tool as a critical success factor in implementing routine Health Related Quality of Life assessment in clinical practice. This decision assumes particularly importance when utilization of results in real time and integration into clinical protocols are considered.

Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change.

PubMed

Luckett, Tim; King, Madeleine; Butow, Phyllis; Friedlander, Michael; Paris, Tim

2010-05-01

Researchers wishing to assess the health-related quality of life (HRQoL) of women with gynecologic cancers have a range of questionnaires to choose from. In general, disease-, treatment-, or symptom-specific questionnaires are assumed to be better able to identify between-group differences (sensitivity) and changes over time (responsiveness) than are cancer-specific or generic questionnaires. However, little work has tested this assumption in oncology. We set out to (a) identify all multidimensional HRQoL questionnaires used in studies with women with gynecologic cancer and (b) evaluate their track records in identifying minimal clinically important differences (MCIDs), with a view to making recommendations. We searched MEDLINE using the term quality of life and each gynecologic cancer type, as well as the names of identified questionnaires. We used 10% of the scale range as the threshold for an MCID. We identified 1 generic (SF-36/SF-12), 3 cancer-specific (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] C30, Functional Assessment of Cancer Therapy-General [FACT-G], and short-form Cancer Rehabilitation Evaluation System [CARES-SF]), and 1 disease-specific (QOL-Ovarian Cancer Patient Version) HRQoL questionnaires and 5 disease-specific (QLQ-OV28, FACT-O for ovarian, QLQ-CX24, FACT-Cx for cervical and FACT-V for vulvar), 1 treatment-specific (FACT and Gynecologic Oncology Group-Ntx for neurotoxicity), and 2 symptom-specific (FACT-Anemia and Functional Assessment of Chronic Illness and Therapy [FACIT]-Fatigue) modules. Twenty-seven articles reported results from 26 studies in which an MCID had been identified. The FACIT's anemia and fatigue subscales were more sensitive, and the neurotoxicity subscale more sensitive and responsive than the FACT-G on at least 1 comparison. However, we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT questionnaires or vice versa. The evidence we reviewed offered little support for the hypothesis that disease-, symptom-, or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic questionnaires. However, conclusions were limited by the small number of head-to-head comparisons available. We summarize the clinical contexts in which each instrument identified an MCID to inform choice of questionnaire(s), sample size calculations, and interpretation of results in future studies.

Real-time Continuous Esophageal High-resolution Manometry (HRM) During Laparoscopic Heller Myotomy and Dor Fundoplication for the Treatment of Achalasia. A Promising Novelty in Regards of Perfecting Surgical Technique: Could It Guide Surgical Technique Toward Excellent Results?

PubMed

Triantafyllou, Tania; Doulami, Georgia; Papailiou, Joanna; Mantides, Apostolos; Zografos, Georgios; Theodorou, Dimitrios

2016-12-01

High-resolution manometry (HRM) is the gold-standard diagnostic tool for achalasia of the esophagus. Laparoscopic Heller-Dor technique is the preferred surgical approach with success rate estimated 90%. The use of intraoperative HRM provides real-time estimation of intraluminal esophageal pressures and identifies the exact points of esophageal luminal pressure during laparoscopy. Ten patients with achalasia underwent surgery. All patients preoperatively completed 1 manometric study and Quality of Life questionnaires (EORTC QLQ-C30 version 3.0) with Eckardt scores. We collected intraoperative manometry data and repeated manometric studies, EORTC QLQ-C30, and Eckardt scores postoperatively. Median Eckardt score was decreased from 7.5 to 0.5, mean resting pressure decreased from 51.4 to 11.9 mm Hg, whereas mean residual pressure diminished from 45.9 to 9.5 mm Hg postoperatively. The simultaneous use of HRM during the Heller-Dor technique may lead to an individualized management of the disease.

Quality of life in survivors of oropharyngeal cancer: A systematic review and meta-analysis of 1366 patients.

PubMed

Høxbroe Michaelsen, Sanne; Grønhøj, Christian; Høxbroe Michaelsen, Jacob; Friborg, Jeppe; von Buchwald, Christian

2017-06-01

Human papillomavirus (HPV)-associated oropharyngeal cancer (OPC) is rapidly increasing in incidence and has a favourable prognosis compared with HPV-negative disease. Current combined therapies include significant risks of morbidity for the growing group of survivors. This systematic review and meta-analysis investigates how treatment affects quality of life (QoL) in survivors of oropharyngeal cancer. PubMed, EMBASE and the Cochrane Library were systematically searched for all studies reporting patient-assessed QoL at least 1 year after treatment for OPC. In a meta-analysis, weighted average QoL scores from the four most commonly utilised QoL instruments were compared with baseline and reference group scores using the concept of minimal clinically important difference. The meta-analysis included data from 1366 patients from 25 studies and 12 countries. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) was answered by 704 patients, 644 patients answered the EORTC QLQ Head and Neck-35 (H&N-35), 474 patients answered the University of Washington Quality of Life Questionnaire, and 381 patients answered the M. D. Anderson Dysphagia Inventory. Moderate to large clinically important deteriorations in QoL were found in the domains dry mouth and sticky saliva for the EORTC QLQ-H&N35, saliva, chewing, swallowing, speech, taste, appearance and shoulder for the University of Washington Quality of Life Questionnaire, and the global, physical and emotional subscales for the M. D. Anderson Dysphagia Inventory. In conclusion, survivors of OPC face clinically important deteriorations in QoL that most markedly centre on xerostomia, dysphagia and chewing. These ailments indicate a potential for improvement in patient management. Copyright © 2017 Elsevier Ltd. All rights reserved.

A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors.

PubMed

Yun, Young Ho; Kim, Young Ae; Lee, Myung Kyung; Sim, Jin Ah; Nam, Byung-Ho; Kim, Sohee; Lee, Eun Sook; Noh, Dong-Young; Lim, Jae-Young; Kim, Sung; Kim, Si-Young; Cho, Chi-Heum; Jung, Kyung Hae; Chun, Mison; Lee, Soon Nam; Park, Kyong Hwa; Park, Sohee

2017-05-02

We aimed to evaluate the potential benefits of the Leadership and Coaching for Health (LEACH) program on physical activity (PA), dietary habits, and distress management in cancer survivors. We randomly assigned 248 cancer survivors with an allocation ratio of two-to-one to the LEACH program (LP) group, coached by long-term survivors, or the usual care (UC) group. At baseline, 3, 6, and 12 months, we used PA scores, the intake of vegetables and fruits (VF), and the Post Traumatic Growth Inventory (PTGI) as primary outcomes and, for secondary outcomes, the Ten Rules for Highly Effective Health Behavior adhered to and quality of life (QOL), the Hospital Anxiety and Depression Scale (HADS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). For primary outcomes, the two groups did not significantly differ in PA scores or VF intake but differed marginally in PTGI. For secondary outcomes, the LP group showed a significantly greater improvement in the HADS anxiety score, the social functioning score, and the appetite loss and financial difficulties scores of the EORTC QLQ-C30 scales from baseline to 3 months. From baseline to 12 months, the LP group showed a significantly greater decrease in the EORTC QLQ-C30 fatigue score and a significantly greater increase in the number of the Ten Rules for Highly Effective Health Behavior. Our findings indicate that the LEACH program, coached by long-term survivors, can provide effective management of the QOL of cancer survivors but not of their PA or dietary habits. Clinical trial information can be found for the following: NCT01527409 (the date when the trial was registered: February 2012).

Minimal Clinically Important Difference of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for Fatigue Worsening in Asian Breast Cancer Patients.

PubMed

Chan, Alexandre; Yo, Tiffany Eri; Wang, Xiao Jun; Ng, Terence; Chae, Jung-Woo; Yeo, Hui Ling; Shwe, Maung; Gan, Yan Xiang

2018-03-01

The minimal clinically important difference (MCID) of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), a questionnaire that measures cancer-related fatigue, has not been established in patients with cancer. This study aims to determine the MCID of the MFSI-SF. Breast cancer patients completed the MFSI-SF and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) before chemotherapy and at least three weeks later. The EORTC-QLQ-C30 fatigue scale (EORTC-FA) was used as an anchor, and a receiver operating characteristic (ROC) curve was also used to identify the optimal MCID cut-off for fatigue deterioration. A distribution-based approach used one-third of the SD, half of the SD, and one SEM of the total MFSI-SF score to determine the MCID. A total of 201 patients were analyzed. Change scores of the MFSI-SF and EORTC-FA were moderately correlated (r = 0.47, P < 0.001). The EORTC-FA-anchored MCID was 8.69 points (95% CI: 4.03-13.34). The MCID attained from the ROC curve method was 4.50 points (sensitivity: 68.8%; specificity: 64.1%). For the distribution-based approach, the MCIDs corresponding to one-third of the SD, half of the SD, and one SEM were 5.39, 8.99, and 10.79 points, respectively. The MCID of the MFSI-SF identified by all approaches ranged from 4.50 to 10.79 points. The MCID can be used to interpret the clinical significance of fatigue deterioration in patients with breast cancer and to determine sample sizes for future clinical trials. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Outcomes of xerostomia-related quality of life for nasopharyngeal carcinoma treated by IMRT: based on the EORTC QLQ-C30 and H&N35 questionnaires.

PubMed

Bian, Xiuhua; Song, Tao; Wu, Shixiu

2015-01-01

The aim of this study was to review the published literature addressing the question of whether intensity-modulated radiotherapy (IMRT) resulted in an improvement of quality of life (QoL), especially xerostomia-related QoL of all nasopharyngeal carcinoma patients as time progressed. A literature search of PubMed, Embase and Google Scholar was performed, only reports containing original data of the QoL scores after treated by IMRT were included. Two independent reviewers extracted information of study design, study population, interventions, outcome measures and conclusions for each article. The inclusion criteria were met by 14 articles covering outcomes based on the questionnaires treated by IMRT. Data from same questionnaires (European Organization of Research and Treatment of Cancer QLQ-C30 and H&N35 questionnaires) were exacted and we analyzed four items (global health status, dry mouth and sticky saliva, swallowing, social eating and social contact), which have a close relationship with xerostomia-related QoL. Results indicated that a maximal deterioration of most QoL scales including global health status developed during treatment or at the end of the treatment course and then followed by a gradual recovery to 1 year, 1-2 years after IMRT, compared with their baseline level, some specific head and neck items, most in the EORTC QLQ H&N35, remained worse for the surviving patients. In conclusion, the published data reasonably support the benefits of IMRT in improving QoL, but xerostomia-related items still had a significantly negative effect in 2 years to impact a survivor's QoL.

Determinants of patient satisfaction with care in a Spanish oncology day hospital and its relationship with quality of life.

PubMed

Arraras, Juan Ignacio; Illarramendi, Jose Juan; Viudez, Antonio; Ibáñez, Berta; Lecumberri, Maria Jose; de la Cruz, Susana; Hernandez, Berta; Zarandona, Uxue; Cambra, Koldo; Martinez, Maite; Salgado, Esteban; Lainez, Nuria; Vera, Ruth

2013-11-01

This study evaluates satisfaction with care (SC) in cancer patients treated at a Spanish day hospital to identify SC determinants and assess the relationship between SC and quality of life. One hundred seventy-six patients with different tumour sites and disease stages completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Cancer Outpatient Satisfaction with Care questionnaire for chemotherapy (OUT-PATSAT35 CT), the Oberst patients' perception of care quality and satisfaction scales, and an item on intention to recommend the hospital. Frequencies in the SC instruments, Spearman correlations between each scale of the OUT-PATSAT35 CT and overall satisfaction and between the subscales of OUT-PATSAT35 CT and of QLQ-C30 were calculated, and the determinants of patients' SC were calculated through multivariate regression models. Satisfaction with care was high: mean scores were >70 in all OUT-PATSAT35 CT areas except doctor availability and environment. These scores were in line with the other SC instruments. Correlation with overall satisfaction was high and statistically significant (p < 0.01) for all subscales, especially for the nurses domain, which also had higher SC scores. Correlations between the EORTC QLQ-C30 and the OUT-PATSAT35 CT were low (≤ 0.35). Younger patients and those with breast cancer showed significantly lower satisfaction in most subscales. Unmarried patients and patients that had undergone surgery reported lower satisfaction only in specific subscales. Satisfaction with care among cancer patients treated at the day hospital is high. Nurses play a key and successful role. Age and tumour location revealed stronger relationships with SC. Correlations between SC and quality of life indicate that these concepts are complementary. Copyright © 2013 John Wiley & Sons, Ltd.

Quality of life in responders after palliative radiation therapy for painful bone metastases using EORTC QLQ-C30 and EORTC QLQ-BM22: results of a Brazilian cohort.

PubMed

Mendez, Lucas C; Raman, Srinivas; Wan, Bo Angela; da Silva, José Luiz Padilha; Moraes, Fábio Y; Lima, Kennya M L B; Silva, Maurício F; Diz, Maria Del Pilar Estevez; Chow, Edward; Marta, Gustavo Nader

2017-08-01

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment. A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site. From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33). Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

Health-related quality of life questionnaires in lung cancer trials: a systematic literature review

PubMed Central

2013-01-01

Background Lung cancer is one of the leading causes of cancer deaths. Treatment goals are the relief of symptoms and the increase of overall survival. With the rising number of treatment alternatives, the need for comparable assessments of health-related quality of life (HRQoL) parameters grows. The aim of this paper was to identify and describe measurement instruments applied in lung cancer patients under drug therapy. Methods We conducted a systematic literature review at the beginning of 2011 using the electronic database Pubmed. Results A total of 43 studies were included in the review. About 17 different measurement instruments were identified, including 5 generic, 5 cancer-specific, 4 lung cancer-specific and 3 symptom-specific questionnaires. In 29 studies at least 2 instruments were used. In most cases these were cancer and lung cancer-specific ones. The most frequently used instruments are the EORTC QLQ-C30 and its lung cancer modules LC13 or LC17. Only 5 studies combined (lung) cancer-specific questionnaires with generic instruments. Conclusions The EORTC-C30 and EORTC-LC13 are the most frequently used health-related quality of life measurement instruments in pharmacological lung cancer trials. PMID:23680096

The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

PubMed

Thomson, H J; Winters, Z E; Brandberg, Y; Didier, F; Blazeby, J M; Mills, J

2013-03-01

A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

Patient-reported symptom questionnaires in laryngeal cancer: voice, speech and swallowing.

PubMed

Rinkel, R N P M; Verdonck-de Leeuw, I M; van den Brakel, N; de Bree, R; Eerenstein, S E J; Aaronson, N; Leemans, C R

2014-08-01

To validate questionnaires on voice, speech, and swallowing among laryngeal cancer patients, to assess the need for and use of rehabilitation services, and to determine the association between voice, speech, and swallowing problems, and quality of life and distress. Laryngeal cancer patients at least three months post-treatment completed the VHI (voice), SHI (speech), SWAL-QOL (swallowing), EORTC QLQ-C30, QLQ-HN35, HADS, and study-specific questions on rehabilitation. Eighty-eight patients and 110 healthy controls participated. Cut off scores of 15, 6, and 14 were defined for the VHI, SHI, and SWAL-QOL (sensitivity > 90%; specificity > 80%). Based on these scores, 56% of the patients reported voice, 63% speech, and 54% swallowing problems. VHI, SHI, and SWAL-QOL scores were associated significantly with quality of life (EORTC QLQ-C30 global quality of life scale) (r = .43 (VHI and SHI) and r = .46 (SWAL-QOL)) and distress (r = .50 (VHI and SHI) and r = .58 (SWAL-QOL)). In retrospect, 32% of the patients indicated the need for rehabilitation at time of treatment, and 81% of these patients availed themselves of such services. Post-treatment, 8% of the patients expressed a need for rehabilitation, and 20% of these patients actually made use of such services. Psychometric characteristics of the VHI, SHI, and SWAL-QOL in laryngeal cancer patients are good. The prevalence of voice, speech, and swallowing problems is high, and clearly related to quality of life and distress. Although higher during than after treatment, the perceived need for and use of rehabilitation services is limited. Copyright © 2014 Elsevier Ltd. All rights reserved.

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project.

PubMed

Blade, Joan; Calleja, Miguel Ángel; Lahuerta, Juan José; Poveda, José Luis; de Paz, Héctor David; Lizán, Luis

2018-02-22

To define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM). A literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project. Fifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction. A consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Mobile App Delivery of the EORTC QLQ-C30 Questionnaire to Assess Health-Related Quality of Life in Oncological Patients: Usability Study.

PubMed

Kessel, Kerstin A; Vogel, Marco Me; Alles, Anna; Dobiasch, Sophie; Fischer, Hanna; Combs, Stephanie E

2018-02-20

Mobile apps are evolving in the medical field. However, ongoing discussions have questioned whether such apps are really valuable and whether patients will accept their use in day-to-day clinical life. Therefore, we initiated a usability study in our department. We present our results of the first app prototype and patient testing of health-related quality of life (HRQoL) assessment in oncological patients. We developed an app prototype for the iOS operating system within eight months in three phases: conception, initial development, and pilot testing. For the HRQoL assessment, we chose to implement only the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30; German version 3). Usability testing was conducted for three months. Participation was voluntary and pseudonymized. After completion of the QLQ-C30 questionnaire using iPads provided by our department, we performed a short survey with 10 questions. This survey inquired about patients' opinions regarding general aspects, including technical advances in medicine, mobile and app assistance during cancer treatment, and the app-specific functions (eg, interface and navigation). After logging into the app, the user can choose between starting a questionnaire, reviewing answers (administrators only), and logging out. The questionnaire is displayed with the same information, questions, and answers as on the original QLQ-C30 sheet. No alterations in wording were made. Usability was tested with 81 patients; median age was 55 years. The median time for completing the HRQoL questionnaire on the iPad was 4.0 minutes. Of all participants, 84% (68/81) owned a mobile device. Similarly, 84% (68/81) of participants would prefer a mobile version of the HRQoL questionnaire instead of a paper-based version. Using the app in daily life during and after cancer treatment would be supported by 83% (67/81) of participants. In the prototype version of the app, data were stored on the device; in the future, 79% (64/81) of the patients would agree to transfer data via the Internet. Our usability test showed good results regarding attractiveness, operability, and understandability. Moreover, our results demonstrate a high overall acceptance of mobile apps and telemedicine in oncology. The HRQoL assessment via the app was accepted thoroughly by patients, and individuals are keen to use it in clinical routines, while data privacy and security must be ensured. ©Kerstin A Kessel, Marco M E Vogel, Anna Alles, Sophie Dobiasch, Hanna Fischer, Stephanie E Combs. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.02.2018.

Health-related quality of life in melanoma patients: Impact of melanoma-related limb lymphoedema.

PubMed

Gjorup, Caroline A; Groenvold, Mogens; Hendel, Helle W; Dahlstroem, Karin; Drzewiecki, Krzysztof T; Klausen, Tobias W; Hölmich, Lisbet R

2017-11-01

To explore health-related quality of life (HRQoL) in recurrence-free melanoma patients, with a focus on the association between melanoma-related limb lymphoedema and HRQoL. HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the breast cancer module (EORTC QLQ-BR23) subscales body image and future perspective, the Functional Assessment for Cancer Therapy-General subscale social/family well-being and the Hospital Anxiety and Depression Scale. Data were analysed using linear and ordinal logistic regression adjusting for age and gender. A total of 431 melanoma patients who had undergone wide local excision and axillary or inguinal sentinel lymph node biopsy (SLNB) and/or complete lymph node dissection (CLND) participated. No patients had had recurrence of the disease or had received adjuvant radiotherapy. The HRQoL scores improved with time after surgery. Melanoma-related limb lymphoedema was present in 109 patients (25%). Patients with lymphoedema had significantly worse HRQoL scores in the EORTC QLQ-C30 subscales global health status/quality of life, role and social functioning, fatigue, pain and financial difficulties, as well as in the QLQ-BR23 body image subscale. No associations were found between the limb affected (upper or lower limb), clinical stage of lymphoedema, duration of lymphoedema or type of surgery (SLNB or CLND) and HRQoL. We found an interaction with age and gender in the associations between lymphoedema and HRQoL: younger patients and women with lymphoedema had worse social functioning and women had significantly more impaired body image. The negative impact of melanoma-related limb lymphoedema on HRQoL emphasises the importance of developing strategies for increasing awareness and improving prevention and treatment of lymphoedema. Copyright © 2017 Elsevier Ltd. All rights reserved.

Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore.

PubMed

Chan, Alexandre; Lew, Claire; Wang, Xiao Jun; Ng, Terence; Chae, Jung-Woo; Yeo, Hui Ling; Shwe, Maung; Gan, Yan Xiang

2018-01-19

Currently, several fatigue measurement instruments are available to evaluate and measure cancer-related fatigue. Amongst them, Multidimensional Fatigue Syndrome Inventory-Short Form (MFSI-SF) is a self-reported instrument and a multidimensional scale that aims to capture the global, somatic, affective, cognitive and behavioural symptoms of fatigue. This study examines the psychometric properties and measurement equivalence of the English and Chinese versions of MFSI-SF in breast cancer and lymphoma patients in Singapore. Patients were recruited from National Cancer Centre Singapore. Validity, reliability and responsiveness of MFSI-SF were evaluated in this study. Convergent validity was evaluated by correlating total and subscales of MFSI-SF to known related constructs in EORTC QLQ-C30. Known group validity was assessed based on patients' cancer stage, pain, insomnia and depression symptoms. Reliability was evaluated by Cronbach's α. Responsiveness analyses were performed with patients who have undergone at least one cycle of chemotherapy. Multiple regression was used to compare the total and subscale scores of MSFI-SF between the two language versions. Data from 246 (160 English and 86 Chinese version) breast cancer and lymphoma patients were included in the study. Moderate to high correlations were observed between correlated MFSI-SF subscales and EORTC QLQ-C30 domains (|r| = 0.524 to 0.774) except for a poor correlation (r = 0.394) observed between MFSI-SF vigour subscale and EORTC QLQ-C30 role functioning subscale. Total MFSI-SF scores could differentiate between patients with higher depression, pain and insomnia status. Internal consistency of MFSI-SF was also high (α = 0.749 to 0.944). Moderate correlation was observed between change in total MFSI-SF score and change in fatigue symptom scale score and global QoL score on EORTC QLQ-C30 (|r| = 0.478 and 0.404 respectively). Poor correlations were observed between change in scores of hypothesised subscales (|r| = 0.202 to 0.361) except for a moderate correlation between change in MFSI-SF emotional fatigue score and change in EORTC QLQ-C30 emotional functioning domain score. Measurement equivalence was established for all subscales and total MFSI-SF score except for the emotional and vigour subscales. This study supports the use of MFSI-SF as a reasonably valid scale with good internal consistency for measuring fatigue levels in the Singapore cancer population.

Concurrent chemoradiotherapy degrades the quality of life of patients with stage II nasopharyngeal carcinoma as compared to radiotherapy

PubMed Central

Pan, Xin-Bin; Huang, Shi-Ting; Chen, Kai-Hua; Jiang, Yan-Ming; Ma, Jia-Lin; Qu, Song; Li, Ling; Chen, Long; Zhu, Xiao-Dong

2017-01-01

The purpose of this study was to compare the quality of life (QoL) of stage II nasopharyngeal carcinoma (NPC) patients treated with radiotherapy (RT) versus concurrent chemoradiotherapy (CCRT). In a cross-sectional study, these patients were treated with RT (n = 55) or CCRT (n = 51) between June 2008 and June 2013. For all subjects, disease-free survival was more than 3 years. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questions and the Head and Neck 35 (EORTC QLQ-H&N35) questions. RT had better outcomes than CCRT for global QoL, functional scales, symptom scales of fatigue and insomnia, financial problems, and weight gain. Survivors receiving 1 cycle of concurrent chemotherapy had worse QoL outcomes than survivors receiving 2 cycles of concurrent chemotherapy. Patients receiving 3 cycles of concurrent chemotherapy had the best QoL outcomes. Thus, CCRT adversely affects the QoL of patients with stage II NPC as compared to radiotherapy. PMID:28152511

Evaluation of Social Support, Quality of Life, and Body Image in Women with Breast Cancer.

PubMed

Spatuzzi, Roberta; Vespa, Anna; Lorenzi, Primo; Miccinesi, Guido; Ricciuti, Marcello; Cifarelli, Wanda; Susi, Marina; Fabrizio, Tommaso; Ferrari, Maria G; Ottaviani, Marica; Giulietti, Maria V; Merico, Fabiana; Aieta, Michele

2016-02-01

This study was aimed at comparing the quality of life, body image, and perceived social support in women with breast cancer surgery. Patients receiving breast-conserving surgery (BCS) (n = 72), mastectomy alone (n = 44), and mastectomy with breast reconstruction (n = 41) were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the EORTC Breast Cancer Module (QLQ-BR23), the Body Image Scale (BIS) and the Multidimensional Scale of Perceived Social Support (MSPSS). The results indicated that the BCS group had a better body image compared with the other 2 groups and better role functioning compared with the mastectomy-alone group. In the reconstruction group, body image correlated with perceived social support, especially from family and significant others. These results suggest that a positive perception of a supportive social network can help women with breast reconstruction to better cope with the psychological effects of surgery on their body image.

Quality of Life in a Prospective, Multicenter Phase 2 Trial of Neoadjuvant Full-Dose Gemcitabine, Oxaliplatin, and Radiation in Patients With Resectable or Borderline Resectable Pancreatic Adenocarcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Serrano, Pablo E.; Herman, Joseph M.; Griffith, Kent A.

Purpose: To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma. Methods and Materials: Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores weremore » compared with baseline. A change >10% was considered a minimal clinically important difference. Results: Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (−8, P=.02). This was in parallel with deterioration in physical functioning (−14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (−13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit. Conclusions: The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical resection, most domains returned back to baseline levels by 6 months.« less

Symptoms and health-related quality of life in patients with advanced cancer - A population-based study in Greenland.

PubMed

Augustussen, Mikaela; Sjøgren, Per; Timm, Helle; Hounsgaard, Lise; Pedersen, Michael Lynge

2017-06-01

The aims were to describe symptoms and health-related quality of life (HRQoL) in Greenlandic patients with advanced cancer and to assess the applicability and internal consistency of the Greenlandic version of the EORTC-QLQ-C30 core version 3.0. A Greenlandic version of the EORTC QLQ-C30 v.3.0 was developed. The translation process included independent forward translation, reconciliation and independent back translation by native Greenlandic-speaking translators who were fluent in English. After pilot testing, a population-based cross-sectional study of patients with advanced cancer receiving palliative treatment was conducted. Internal consistency was examined by calculating Cronbach's alpha coefficients for five function scales and three symptom scales. Of the 58 patients who participated in the study, 47% had reduced social functioning, 36% had reduced physical and role functioning and 19% had reduced emotional and cognitive functioning. Furthermore, 48% reported fatigue, and 33% reported financial problems. The Greenlandic version of the EORTC had good applicability in the assessment of symptoms and quality of life. Acceptable Cronbach's alpha coefficients (above 0.70) were observed for the physical, role and social functioning scales, the fatigue scale and the global health status scale. Patients with undergoing palliative treatment in Greenland for advanced cancer reported high levels of social and financial problems and reduced physical functioning. This indicates a potential for improving palliative care service and increasing the focus on symptom management. The Greenlandic version of the EORTC-QLQ-C30 represents an applicable and reliable tool to describe symptoms and health-related quality of life among Greenlandic patients with advanced cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer.

PubMed

van Leeuwen, Marieke; Kieffer, Jacobien M; Efficace, Fabio; Fosså, Sophie D; Bolla, Michel; Collette, Laurence; Colombel, Marc; De Giorgi, Ugo; Holzner, Bernhard; van de Poll-Franse, Lonneke V; van Poppel, Hendrik; White, Jeff; de Wit, Ronald; Osanto, Susanne; Aaronson, Neil K

2017-05-11

Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer. In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce. Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions. The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed.

Fatigue in Patients With Advanced Terminal Cancer Correlates With Inflammation, Poor Quality of Life and Sleep, and Anxiety/Depression.

PubMed

Rodrigues, Alex Rua; Trufelli, Damila Cristina; Fonseca, Fernando; de Paula, Larissa Carvalho; Giglio, Auro Del

2016-12-01

To assess which laboratory and clinical factors are associated with fatigue in patients with terminal cancer. We evaluated 51 patients with advanced incurable solid tumors using the Chalder Fatigue Questionnaire (CFQ) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale for fatigue; the Pittsburgh Sleep Quality Index (PSQI-BR) for sleep quality; the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression; the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire, Version 3.0 (QLQ C-30); and Functional Assessment of Cancer Therapy (FACT) for quality of life. We also analyzed several inflammatory markers and the modified Glasgow prognostic score (mGPS). We observed severe fatigue in 19 (38%) patients (FACIT-F score >36). There was a significant correlation between fatigue as evaluated by the CFQ and quality of sleep and between the CFQ mental fatigue subscale scores and TNF-α level. When fatigue was evaluated using the FACIT-F scale, we observed a significant association between fatigue and anxiety/depression, quality of sleep, mGPS, and hemoglobin levels. Fatigue measured both with the CFQ and FACIT-F scale correlated with poor quality of life according to the EORTC QLQ C-30. In patients with advanced cancer, fatigue is a common symptom associated with the presence of inflammation, poor quality of sleep, depression/anxiety, and poor quality of life. © The Author(s) 2015.

Health-related quality of life of cancer patients with peripherally inserted central catheter: a pilot study.

PubMed

Kang, Junren; Chen, Wei; Sun, Wenyan; Ge, Ruibin; Li, Hailong; Ma, Enling; Su, Qingxia; Cheng, Fang; Hong, Jinhua; Zhang, Yuanjuan; Lei, Cheng; Wang, Xinchuan; Jin, Aiyun; Liu, Wanli

2017-09-11

This pilot exploratory study aimed to compare the health-related quality of life (HRQOL) among patients diagnosed with different types of cancer receiving peripherally inserted central catheters (PICCs). A multicenter cross-section study of cancer patients with PICCs was performed from February 1, 2013 to April 24, 2014. The primary objective of this study was to compare HRQOL in different cancer type patients with PICC. HRQOL was examined based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30). Multiple linear regression models were conducted for coping with potential confounding variables. We also examined PICC-related quality of daily life with a self-made questionnaire. Three hundred and fifty-seven cancer patients with PICC completed the survey in nine teaching hospitals. Lung cancer patients with PICC reported the worst dyspnea. Digestive tract cancer patients reported the worst appetite loss. Patients with hematologic malignancy reported the worst emotional, social function, fatigue and financial impact. Breast cancer patients reported better HRQOL. Baseline variables were proven not significant predictors of EORTC QLQ-C30 global health status. In self-made survey, pain after PICC insertion was null or a little in 98.6% of cancer patients. Limitation of upper extremity activity was null or a little in 94.1% of patients. HRQOL varies in different types of cancer patients with PICC. PICC may have a low impact on cancer patients' HRQOL. Further large sample studies are needed.

Assessment of radiation-induced xerostomia: validation of the Italian version of the xerostomia questionnaire in head and neck cancer patients.

PubMed

Pellegrino, Federica; Groff, Elena; Bastiani, Luca; Fattori, Bruno; Sotti, Guido

2015-04-01

Xerostomia is the most common acute and late side effect of radiation treatment for head and neck cancer. Affecting taste perception, chewing, swallowing and speech, xerostomia is also the major cause of decreased quality of life. The aims of this study were to validate the Italian translation of the self-reported eight-item xerostomia questionnaire (XQ) and determine its psychometric properties in patients treated with radiotherapy for head and neck cancer. An observational cross-sectional study was conducted in the Radiotherapy Unit of the Veneto Institute of Oncology - IOV in Padua. The XQ was translated according to international guidelines and filled out by 102 patients. Construct validity was assessed using principal component analysis, internal consistency using Cronbach's α coefficient and test-retest reliability at 1-month interval using the intraclass correlation coefficient (ICC). Criterion-related validity was evaluated to compare the Italian version of XQ with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire (QLQ-C30) and its Head and Neck Cancer Module (QLQ-H&N35). Cronbach's α for the Italian version of XQ was strong at α = 0.93, test-retest reliability was also strong (0.79) and factor analysis confirmed that the questionnaire was one-dimensional. Criterion-related validity was excellent with high association with the EORTC QLQ-H&N35 xerostomia and sticky saliva scales. The Italian version of XQ has excellent psychometric properties and can be used to evaluate the impact of emerging radiation delivery techniques aiming at preventing xerostomia.

Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

PubMed

Winstanley, Julie B; Young, Teresa E; Boyle, Frances M; Bergenmar, Mia; Bottomley, Andrew; Burmeister, Bryan; Campana, Luca G; Garioch, Jennifer J; King, Madeleine; Nikolic, Dejan V; van de Poll-Franse, Lonneke V; Saw, Robyn; Thompson, John F; White, Edward G

2015-02-01

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

Health-Related Quality of Life in Elderly Patients With Newly Diagnosed Glioblastoma Treated With Short-Course Radiation Therapy Plus Concomitant and Adjuvant Temozolomide

DOE Office of Scientific and Technical Information (OSTI.GOV)

Minniti, Giuseppe, E-mail: gminniti@ospedalesantandrea.it; Department of Neurological Sciences, Neuromed Institute, Pozzilli; Scaringi, Claudia

2013-06-01

Purpose: To describe the quality of life (QOL) in elderly patients with glioblastoma (GBM) treated with an abbreviated course of radiation therapy (RT; 40 Gy in 15 fractions) plus concomitant and adjuvant temozolomide (TMZ). Methods and Materials: Health-related QOL (HRQOL) was assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30, version 3) and EORTC Quality of Life Questionnaire Brain Cancer Module (QLQ-BN20). Changes from baseline in the score of 9 preselected domains (global QLQ, social functioning, cognitive functioning, emotional functioning, physical functioning, motor dysfunction, communication deficit, fatigue, insomnia) were determined 4 weeksmore » after RT and thereafter every 8 weeks during the treatment until disease progression. The proportion of patients with improved HRQOL scores, defined as a change of 10 points or more, and duration of changes were recorded. Results: Sixty-five patients completed the questionnaires at baseline. The treatment was consistently associated with improvement or stability in most of the preselected HRQOL domains. Global health improved over time; mean score differed by 9.6 points between baseline and 6-month follow-up (P=.03). For social functioning and cognitive functioning, mean scores improved over time, with a maximum difference of 10.4 points and 9.5 points between baseline and 6-month follow-up (P=.01 and P=.02), respectively. By contrast, fatigue worsened over time, with a difference in mean score of 5.6 points between baseline and 4-month follow-up (P=.02). Conclusions: A short course of RT in combination with TMZ in elderly patients with GBM was associated with survival benefit without a negative effect on HRQOL until the time of disease progression.« less

[Principles of direct surgical procedures on the pancreas in surgical treatment of chronic pancreatitis].

PubMed

Kopchak, V M; Khomiak, I V; Cheverdiuk, D A; Kopchak, K V; Duvalko, A V; Serdiuk, V P

2012-01-01

An analysis of treatment of 584 patients with complicated forms of chronic pancreatitis operated during 2000-2100 years was carried out. Quality of life of postoperative patients was estimated according to a technique of calculations of modules EORTC QLQ-C30 and EORTC QLQ-PAN26. The indicators of quality of life have improved by 19.7% in performance of saving duodenal outflow of operations of pancreatic juice. Change of the surgical strategy has led to decreased number of postoperative complications by 4.6% and to satisfactory long-term results in 92.6% of the patients.

Quality of life in patients after total pancreatectomy is comparable with quality of life in patients who undergo a partial pancreatic resection.

PubMed

Epelboym, Irene; Winner, Megan; DiNorcia, Joseph; Lee, Minna K; Lee, James A; Schrope, Beth; Chabot, John A; Allendorf, John D

2014-03-01

Quality of life after total pancreatectomy (TP) is perceived to be poor secondary to insulin-dependent diabetes and pancreatic insufficiency. As a result, surgeons may be reluctant to offer TP for benign and premalignant pancreatic diseases. We retrospectively reviewed presenting features, operative characteristics, and postoperative outcomes of all patients who underwent TP at our institution. Quality of life was assessed using institutional questionnaires and validated general, pancreatic disease-related, and diabetes-related instruments (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30 and module EORTC-PAN26], Audit of Diabetes Dependent Quality of Life), and compared with frequency-matched controls, patients after a pancreaticoduodenectomy (PD). Continuous variables were compared using Student t-test or analysis of variance. Categorical variables were compared using χ(2) or Fisher exact test. Between 1994 and 2011, 77 TPs were performed. Overall morbidity was 49%, but only 15.8% patients experienced a major complication. Perioperative mortality was 2.6%. Comparing 17 TP and 14 PD patients who returned surveys, there were no statistically significant differences in quality of life in global health, functional status, or symptom domains of EORTC QLQ-C30 or in pancreatic disease-specific EORTC-PAN26. TP patients had slightly but not significantly higher incidence of hypoglycemic events as compared with PD patients with postoperative diabetes. A negative impact of diabetes assessed by Audit of Diabetes Dependent Quality of Life did not differ between TP and PD. Life domains most negatively impacted by diabetes involved travel and physical activity, whereas self-confidence, friendships and personal relationships, motivation, and feelings about the future remained unaffected. Although TP-induced diabetes negatively impacts select activities and functions, overall quality of life is comparable with that of patients who undergo a partial pancreatic resection. Copyright © 2014. Published by Elsevier Inc.

Item response theory and factor analysis as a mean to characterize occurrence of response shift in a longitudinal quality of life study in breast cancer patients

PubMed Central

2014-01-01

Background The occurrence of response shift (RS) in longitudinal health-related quality of life (HRQoL) studies, reflecting patient adaptation to disease, has already been demonstrated. Several methods have been developed to detect the three different types of response shift (RS), i.e. recalibration RS, 2) reprioritization RS, and 3) reconceptualization RS. We investigated two complementary methods that characterize the occurrence of RS: factor analysis, comprising Principal Component Analysis (PCA) and Multiple Correspondence Analysis (MCA), and a method of Item Response Theory (IRT). Methods Breast cancer patients (n = 381) completed the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, immediately following surgery, and three and six months after surgery, according to the “then-test/post-test” design. Recalibration was explored using MCA and a model of IRT, called the Linear Logistic Model with Relaxed Assumptions (LLRA) using the then-test method. Principal Component Analysis (PCA) was used to explore reconceptualization and reprioritization. Results MCA highlighted the main profiles of recalibration: patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa. The LLRA model indicated a downward or upward recalibration for each dimension. At six months, the recalibration effect was statistically significant for 11/22 dimensions of the QLQ-C30 and BR23 according to the LLRA model (p ≤ 0.001). Regarding the QLQ-C30, PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales. Conclusions Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS. MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS. PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS. PMID:24606836

Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach.

PubMed

Koller, Michael; Aaronson, Neil K; Blazeby, Jane; Bottomley, Andrew; Dewolf, Linda; Fayers, Peter; Johnson, Colin; Ramage, John; Scott, Neil; West, Karen

2007-08-01

The European Organisation for Research and Treatment of Cancer quality of life (EORTC QL) questionnaires are used in international trials and therefore standardised translation procedures are required. This report summarises the EORTC translation procedure, recent accomplishments and challenges. Translations follow a forward-backward procedure, independently carried out by two native-speakers of the target language. Discrepancies are arbitrated by a third consultant, and solutions are reached by consensus. Translated questionnaires undergo a pilot-testing. Suggestions are incorporated into the final questionnaire. Requests for translations originate from the module developers, physicians or pharmaceutical industry, and most translations are performed by professional translators. The translation procedure is managed and supervised by a Translation Coordinator within the EORTC QL Unit in Brussels. To date, the EORTC QLQ-C30 has been translated and validated into more than 60 languages, with further translations in progress. Translations include all major Western, and many African and Asian languages. The following translation problems were encountered: lack of expressions for specific symptoms in various languages, the use of old-fashioned language, recent spelling reforms in several European countries and different priorities of social issues between Western and Eastern cultures. The EORTC measurement system is now registered for use in over 9000 clinical trials worldwide. The EORTC provides strong infrastructure and quality control to produce robust translated questionnaires. Nevertheless, translation problems have been identified. The key to improvements may lie in the particular features and strengths of the group, consisting of researchers from 21 countries representing 25 languages and include the development of simple source versions, the use of advanced computerised tools, rigorous pilot-testing, certification procedures and insights from a unique cross-cultural database of nearly 40,000 questionnaire responses.

The association of quality of life with potentially remediable disruptions of circadian sleep/activity rhythms in patients with advanced lung cancer.

PubMed

Grutsch, James F; Ferrans, Carol; Wood, Patricia A; Du-Quiton, Jovelyn; Quiton, Dinah Faith T; Reynolds, Justin L; Ansell, Christine M; Oh, Eun Young; Daehler, Mary Ann; Levin, Robert D; Braun, Donald P; Gupta, Digant; Lis, Christopher G; Hrushesky, William J M

2011-05-23

Cancer patients routinely develop symptoms consistent with profound circadian disruption, which causes circadian disruption diminished quality of life. This study was initiated to determine the relationship between the severity of potentially remediable cancer-associated circadian disruption and quality of life among patients with advanced lung cancer. We concurrently investigated the relationship between the circadian rhythms of 84 advanced lung cancer patients and their quality of life outcomes as measured by the EORTC QLQ C30 and Ferrans and Powers QLI. The robustness and stability of activity/sleep circadian daily rhythms were measured by actigraphy. Fifty three of the patients in the study were starting their definitive therapy following diagnosis and thirty one patients were beginning second-line therapy. Among the patients who failed prior therapy, the median time between completing definitive therapy and baseline actigraphy was 4.3 months, (interquartile range 2.1 to 9.8 months). We found that circadian disruption is universal and severe among these patients compared to non-cancer-bearing individuals. We found that each of these patient's EORTC QLQ C30 domain scores revealed a compromised capacity to perform the routine activities of daily life. The severity of several, but not all, EORTC QLQ C30 symptom items correlate strongly with the degree of individual circadian disruption. In addition, the scores of all four Ferrans/Powers QLI domains correlate strongly with the degree of circadian disruption. Although Ferrans/Powers QLI domain scores show that cancer and its treatment spared these patients' emotional and psychological health, the QLI Health/Function domain score revealed high levels of patients' dissatisfaction with their health which is much worse when circadian disruption is severe. Circadian disruption selectively affects specific Quality of Life domains, such as the Ferrans/Powers Health/Function domain, and not others, such as EORTC QLQ C30 Physical Domain. These data suggest the testable possibility that behavioral, hormonal and/or light-based strategies to improve circadian organization may help patients suffering from advanced lung cancer to feel and function better.

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

PubMed

Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

The equivalence and difference between the English and Chinese versions of two major, cancer-specific, health-related quality-of-life questionnaires.

PubMed

Cheung, Yin-Bun; Thumboo, Julian; Goh, Cynthia; Khoo, Kei-Siong; Che, William; Wee, Joseph

2004-12-15

English and Chinese are two of the most widely used primary languages in the world. Patients in many cancer centers have a variety of ethnic backgrounds and primary languages. The comparability of version 4 of the English and Chinese versions of the Functional Assessment of Cancer Therapy-General (FACT-G) and version 3 of the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) have not been established. In total, 1136 ethnic Chinese patients with cancer were recruited from the National Cancer Centre of Singapore. Patients chose to answer an English or Chinese questionnaire, according to their own preference. Multiple regression analysis was used to adjust for differences in demographic and health characteristics. Equivalence was confirmed if the 90% confidence intervals of the adjusted mean difference fell completely within an equivalence zone of +/- 0.25 standard deviations (SD). The English and Chinese versions of the Total, Emotional, and Functional Well Being Scales of the FACT-G and the Physical and Emotional Functioning Scales of the EORTC QLQ-C30 were equivalent. Scores for the other scales on the two questionnaires, at most, had a small differences that did not exceed 0.5 SD. Nevertheless, the Chinese translation of the question "I have a lack of energy" in the Physical Well Being Scale of the FACT-G produced results that differed from the results produced by the original English version. Data collected from English-speaking and Chinese-speaking respondents were capable of being pooled, and either version could be used for bilingual respondents. Nevertheless, the authors recommend modification of the Physical Well Being question that produced different results ("I have a lack of energy").

Clinical benefit of eculizumab in patients with no transfusion history in the International Paroxysmal Nocturnal Haemoglobinuria Registry.

PubMed

Almeida, Antonio M; Bedrosian, Camille; Cole, Alexander; Muus, Petra; Schrezenmeier, Hubert; Szer, Jeff; Rosse, Wendell F

2017-09-01

Eculizumab reduces intravascular haemolysis and improves disease symptoms in patients with paroxysmal nocturnal haemoglobinuria (PNH). To characterise, in a real-world setting, the effect of eculizumab in patients with haemolytic PNH (lactase dehydrogenase (LDH) ≥ 1.5 upper limit of normal) and no history of red blood cell transfusion, including those with high disease activity (HDA). Three populations from the International PNH Registry were studied: (i) non-transfused, untreated; (ii) non-transfused, eculizumab-treated and (iii) transfused, eculizumab-treated (≥1 transfusions in 6 months prior to eculizumab initiation). Using multivariate linear regression, the primary outcome was mean absolute change from baseline to 6 months in LDH (U/L) in non-transfused patients who were treated with eculizumab versus those who remained untreated. Secondary outcomes were mean changes in functional assessment of chronic illness therapy (FACIT)-Fatigue and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30 Fatigue scores from baseline to last available assessment. The study population included (i) 144 non-transfused, untreated patients; (ii) 45 non-transfused, eculizumab-treated patients and (iii) 105 transfused, eculizumab-treated patients. Of these, 136/144, 43/45 and 99/105 had HDA respectively. Compared with untreated patients, non-transfused, treated patients had greater absolute reduction in LDH (-1318.8 vs -39.4; P < 0.001) and greater percentage reduction in LDH (-69.9 vs -1.6%; P < 0.001). Clinically meaningful improvements in FACIT-Fatigue (73.7 vs 24.6%, respectively) and in EORTC-QLQ-C30 (84.2 vs 33.3%, respectively) were observed. Non-transfused, treated patients with HDA had significantly reduced LDH levels (P < 0.001) and clinically meaningful improvements in FACIT-Fatigue (P = 0.003) and EORTC-QLQ-C30 (P = 0.020) versus untreated patients. Significant LDH reduction and clinically meaningful improvement in fatigue were observed in patients with PNH and HDA treated with eculizumab versus untreated patients, irrespective of transfusion history. © 2017 Royal Australasian College of Physicians.

International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15.

PubMed

Hjermstad, Marianne J; Bergenmar, Mia; Bjordal, Kristin; Fisher, Sheila E; Hofmeister, Dirk; Montel, Sébastien; Nicolatou-Galitis, Ourania; Pinto, Monica; Raber-Durlacher, Judith; Singer, Susanne; Tomaszewska, Iwona M; Tomaszewski, Krzysztof A; Verdonck-de Leeuw, Irma; Yarom, Noam; Winstanley, Julie B; Herlofson, Bente B

2016-09-01

This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients. The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test-retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks. Five hundred seventy-two patients (median age 60.3, 54 % females) were analyzed. Completion took <10 min for 84 %, 40 % expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight-item scale named OH-QoL score, a two-item information scale, a two-item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink). Face and convergent validity and internal consistency were confirmed. Test-retest reliability (n = 60) was demonstrated as was RCA for patients undergoing chemotherapy (n = 117; p = 0.06). The resulting QLQ-OH15 discriminated between clinically distinct patient groups, e.g., low performance status vs. higher (p < 000.1), and head-and-neck cancer versus other cancers (p < 0.03). The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management. ClinicalTrials.gov Identifier: NCT01724333.

Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma.

PubMed

Petrella, Teresa M; Robert, Caroline; Richtig, Erika; Miller, Wilson H; Masucci, Giuseppe V; Walpole, Euan; Lebbe, Celeste; Steven, Neil; Middleton, Mark R; Hille, Darcy; Zhou, Wei; Ibrahim, Nageatte; Cebon, Jonathan

2017-11-01

Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma. Patients received pembrolizumab 10 mg/kg every 2 (Q2W) or every 3 weeks (Q3W) for up to 2 years, or four cycles of ipilimumab 3 mg/kg Q3W. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was administered at baseline and throughout the study. Patient-reported outcome (PRO) analyses were pre-specified exploratory endpoints; the primary PRO assessment was the score change from baseline to week 12 in EORTC QLQ-C30 global health status (GHS)/HRQoL score between the arms using constrained longitudinal data analysis. The PRO analysis population included 776 patients: pembrolizumab Q2W (n = 270); pembrolizumab Q3W (n = 266); ipilimumab (n = 240). Baseline GHS was similar across arms. QLQ-C30 compliance rates at week 12 were 87% (n = 214), 97% (n = 226), and 96% (n = 178), for the pembrolizumab Q2W, pembrolizumab Q3W, and ipilimumab arms, respectively. From baseline to week 12, GHS/HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of -1.9 and -2.5 for pembrolizumab versus -10.0 for ipilimumab; p < 0.001 for each pembrolizumab arm versus ipilimumab). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31% for pembrolizumab Q2W; 29% for Q3W and 44% for ipilimumab), with similar trends observed for individual functioning and symptoms scales. HRQoL was better maintained with pembrolizumab than with ipilimumab in patients with ipilimumab-naive advanced melanoma. CLINICALTRIALS. NCT01866319. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

[Quality of life after extensive pelvic surgery].

PubMed

Levý, M; Lipská, L; Visokai, V; Šimša, J

Multiorgan resections in the small pelvis are standard procedures in oncosurgery and some indications have no alternative. In advanced pelvic cancer, pelvic exenteration with en bloc resection of the involved organs and structures, including portions of the bony pelvis, is indicated. The 5-year survival rate is fairly good, around 50%, but little is known about the long-term quality of life. The aim was to describe the quality of life of long-term total pelvic exenteration survivors. In total, 63 pelvic exenterations were performed between 2000 to 2015 at the Department of Surgery, Thomayer Hospital, First Faculty of Medicine, Charles University in Prague, mostly for primary or relapsed rectal cancer. In this retrospective cohort study, the quality of life was assessed using the EORTC QLQ-C30 (version 3.0) and the EORTC QLQ-CR29 questionnaires. The completed questionnaires were scored according to EORTC instructions. At the time of this survey, 24 patients after TPE were surviving longer than one year after the surgery. The five-year survival of all patients was 49%, median survival 4.6 years, and median follow-up 15 months. Most of our patients reported a good level of their physical, emotional, cognitive and social functions. Some patients reported a worse body image, and of course a worsening in their sexual life. Regarding symptom-oriented questions, some patients evaluated the necessity of more frequent care of the stomia as slightly problematic; most patients reported impotence (men) or painful sexual intercourse (women). Long-term quality of life in survivors of pelvic exenteration for rectal cancer is comparable with reported results following primary rectal cancer resection with the exception of the sexual function. The quality of life gradually improves in the course of weeks to months from the surgery. pelvic exenteration quality of life.

Dutch validation of the low anterior resection syndrome score.

PubMed

Hupkens, B J P; Breukink, S O; Olde Reuver Of Briel, C; Tanis, P J; de Noo, M E; van Duijvendijk, P; van Westreenen, H L; Dekker, J W T; Chen, T Y T; Juul, T

2018-04-21

The aim of this study was to validate the Dutch translation of the low anterior resection syndrome (LARS) score in a population of Dutch rectal cancer patients. Patients who underwent surgery for rectal cancer received the LARS score questionnaire, a single quality of life (QoL) category question and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. A subgroup of patients received the LARS score twice to assess the test-retest reliability. A total of 165 patients were included in the analysis, identified in six Dutch centres. The response rate was 62.0%. The percentage of patients who reported 'major LARS' was 59.4%. There was a high proportion of patients with a perfect or moderate fit between the QoL category question and the LARS score, showing a good convergent validity. The LARS score was able to discriminate between patients with or without neoadjuvant radiotherapy (P = 0.003), between total and partial mesorectal excision (P = 0.008) and between age groups (P = 0.039). There was a statistically significant association between a higher LARS score and an impaired function on the global QoL subscale and the physical, role, emotional and social functioning subscales of the EORTC QLQ-C30 questionnaire. The test-retest reliability of the LARS score was good, with an interclass correlation coefficient of 0.79. The good psychometric properties of the Dutch version of the LARS score are comparable overall to the earlier validations in other countries. Therefore, the Dutch translation can be considered to be a valid tool for assessing LARS in Dutch rectal cancer patients. Colorectal Disease © 2018 The Association of Coloproctology of Great Britain and Ireland.

Association of social support, functional status, and psychological variables with changes in health-related quality of life outcomes in patients with colorectal cancer.

PubMed

Gonzalez-Saenz de Tejada, M; Bilbao, A; Baré, M; Briones, E; Sarasqueta, C; Quintana, J M; Escobar, A

2016-08-01

The aim of this study was to explore the association of social support received, and functional and psychological status of colorectal cancer patients before surgery with changes in health-related quality of life (HRQoL) outcomes measured by EORTC QLQ-C30 at 1-year post-intervention. Consecutive patients that were because of undergo therapeutic surgery for the first time for colon or rectum cancer in nine hospitals in Spain were eligible for the study. Patients completed questionnaires before surgery and 12 months afterwards: one HRQoL instrument, the EORTC QLQ-C30; a social network and social support questionnaire, the Duke-UNC Functional Social Support Questionnaire; the Hospital Anxiety and Depression Scale, to assess anxiety and depression; and the Barthel Index, to assess functional status; as well as questions about sociodemographic information. General linear models were built to explore the association of social support, functional status, and psychological variables with changes in HRQoL 12 months after intervention. A total of 972 patients with colorectal cancer took part in the study. Patients' functional status, social support, and anxiety and depression were associated with changes in at least one HRQoL domain. The higher functional status, and the higher social support, the more they improved in HRQoL domains. Regarding anxiety and depression, the more anxiety and depression patients have at baseline, less they improve in HRQoL domains. Patients with colorectal cancer who have more social support and no psychological distress may have better results in HRQoL domains at 1 year after surgery. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Relationship between anxiety disorders and domains of health related quality of life among Nigerians with breast cancer.

PubMed

Fatiregun, Olamijulo Adedeji; Olagunju, Andrew Toyin; Erinfolami, Adebayo Rasheed; Arogunmati, Olubunmi Ayodele; Fatiregun, Omolara Amina; Adeyemi, Joseph Dada

2017-02-01

Health Related Quality of life (HRQoL) is increasingly recognised as an important indicator of outcome and well-being in oncology care. We set out in this study to evaluate whether significant association exists between anxiety disorders (ADs) and HRQoL in breast cancer, such that any intervention addressing ADs would potentially improve HRQoL. A cross sectional evaluation of 200 attendees of an oncology clinic was done using designed questionnaire to gather socio-demographic and clinical data. Subsequently, the Schedule for clinical Assessment in Neuropsychiatry was used to ascertain ADs and the European Organization for Research and Treatment of Cancer QOL Questionnaire (THE EORTC QLQ-C30) Version 3 with its breast specific supplement (QLQ-BR-23) was used to profile HRQoL in participants. The mean age of participants was 49.6(±11.2) years, and 54% of participants had stage III and IV breast cancer. Findings on EORTC QLQ-C30 following univariate analyses showed association between ADs and poorer mean scores on global health status, functional domains including physical, emotional, social, and cognitive functions (p < 0.05). On the symptom scale, those with ADs had higher symptom load including fatigue, pain, insomnia, appetite loss, diarrhoea and financial difficulties (p < 0.05). Similarly, the QLQ-BR-23 showed correlation between ADs and poorer mean scores on breast cancer specific issues like body image, future perspectives, sexual functioning, sexual enjoyment, systemic therapy side-effects, upset by hair loss and breast symptoms (p < 0.05). Findings after controlling for age, treatment, cancer duration, recurrence and stage showed the same pattern of relationship between ADs and HRQoL; however, the global health status, cognition, sexual functioning, and higher symptom load with respect to appetite loss and financial difficulties were not independently related with ADs. Scaling up of oncological services, supportive care and targeted psychosocial interventions are indicated for optimal outcome of breast cancer. Longitudinal research with focus on the complex relationship between HRQoL and ADs along with their modifiable determinants across the trajectories of breast cancer is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

MS-20, a chemotherapeutical adjuvant, reduces chemo-associated fatigue and appetite loss in cancer patients.

PubMed

Chi, Kwan-Hwa; Chiou, Tzeon-Jye; Li, Chung-Pin; Chen, Sheng-Yu; Chao, Yee

2014-01-01

A small pilot study of the fermented soybean extract MicrSoy-20(MS-20) demonstrated its ability to restore chemotherapy-induced immunosuppression and improve quality of life (QoL). This randomized, cross-over, comparative trial was conducted to confirm the effects of MS-20 on QoL and to understand its underlying mechanism when used in conjunction with chemotherapy. One hundred forty-three patients undergoing cancer chemotherapy were randomly assigned to 2 groups. Group 1 was administered MS-20 for 1 wk followed by 3 wk of concomitant MS-20 plus chemotherapy. Group 2 was administered chemotherapy for 3 wk. QoL was assessed by the EORTC/QLQ-C30 questionnaire and visual analogue scales (VAS). Changes in immunological parameters and antioxidant profiles were also examined. Significant increases were observed in EORTC/QLQ-C30 scores for physical (4.45, P = 0.023) and social (3.99, P = 0.023) functioning in Group 1 patients compared to Group 2 patients. VAS scores for fatigue and appetite loss significantly improved with MS-20 treatment (P < 0.001). Group 1 patients exhibited smaller decreases in peripheral blood mononuclear cells compared to Group 2 patients (P = 0.026). Other immunological parameters, antioxidant, and safety profiles were not significantly different between treatment groups. Addition of MS-20 as an adjuvant to chemotherapy can be effective in improving QoL for cancer patients.

Validation of the German prostate-specific module.

PubMed

Bestmann, Beate; Rohde, Volker; Siebmann, Jens-Ulrich; Galalae, Razvan; Weidner, Wolfgang; Küchler, Thomas

2006-02-01

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Does awareness of diagnosis influence health related quality of life in north Indian patients with lung cancer ?

PubMed

Aggarwal, Ashutosh Nath; Singh, Navneet; Gupta, Dheeraj; Behera, Digambar

2016-05-01

Several patients with cancer in India are not aware of their diagnosis. We evaluated the impact of awareness of cancer diagnosis on health-related quality of life (HRQL) in newly diagnosed patients with lung cancer. A total of 391 treatment-naïve patients with lung cancer, seen at the Lung Cancer Clinic of a tertiary care hospital in north India, were categorized into those aware of their diagnosis (group A) and those not aware (group B). All patients answered Hindi versions of abbreviated World Health Organization Quality of Life questionnaire (WHOQOL-Bref) and European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), and its lung cancer module, EORTC QLQ-LC13. Various domain scores were computed and compared between the two groups. Analysis of covariance was used to determine significance of differences after adjustment for potential confounding factors. Only 117 (29.9%) patients were aware of their diagnosis. Of all, 302 (77.2%) patients had non-small cell lung cancer, and 301 (77.0%) had advanced disease. All HRQL domain scores were similar between the two groups, except that group B patients had significantly poorer median (interquartile range) Physical [39.3 (28.6-50.0) vs 46.4 (28.6-57.1)] and Environment [46.9 (40.6-56.3) vs 53.1 (0.6-65.6)] domain scores of WHOQOL-Bref, and p0 hysical function [60.0 (40.0-73.3) vs 66.7 (46.7-80.0)] and Fatigue [66.7 (55.6-77.8) vs 66.7 (44.4-66.7)] scores of QLQ-C30. After adjusting for gender, age, education, family income, and tumour extent, these differences were not significant. Disclosure of cancer diagnosis, or lack of it, had no significant impact on HRQL in patients with lung cancer after adjustment of potential confounders.

Health-related quality of life and psychological distress among cancer survivors in a middle-income country.

PubMed

Subramaniam, Shridevi; Kong, Yek-Ching; Chinna, Karuthan; Kimman, Merel; Ho, Yan-Zheng; Saat, Nadiah; Abdul Malik, Rozita; Taib, Nur Aishah; Abdullah, Matin Mellor; Chin-Chye Lim, Gerard; Ibrahim Tamin, Nor-Saleha; Woo, Yin-Ling; Chang, Kian-Meng; Goh, Pik-Pin; Yip, Cheng-Har; Bhoo-Pathy, Nirmala

2018-06-01

Quality of life and psychological well-being are important patient-centered outcomes, which are useful in evaluation of cancer care delivery. However, evidence from low- and middle-income countries remains scarce. We assessed health-related quality of life (HRQoL) and prevalence of psychological distress (anxiety or depression), as well as their predictors, among cancer survivors in a middle-income setting. Through the ASEAN Costs in Oncology study, 1490 newly-diagnosed cancer patients were followed-up in Malaysia for one year. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EuroQol-5 (EQ-5D) dimensions questionnaires at baseline, 3 months and 12 months. Psychological distress was assessed using Hospital Anxiety and Depression Scale. Data were modeled using general linear and logistic regressions analyses. One year after diagnosis, the mean EORTC QLQ-C30 Global Health score of the cancer survivors remained low at 53.0 over 100 (SD 21.4). Fifty-four percent of survivors reported at least moderate levels of anxiety while 27% had at least moderate levels of depression. Late stage at diagnosis was the strongest predictor of low HRQoL. Increasing age, being married, high-income status, hospital type, presence of comorbidities, and chemotherapy administration were also associated with worse HRQoL. The significant predictors of psychological distress were cancer stage and hospital type. Cancer survivors in this middle-income setting have persistently impaired HRQoL and high levels of psychological distress. Development of a holistic cancer survivorship program addressing wider aspects of well-being is urgently needed in our settings. This article is protected by copyright. All rights reserved.

Validation of the M. D. Anderson Symptom Inventory multiple myeloma module

PubMed Central

2013-01-01

Background The symptom burden associated with multiple myeloma (MM) is often severe. Presently, no instrument comprehensively assesses disease-related and treatment-related symptoms in patients with MM. We sought to validate a module of the M. D. Anderson Symptom Inventory (MDASI) developed specifically for patients with MM (MDASI-MM). Methods The MDASI-MM was developed with clinician input, cognitive debriefing, and literature review, and administered to 132 patients undergoing induction chemotherapy or stem cell transplantation. We demonstrated the MDASI-MM’s reliability (Cronbach α values); criterion validity (item and subscale correlations between the MDASI-MM and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC MM module (QLQ-MY20)), and construct validity (differences between groups by performance status). Ratings from transplant patients were examined to demonstrate the MDASI-MM’s sensitivity in detecting the acute worsening of symptoms post-transplantation. Results The MDASI-MM demonstrated excellent correlations with subscales of the 2 EORTC instruments, strong ability to distinguish clinically different patient groups, high sensitivity in detecting change in patients’ performance status, and high reliability. Cognitive debriefing confirmed that the MDASI-MM encompasses the breadth of symptoms relevant to patients with MM. Conclusion The MDASI-MM is a valid, reliable, comprehensive-yet-concise tool that is recommended as a uniform symptom assessment instrument for patients with MM. PMID:23384030

Uncaria tomentosa (cat's claw) improves quality of life in patients with advanced solid tumors.

PubMed

de Paula, Larissa Carvalho Lopes; Fonseca, Fernando; Perazzo, Fabio; Cruz, Felipe Melo; Cubero, Daniel; Trufelli, Damila Cristina; Martins, Suelen Patrícia Dos Santos; Santi, Patrícia Xavier; da Silva, Eliana Araújo; Del Giglio, Auro

2015-01-01

Cat's claw (Uncaria tomentosa) is a native Amazon plant that exhibits anti-inflammatory and antitumor properties. We wanted to assess its activity for symptom management of terminal cancer patients. This prospective phase II study assessed the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day in patients with advanced solid tumors who had no further therapeutic options and a life expectancy of at least 2 months. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and Functional Assessment of Chronic Illness Therapy - Fatigue questionnaires were used to assess the participants' quality of life, the Hospital Anxiety and Depression Scale questionnaire was used to assess anxiety and depression, and the Pittsburgh Sleep Quality Index was used to assess sleep quality. In addition, several biochemical and inflammatory parameters were analyzed. Fifty-one volunteers were recruited. Their median age was 64 (range, 33-85) years, and 47% of patients were female. More than 65% of patients had scores on the Karnofsky Performance Scale of 80% or less. Treatment improved the patients' overall quality of life (p=0.0411) and social functioning (p=0.0341), as assessed by the EORTC QLQ C-30, and reduced fatigue (p=0.0496) according to the Chalder Fatigue Questionnaire. None of the biochemical or inflammatory parameters assessed (interleukin-1 and -6, C-reactive protein, tumor necrosis factor-α, erythrocyte sedimentation rate, and α-1-acid glycoprotein) changed significantly. No tumor response was detected according to the Response Evaluation Criteria In Solid Tumors; however, the disease stabilized for more than 8 months in four participants. The medication was well tolerated by most patients. Use of cat's claw might be beneficial in patients with advanced cancer by improving their quality of life and reducing fatigue. The mechanism of action does not seem to be related to the anti-inflammatory properties of this plant.

A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A.

2013-12-01

Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, versionmore » 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment.« less

EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries.

PubMed

Arraras, Juan Ignacio; Wintner, Lisa M; Sztankay, Monika; Tomaszewski, Krzysztof A; Hofmeister, Dirk; Costantini, Anna; Bredart, Anne; Young, Teresa; Kuljanic, Karin; Tomaszewska, Iwona M; Kontogianni, Meropi; Chie, Wei-Chu; Kulis, Dagmara; Greimel, Eva

2017-05-01

Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Assessment of quality of life of nasopharyngeal carcinoma patients with EORTC QLQ-C30 and H and N-35 modules

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cengiz, Mustafa; Ozyar, Enis; Esassolak, Mustafa

2005-12-01

Purpose: The current study reports on long-term quality of life (QoL) status after conventional radiotherapy in 187 nasopharyngeal carcinoma patients from 14 centers in Turkey. Patients and Methods: Patients with the diagnosis of nasopharyngeal carcinoma, who were treated in 14 centers in Turkey with minimum 6 months of follow-up and were in complete remission, were asked to complete Turkish versions of EORTC QLQ-C30 questionnaire and the HN-35 module. Each center participated with the required clinical data that included age at diagnosis, gender, symptoms on admission, follow-up period, treatment modalities, radiotherapy dose, and AJCC 1997 tumor stage. Each patient's 33 QoLmore » scores, which included function, global health status, and symptoms, were calculated as instructed in EORTC QLQ-C30 scoring manual. All of the scales and single-item measures range from 0 to 100. A high score represents a higher response level. Kruskal-Wallis and Mann-Whitney U nonparametric tests were used for comparisons. Results: One hundred eighty-seven patients with median age of 46 years (range, 16-79 years) participated and completed the questionnaires. Median follow-up time was 3.4 years (range, 6 months-24 years). All patients have received external-beam radiotherapy. Beside external-beam radiotherapy, 59 patients underwent brachytherapy boost, 70 patients received concomitant chemotherapy, and 95 patients received adjuvant/neoadjuvant chemotherapy. Most of the patients in the analysis (75%) were in advanced stage (Stage III, n = 85 [45.4%]; Stage IV, n = 55 [29%]). Mean global health status was calculated as 73. Parameters that increased global health status were male gender, early-stage disease, and less than 4-year follow-up (p < 0.05). Functional parameters were better in males and in early-stage disease. Factors that yielded better symptom scores were short interval after treatment (10 scores), male gender (7 scores), and lower radiation dose (6 scores). Neoadjuvant or adjuvant chemotherapy did not have any effect on QoL, whereas concomitant chemotherapy adversely affected 5 symptom scores. Conclusion: Quality of life is adversely affected in our nasopharyngeal carcinoma patients treated with combined therapies. The factors that adversely affect quality of life are advanced tumor stage, female gender, and long-term follow-up. Further controlled studies to evaluate both preradiotherapy and postradiotherapy status are necessary to clarify the contribution of each treatment modality to QoL.« less

Psychometric characteristics of health-related quality-of-life questionnaires in oropharyngeal dysphagia.

PubMed

Timmerman, Angelique A; Speyer, Renée; Heijnen, Bas J; Klijn-Zwijnenberg, Iris R

2014-04-01

Dysphagia can have severe consequences for the patient's health, influencing health-related quality of life (HRQoL). Sound psychometric properties of HRQoL questionnaires are a precondition for assessing the impact of dysphagia, the focus of this study, resulting in recommendations for the appropriate use of these questionnaires in both clinical practice and research contexts. We performed a systematic review starting with a search for and retrieval of all full-text articles on the development of HRQoL questionnaires related to oropharyngeal dysphagia and/or their psychometric validation from the electronic databases PubMed and Embase published up to June 2011. Psychometric properties were judged according to quality criteria proposed for health status questionnaires. Eight questionnaires were included in this study. Four are aimed solely at HRQoL in oropharyngeal dysphagia: the deglutition handicap index (DHI), dysphagia handicap index (DHI'), M.D. Anderson Dysphagia Inventory (MDADI), and SWAL-QOL, while the EDGQ, EORTC QLQ-STO 22, EORTC QLQ-OG 25 and EORTC QLQ-H&N35 focus on other primary diseases resulting in dysphagia. The psychometric properties of the DHI, DHI', MDADI, and SWAL-QOL were evaluated. For appropriate applicability of HRQoL questionnaires, strong scores on the psychometric criteria face validity, criterion validity, and interpretability are prerequisites. The SWAL-QOL has the strongest ratings for these criteria, while the DHI' is the most easy to apply given its 25 items and the use of a uniform scoring format. For optimal use of HRQoL questionnaires in diverse settings, it is necessary to combine psychometric and utility approaches.

Randomized study of sequential cisplatin-topotecan/carboplatin-paclitaxel versus carboplatin-paclitaxel: effects on quality of life.

PubMed

Brotto, Lori; Brundage, Michael; Hoskins, Paul; Vergote, Ignace; Cervantes, Andres; Casado, Herraez A; Poveda, A; Eisenhauer, Elizabeth; Tu, Dongsheng

2016-03-01

A recent phase III trial compared the efficacy of cisplatin-topotecan (a topoisomerase I inhibitor) followed by carboplatin-paclitaxel (Arm 1) versus paclitaxel-carboplatin (Arm 2) in women with newly diagnosed stage IIB or greater ovarian cancer. There was a significantly lower response rate in the experimental arm compared to standard treatment, and less likelihood of normalized CA125 within the first 3 months. At 43 months follow-up, there were no significant group differences in progression-free survival. There were also significantly more side effects in the experimental arm. The current study examined quality of life (QoL) endpoints using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the ovarian cancer module, QLQ-OV28, administered prior to randomization, at day 1 of treatment cycles 3, 5, and 7, at completion of the last cycle, and at 3 and 6 months following completion of chemotherapy. Global QoL, physical symptoms, fatigue, and role, emotional, cognitive and social function (all from the EORTC QLQ-C30) significantly improved in both treatment arms, with no significant between-arm differences. Between-group differences in pain, insomnia, and peripheral neuropathy reported while on treatment did not differ at follow-up. Nausea and vomiting improved more with standard treatment both during and after treatment. Body image significantly differed between the groups only at cycle 5 (more deterioration in Arm 2) but group differences disappeared at follow-up. A stratified analysis of global QoL by debulking surgery status found no greater effect indicating that overall improvements in QoL were unrelated to surgical recovery. There was no significant QoL advantage of cisplatin-topotecan. This finding, combined with no progression-free survival conferred by this combination, reaffirms carboplatin-paclitaxel as the standard of care for women with newly diagnosed ovarian cancer.

Quality of Life among Breast Cancer Patients In Malaysia.

PubMed

Ganesh, Sri; Lye, Munn-Sann; Lau, Fen Nee

2016-01-01

Among the factors reported to determine the quality of life of breast cancer patients are socio- demographic background, clinical stage, type of treatment received, and the duration since diagnosis. The objective of this study was to determine the quality of life (QOL) scores among breast cancer patients at a Malaysian public hospital. This cross-sectional study of breast cancer patients was conducted between March to June 2013. QOL scores were determined using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer supplementary measure (QLQ-BR23). Both the QLQ-C30 and QLQ-BR23 assess items from functional and symptom scales. The QLQ-C30 in addition also measures the Global Health Status (GHS). Systematic random sampling was used to recruit patients. 223 breast cancer patients were recruited with a response rate of 92.1%. The mean age of the patients was 52.4 years (95% CI = 51.0, 53.7, SD=10.3). Majority of respondents are Malays (60.5%), followed by Chinese (19.3%), Indians (18.4%), and others (1.8%). More than 50% of respondents are at stage III and stage IV of malignancy. The mean Global Health Status was 65.7 (SD = 21.4). From the QLQ-C30, the mean score in the functioning scale was highest for 'cognitive functioning' (84.1, SD=18.0), while the mean score in the symptom scale was highest for 'financial difficulties' (40.1, SD=31.6). From the QLQ-BR23, the mean score for functioning scale was highest for 'body image' (80.0, SD=24.6) while the mean score in the symptom scale was highest for 'upset by hair loss' (36.2, SD=29.4). Two significant predictors for Global Health Status were age and employment. The predictors explained 10.6% of the variation of global health status (R2=0.106). Age and employment were found to be significant predictors for Global Health Status (GHS). The Quality of Life among breast cancer patients reflected by the GHS improves as age and employment increases.

Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

PubMed

Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

2018-02-01

The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

[Quality of life in Chilean breast cancer survivors].

PubMed

Irarrázaval, M Elisa; Kleinman, Pascale; Silva R, Fernando; Fernández González, Loreto; Torres, Camilo; Fritis, Marcela; Barriga, Carolina; Waintrub, Herman

2016-12-01

Quality of Life (QOL) assessment may evaluate the impact of diseases and their treatment on the overall well-being of patients. To assess QOL in Chilean breast cancer survivors. Ninety one female breast cancer patients aged 60 ± 10 years, who finished their oncologic treatment at least a year prior to the assessment, who were disease free and in medical follow-up were included in the study. They completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 core questionnaire and the breast cancer module QLQ-BR23. Forty eight percent of respondents were long term survivors (more than five years). Global QOL scores were high (73.6 ± 18.2), emotional scale had the lowest scores in QLQ-C30 functional scales (72.1). Symptoms with the highest scores were: Insomnia (= 21.2), pain (= 20.8), and fatigue (= 19.1). Body image, sexual function, and concern about the future were the most relevant problems. Body image was superior in patients with breast-conserving surgery (p = 0.008), and cognitive function was better in patients in early disease stage (p = 0.03) and in those with more than five years of survival (p = 0.04). Even when global QOL scores were high, some symptoms were prevalent. Awareness about these problems and symptoms should improve their diagnosis and treatment.

Quality-of-Life Priorities in Patients with Thyroid Cancer: A Multinational European Organisation for Research and Treatment of Cancer Phase I Study.

PubMed

Singer, Susanne; Husson, Olga; Tomaszewska, Iwona M; Locati, Laura D; Kiyota, Naomi; Scheidemann-Wesp, Ulrike; Hofmeister, Dirk; Winterbotham, Melanie; Brannan, Christine; Araújo, Cláudia; Gamper, Eva M; Kulis, Dagmara; Rimmele, Harald; Andry, Guy; Licitra, Lisa

2016-11-01

The objectives of this study were to determine quality of life (QoL) issues that are relevant to thyroid cancer patients cross-culturally, and to identify those with highest relevance to them in addition to the more general issues covered by the core European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). A systematic literature search provided a list of potentially relevant QoL issues to supplement the core questionnaire EORTC QLQ-C30, which is widely used in research and in care and addresses QoL issues relevant to all groups of cancer patients. A panel of experts revised this list, and thyroid cancer patients rated the issues regarding their relevance for QoL by selecting the 25 issues that they would include in a thyroid cancer-specific QoL module. The literature search and expert discussion provided a list of 71 QoL issues that was rated by thyroid cancer patients (n = 110) from seven countries. All issues were of high priority to at least some of the patients. The most frequently selected issues were sudden attacks of tiredness, exhaustion, quality of sleep, employment, social support, fear of cancer progression, fear of second operation, difficulties swallowing, and globus sensation. Thyroid cancer patients cross-culturally rate fatigue-related issues as highly important for their QoL, calling for increased efforts to find successful treatments for this problem. Vocational rehabilitation is also highly relevant for them and should therefore be an important aim of multidisciplinary care. The third important area of concern is psychological issues, especially fear of progression and of additional treatments.

A systematic review of the scales used for the measurement of cancer-related fatigue (CRF).

PubMed

Minton, O; Stone, P

2009-01-01

Fatigue in cancer is very common and can be experienced at all stages of disease and in survivors. There is no accepted definition of cancer-related fatigue (CRF) and no agreement on how it should be measured. A number of scales have been developed to quantify the phenomenon of CRF. These vary in the quality of psychometric properties, ease of administration, dimensions of CRF covered and extent of use in studies of cancer patients. This review seeks to identify the available tools for measuring CRF and to make recommendations for ongoing research into CRF. A systematic review methodology was used to identify scales that have been validated to measure CRF. The inclusion criteria required the scale to have been validated for use in cancer patients and/or widely used in this population. Scales also had to meet a minimum quality score for inclusion. The reviewers identified 14 scales that met the inclusion criteria. The most commonly used scales and best validated were the Functional Assessment of Cancer Therapy Fatigue (FACT F), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) (fatigue subscale) and the Fatigue Questionnaire (FQ). Unidimensional scales are the easiest to administer and have been most widely used. The authors recommend the use of the EORTC QLQ C30 fatigue subscale or the FACT F. The FQ gives a multidimensional assessment and has also been widely used. A substantial minority of the scales identified have not been used extensively or sufficiently validated in cancer patients and cannot be recommended for routine use without further validation.

[Computer-based quality-of-life monitoring in head and neck cancer patients: a validation model using the EORTC-QLQ C30 and EORTC- H&N35 Portuguese PC-software version].

PubMed

Silveira, Augusta; Gonçalves, Joaquim; Sequeira, Teresa; Ribeiro, Cláudia; Lopes, Carlos; Monteiro, Eurico; Pimentel, Francisco Luís

2011-12-01

Quality of Life is a distinct and important emerging health focus, guiding practice and research. The routine Quality of Life evaluation in clinical, economic, and epidemiological studies and in medical practice promises a better Quality of Life and improved health resources optimization. The use of information technology and a Knowledge Management System related to Quality of Life assessment is essential to routine clinical evaluation and can define a clinical research methodology that is more efficient and better organized. In this paper, a Validation Model using the Quality of Life informatics platform is presented. Portuguese PC-software using European Organization for Research and Treatment of Cancer questionnaires (EORTC-QLQ C30 and EORTC-H&N35), is compared with the original paper-pen approach in the Quality of Life monitoring of head and neck cancer patients. The Quality of Life informatics platform was designed specifically for this study with a simple and intuitive interface that ensures confidentiality while providing Quality of Life evaluation for all cancer patients. For the Validation Model, the sample selection was random. Fifty-four head and neck cancer patients completed 216 questionnaires (108 using the informatics platform and 108 using the original paper-pen approach) with a one-hour interval in between. Patient preferences and computer experience were registered. Quality of Life informatics platform showed high usability as a user-friendly tool. This informatics platform allows data collection by auto-reply, database construction, and statistical data analysis and also facilitates the automatic listing of the questionnaires. When comparing the approaches (Wilcoxon test by item, percentile distribution and Cronbach's alpha), most of the responses were similar. Most of the patients (53.6%) reported a preference for the software version. The Quality of Life informatics platform has revealed to be a powerful and effective tool, allowing a real time analysis of Quality of Life data. Computer-based quality-of-life monitoring in head and neck cancer patients is essential to get clinically meaningful data that can support clinical decisions, identify potential needs, and support a stepped-care model. This represents a fundamental step for routine Quality of Life implementation in the Oncology Portuguese Institute (IPO-Porto), ORL and C&P department services clinical practice. Finally, we propose a diagram of diagnostic performance, considerating the generalized lack of mycological diagnosis in Portugal, which emphasizes the need for a careful history, focused on quantifying the latency period.

A cross-sectional survey of quality of life in colostomates: a report from Iran

PubMed Central

2012-01-01

Background Considering the complications that colostomies may cause, patient self-assessments of their social, emotional, physical, sexual and functional conditions may help their surgeons to evaluate the impact of their interventions or use supplementary methods to maintain patient functional status or decrease its loss to the minimum level. The aim of this study was to evaluate the Quality of Life in Iranian patients with colostomies and to compare the age and gender differences among them. Method This cross-sectional study was conducted from 2009 to 2010 to evaluate the quality of life of 96 patients who had undergone surgery for rectal cancer and had permanent colostomies. The European Organization for Research and Treatment of Cancers Quality of Life Questionnaire (EORTC QLQ)-C30 and the EORTC QLQ-CR38 were used to assess patient Quality of Life. Results The mean scores for the functional subscales were as follows: Physical Function, 70.9 (±2.2); Role Function, 68.4 (±2.6); Emotional Function, 56.9 (±2.7); Cognitive Function, 68.7 (± 2.6); and Social Function, 64.2 (±3.3). The EORTC questionnaires showed significant differences between males and females. Males had better body image scores. Sexual Function and Sexual Enjoyment were impaired in both males and females, but males had significantly higher scores and better roles in Physical and Sexual Functions. More sexual enjoyment problems in older ages were observed in both males and females. Conclusion Having a colostomy was associated with a high level of emotional and sexual function impairment. The differing challenges between males and females should encourage us to design sex-specific interventions that improve the quality of life in this group of patients. PMID:23170951

A cross-sectional survey of quality of life in colostomates: a report from Iran.

PubMed

Mahjoubi, Bahar; Mirzaei, Rezvan; Azizi, Rasoul; Jafarinia, Mehdi; Zahedi-Shoolami, Leila

2012-11-21

Considering the complications that colostomies may cause, patient self-assessments of their social, emotional, physical, sexual and functional conditions may help their surgeons to evaluate the impact of their interventions or use supplementary methods to maintain patient functional status or decrease its loss to the minimum level. The aim of this study was to evaluate the Quality of Life in Iranian patients with colostomies and to compare the age and gender differences among them. This cross-sectional study was conducted from 2009 to 2010 to evaluate the quality of life of 96 patients who had undergone surgery for rectal cancer and had permanent colostomies. The European Organization for Research and Treatment of Cancers Quality of Life Questionnaire (EORTC QLQ)-C30 and the EORTC QLQ-CR38 were used to assess patient Quality of Life. The mean scores for the functional subscales were as follows: Physical Function, 70.9 (±2.2); Role Function, 68.4 (±2.6); Emotional Function, 56.9 (±2.7); Cognitive Function, 68.7 (± 2.6); and Social Function, 64.2 (±3.3). The EORTC questionnaires showed significant differences between males and females. Males had better body image scores. Sexual Function and Sexual Enjoyment were impaired in both males and females, but males had significantly higher scores and better roles in Physical and Sexual Functions. More sexual enjoyment problems in older ages were observed in both males and females. Having a colostomy was associated with a high level of emotional and sexual function impairment. The differing challenges between males and females should encourage us to design sex-specific interventions that improve the quality of life in this group of patients.

Health-related quality of life in Asian patients with breast cancer: a systematic review

PubMed Central

Gernaat, Sofie A M; Hartman, Mikael

2018-01-01

Objective To summarise the evidence on determinants of health-related quality of life (HRQL) in Asian patients with breast cancer. Design Systematic review conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and registered with PROSPERO (CRD42015032468). Methods According to the PRISMA guidelines, databases of MEDLINE (PubMed), Embase and PsycINFO were systematically searched using the following terms and synonyms: breast cancer, quality of life and Asia. Articles reporting on HRQL using EORTC-QLQ-C30, EORTC-QLQ-BR23, FACT-G and FACT-B questionnaires in Asian patients with breast cancer were eligible for inclusion. The methodological quality of each article was assessed using the quality assessment scale for cross-sectional studies or the Newcastle-Ottawa Quality Assessment Scale for cohort studies. Results Fifty-seven articles were selected for this qualitative synthesis, of which 43 (75%) were cross-sectional and 14 (25%) were longitudinal studies. Over 75 different determinants of HRQL were studied with either the EORTC or FACT questionnaires. Patients with comorbidities, treated with chemotherapy, with less social support and with more unmet needs have poorer HRQL. HRQL improves over time. Discordant results in studies were found in the association of age, marital status, household income, type of surgery, radiotherapy and hormone therapy and unmet sexuality needs with poor global health status or overall well-being. Conclusions In Asia, patients with breast cancer, in particular those with other comorbidities and those treated with chemotherapy, with less social support and with more unmet needs, have poorer HRQL. Appropriate social support and meeting the needs of patients may improve patients’ HRQL. PMID:29678980

Evaluation of a nurse-led management program to complement the treatment of adolescent acute lymphoblastic leukemia patients.

PubMed

Lin, Hailong; Zhou, Shiyan; Zhang, Dongxiu; Huang, Leting

2016-11-01

To evaluate a nurse-led management model of adolescent acute lymphoblastic leukemia (ALL) patients and improve their psychological care and quality of life. Seventy-three adolescent ALL patients participated in an open, controlled clinical trial and were randomized into a nurse-led management model group (n=36) and a doctor-led management model group (n=37). Two assessment questionnaires were administered to assess and compare the 2 models during a 1.5-year follow-up period: the hospital anxiety and depression scale (HADS) questionnaire was administered at 6 different time points, and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 different time points. There were no differences in anxiety and depression between the groups according to the first-administered questionnaire (the mean anxiety and depression scores of the nurse-led group were 14.2±4.1 and 10.8±2.7, respectively; those of the doctor-led group were 13.8±3.8 and 10.6±2.2, respectively). However, repeated measures analysis of variance detected differences in subsequent HADS-based scores as a function of time between the 2 groups (p<0.05). Moreover, the Holm-Sidak's multiple comparisons tests showed that patients of the nurse-led group had significantly decreased mean anxiety scores compared to those in the doctor-led group at the third and subsequent sessions, as well as in mean depression scores from the second session onwards (all p<0.05). According to the last-administered EORTC QLQ-C30 questionnaire, there were statistical differences in cognitive, emotional, social, and quality of life scales between the 2 groups (all p<0.05), but not in role and physical scales (all p>0.05). It is necessary to offer unique cognitive, psychological, and behavioral management models to adolescent ALL patients that are tailored toward their age group. Strengthening such management is more conducive to alleviating or even reversing psychological problems, and to improving patients' quality of life while ensuring complication-free follow-up periods. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of life quality, self-confidence and sexual functions in patients with total and partial laryngectomy.

PubMed

Batıoğlu-Karaaltın, Ayşegül; Binbay, Zerrin; Yiğit, Özgür; Dönmez, Zehra

2017-04-01

In this study patients who have undergone partial (PL) or total laryngectomy (TL) were evaluated for life quality, self-esteem and sexual dysfunctions. 108 patients who received TL or PL without tracheostoma were included in this study. During patient interview, sociodemographical data form, European Organization for Research and Treatment of Cancer, Life Questionnaire Core 30 Items, Cancer and Head and Neck module-35 Items (EORTC QLQ-C30 and H&N35) were filled and patients were also asked to fill in Arizona Sexual Experiences Scale (ASEX), Beck's Depression Inventory (BDI), Beck's Anxiety Inventory (BAI) and Rosenberg Self-Esteem Scale (RSES) forms. Depression and anxiety scores and points taken from RSES were significantly different between TL and PL patients (p=0.045, p=0.041 and p=0.006 respectively). Although the difference was not significant in ASEX (p=0.174), the average scores of sexuality subunit (QL-35 59-60) of EORTC QLQ-H&N35 module were significantly different in these patients (p<0.001). Besides, it was shown that 90.3% of TL patients and 63.9% of PL patients have experienced negative effects in sexual functions. TL patients were more often observed to have problems regarding depression, anxiety, self-esteem and sexual functions and it is concluded that they may need psychosocial support more than PL patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Dietary pattern and health-related quality of life among breast cancer survivors.

PubMed

Kim, Na-Hui; Song, Sihan; Jung, So-Youn; Lee, Eunsook; Kim, Zisun; Moon, Hyeong-Gon; Noh, Dong-Young; Lee, Jung Eun

2018-05-10

There is limited evidence for the association between dietary pattern and quality of life among breast cancer survivors. We examined the association between dietary patterns and health-related quality of life (HRQoL) among Korean breast cancer survivors. Our study included a total of 232 women, aged 21 to 79 years, who had been diagnosed with stage I to III breast cancer and who underwent breast cancer surgery at least 6 months prior to our baseline evaluation. We assessed HRQoL using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23). We conducted a factor analysis to identify the major dietary patterns and used a generalized linear model to obtain the least squares mean (LS mean) and 95% confidence interval (CI) for HRQoL according to the dietary pattern scores. We identified 2 major dietary patterns: the Healthy dietary pattern and the Western dietary pattern. We found that breast cancer survivors who had higher Healthy dietary pattern scores tended to have lower dyspnea scores but higher insomnia scores, compared to breast cancer survivors with lower Healthy dietary pattern scores. For dyspnea, the LS mean (95% CI) was 8.86 (5.05-15.52) in the bottom quartile and 2.87 (1.62-5.08) in the top quartile (p for trend = 0.005). This association was limited to survivors with stage I for dyspnea or survivors with stage II or III for insomnia. Healthy dietary patterns were associated with better scores for dyspnea but worse scores for insomnia among breast cancer survivors. Other components of EORTC QLQ did not vary by dietary patterns overall, but they warrant further investigation for subgroups of breast cancer survivors.

Survey of return to work of head and neck cancer survivors: A report from a tertiary cancer center in India.

PubMed

Agarwal, Jaiprakash; Krishnatry, Rahul; Chaturvedi, Pankaj; Ghosh-Laskar, Sarbani; Gupta, Tejpal; Budrukkar, Ashwani; Murthy, Vedang; Deodhar, Joyita; Nair, Deepa; Nair, Sudhir; Dikshit, Rajesh; D'Cruz, Anil K

2017-05-01

The rates and factors associated with the return to work of head and neck cancer survivors from low- and middle-income countries, such as India, are largely unknown. We conducted a preliminary cross-sectional survey of 250 consecutive eligible head and neck cancer survivors (age <60; ≥6 months posttreatment) to identify return to work rates and sociodemographic, clinical, and quality of life (QOL; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions [EORTC-QLQ-C30] and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions [EORTC-QLQ-H&N35]) correlates. In our cohort, 92.4% of the patients were employed pretreatment, 65.6% and 81.2% returned to work at 6 months posttreatment and by the time of the survey (median follow-up 19 months), respectively. Family structure (<2 male children, p = .008; eldest child age <20 years, p = .04), a higher level of education (vocational or professional training, p = .013) and female sex (p = .001) were associated with higher return to work. Head and neck cancer survivors who returned to work had better global quality of life (QOL; p = .014) and less coughing (p = .001) but more problems related to sticky saliva (p = .004). Further studies are needed to address the large unmet needs regarding identification and amelioration of barriers to return to work for head and neck cancer survivors in low- and middle-income countries, such as India. © 2017 Wiley Periodicals, Inc. Head Neck 39: 893-899, 2017. © 2017 Wiley Periodicals, Inc.

Analysis of Postsurgical Health-Related Quality of Life and Quality of Voice of Patients With Laryngeal Carcinoma.

PubMed

Luo, Jie; Wu, Jieli; Lv, Kexing; Li, Kaichun; Wu, Jianhui; Wen, Yihui; Li, Xiaoling; Tang, Haocheng; Jiang, Aiyun; Wang, Zhangfeng; Wen, Weiping; Lei, Wenbin

2016-01-01

This study aims to analyze the postsurgical health-related quality of life (HRQOL) and quality of voice (QOV) of patients with laryngeal carcinoma with an expectation of improving the treatment and HRQOL of these patients. Based on the collection of information of patients with laryngeal carcinoma regarding clinical characteristics (age, TNM stage, with or without laryngeal preservation and/or neck dissection, with or without postoperative irradiation and/or chemotherapy, etc.), QOV using Voice Handicap Index (VIH) scale and HRQOL using EORTC QLQ-C30 and EORTCQLQ-H&N35 scales, the differences of postsurgical HRQOL related to their clinical characteristics were analyzed using univariate nonparametric tests, the main factors impacting the postsurgical HRQOL were analyzed using regression analyses (generalized linear models) and the correlation between QOV and HRQOL analyzed using spearman correlation analysis. A total of 92 patients were enrolled in this study, on whom the use of EORTC QLQ-C30, EORTC QLQ-H&N35 and VHI scales revealed that: the differences of HRQOL were significant among patients with different ages, TNM stages, and treatment modalities; the main factors impacting the postsurgical HRQOL were pain, speech disorder, and dry mouth; and QOV was significantly correlated with HRQOL. For the patients with laryngeal carcinoma included in our study, the quality of life after open surgeries were impacted by many factors predominated by pain, speech disorder, and dry mouth. It is suggested that doctors in China do more efforts on the patients' postoperative pain and xerostomia management and speech rehabilitation with the hope of improving the patients' quality of life.

[Validation of the Spanish version of the Palliative Care Outcome Scale].

PubMed

Serra-Prat, Mateu; Nabal, Maria; Santacruz, Víctor; Picaza, Josep M; Trelis, Jordi

2004-10-02

The objective of this study was to translate the Palliative Care Outcome Scale (POS) into Spanish and to validate it. The translation and adaptation was based on the conceptual equivalence of the terms used. In order to study the psychometric properties, 200 patients receiving palliative care were asked to fill out the POS questionnaire, the European Organization for Research on Cancer Treatment Quality of Life Questionnaire (EORCT QLQ C-30), the Barthel Index and the Karnofsky Index on their first visit. The Spanish version of the POS questionnaire was given to the patients again, a week later, to measure the intra-observer reliability. There were no major problems with the translation and adaptation process. The Spanish POS adapted very well for both the staff and the patients versions. Inter- and intra-observer reliability was good, with intraclass correlation coefficients of between 0.61 and 0.93 according to the item. Internal consistency analysis showed a Cronbach's alpha of 0.62 for the staff version and 0.64 for the patients version. Most of the Spanish POS correlated with the EORTC QLQ C-30 emotional function scale and quality of life scale. The Spanish POS is a valid and reliable instrument for measuring the quality of life of patients receiving palliative care. It is useful in research as well as in everyday clinical practice.

Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial.

PubMed

Côté, Mathieu; Trudel, Mathieu; Wang, Changshu; Fortin, André

2016-04-01

Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas. Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week. Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438). At the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo. © The Author(s) 2015.

Quality of Life in Women After Pelvic Exenteration for Gynecological Malignancies: A Multicentric Study.

PubMed

Dessole, Margherita; Petrillo, Marco; Lucidi, Alessandro; Naldini, Angelica; Rossi, Martina; De Iaco, Pierandrea; Marnitz, Simone; Sehouli, Jalid; Scambia, Giovanni; Chiantera, Vito

2018-02-01

This retrospective, multicentric study investigates quality-of-life issues and emotional distress in gynecological cancer survivors submitted to pelvic exenteration (PE). The Global Health Status scale of European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30; the EORTC QLQ-CX24 (CX24), and EORTC QLQ-OV28 questionnaires were administered at least 12 months from surgery only in women with no evidence of further recurrence after PE. Statistical analysis was performed by the analysis of variance (for repeated measures. Ninety-six subjects affected by gynecological malignancies receiving PE were enrolled in the study. Anterior PE was performed in 47 patients (49%), posterior PE was performed in 29 cases (30.2%), and total PE performed in 20 women (20.8%). In 38 cases (39.6%), a definitive colostomy was performed. Urinary diversion with continent pouch was created in 11 patients. (11.5%), whereas in the remaining cases, a noncontinent pouch was reconstructed. Patients showed a significant discomfort in attitude to disease (71.5 ± 4.7), body image (48.9 ± 6.4), financial difficulties (56.2 ± 5.8), gastrointestinal symptoms (constipation, 47.8 ± 5.1; diarrhea, 62.4 ± 6.6; appetite loss, 43.6 ± 6.7), insomnia (64.5 ± 6.6), Global Health Status (64.6 ± 3.8), physical functioning (65.8 ± 4.6), role functioning (58.8 ± 5.8), and emotional functioning (67.4 ± 4.2). A higher number of ostomies (hazard rate [HR], 7.613; P = 0.012), the creation of a noncontinent bladder (HR, 8.230; P = 0.009), and of definitive colostomy (HR, 8.516; P = 0.008) emerged as independent predictors of poorer Global Health Status scores. Older age (HR, 11.235; P = 0.003), vaginal/vulvar cancer (HR, 7.369; P = 0.013), total/posterior PE (HR, 7.393; P = 0.013), higher number of ostomies (HR, 7.613; P = 0.012), the creation of a noncontinent bladder (HR, 8.230; P = 0.009), and of definitive colostomy (HR, 8.516; P = 0.008) emerged as independent predictors of lower body image levels. Long-term psycho-oncological support is strongly recommended. The reduction of ostomies seems the most effective way to improve patients' quality of life.

Quality of life in patients with advanced lung cancer treated at home and at a palliative care unit.

PubMed

Leppert, Wojciech; Turska, Anna; Majkowicz, Mikolaj; Dziegielewska, Sylwia; Pankiewicz, Piotr; Mess, Eleonora

2012-08-01

To assess quality of life (QOL) in patients with advanced lung cancer. A prospective study of 78 patients cared at home and at a palliative care unit (PCU) with 2 QOL assessments was conducted. Fifty patients completed the study. In the EORTC QLQ-C30 role, cognitive, social functioning, global QOL, fatigue, pain, dyspnea, and appetite deteriorated; nausea/vomiting improved; dyspnea was more intense in the case of in-home patients. In the EORTC QLQ-LC13 hemoptysis improved; pain in other parts was more intense in the PCU patients. Pain (Visual Analogue scale) was more intense in the PCU patients; the level of activity (Karnofsky) decreased in the case of patients treated at home. QOL deteriorated with few differences between home and the PCU patients.

Comparative Effectiveness of Sphincter-Sparing Surgery versus Abdominoperineal Resection in Rectal Cancer: Patient-Reported Outcomes in National Surgical Adjuvant Breast and Bowel Project Randomized Trial R-04

PubMed Central

Russell, Marcia M.; Ganz, Patricia A.; Lopa, Samia; Yothers, Greg; Ko, Clifford Y.; Arora, Amit; Atkins, James N.; Bahary, Nathan; Soori, Gamini; Robertson, John M.; Eakle, Janice; Marchello, Benjamin T.; Wozniak, Timothy F.; Beart, Robert W.; Wolmark, Norman

2015-01-01

Objective NSABP R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II–III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). Methods To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by non-randomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, gender, stage, intended surgery, and randomly assigned chemoradiotherapy. Results Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at one year. For the EORTC-QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P=0.0005) at one year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P=0.02) at one year than did those undergoing SSS. For the EORTC-QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at one year (26.9 vs 21.5, P=0.03). SSS patients reported worse GI tract symptoms than did the APR patients (18.9 vs 15.2, P<0.0001), as well as weight loss (10.1 vs 6.0, P=0.002). Conclusions Symptoms and functional problems were detected at one year by EORTC-QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer. PMID:24670844

Quality of Life in CAM and Non-CAM Users among Breast Cancer Patients during Chemotherapy in Malaysia

PubMed Central

Chui, Ping Lei; Abdullah, Khatijah Lim; Wong, Li Ping; Taib, Nur Aishah

2015-01-01

Background Complementary and alternative medicine (CAM) use has become increasingly popular among patients with cancer. The purposes of this study were to compare the QOL in CAM users and non-CAM users and to determine whether CAM use influences QOL among breast cancer patients during chemotherapy. Methodology A cross-sectional survey was conducted at two outpatient chemotherapy centers. A total of 546 patients completed the questionnaires on CAM use. QOL was evaluated based on the European Organization for Research and Treatment of Cancer (EORTC) core quality of life (QLQ-C30) and breast cancer-specific quality of life (QLQ-BR23) questionnaires. Results A total of 70.7% of patients were identified as CAM users. There was no significant difference in global health status scores and in all five subscales of the QLQ C30 functional scales between CAM users and non-CAM users. On the QLQ-C30 symptom scales, CAM users (44.96±3.89) had significantly (p = 0.01) higher mean scores for financial difficulties than non-CAM users (36.29±4.81). On the QLQ-BR23 functional scales, CAM users reported significantly higher mean scores for sexual enjoyment (6.01±12.84 vs. 4.64±12.76, p = 0.04) than non-CAM users. On the QLQ-BR23 symptom scales, CAM users reported higher systemic therapy side effects (41.34±2.01 vs. 37.22±2.48, p = 0.04) and breast symptoms (15.76±2.13 vs. 11.08±2.62, p = 0.02) than non-CAM users. Multivariate logistic regression analysis indicated that the use of CAM modality was not significantly associated with higher global health status scores (p = 0.71). Conclusion While the findings indicated that there was no significant difference between users and non-users of CAM in terms of QOL, CAM may be used by health professionals as a surrogate to monitor patients with higher systemic therapy side effects and breast symptoms. Furthermore, given that CAM users reported higher financial burdens (which may have contributed to increased distress), patients should be encouraged to discuss the potential benefits and/or disadvantages of using CAM with their healthcare providers. PMID:26451732

Cross-cultural adaptation, reliability, and validity of the Turkish version of the Cancer Fatigue Scale in patients with breast cancer

PubMed

Şahin, Sedef; Huri, Meral; Aran, Orkun Tahir; Uyanık, Mine

2018-02-23

Background/aim: The Cancer Fatigue Scale (CFS) was developed to evaluate the severity of fatigue in patients with breast cancer. The aim of this study is to translate and culturally adapt a Turkish version and investigate the validity and reliability of the CFS in Turkish patients with fatigue symptoms. Materials and methods: Eighty participants completed the Turkish version of the CFS for breast cancer and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire ″Core 30″ (EORTC QLQ-C30). Test-retest reliability was evaluated by repeating the CFS with a 7-day interval. Results: The CFS demonstrated high test-retest reliability (ICC = 0.95) and good internal consistency (Cronbach′s alpha = 0.74) for all domains. The Kaiser-Meyer-Olkin measure of sampling adequacy was found to be 0.819, which is considered to be satisfactory (>0.5). Correlations between domains of CFS physical and EORTC physical (r: 0.77), CFS cognitive and EORTC cognitive (r: 0.70), and CFS physical and EORTC fatigue (r: 0.80) were found to be significant. Conclusion: The Turkish version of the CFS is a reliable and valid instrument to assess physical, effective, and cognitive dimensions of fatigue. The CFS may be used to evaluate the severity of fatigue in Turkish-speaking breast cancer patients.

Testing mapping algorithms of the cancer-specific EORTC QLQ-C30 onto EQ-5D in malignant mesothelioma.

PubMed

Arnold, David T; Rowen, Donna; Versteegh, Matthijs M; Morley, Anna; Hooper, Clare E; Maskell, Nicholas A

2015-01-23

In order to estimate utilities for cancer studies where the EQ-5D was not used, the EORTC QLQ-C30 can be used to estimate EQ-5D using existing mapping algorithms. Several mapping algorithms exist for this transformation, however, algorithms tend to lose accuracy in patients in poor health states. The aim of this study was to test all existing mapping algorithms of QLQ-C30 onto EQ-5D, in a dataset of patients with malignant pleural mesothelioma, an invariably fatal malignancy where no previous mapping estimation has been published. Health related quality of life (HRQoL) data where both the EQ-5D and QLQ-C30 were used simultaneously was obtained from the UK-based prospective observational SWAMP (South West Area Mesothelioma and Pemetrexed) trial. In the original trial 73 patients with pleural mesothelioma were offered palliative chemotherapy and their HRQoL was assessed across five time points. This data was used to test the nine available mapping algorithms found in the literature, comparing predicted against observed EQ-5D values. The ability of algorithms to predict the mean, minimise error and detect clinically significant differences was assessed. The dataset had a total of 250 observations across 5 timepoints. The linear regression mapping algorithms tested generally performed poorly, over-estimating the predicted compared to observed EQ-5D values, especially when observed EQ-5D was below 0.5. The best performing algorithm used a response mapping method and predicted the mean EQ-5D with accuracy with an average root mean squared error of 0.17 (Standard Deviation; 0.22). This algorithm reliably discriminated between clinically distinct subgroups seen in the primary dataset. This study tested mapping algorithms in a population with poor health states, where they have been previously shown to perform poorly. Further research into EQ-5D estimation should be directed at response mapping methods given its superior performance in this study.

Listen to their answers! Response behaviour in the measurement of physical and role functioning

PubMed Central

Hak, Tony; Sprangers, Mirjam A. G.; Groen, Harry J. M.; van der Wal, Gerrit; The, Anne-Mei

2008-01-01

Background Quality of life (QoL) is considered to be an indispensable outcome measure of curative and palliative treatment. However, QoL research often yields findings that raise questions about what QoL measurement instruments actually assess and how the scores should be interpreted. Objective To investigate how patients interpret and respond to questions on the EORTC-QLQ-C30 over time and to find explanations to account for counterintuitive findings in QoL measurement. Methods Qualitative investigation was made of the response behaviour of small-cell lung cancer patients (n = 23) in the measurement of QoL with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Focus was on physical functioning (PF, items 1 to 5), role functioning (RF, items 6 and 7), global health and QoL rating (GH/QOL, items 29 and 30). Interviews were held at four points: at the start of the chemotherapy, 4 weeks later, at the end, and 6 weeks after the end of chemotherapy. Patients were asked to ‘think aloud’ when filling in the questionnaire. Results Patients used various response strategies when answering questions about problems and limitations in functioning, which impacted the accuracy of the scale. Patients had scores suggesting they were less limited than they actually were by taking the wording of questions literally, by guessing their functioning in activities that they did not perform, and by ignoring or excluding certain activities that they could not perform. Conclusion Terminally ill patients evaluate their functioning in terms of what they perceive to be normal under the circumstances. Their answers can be interpreted in terms of change in the appraisal process (Rapkin and Schwartz 2004; Health and Quality of Life Outcomes, 2, 14). More care should be taken in assessing the quality of a set of questions about physical and role functioning. PMID:18389384

Listen to their answers! Response behaviour in the measurement of physical and role functioning.

PubMed

Westerman, Marjan J; Hak, Tony; Sprangers, Mirjam A G; Groen, Harry J M; van der Wal, Gerrit; The, Anne-Mei

2008-05-01

Quality of life (QoL) is considered to be an indispensable outcome measure of curative and palliative treatment. However, QoL research often yields findings that raise questions about what QoL measurement instruments actually assess and how the scores should be interpreted. To investigate how patients interpret and respond to questions on the EORTC-QLQ-C30 over time and to find explanations to account for counterintuitive findings in QoL measurement. Qualitative investigation was made of the response behaviour of small-cell lung cancer patients (n = 23) in the measurement of QoL with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Focus was on physical functioning (PF, items 1 to 5), role functioning (RF, items 6 and 7), global health and QoL rating (GH/QOL, items 29 and 30). Interviews were held at four points: at the start of the chemotherapy, 4 weeks later, at the end, and 6 weeks after the end of chemotherapy. Patients were asked to 'think aloud' when filling in the questionnaire. Patients used various response strategies when answering questions about problems and limitations in functioning, which impacted the accuracy of the scale. Patients had scores suggesting they were less limited than they actually were by taking the wording of questions literally, by guessing their functioning in activities that they did not perform, and by ignoring or excluding certain activities that they could not perform. Terminally ill patients evaluate their functioning in terms of what they perceive to be normal under the circumstances. Their answers can be interpreted in terms of change in the appraisal process (Rapkin and Schwartz 2004; Health and Quality of Life Outcomes, 2, 14). More care should be taken in assessing the quality of a set of questions about physical and role functioning.

Longitudinal validation and comparison of the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) and the Functional Assessment of Cancer-Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx).

PubMed

Cheng, Hui Lin; Molassiotis, Alex

2018-06-05

To validate and compare the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) and the Functional Assessment of Cancer-Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) for measuring chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. Patients were assessed with the EORTC QLQ-CIPN20, FACT/GOG-Ntx, National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) and World Health Organization criterion of CIPN (WHO-CIPN) from baseline up to 10 assessment points. Internal consistency reliability, convergent validity, discriminant validity and responsiveness of the EORTC QLQ-CIPN20 and FACT/GOG-Ntx were evaluated, respectively. Correlation and regression analysis were used to examine the relationships between these two scales. Internal reliability coefficients for both scales were above 0.80 across all assessment points. Moderate correlations of the two scales were found with WHO-CIPN (r s  = 0.40-0.44; r s  = -0.42 to -0.46, all P < 0.05) and NCI-CTCAE (r s  = 0.46-0.57; r s  = -0.44 to -0.55, all P < 0.01) at most assessment points. Older patients reported significantly more CIPN symptoms than younger counterparts did (P < 0.05). The hypothesized factor structures of both scales were not confirmed (χ2/df = 3.70-7.01; χ2/df = 2.14-10.43, all P < 0.001). Both scales demonstrated responsiveness with small-to-moderate effect size (r = 0.09-0.46, r = 0.11-0.35). The two scales were highly correlated and were predicted by all domains of each other at specific assessment points (R 2  = 0.62-0.87; R 2  = 0.76-0.85; respectively, all P < 0.001). The Chinese version of the EORTC QLQ-CIPN20 and FACT/GOG-Ntx demonstrated acceptable reliability, validity and responsiveness and was found comparable in measuring CIPN among Chinese cancer patients at specific assessment points. © 2018 John Wiley & Sons Australia, Ltd.

Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument.

PubMed

Espinoza-Zamora, José Ramiro; Portilla-Espinosa, César Miguel; Labardini-Méndez, Juan Rafael; Cervera, Eduardo; Niesvisky, Ruben; Oñate-Ocaña, Luis F

2015-06-01

Health-related quality of life (HRQL) has become an important outcome measurement in hematology. Our aim was to validate the quality of life questionnaire (QLQ)-MY20 instrument in patients with multiple myeloma (MM) in Mexico. The Mexican-Spanish versions of the QLQ-C30 and QLQ-MY20 instruments were applied to patients with MM at a cancer referral centre. Reliability and validity tests were performed. Test-retest was carried out in selected patients. Ninety-eight patients with MM were included in this study. Questionnaire compliance rates were high, and the instrument was well accepted; internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of seven of nine multi-item scales of the QLQ-C30 and of all three multi-item scales of the QLQ-MY20 instruments were >0.7 (range, 0.36-0.89). The scales of the QLQ-C30 and QLQ-MY20 instruments distinguished among clinically distinct groups of patients; 9 of 15 scales of the QLQ-C30 and all 4 scales of the QLQ-MY20 presented responsiveness after change over time. The Mexican-Spanish version of the QLQ-MY20 questionnaire is reliable and valid for the assessment of HRQL in patients with MM and can be used in clinical trials in the Mexican community.

Assessment of quality of life in patients treated with accelerated radiotherapy for laryngeal and hypopharyngeal carcinomas.

PubMed

Allal, A S; Dulguerov, P; Bieri, S; Lehmann, W; Kurtz, J M

2000-05-01

This study was conducted to evaluate quality of life (QOL) and functional outcome in patients with carcinomas of the larynx and hypopharynx treated with accelerated radiotherapy (RT). Between January 1991 and September 1996, 21 patients treated with accelerated concomitant boost RT schedule (69.9 Gy in 5. 5 weeks) for laryngeal (n = 10) or hypopharyngeal (n = 11) carcinomas and who remained free of disease at 1-year minimum follow-up were evaluated. The functional outcome was assessed by the subjective Performance Status Scale for Head and Neck cancer (PSSHN) and general QOL by the European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQ-C30). The median length of follow-up was 37 months (range, 13 to 75). The PSSHN scores were 89, 84, and 86, respectively, for eating in public, understandability of speech and normalcy of diet (100 = normal function). Significantly lower scores for understandability of speech were observed in patients with advanced and laryngeal carcinomas. Normalcy of diet was affected negatively by the severity of xerostomia. All mean functional scale scores of the EORTC QLQ-C30 module were 20% to 25% below the higher score. Most of these scale scores were significantly affected by the severity of xerostomia. Patients treated with concomitant boost RT for laryngeal and hypopharyngeal carcinomas appear to have similar QOL and functional outcome to those reported for patients treated with conventional or hyperfractionated RT. As expected, many QOL scales were affected by the severity of xero- stomia.

Quality of life of early stage colorectal cancer patients in Morocco.

PubMed

Mrabti, Hind; Amziren, Mounia; ElGhissassi, Ibrahim; Bensouda, Youssef; Berrada, Narjiss; Abahssain, Halima; Boutayeb, Saber; El Fakir, Samira; Nejjari, Chakib; Benider, Abdellatif; Mellas, Nawfel; El Mesbahi, Omar; Bennani, Maria; Bekkali, Rachid; Zidouh, Ahmed; Errihani, Hassan

2016-10-12

A multicentre cohort study was held in Morocco, designed to evaluate the quality of life of cancer patients. The aim of this paper is to report the assessment of the quality of life of early colorectal cancer patients, before and after cancer treatment, to identify other factors which are related to this quality of life. We used the third version of the QLQ-C30 questionnaire of the European organization for Research and treatment of Cancer (EORTC) after a transcultural validation. The Data collection was done at inclusion and then every twelve weeks to achieve one year of follow up. Overall 294 patients presented with early colorectal cancer, the median age was 56 years (range: 21-88). The male-female sex ratio was 1.17. At inclusion, the global health status was the most affected functional dimension. For symptoms: financial difficulties and fatigue scores were the highest ones. Emotional and social functions were significantly worse in rectal cancer. Most symptoms were more present in rectal cancer. At inclusion, global health status score was significantly worse in stage III. Anorexia was significantly more important among colorectal female patients. For Patients over 70 years-old, the difference was statistically significant for the physical function item which was lower. Overall, Functional dimensions scores were improved after chemotherapy. The symptoms scores did not differ significantly for patients treated by radiotherapy, between inclusion and at one year. Our EORTC QLQ C30 scores are overall comparable to the reference values. Neither chemotherapy, nor radiotherapy worsened the quality of life at one year.

Brachytherapy versus prostatectomy in localized prostate cancer: Results of a French multicenter prospective medico-economic study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Buron, Catherine; Le Vu, Beatrice; Cosset, Jean-Marc

2007-03-01

Purpose: To prospectively compare health-related quality of life (HRQOL), patient-reported treatment-related symptoms, and costs of iodine-125 permanent implant interstitial brachytherapy (IB) with those of radical prostatectomy (RP) during the first 2 years after these treatments for localized prostate cancer. Methods and Materials: A total of 435 men with localized low-risk prostate cancer, from 11 French hospitals, treated with IB (308) or RP (127), were offered to complete the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire QLQ-C30 version 3 (EORTC QLQ-C30) and the prostate cancer specific EORTC QLQ-PR25 module before and at the end ofmore » treatment, 2, 6, 12, 18, and 24 months after treatment. Repeated measures analysis of variance and analysis of covariance were conducted on HRQOL changes. Comparative cost analysis covered initial treatment, hospital follow-up, outpatient and production loss costs. Results: Just after treatment, the decrease of global HRQOL was less pronounced in the IB than in the RP group, with a 13.5 points difference (p < 0.0001). A difference slightly in favor of RP was observed 6 months after treatment (-7.5 points, p = 0.0164) and was maintained at 24 months (-8.2 points, p = 0.0379). Impotence and urinary incontinence were more pronounced after RP, whereas urinary frequency, urgency, and urination pain were more frequent after IB. Mean societal costs did not differ between IB ( Euro 8,019 at T24) and RP ( Euro 8,715 at T24, p = 0.0843) regardless of the period. Conclusions: This study suggests a similar cost profile in France for IB and RP but with different HRQOL and side effect profiles. Those findings may be used to tailor localized prostate cancer treatments to suit individual patients' needs.« less

Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients

PubMed Central

Ediebah, D. E.; Coens, C.; Maringwa, J. T.; Quinten, C.; Zikos, E.; Ringash, J.; King, M.; Gotay, C.; Flechtner, H.-H.; Schmucker von Koch, J.; Weis, J.; Smit, E. F.; Köhne, C.-H.; Bottomley, A.

2013-01-01

Background We examined if cancer patients' health-related quality of life (HRQoL) scores on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 are affected by the specific time point, before or during treatment, at which the questionnaire is completed, and whether this could bias the overall treatment comparison analyses. Patients and methods A ‘completion-time window’ variable was created on three closed EORTC randomised control trials in lung (non-small cell lung cancer, NSCLC) and colorectal cancer (CRC) to indicate when the QLQ-30 was completed relative to chemotherapy cycle dates, defined as ‘before’, ‘on’ and ‘after’. HRQoL mean scores were calculated using a linear mixed model. Results Statistically significant differences (P < 0.05) were observed on 6 and 5 scales for ‘on’ and ‘after’ comparisons in the NSCLC and two-group CRC trial, respectively. As for the three-group CRC trial, several statistical differences were observed in the ‘before’ to ‘on’ and the ‘on’ to ‘after’ comparisons. For all three trials, including the ‘completion-time window’ variable in the model resulted in a better fit, but no substantial changes in the treatment effects were noted. Conclusions We showed that considering the exact timing of completion within specified windows resulted in statistical and potentially clinically significant differences, but it did not alter the conclusions of treatment comparison in these studies. PMID:22935549

Phase 1/2 Trial of 5-Fraction Stereotactic Radiosurgery With 5-mm Margins With Concurrent and Adjuvant Temozolomide in Newly Diagnosed Supratentorial Glioblastoma: Health-Related Quality of Life Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pollom, Erqi L.; Fujimoto, Dylann; Wynne, Jacob

Purpose: We report a longitudinal assessment of health-related quality of life (HRQOL) in patients with glioblastoma (GBM) treated on a prospective dose escalation trial of 5-fraction stereotactic radiosurgery (25-40 Gy in 5 fractions) with concurrent and adjuvant temozolomide. Methods: HRQOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) general, the EORTC quality of life questionnaire-brain cancer specific module (QLQ-BN20), and the M.D. Anderson Symptom Inventory–Brain Tumor (MDASI-BT). Questionnaires were completed at baseline and at every follow-up visit after completion of radiosurgery. Changes from baseline for 9 predefined HRQOL measures (globalmore » quality of life, physical functioning, social functioning, emotional functioning, motor dysfunction, communication deficit, fatigue, insomnia, and future uncertainty) were calculated at every time point. Results: With a median follow-up time of 10.4 months (range, 0.4-52 months), 139 total HRQOL questionnaires were completed by the 30 patients on trial. Compliance with HRQOL assessment was 76% at 12 months. Communication deficit significantly worsened over time, with a decline of 1.7 points per month (P=.008). No significant changes over time were detected in the other 8 scales of our primary analysis, including global quality of life. Although 8 patients (27%) experienced adverse radiation effects (ARE) on this dose escalation trial, it was not associated with a statistically significant decline in any of the primary HRQOL scales. Disease progression was associated with communication deficit, with patients experiencing an average worsening of 13.9 points per month after progression compared with 0.7 points per month before progression (P=.01). Conclusion: On this 5-fraction dose escalation protocol for newly diagnosed GBM, overall HRQOL remained stable and appears similar to historical controls of 30 fractions of radiation therapy. Tumor recurrence was associated with worsening communication deficit, and ARE did not correlate with a decline in HRQOL.« less

Validation of the EORTC QLQ-INFO 25 questionnaire in Lebanese cancer patients: Is ignorance a Bliss?

PubMed

Tabchi, Samer; El Rassy, Elie; Khazaka, Aline; El Karak, Fadi; Kourie, Hampig Raphael; Chebib, Ralph; Assi, Tarek; Ghor, Maya; Naamani, Lara; Richa, Sami; Ghosn, Marwan; Kattan, Joseph

2016-06-01

Despite worldwide trends toward optimizing full disclosure of information (DOI), the prevailing belief that cancer diagnosis should be concealed from patients, for their own good, has endured for a substantial period of time in Middle Eastern communities. This study would assess the reliability of the Arabic translated version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-INFO 25). The study was also designed to quantify DOI to Lebanese cancer patients and determine patient satisfaction with this DOI. Moreover, we compared the differences in the level of information among groups based on clinical and biographical variables. A sample of patients, being treated for a variety of malignancies, was prospectively evaluated. A physician interviewed patients using the Arabic version of the EORTC QLQ-INFO 25, on the day of hospitalization for chemotherapy, before treatment was administered. In total 201 patients were interviewed. The translated version of the EORTC QLQ-INFO 25 showed high reliability when assessed using Cronbach's alpha coefficients for internal consistency with values scoring higher than 0.7 for all scales and the full questionnaire. There was a considerable lack of information provided to the participants with 38.8 % being unaware of their diagnosis and more than half being uninformed about the extent of their disease. Paradoxically, 86.5 % of patients expressed their satisfaction about the amount of information they received and 89.5 % believe the information provided was helpful. Further analysis showed no significant association between gender, marital status, cancer site and stage and the amount of information received. However, age and level of education were associated with DOI such as younger and more educated patients received more information. Older patients were also found to be the most satisfied with the information they received, despite having less access to information. Although a high proportion of patients were not properly informed about their diagnosis, the overwhelming majority were satisfied with the amount of information they received and believed it was useful, reflecting the complexity of Middle Eastern cultural influences on cancer patients' perspectives.

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

PubMed Central

van Hooft, Jeanin E; Bemelman, Willem A; Breumelhof, Ronald; Siersema, Peter D; Kruyt, Philip M; van der Linde, Klaas; Veenendaal, Roeland A; Verhulst, Marie-Louise; Marinelli, Andreas W; Gerritsen, Josephus JGM; van Berkel, Anne-Marie; Timmer, Robin; Grubben, Marina JAL; Scholten, Pieter; Geraedts, Alfons AM; Oldenburg, Bas; Sprangers, Mirjam AG; Bossuyt, Patrick MM; Fockens, Paul

2007-01-01

Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267. PMID:17608947

The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

PubMed

Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S

2017-01-01

The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Long term effects of extended adjuvant endocrine therapy on quality of life in breast cancer patients.

PubMed

Kool, M; Fontein, D B Y; Meershoek-Klein Kranenbarg, E; Nortier, J W R; Rutgers, E J T; Marang-van de Mheen, P J; van de Velde, C J H

2015-06-01

The standard treatment for hormone-receptor positive, postmenopausal early breast cancer patients is 5 years of adjuvant endocrine therapy. Previous studies demonstrate that prolonging adjuvant endocrine therapy may improve disease-free survival. However, endocrine therapy is known for its adverse events, which may negatively affect Quality of Life (QoL). The aim of this study is to assess the impact of extended adjuvant endocrine therapy on long-term QoL outcomes. 471 patients selected from the IDEAL trial were invited to complete a questionnaire 1-1.5 years after starting with extended therapy. The questionnaire consisted of the EORTC QLQ-C30 and QLQ-BR23 questionnaires. Mean QoL outcomes were compared with EORTC reference values for stage I and II breast cancer patients and the general population. Furthermore, QoL outcomes were compared between different treatment regimens. A difference of eight points was considered clinically relevant. IDEAL patients receiving extended adjuvant endocrine therapy have significantly and clinically relevant better global QoL compared with reference values for stage I and II breast cancer patients (79.6 versus 64.6; p < 0.01) and the general population (79.6 versus 71.2; p < 0.01). Similar results were found for emotional function, pain, appetite loss, diarrhea and financial problems. Between treatment regimens prior to extended adjuvant endocrine therapy, differences were only found on specific QoL domains (e.g. arm symptoms). Breast cancer patients on extended adjuvant endocrine therapy have significantly and clinically relevant better global QoL compared with other stage I-II breast cancer patients and the general population, 6-8.5 years after diagnosis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Patients attitudes towards sleep disturbances during chemotherapy.

PubMed

Romito, F; Cormio, C; De Padova, S; Lorusso, V; Berio, M A; Fimiani, F; Piattelli, A; Palazzo, S; Abram, G; Dudine, L; Guglielmi, A; Galise, I; Romito, S; Mattioli, V

2014-05-01

Sleep disturbances are among the most distressing symptoms in cancer: they often co-occur with fatigue, pain and psychological distress. Despite the negative impact on quality of life, patients rarely seek help for managing their sleep disturbances. This paper presents the results of a multicentre observational study on patients' attitudes towards their sleep problems. The study also investigates symptom correlates. Patients responded to a semi-structured interview and completed the following questionnaires: Pittsburgh Sleep Quality Index; Brief Fatigue Inventory; Hospital Anxiety and Depression Scale; and European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life QLQ-C30 Questionnaire (QLQ-C30). Four hundred and three cancer patients were enrolled in the study. Bad sleepers constituted 66% of the sample. Thirty-eight per cent of them had not turned to any professional to solve their sleep disturbances because they had various beliefs about the importance of the problem and the possibility to be treated. The main correlates of sleep disturbances were psychological distress, reduced physical functioning and reduced overall quality of life. In conclusion, there is a need to sensitise patients to actively search for a solution to their sleep disturbances so they can be solved along with other co-occurring symptoms. Doctors could also be encouraged to dedicate more attention to routinely asking cancer patients about eventual sleep disturbances. © 2013 John Wiley & Sons Ltd.

The Quality-of-Life Effects of Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Herman, Joseph M., E-mail: jherma15@jhmi.edu; Narang, Amol K.; Griffith, Kent A.

Purpose: Existing studies that examine the effect of neoadjuvant chemoradiation (CRT) for locally advanced rectal cancer on patient quality of life (QOL) are limited. Our goals were to prospectively explore acute changes in patient-reported QOL endpoints during and after treatment and to establish a distribution of scores that could be used for comparison as new treatment modalities emerge. Methods and Materials: Fifty patients with locally advanced rectal cancer were prospectively enrolled at 2 institutions. Validated cancer-specific European Organization for Research and Treatment of Cancer (EORTC QLQ-CR30) and colorectal cancer-specific (EORTC QLQ-CR38 and EORTC QLQ-CR 29) QOL questionnaires were administered tomore » patients 1 month before they began CRT, at week 4 of CRT, and 1 month after they had finished CRT. The questionnaires included multiple symptom scales, functional domains, and a composite global QOL score. Additionally, a toxicity scale was completed by providers 1 month before the beginning of CRT, weekly during treatment, and 1 month after the end of CRT. Results: Global QOL showed a statistically significant and borderline clinically significant decrease during CRT (-9.50, P=.0024) but returned to baseline 1 month after the end of treatment (-0.33, P=.9205). Symptoms during treatment were mostly gastrointestinal (nausea/vomiting +9.94, P<.0001; and diarrhea +16.67, P=.0022), urinary (dysuria +13.33, P<.0001; and frequency +11.82, P=.0006) or fatigue (+16.22, P<.0001). These symptoms returned to baseline after therapy. However, sexual enjoyment (P=.0236) and sexual function (P=.0047) remained persistently diminished after therapy. Conclusions: Rectal cancer patients undergoing neoadjuvant CRT may experience a reduction in global QOL along with significant gastrointestinal and genitourinary symptoms during treatment. Moreover, provider-rated toxicity scales may not fully capture this decrease in patient-reported QOL. Although most symptoms are transient, impairment in sexual function may persist after the completion of therapy and merits further investigation.« less

[The impact of preoperative stoma siting and stoma care education on patient's quality of life].

PubMed

Gulbiniene, Jurgita; Markelis, Rytis; Tamelis, Algimantas; Saladzinskas, Zilvinas

2004-01-01

The aim of study was to assess if preoperative stoma selection and adequate patient's teaching can affect the postoperative patient's quality of life. The study was performed in two university hospitals of Lithuania: Kaunas University of Medicine Hospital and Kaunas Oncology Hospital. Patients were divided into three groups. Patients were asked to answer the questionnaire the day before the stoma creation operation and two months after the operation. Questionnaires EORTC QLQ-C30, EORTC QLQ-CR38 and 10 supplementary questions were used. The results of the study show that following the stoma operation, when compared with preoperative results, general quality of life did not change significantly in groups I and II. Patients who received adequate education and preoperative stoma siting had better emotional functioning and less gastrointestinal problems. The financial problems of the patients in group I were significantly less than in the control group. Patients who received the adequate teaching without preoperative stoma selection experience better sexual satisfaction compared with control group. Stoma related problems were less in group I and II when comparing with the control group. The quality of the patients' teaching, adequacy and comfort of stoma site and satisfaction with the medical staff were significantly better in the group I and group II when compared to control group. Moreover, these results were significantly higher in the group I than in group II. CONCLUSIONS. The teaching the patients preoperatively and postoperative proceeding helps them to gain better experience in self stoma care hence reducing the psychological, physical, emotional, social and sexual problems.

Living with the physical and mental consequences of an ostomy: a study among 1-10-year rectal cancer survivors from the population-based PROFILES registry.

PubMed

Mols, Floortje; Lemmens, Valery; Bosscha, Koop; van den Broek, Wim; Thong, Melissa S Y

2014-09-01

This study examined the physical and mental consequences of an ostomy among 1-10-year rectal cancer survivors. Patients with rectal cancer diagnosed from 2000 to 2009, as registered in the population-based Eindhoven Cancer Registry, received a questionnaire on quality of life (QOL; EORTC QLQ-C30), disease-specific health status (EORTC QLQ-CR38), depression and anxiety (HADS), illness perceptions (Brief Illness Perception Questionnaire), and health care utilization; 76% (n = 1019) responded. A total of 408 (43%) rectal cancer survivors had an ostomy at survey and they reported a statistically significant and clinically relevant lower physical, role, and social functioning, and global health status/QOL but fewer problems with constipation and diarrhea compared with those without an ostomy. Also, they had a significantly worse body image, more male sexual problems, and fewer gastrointestinal problems although these differences were not clinically relevant. No differences regarding the prevalence of symptoms of anxiety and depression were found. Survivors with an ostomy believed that their illness have significantly more serious consequences, will last longer (clinically relevant), and were more concerned about their illness compared with those without an ostomy. Survivors with an ostomy visited their medical specialist, but not their general practitioner, significantly more often. Also, they more often received additional support after cancer treatment. Rectal cancer survivors with an ostomy have a lower QOL, worse illness perceptions, and a higher health care consumption compared with those without an ostomy 1-10 years after diagnosis. Copyright © 2014 John Wiley & Sons, Ltd.

The effects of illness beliefs and chemotherapy impact on quality of life in Japanese and Dutch patients with breast or lung cancer.

PubMed

van der Kloot, Willem A; Uchida, Yuka; Inoue, Kenichi; Kobayashi, Kunihiko; Yamaoka, Kazue; Nortier, Hans W R; Kaptein, Ad A

2016-02-01

Responses to diagnosis and treatment of cancer are mediated by a patient's illness perceptions. Such perceptions, though different among individuals, may be culturally dependent, and act upon health related quality of life (HRQOL). Over time, individual patients show different types of response trajectories. Four issues were investigated: (I) country and disease differences in illness beliefs between Japanese and Dutch patients with lung or breast cancer; (II) country and disease differences in HRQOL in early chemotherapy; (III) individual, country, and disease differences among HRQOL trajectories; (IV) the impact of illness beliefs on HRQOL trajectories. A total of 89 Japanese and Dutch patients with lung or breast cancer cooperated immediately before, one week after, and eight weeks after the start of chemotherapy. Data included the EORTC QLQ-C30 quality of life (QL) questionnaire and the Brief Illness Perception Questionnaire (B-IPQ). EORTC QLQ-C30 scales were summarized by two dimensions: generalized quality of life (GENQOL) and psychological well-being (PSYQOL). (I) Japanese patients had higher means on B-IPQ's concern and time line than Dutch patients. Japanese lung cancer patients had a higher mean on treatment control than all other patients; (II) no differences between country and cancer type occurred on the two HRQOL dimensions. First assessment HRQOL differed significantly from the second and third assessments without differences between the latter two. Between the first two assessments, a decrease in GENQOL occurred, together with an improvement in PSYQOL; (III) individual differences dominated the trajectories; (IV) negative beliefs usually coincided with lower scores on GENQOL and PSYQOL. Patients initially lower on PSYQOL generally showed larger improvement. Individual differences in HRQOL dominate differences between culture and cancer type, and illness beliefs influence HRQOL changes in individual patients. Clinical application is possible through influencing the patient's illness beliefs to create an optimal starting position for chemotherapy.

Quality of life in women undergoing urinary diversion for bladder cancer: results of a multicenter study among long-term disease-free survivors.

PubMed

Gacci, Mauro; Saleh, Omar; Cai, Tommaso; Gore, John L; D'Elia, Carolina; Minervini, Andrea; Masieri, Lorenzo; Giannessi, Claudia; Lanciotti, Michele; Varca, Virginia; Simonato, Alchiede; Serni, Sergio; Carmignani, Giorgio; Carini, Marco

2013-03-12

Women undergoing radical cystectomy (RC) and urinary diversion for bladder cancer experience substantial limitations in health-related quality of life (HRQOL). However, the level of discomfort caused by different urinary diversion has been never evaluated in long term survivors. The aim of this multicenter study is to evaluate differences in HRQOL among recurrence-free women undergoing cutaneous ureterostomy (CUS), Bricker's ileal conduit (BK-IC) and Orthotopic neobladder VIP (ONB-VIP) in disease-free females treated with radical cystectomy (RC), with long-term follow up (mean 60.1 months; range 36-122 months). All consecutively treated female patients from two urological institutions who underwent RC and urinary diversion from January 2000 to December 2008, with no evidence of tumor recurrence at a minimum follow up of 36 months, were included. Patients received the European Organisation for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-BL). Clinical data and questionnaire results were analyzed in order to evaluate the HRQOL differences among diversion groups. We identified 37 females (median age: 68, range 45-82 years), including 12 status-post CUS, 16 who underwent BK-IC, and 9 who underwent ONB-VIP. Most were healthy (24/37 with no comorbidities, 4/37 Charlson 1-2, 9/37 Charlson 3 or greater - we didn't considered bladder cancer in Charlson evaluation because bladder cancer was the main inclusion criteria). Women undergoing CUS endorsed worse FACT-BL scores compared with BK-IC and ONB-VIP patients, worse HRQOL regarding physical and emotional well-being (p=0.008 and p=0.02, respectively), and a trend toward worse EORTC QLQ-C30 scores for appetite loss and fatigue (p=0.05 for both). In our study long-term disease-free females treated with CUS endorsed worse HRQOL compared with women who underwent BK-IC or ONB-VIP, mostly due to worse physical and emotional perception of their body image.

Health-related quality of life of prostate cancer patients compared to the general German population: age-specific results.

PubMed

Zenger, Markus; Hinz, Andreas; Stolzenburg, Jens-Uwe; Rabenalt, Robert; Schwalenberg, Thilo; Schwarz, Reinhold

2009-01-01

The objective of this study was to examine the age-specific health-related quality of life (HRQOL) of prostate cancer patients (PCPs). 387 PCPs were asked to self-assess their HRQOL with the EORTC QLQ-C30 questionnaire. Patients' data were compared with those of the general German population. The reported global health/QOL scores of the study group and the general German population are nearly equal. However, most of the subdomains of HRQOL are negatively affected in PCPs, especially in younger patients (

Application of an IRT Polytomous Model for Measuring Health Related Quality of Life

ERIC Educational Resources Information Center

Tejada, Antonio J. Rojas; Rojas, Oscar M. Lozano

2005-01-01

Background: The Item Response Theory (IRT) has advantages for measuring Health Related Quality of Life (HRQOL) as opposed to the Classical Tests Theory (CTT). Objectives: To present the results of the application of a polytomous model based on IRT, specifically, the Rating Scale Model (RSM), to measure HRQOL with the EORTC QLQ-C30. Methods: 103…

Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurt, Christopher N., E-mail: hurtcn@cardiff.ac.uk; Mukherjee, Somnath; Bridgewater, John

Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT. Methods and Materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-basedmore » CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26). Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity. Conclusions: Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.« less

Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab.

PubMed

Topp, Max S; Zimmerman, Zachary; Cannell, Paul; Dombret, Hervé; Maertens, Johan; Stein, Anthony; Franklin, Janet; Tran, Qui; Cong, Ze; Schuh, Andre C

2018-05-08

In the phase 3 TOWER study, blinatumomab significantly improved overall survival in adults with relapsed or refractory (R/R) Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (BCP-ALL) relative to standard-of-care chemotherapy. A secondary objective of this study was to assess the impact of blinatumomab on health-related quality of life (HRQL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This analysis included the 342 of 405 randomized patients for whom baseline and ≥1 post-baseline result were available in any EORTC multi-item scale or single-item measure. In general, patients receiving blinatumomab (n=247) reported better posttreatment HRQL across all QLQ-C30 subscales, based on descriptive mean change from baseline, than did those receiving chemotherapy (n=95). The hazard ratios for time to a ≥10-point deterioration from baseline (TTD) in HRQL or death ranged from 0.42 to 0.81 in favor of blinatumomab, with the upper bounds of the 95% CI <1.0 across all measures, except insomnia, social functioning, and financial difficulties; sensitivity analysis of TTD in HRQL without the event of death were consistent with these findings. When treatment effect over time was tested using a restricted maximum likelihood-based mixed model for repeated measures analysis, p<0.05 was reached for blinatumomab vs chemotherapy for all subscale measures except financial difficulties. The clinically meaningful benefits in overall survival and HRQL support the clinical value of blinatumomab in patients with R/R Ph- BCP-ALL when compared with chemotherapy. Funded by Amgen (TOWER ClinicalTrials.gov number, NCT02013167). Copyright © 2018 American Society of Hematology.

Which Questionnaire Should Be Used to Measure Quality-of-Life Utilities in Patients with Acute Leukemia? An Evaluation of the Validity and Interpretability of the EQ-5D-5L and Preference-Based Questionnaires Derived from the EORTC QLQ-C30.

PubMed

van Dongen-Leunis, Annemieke; Redekop, W Ken; Uyl-de Groot, Carin A

The aim of this study was to assess the validity and interpretability of different preference-based questionnaires (generic 5-level EuroQol five-dimensional questionnaire [EQ-5D-5L], cancer-specific Quality of Life Questionnaire Preference-Based Measure, and European Organization of Randomized Controlled Trials 8 Dimension [EORTC-8D]) in patients with acute leukemia. Patients who participated in Hemato-Oncologie voor Volwassenen Nederland (HOVON - the Haemato Oncology Foundation for Adults in the Netherlands) clinical trials between 1999 and 2011 at a single hospital were invited to complete the questionnaires. Interpretability was evaluated by the frequency of incomplete data and highest and lowest possible scores. Content validity was evaluated by exploring the health-related quality-of-life domains included in the questionnaires. Construct validity was assessed using correlations with other quality-of-life scales (EQ-visual analogue scale score and global quality-of-life scale of the EORTC Quality of Life Questionnaire) and ability to distinguish between patients with different health statuses. Questionnaires were returned by 89% (111 of 125) of the patients. Six to seven respondents did not return full questionnaires. Perfect health on the EQ-5D-5L was reported by 32 respondents and many of them (N = 17) did report health problems on other questionnaires. All questionnaires were strongly correlated (range 0.61-0.78) with other quality-of-life scales and yielded substantially different utility values for patients with different health statuses. Nevertheless, the disease-specific preference-based questionnaires showed greater discriminatory power. Although the Quality of Life Questionnaire Preference-Based Measure and the EORTC-8D appear to have better validity, this study does not provide any strong evidence against the use of the EQ-5D-5L for measuring quality-of-life utilities in acute leukemia. However, our findings need to be confirmed in larger longitudinal studies. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Mapping the EORTC QLQ-C30 onto the EQ-5D-3L: assessing the external validity of existing mapping algorithms.

PubMed

Doble, Brett; Lorgelly, Paula

2016-04-01

To determine the external validity of existing mapping algorithms for predicting EQ-5D-3L utility values from EORTC QLQ-C30 responses and to establish their generalizability in different types of cancer. A main analysis (pooled) sample of 3560 observations (1727 patients) and two disease severity patient samples (496 and 93 patients) with repeated observations over time from Cancer 2015 were used to validate the existing algorithms. Errors were calculated between observed and predicted EQ-5D-3L utility values using a single pooled sample and ten pooled tumour type-specific samples. Predictive accuracy was assessed using mean absolute error (MAE) and standardized root-mean-squared error (RMSE). The association between observed and predicted EQ-5D utility values and other covariates across the distribution was tested using quantile regression. Quality-adjusted life years (QALYs) were calculated using observed and predicted values to test responsiveness. Ten 'preferred' mapping algorithms were identified. Two algorithms estimated via response mapping and ordinary least-squares regression using dummy variables performed well on number of validation criteria, including accurate prediction of the best and worst QLQ-C30 health states, predicted values within the EQ-5D tariff range, relatively small MAEs and RMSEs, and minimal differences between estimated QALYs. Comparison of predictive accuracy across ten tumour type-specific samples highlighted that algorithms are relatively insensitive to grouping by tumour type and affected more by differences in disease severity. Two of the 'preferred' mapping algorithms suggest more accurate predictions, but limitations exist. We recommend extensive scenario analyses if mapped utilities are used in cost-utility analyses.

The effect of cancer stage and treatment modality on quality of life in oropharyngeal cancer.

PubMed

Oates, Justine; Davies, Sarah; Roydhouse, Jessica K; Fethney, Judith; White, Kate

2014-01-01

To examine changes in health-related quality of life among oropharyngeal cancer patients by stages and across treatment types among advanced cancer patients. Individual prospective cohort study. All newly diagnosed patients with oropharyngeal cancer treated with curative intent were routinely assessed. The European Organization for Research and Treatment of Cancer (EORTC) both the Main Module quality-of-life questionnaire (QLQ-C30) and the Head and Neck Cancer (HNC) Module (QLQ-H&N35) were administered at diagnosis and 3, 6, and 12 months thereafter. Complete case analysis was used following assessment of missing data. The proportion of patients with clinically significant deterioration (changes of ≥ 10 points) from baseline were calculated for each follow-up time point and compared by stage (I/II vs. III/IV) and then treatment type (chemotherapy and radiotherapy [CRT] vs. surgery and postoperative radiotherapy [S&PORT]). Deterioration in most domains was most frequent for stage III/IV patients at 3 months (both modules), whereas stage I/II patients experienced this at 6 months (QLQ-C30) and 12 months (H&N35). Among stage III/IV patients, this happened at all time points for S&PORT patients (QLQ-C30) versus 12 months for CRT patients (H&N35). The number of patients reporting deterioration was lower for most domains at 12 months compared to earlier periods, although dry mouth remained a problem for most patients (60%-85% across treatment/stage groups). Our preliminary findings suggest that general and disease-specific deterioration is of most concern for stage I/II patients at 6 and 12 months and at 3 months for advanced cancer patients. For stage III/IV patients receiving S&PORT, general deterioration remains a problem after diagnosis, whereas for CRT patients, disease-specific deterioration is of most concern at 12 months. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Assessment of quality of life in patients with rectal cancer treated by preoperative radiotherapy: A longitudinal prospective study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Allal, Abdelkarim S.; Gervaz, Pascal; Gertsch, Philippe

2005-03-15

Purpose: To assess prospectively the quality of life (QOL) of patients treated by preoperative radiotherapy (RT) and surgery for locally advanced rectal cancer. Methods and materials: We studied 53 patients treated with bi-fractionated RT (50 Gy in 40 fractions within 4 weeks) followed at a median interval of 45 days by abdominoperineal resection in 11 patients and low anterior resection in 42 patients. Their QOL was assessed using two self-rating questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC): one was cancer specific (EORTC QLQ-C30) and one was site specific (EORTC QLQ-C38). The questionnaires were completedmore » before RT and 12-16 months after RT, at which time 17 patients had undergone colostomy. We hypothesized that at least some scores of the various scales would vary between the two analyses. Results: Compared with the pre-RT scores, at 1 year, patients reported statistically significant improvement in their emotional state (median 75 vs. 100, p <0.0001), perspective of the future (67 vs. 100, p = 0.0004), and their global QOL (75 vs. 83, p = 0.0008), as well as a decrease in GI symptoms (13 vs. 0, p = 0.002). However, the sexual dysfunction score increased significantly, particularly in men (17 vs. 83, p = 0.0045), and a trend toward a lower body image score was observed (100 vs. 89, p = 0.068). At 1 year, patients with colostomies reported similar or significantly improved symptom scores for fatigue, pain, GI problems, and sleep disturbance, but no such improvements were observed in patients without stomas. Conclusion: One year after combined treatment for locally advanced rectal cancer, patients exhibited statistically significant improvement in some important QOL outcomes, including global QOL, despite a decrease in sexual function and body image. Any additional improvement in QOL outcome may require refinements in the RT and surgical techniques to reduce late sequelae, particularly sexual dysfunction. Our results suggest that QOL considerations do not justify sphincter-conserving approaches if locoregional tumor control would be compromised.« less

Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.

PubMed

Harbeck, N; Iyer, S; Turner, N; Cristofanilli, M; Ro, J; André, F; Loi, S; Verma, S; Iwata, H; Bhattacharyya, H; Puyana Theall, K; Bartlett, C H; Loibl, S

2016-06-01

In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups. Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model. Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone. Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. NCT01942135. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial

PubMed Central

Harbeck, N.; Iyer, S.; Turner, N.; Cristofanilli, M.; Ro, J.; André, F.; Loi, S.; Verma, S.; Iwata, H.; Bhattacharyya, H.; Puyana Theall, K.; Bartlett, C. H.; Loibl, S.

2016-01-01

Background In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2− endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups. Patients and methods Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1–4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0–100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model. Results Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5–67.7 versus 63.0, 95% CI 60.6–65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (−3.3, 95% CI −5.1 to −1.5 versus 2.0, 95% CI −0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone. Conclusion Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. Clinical Trial Registration NCT01942135. PMID:27029704

Is the Life Space Assessment applicable to a palliative care population? Its relationship to measures of performance and quality of life.

PubMed

Phillips, Jane Louise; Lam, Lawrence; Luckett, Tim; Agar, Meera; Currow, David

2014-06-01

The spatial environments that palliative care patients frequent for business and leisure constrict as their disease progresses and their physical functioning deteriorates. Measuring a person's movement within his or her own environment is a clinically relevant and patient-centered outcome because it measures function in a way that reflects actual and not theoretical participation. This exploratory study set out to test whether the Life-Space Assessment (LSA) would correlate with other commonly used palliative care outcome measures of function and quality of life. The baseline LSA, Australia-modified Karnofsky Performance Status Scale (AKPS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative (EORTC QLQ-C15-PAL) scores from two large clinical trials were used to calculate correlation coefficients between the measures. Convergent validity analysis was undertaken by comparing LSA scores between participants with higher (≥70) and lower (≤60) AKPS scores. The LSA was correlated significantly and positively with the AKPS, with a moderate correlation coefficient of 0.54 (P<0.001). There was a significant weak negative correlation between the LSA and the EORTC QLQ-C15-PAL, with a small coefficient of -0.22 (P=0.027), but a strong correlation between the LSA and the EORTC QLQ-C15-PAL item related to independent activities of daily living (r=-0.654, P<0.01). A significant difference in the LSA score between participants with higher (≥70) and lower (≤60) AKPS scores t(97)=-4.35, P<0.001) was found. The LSA appears applicable to palliative care populations given the convergent validity and capacity of this instrument to differentiate a person's ability to move through life-space zones by performance status. Further research is required to validate and apply the LSA within community palliative care populations. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial.

PubMed

Groenvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette; Neergaard, Mette Asbjoern; Nielsen, Jan Bjoern; Pedersen, Lise; Sjøgren, Per; Strömgren, Annette Sand; Vejlgaard, Tove Bahn; Gluud, Christian; Lindschou, Jane; Fayers, Peter; Higginson, Irene J; Johnsen, Anna Thit

2017-10-01

Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

A structured review of health utility measures and elicitation in advanced/metastatic breast cancer.

PubMed

Hao, Yanni; Wolfram, Verena; Cook, Jennifer

2016-01-01

Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy - General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities.

A structured review of health utility measures and elicitation in advanced/metastatic breast cancer

PubMed Central

Hao, Yanni; Wolfram, Verena; Cook, Jennifer

2016-01-01

Background Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Methods Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. Results A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy – General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Conclusion Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities. PMID:27382319

Quality of life and disease understanding: impact of attending a patient-centered cancer symposium.

PubMed

Padrnos, Leslie; Dueck, Amylou C; Scherber, Robyn; Glassley, Pamela; Stigge, Rachel; Northfelt, Donald; Mikhael, Joseph; Aguirre, Annette; Bennett, Robert M; Mesa, Ruben A

2015-06-01

To evaluate the impact of a patient-centered symposium as an educational intervention on a broad population of cancer patients. We developed a comprehensive patient symposium. Through voluntary questionnaires, we studied the impact of this cancer symposium on quality of life, cancer-specific knowledge, and symptom management among cancer patients. Symposium attendees were provided surveys prior to and 3 months following the educational intervention. Surveys included (1) EORTC-QLQ-C30; (2) disease understanding tool developed for this conference; (3) validated disease-specific questionnaires. Changes over time were assessed using McNemar's tests and paired t-tests for categorical and continuous variables, respectively. A total of 158 attendees completed the pre-convention survey. Most respondents reported at least "quite a bit" of understanding regarding treatment options, screening modalities, symptomatology, and cancer-related side effects. Attendees endorsed the least understanding of disease-related stress, risk factors, fatigue management, and legal issues related to disease/treatment. At 3 months, there was improvement in understanding (12 of 14 areas of self-reported knowledge especially regarding nutrition, and stress/fatigue management). However, no significant change was seen in QLQ-C30 functioning, fatigue, pain, or insomnia. A patient symposium, as an educational intervention improves a solid knowledge base amongst attendees regarding their disease, increases knowledge in symptom management, but may be insufficient to impact QoL as a single intervention. © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Effect of prophylactic percutaneous endoscopic gastrostomy tube on swallowing in advanced head and neck cancer: A randomized controlled study.

PubMed

Axelsson, Lars; Silander, Ewa; Nyman, Jan; Bove, Mogens; Johansson, Leif; Hammerlid, Eva

2017-05-01

Dysphagia is common in head and neck cancer. A percutaneous endoscopic gastrostomy (PEG) tube is used to facilitate nutrition; however, some retrospective studies have indicated that the PEG tube causes dysphagia. A randomized study of patients with head and neck cancer was conducted with up to 10 years of follow-up. Patients were randomized to either the prophylactic PEG tube group (study group) or the common clinical nutritional support group (control group). At each follow-up, a dietician assessed the oral intake, noted the patients' weight, and if the patients used a PEG tube. Dysphagia was also assessed by the quality of life questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC-QLQ-H&N35). One hundred thirty-four patients were included in this study. There was no significant difference in swallowing function between the groups after 12 months, 24 months, and 8 years based on the EORTC-QLQ-H&N35, the oral intake scale, tube dependence, esophageal intervention, weight, body mass index (BMI), and overall survival. A prophylactic PEG tube can be used without an increased risk of long-term dysphagia in patients with head and neck cancer. © 2017 Wiley Periodicals, Inc. Head Neck 39: 908-915, 2017. © 2017 Wiley Periodicals, Inc.

Prospective assessment of the quality of life in patients treated surgically for rectal cancer with lower anterior resection and abdominoperineal resection.

PubMed

Monastyrska, E; Hagner, W; Jankowski, M; Głowacka, I; Zegarska, B; Zegarski, W

2016-11-01

Rectal cancer is the most common malignant neoplasm of the gastrointestinal tract. The aim of the study was to assess the quality of life in patients undergoing surgical treatment for the rectal cancer, either lower anterior or abdominoperineal resection. 100 patients suffering from rectal cancer were selected for a prospective study (50-APR, 50-LAR). The quality of life was assessed two times: at the admission to the Department and 6 months following surgery. For assessment of the quality of life, two standard questionnaires were used, EORT QLQ-C30 and EORTC QLQ-C29. The studied groups were not different with respect to demographic factors. The patients who underwent LAR spent less time in hospital (p = 0.00001). The patients undergoing APR scored less with respect to physical ability (p = 0.0434), cognitive (p = 0.0363) and emotional state (p = 0.0463) and on symptom scale (nausea and vomiting - p: 0.0199, diarrhea - p: 0.0000, constipation (p = 0.0018)); however, the patients who were treated with LAR scored less on pain scale (p = 0.0189). The QLQ-C29 questionnaire revealed impaired functioning of patients 6 months following APR in terms of life chances (p = 0.0000) and problems with body weight (p = 0.0212). In both groups, the quality of life improved 6 months after surgery. LAR is a chance for better quality of life for many patients. Six months after surgery, the quality of life of patients improves regardless of the operating method (APR, LAR). Copyright © 2016 Elsevier Ltd, BASO ~ the Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Scintigraphic assessment of salivary function after intensity-modulated radiotherapy for head and neck cancer: correlations with parotid dose and quality of life.

PubMed

Chen, Wen-Cheng; Lai, Chia-Hsuan; Lee, Tsair-Fwu; Hung, Chao-Hsiung; Liu, Kuo-Chi; Tsai, Ming-Fong; Wang, Wen-Hung; Chen, Hungcheng; Fang, Fu-Ming; Chen, Miao-Fen

2013-01-01

We investigated salivary function using quantitative scintigraphy and sought to identify functional correlations between parotid dose and quality of life (QoL) for head and neck cancer (HNC) patients receiving intensity-modulated radiotherapy (IMRT). Between August, 2007 and June, 2008, 31 patients treated IMRT for HNC were enrolled in this prospective study. Salivary excretion function (SEF) was previously measured by salivary scintigraphy at annual intervals for 2 years after IMRT. A dose-volume histogram of each parotid gland was calculated, and the normal tissue complication probability (NTCP) was used to determine the tolerance dose. QoL was longitudinally assessed by the EORTC QLQ-C30 and H&N35 questionnaires prior to RT, and at one, three, 12 and 24 months after RT. A significant correlation was found between the reduction of SEF and the mean parotid dose measured at 1 year (correlation coefficient, R(2)=0.651) and 2 years (R(2)=0.310) after IMRT (p<0.001). The TD(50) of the parotid gland at 1 year after IMRT is 43.6 Gy, comparable to results from western countries. We further found that contralateral parotid and submandibular gland function preservation was correlated with reduced sticky saliva and a better QoL compared to the functional preservation of both parotid glands, as determined by the EORTC QLQ-H&N35 questionnaire. A significant correlation was found between the reduction of SEF and the mean parotid dose. Preservation of contralateral parotid and submandibular gland function predicts a better QoL compared to preservation of the function of both parotid glands. Copyright © 2012 Elsevier Ltd. All rights reserved.

Patients after colostomy: relationship between quality of life and acceptance of disability and social support.

PubMed

Zhang, Tie-Ling; Hu, Ai-Ling; Xu, Hong-Lian; Zheng, Mei-Chun; Liang, Ming-Juan

2013-11-01

The aim of this research was to explore quality of life (QOL) and acceptance of disability and social support of colostomy patients as well as the relationship between these factors. A descriptive, correlational study was conducted using four scales: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-CR38) scales, the Acceptance of Disability Scale (ADS), and the Social Relational Quality Scale (SRQS). A convenience sample of 111 colostomy patients from four hospitals in Guangzhou who underwent colostomy operation at least one month prior to the study and who visited the stoma clinic or association from August 2011 to February 2012 was evaluated for inclusion in the study. All statistical analyses were performed using SPSS 17.0 software (SPSS Inc., Chicago, IL, USA). The patients' general health status was better than the reference level recommended by European Organization for Research and Treatment of Cancer, and the overall ADS score was average. The SRQS score was similar to that found in a Hong Kong study. The general health status and dimensions of QOL were significantly correlated with ADS and all of its dimensions (P < 0.05). The general health status and dimensions of QOL were also significantly correlated with SRQS and all of its dimensions (P < 0.05). QOL, acceptance of disability, and social relational quality of colostomy patients were closely related. Our results emphasize that patients should work to form rational values and close bonds with families and friends to achieve a better QOL.

Web-based information and support for patients with a newly diagnosed neuroendocrine tumor: a feasibility study.

PubMed

Bouma, Grietje; de Hosson, Lotte D; van Woerkom, Claudia E; van Essen, Hennie; de Bock, Geertruida H; Admiraal, Jolien M; Reyners, Anna K L; Walenkamp, Annemiek M E

2017-07-01

Patients with a neuroendocrine tumor (NET) frequently experience physical and psychosocial complaints. Novel strategies to provide information to optimize supportive care in these patients are of interest. The aim of this study was to examine whether the use of a web-based system consisting of self-screening of problems and care needs, patient education, and self-referral to professional health care is feasible in NET patients and to evaluate their opinion on this. Newly diagnosed NET patients were randomized between standard care (n = 10) or intervention with additional access to the web-based system (n = 10) during 12 weeks. Patients completed questionnaires regarding received information, distress, quality of life (QoL), and empowerment. The intervention group completed a semi-structured interview to assess patients' opinion on the web-based system. The participation rate was 77% (20/26 invited patients) with no dropouts. The use of the web-based system had a negative effect on patients' perception and satisfaction of received information (range Cohen's d -0.88 to 0.13). Positive effects were found for distress (Cohen's d 0.75), global QoL (subscale European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, Cohen's d 0.46), resolving problems with social functioning and finding information (subscales EORTC QLQ-GINET 21, Cohen's d 0.69, respectively, 1.04), and feeling informed (subscale empowerment questionnaire, Cohen's d 0.51). The interview indicated that the web-based system was of additional value to standard care. Use of this web-based system is feasible. Contradictory effects on informing and supporting NET patients were found and should be subject of further research. NCT01849523.

Biologically based therapies are commonly self-prescribed by Brazilian women for the treatment of advanced breast cancer or its symptoms.

PubMed

Alfano, Ana Camila Callado; Paiva, Carlos Eduardo; Rugno, Fernanda Capella; da Silva, Raquel Haas; Paiva, Bianca Sakamoto Ribeiro

2014-05-01

Breast cancer (BC) might be associated with loss of function in affected patients, with a direct impact on their quality of life (QOL). Many women with metastatic BC seek relief of symptoms, including the use of complementary and alternative medicine (CAM) to cure cancer. The present study aimed to identify the pattern of CAM used by patients with metastatic BC and to assess the correlation between CAM use and scores on anxiety, depression, and QOL scales. A total of 126 women with metastatic BC were interviewed using four instruments: (1) a questionnaire containing socioeconomic, clinical, and demographic data and CAM use; (2) European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ)-C30; (3) EORTC QLQ-BR23; and (4) the Hospital Anxiety and Depression Scale. Fifty percent of the participants reported the use of at least one CAM modality. Biologically based practices were the most frequently used to treat BC and/or its symptoms, the most commonly discussed with the oncologists, and one of the CAM categories in which more patients reported a desire to learn more about. The overall use of CAM was not correlated with the scores on the anxiety, depression, and QOL scales. However, analysis of the association of the QOL scores with specific CAM modalities revealed some potential associations (especially for food supplements, art therapy, psychotherapy, and prayer). Women with metastatic BC frequently make use of CAM to treat the cancer and/or its symptoms. Biologically based practices seem to be particularly important in Brazil. An association between specific CAM modalities and some QOL domains was suggested, but it needs further confirmation.

Reliability and Validity of the Korean Version of the Cancer Stigma Scale.

PubMed

So, Hyang Sook; Chae, Myeong Jeong; Kim, Hye Young

2017-02-01

In this study the reliability and validity of the Korean version of the Cancer Stigma Scale (KCSS) was evaluated. The KCSS was formed through translation and modification of Cataldo Lung Cancer Stigma Scale. The KCSS, Psychological Symptom Inventory (PSI), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) were administered to 247 men and women diagnosed with one of the five major cancers. Construct validity, item convergent and discriminant validity, concurrent validity, known-group validity, and internal consistency reliability of the KCSS were evaluated. Exploratory factor analysis supported the construct validity with a six-factor solution; that explained 65.7% of the total variance. The six-factor model was validated by confirmatory factor analysis (Q (χ²/df)= 2.28, GFI=.84, AGFI=.81, NFI=.80, TLI=.86, RMR=.03, and RMSEA=.07). Concurrent validity was demonstrated with the QLQ-C30 (global: r=-.44; functional: r=-.19; symptom: r=.42). The KCSS had known-group validity. Cronbach's alpha coefficient for the 24 items was .89. The results of this study suggest that the 24-item KCSS has relatively acceptable reliability and validity and can be used in clinical research to assess cancer stigma and its impacts on health-related quality of life in Korean cancer patients. © 2017 Korean Society of Nursing Science

Comparison of Quality of Life and Nutritional Status in Gastric Cancer Patients Undergoing Gastrectomies.

PubMed

Lim, Hee-Sook; Cho, Gyu-Seok; Park, Yoon-Hyung; Kim, Soon-Kyung

2015-07-01

The aim of this study was to compare the quality of life (QoL) depending on the postoperative survival period or nutritional status in gastric cancer patients. Surviving gastric cancer patients (n = 222) after the gastrectomy were included in the study at Soonchunhyang University Bucheon Hospital from April 2010 to August 2012. The Korean versions of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and a gastric cancer-specific module, the EORTC QLQ-STO22, were used to assess the QoL. The postoperative survival period of the patients fell into two groups; the less-than-1-year group or the more-than-1-year group, and the nutritional status of the patients fell into three groups by a score of patient generated-subjective global assessment (SGA)-A, B, and C. As a result, the rate of malnutrition was 34.5% in the less-than-1-year group and 19.8% in the more-than-1-year group, respectively. Score for the fatigue (p = 0.006), loss of appetite (p = 0.002), reflux (p = 0.027) and body image (p = 0.004) in which the QoL was significantly lower in the less-than-1-year group than in the more-than-1-year group. The score of QoL according to the nutritional status of all subjects, overall health status (p = 0.043), physical functioning (p = 0.016), fatigue (p = 0.006), pain (p = 0.028), loss of appetite (p = 0.017), reflux (p = 0.003), eating restriction (p = 0.002), anxiety (p = 0.010), and body image (p = 0.001) was significantly lower in the SGA-C group than in other SGA groups. These results suggest that the nutritional status of the gastrectomy patients with stomach cancer may impact on their QoL. It is necessary to to develop nutritional intervention to improve QoL in gastric cancer patients with postoperative malnutrition.

Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer.

PubMed

Hjermstad, Marianne Jensen; Kaasa, Stein; Caraceni, Augusto; Loge, Jon H; Pedersen, Tore; Haugen, Dagny Faksvåg; Aass, Nina

2016-09-01

Breakthrough cancer pain (BTP) represents a treatment challenge. Objectives were to examine the prevalence and characteristics of BTP in an international sample of patients with cancer, and to investigate the relationship between BTP and quality of life (QoL). This was an observational cross-sectional multicentre study. Participating patients completed self-report questionnaires on a touch-screen laptop computer, including the Brief Pain Inventory, Alberta Breakthrough Pain Assessment Tool (ABPAT) and European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ-C30). The study was performed in 17 centres in 8 countries and involved 4 languages (Norwegian, Italian, German and English). Records from a convenience sample of 978 patients with advanced cancer were analysed; mean age was 62.2 years, 48.3% were women and 84.4% had metastatic disease. A total of 296 patients (30%) had no pain, defined as worst pain in the past 24 hours <1 on a 0-10 scale. Of the 682 patients with a pain score ≥1, 393 (58%) reported no BTP on the screening item, while 289 (30%) confirmed flare ups of BTP. Patients with BTP reported significantly higher pain intensity scores (<0.001) than patients without BTP; 57.1% of patients rated BTP at its worst as being severe: ≥7 on a 0-10 scale. Time from onset to peak intensity was <10 min for 42.9%, and average time to pain relief was 27.1 min. BTP was commonly triggered by medication wearing off (28%). Patients with BTP had significantly worse mean outcomes on 10 of 15 functional and symptom scales of the EORTC QLQ-C30 (<0.001). Severe pain intensity in the last week was a powerful predictor of BTP (OR 4.1) and poor QoL (OR 1.9). BTP is highly prevalent with prolonged episodes despite analgaesics, and has a pervasive impact on QoL. Patients reporting high pain intensity should be carefully evaluated for BTP and efficacy of analgaesic treatment, to provide optimal pain management and improve QoL. NCT00972634; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Quality of life in cancer survivors 5 years or more after total gastrectomy: a case-control study.

PubMed

Lee, Seung Soo; Chung, Ho Young; Kwon, Oh Kyoung; Yu, Wansik

2014-01-01

This study investigated how total gastrectomy (TG), along with memories of cancer, affect the subjective wellness of survivors long after surgery. Rational approaches for effectively improving the quality of life (QoL) of these survivors were suggested. Between 2008 and 2013, QoL data of gastric cancer patients who underwent a curative TG, were obtained at 5-year postoperative follow-up visits (5-year survivors) and at visits beyond 5 years (long-term survivors). The control groups for these survivor groups were constructed from volunteers who visited our health-examination center for annual medical checkups. The Korean versions of the European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the gastric cancer specific module, the EORTC QLQ-STO22, were used to assess QoL. Five-year survivors showed worse QoL compared to the control group in role functioning, social functioning, nausea/vomiting, appetite loss, financial difficulties, reflux, eating restrictions, taste, and body image, and better QoL in the emotional and cognitive functioning scales. In long-term survivors, deterioration in QoL were still apparent in financial difficulties, reflux, and eating restrictions, while QoL differences in the remaining scales had diminished. Surviving 5 years after TG does not result in living in a carefree state in terms of QoL. After 5 postoperative years, survivors still need extended care for deteriorated QoL indicators due to symptomatic, behavioral, and financial consequences of surgery. While relevant clinical and institutional approaches are required for corresponding declines in QoL, such efforts must extend beyond 5 postoperative years. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Spiritual well-being and quality of life among Icelanders receiving palliative care: data from Icelandic pilot-testing of a provisional measure of spiritual well-being from the European Organisation for Research and Treatment of Cancer.

PubMed

Asgeirsdottir, G H; Sigurdardottir, V; Gunnarsdottir, S; Sigurbjörnsson, E; Traustadottir, R; Kelly, E; Young, T; Vivat, B

2017-03-01

Palliative care focuses on improving quality of life (QoL). This study examined the feasibility of the Icelandic version of a provisional European Organisation for Research and Treatment of Cancer (EORTC) measure of spiritual well-being (SWB), and explored the relationship between SWB and QoL for palliative care patients in Iceland. Instruments from the EORTC were used: the provisional measure of SWB, which was undergoing pilot-testing in Iceland, and the EORTC QLQ C15-PAL. The correlation between scores was examined and descriptive statistics were used. Structured interviews explored feasibility. Thirty persons participated with average age 72 years. Belief in God or a higher power had the mean 3.33 on a 1-4 scale and the mean for overall SWB was 5.73 on a 1-7 scale. The mean score for global health/QoL was 59.4, physical functioning 48.5 and emotional functioning 78.9 on a 0-100 scale. Overall QoL was positively correlated with SWB showing r(30) = 0.386, P = 0.035. The participants found that answering the provisional EORTC QLQ-SWB prompted an emotional response and took the opportunity to discuss the subject. The provisional SWB measure was found relevant for the Icelandic context, and the study indicates that SWB and QoL are closely connected. © 2015 John Wiley & Sons Ltd.

Prospective external convergence evaluation of two different quality-of-life instruments in lung resection patients.

PubMed

Pompili, Cecilia; Brunelli, Alessandro; Xiumé, Francesco; Refai, Majed; Salati, Michele; Socci, Laura; Di Nunzio, Luca; Sabbatini, Armando

2011-07-01

The interpretation of studies on quality of life (QoL) after lung surgery is often difficult owing to the use of multiple instruments with inconsistent scales and metrics. Although a more standardized approach would be desirable, the most appropriate instrument to be used in this setting is still largely undefined. The aim of the study was to assess the respective ability of two validated QoL instruments (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30/L13 and Short Form (36) Health Survey (SF-36)) to detect perioperative changes in QoL of patients submitted to pulmonary resection for non-small-cell lung cancer (NSCLC). A prospective study on 33 consecutive patients (May 2009-December 2009) was submitted to pulmonary resection. All patients completed both EORTC QLQ-C30 with lung module 13 and SF-36 pre- and postoperatively (3 months). Preoperative changes of all SF-36 and EORTC scales were assessed by using the Cohen's effect-size method. External convergence between different instruments (SF-36 vs EORTC) was assessed by measuring the correlation of scales evaluating the same concepts (physical, psychosocial, and emotional). The correlation coefficients between standardized perioperative changes (effect sizes) of objective functional parameters (forced expiratory volume in 1s (FEV1) and diffusion lung capacity for carbon monoxide (DLCO)) and SF-36 or EORTC scales were also investigated. A poor correlation (r < 0.5) was detected between most of the scales of the two instruments measuring the same QoL concepts, indicating that they may be complementary in investigating different aspects of QoL. Only the SF-36 and EORTC social functioning scales and the SF-36 mental health and EORTC emotional functioning scales had a correlation coefficient >0.5. In general, EORTC was more sensitive in detecting physical or emotional declines but was more conservative in detecting improvements. Both SF-36 and EORTC showed poor correlations (r < 0.5) between perioperative changes in QoL and FEV1 or DLCO, confirming that objective parameters cannot be surrogates to the subjective perception of QoL. In particular, there was a poor correlation between perceived changes in dyspnea and objective changes in FEV1 or DLCO. EORTC behaved similarly to SF-36 in assessing perioperative changes in generic QoL scales, but, with the use of its lung module, provided a more detailed evaluation of specific symptoms. For this reason, EORTC should be regarded as the instrument of choice for measuring QoL in the thoracic surgery setting. Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

PubMed

van Leeuwen, Marieke; Husson, Olga; Alberti, Paola; Arraras, Juan Ignacio; Chinot, Olivier L; Costantini, Anna; Darlington, Anne-Sophie; Dirven, Linda; Eichler, Martin; Hammerlid, Eva B; Holzner, Bernhard; Johnson, Colin D; Kontogianni, Meropi; Kjær, Trille Kristina; Morag, Ofir; Nolte, Sandra; Nordin, Andrew; Pace, Andrea; Pinto, Monica; Polz, Katja; Ramage, John; Reijneveld, Jaap C; Serpentini, Samantha; Tomaszewski, Krzysztof A; Vassiliou, Vassilios; Verdonck-de Leeuw, Irma M; Vistad, Ingvild; Young, Teresa E; Aaronson, Neil K; van de Poll-Franse, Lonneke V

2018-06-04

The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Psychometric Characteristics of a Patient Reported Outcome Measure on Ego-Integrity and Despair among Cancer Patients

PubMed Central

Kleijn, Gitta; Post, Lenneke; Witte, Birgit I.; Bohlmeijer, Ernst T.; Westerhof, Gerben J.; Cuijpers, Pim; Verdonck-de Leeuw, Irma M.

2016-01-01

Purpose To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS)) on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences) and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness) among cancer patients. Methods Cancer patients (n = 164) completed patient reported outcome measures on ego-integrity and despair (NEIS), psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57) or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107)). Confirmatory Factor Analysis was used to assess construct validity. Cronbach’s alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety. Results The majority of all items (94.5%) of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items) and Despair (4 items) had acceptable internal consistency (Cronbach’s alpha .72 and .61, respectively). The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001) with quality of life (r = -.29), distress (r = .44), anxiety (r = .47) and depression (r = .32). Conclusion The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients. PMID:27195750

The experiences of health-related quality of life in patients with nonspecific symptoms who undergo a diagnostic evaluation for cancer: a qualitative interview study.

PubMed

Moseholm, Ellen; Lindhardt, Bjarne Oerskov; Rydahl-Hansen, Susan

2017-09-01

The diagnostic phase of cancer can affect health-related quality of life (HRQoL). The aim of this study was to investigate how patients with nonspecific symptoms experience HRQoL while undergoing diagnostic evaluations for cancer. Twenty-one participants who had completed a fast-track evaluation for possible cancer at one of three hospitals in the Capital Region, Denmark were interviewed 2-4 weeks after completing diagnostic evaluations. The interviews were semi-structured and were supported by an interview guide based on the same themes as in The European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORCT-QLQ-C30). Data analysis was based on qualitative content analysis by Krippendorff. The analysis generated six categories: symptoms, physical-, role-, emotional-, cognitive- and social functioning, and the diagnostic fast-track experience. From these categories, a main theme was identified: Health-related quality of life is not solely affected by the diagnostic process. The results provide a comprehensive understanding of HRQoL in the diagnostic phase of possible cancer, which can be used not only to enhance evidence-based care, but also in the interpretation of the EORTC-QLQ-C30 scores. Psycho-social support with a focus on individual informational needs during the diagnostic phase may be warranted. © 2016 Nordic College of Caring Science.

Hemiparesis after Operation of Astrocytoma Grade II in Adults: Effects of Acupuncture on Sensory-Motor Behavior and Quality of Life

PubMed Central

Yu, Haibo; Schröder, Sven; Li, Zhifeng; Yang, Ying; Chen, Yu; Huang, Xingxian

2013-01-01

To evaluate the effect of acupuncture on hemiparesis and quality of life for adults with brain astrocytoma grade II, we conducted a randomized, observer-blinded clinical trial. Fifty-eight patients were randomized to standard rehabilitation (SR) therapy without acupuncture (n = 20), SR plus standard acupuncture (SA) (n = 19), and SR plus individualized acupuncture (IA) (n = 19). SA points were PC6, SP6, HT1, LU5, BL40, and ST36, while a special concept called “connecting and regulation Ren and Du” and “Jin-3-needling” served as IA. This treatment was individualized according to the clinical syndrome. The outcome was measured by the Barthel Index (BI), the Fugl-Meyer scale (FM), and the EORTC Core Quality of Life Questionnaire (QLQ-C30) with the Brain Cancer Module (BCM20). IA + SR reached significantly higher BI scores than SA + SR, which reached significantly higher BI scores than SR. IA + SR was significantly superior to SA + SR and to SR at the 8th week for the scores of FM motor and sensory assessments and most QLQ-C30-BCM20 items. In conclusion, the individualized acupuncture concept of “connecting and regulating Ren and Du” combined with “Jin-3-needling” offers a promising possibility for the treatment of hemiparesis due to astrocytoma, but further evaluation is mandatory. PMID:23864900

Comparing counseling and dignity therapies in home care patients: A pilot study.

PubMed

Rudilla, David; Galiana, Laura; Oliver, Amparo; Barreto, Pilar

2016-08-01

Several studies have successfully tested psychosocial interventions in palliative care patients. Counseling is the technique most often employed. Dignity therapy (DT) has recently emerged as a tool that can be utilized to address patients' needs at the end of life. The aims of our study were to examine the effects of DT and counseling and to offer useful information that could be put into practice to better meet patients' needs. We developed a pilot randomized controlled trial at the Home Care Unit of the General University Hospital of Valencia (Spain). Some 70 patients were assigned to two therapy groups. The measurement instruments employed included the Patient Dignity Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Resilient Coping Scale (BRCS), the GES Questionnaire, the Duke-UNC-11 Functional Social Support Questionnaire, and two items from the EORTC Quality of Life C30 Questionnaire (EORTC-QLQ-C30). The results of repeated-measures t tests showed statistically significant differences with respect to the dimensions of dignity, anxiety, spirituality, and quality of life for both groups. However, depression increased in the DT group after the intervention, and there were no differences with respect to resilience. Therapy in the counseling group did not negatively affect depression, and resilience did improve. When post-intervention differences between groups were calculated, statistically significant differences in anxiety were found, with lower scores in the counseling group (t(68) = -2.341, p = 0.022, d = 0.560). Our study provided evidence for the efficacy of dignity therapy and counseling in improving the well-being of palliative home care patients, and it found better results in the counseling therapy group with respect to depression, resilience, and anxiety.

Working in silos? - Head & Neck cancer patients during and after treatment with or without early palliative care referral.

PubMed

Ullgren, Helena; Kirkpatrick, Lily; Kilpeläinen, Sini; Sharp, Lena

2017-02-01

The primary aim was to describe patients with Head and Neck (H&N) cancer referred to palliative care and how the care transition from acute oncological to palliative care impacted on both Health related quality of life (HRQoL) and information. The secondary aim was to explore H&N cancer patients' HRQoL and perceived information. H&N cancer patients were identified via the Swedish Cancer Register. Data were collected using the following questionnaires; European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30, INFO25, and a study-specific questionnaire. Out of 289 patients, 203 (70%) responded and among these, 43 (21%) reported being referred to palliative care. Global health was the lowest reported functional scale (median score = 67) and fatigue (median scores 33) the highest reported symptom (QLQ C-30). Patients with a written care plan were significantly more satisfied with information regarding self-care compared to patients without a care plan. Patients referred to palliative care were less satisfied with information regarding disease (p < 0.000), the spread of the disease (p < 0.001) and were more likely to visit hospital emergency departments (43% vs. 19% p < 0.000). To avoid H&N cancer care in silos, a closer integration between the oncology and the palliative care team is needed. Further research on the complex situation of having oncological treatment concurrent with palliative care, is needed. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The european organization for research and treatment of cancer quality of life questionnaire-BR 23 breast cancer-specific quality of life questionnaire: psychometric properties in a Moroccan sample of breast cancer patients

PubMed Central

2014-01-01

Background Quality of life (QOL) and its measurement in cancer patients is becoming increasingly important. Breast cancer diagnosis and treatment are often associated with psychological distress and reduced QoL. In Arabic-speaking countries, QoL of patients with cancer is inadequately studied. The aim of this study was to test the reliability and validity of the Moroccan Arabic version of the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). Methods After translation and cross-cultural adaptation, the questionnaire was tested on breast cancer patients. The participants’ number for the test and the retest were 105 and 37 respectively. Internal consistency was tested using Cronbach’s alpha coefficient (α), the test-retest reliability using intraclass correlation coefficients (ICC). Construct validity was assessed by examining item-convergent and divergent validity. Results The questionnaire was administered to 105 patients. The mean age of patients was 48 years (SD: 16), 62.9% were married. 68.6% of all participants lived in urban area. The average time to complete the QLQ- BR23 was 15 min. Cronbach’s alpha coefficient, were all >0.7, with the exception of breast symptoms and arm symptoms. All items exceeded the 0.4 criterion for convergent validity except item 20 and 23 related to pain and skin problems in the affected breast respectively. Conclusion In general, the findings of this study indicated that the Moroccan Arabic version of the EORTC QLQ-BR23 is a reliable and valid supplementary measure of the QOL in breast cancer patients and can be used in clinical trials and studies of outcome research in oncology. PMID:24447401

The European Organization for Research and Treatment of Cancer quality of life questionnaire-BR23 Breast Cancer-Specific Quality of Life Questionnaire: psychometric properties in a Moroccan sample of breast cancer patients.

PubMed

El Fakir, Samira; Abda, Naima; Bendahhou, Karima; Zidouh, Ahmed; Bennani, Maria; Errihani, Hassan; Benider, Abdelatif; Bekkali, Rachid; Nejjari, Chakib

2014-01-21

Quality of life (QOL) and its measurement in cancer patients is becoming increasingly important. Breast cancer diagnosis and treatment are often associated with psychological distress and reduced QoL. In Arabic-speaking countries, QoL of patients with cancer is inadequately studied.The aim of this study was to test the reliability and validity of the Moroccan Arabic version of the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). After translation and cross-cultural adaptation, the questionnaire was tested on breast cancer patients. The participants' number for the test and the retest were 105 and 37 respectively. Internal consistency was tested using Cronbach's alpha coefficient (α), the test-retest reliability using intraclass correlation coefficients (ICC). Construct validity was assessed by examining item-convergent and divergent validity. The questionnaire was administered to 105 patients. The mean age of patients was 48 years (SD: 16), 62.9% were married. 68.6% of all participants lived in urban area.The average time to complete the QLQ- BR23 was 15 min. Cronbach's alpha coefficient, were all >0.7, with the exception of breast symptoms and arm symptoms. All items exceeded the 0.4 criterion for convergent validity except item 20 and 23 related to pain and skin problems in the affected breast respectively. In general, the findings of this study indicated that the Moroccan Arabic version of the EORTC QLQ-BR23 is a reliable and valid supplementary measure of the QOL in breast cancer patients and can be used in clinical trials and studies of outcome research in oncology.

Information perception, wishes, and satisfaction in ambulatory cancer patients under active treatment: patient-reported outcomes with QLQ-INFO25

PubMed Central

Pinto, Ana Catarina; Ferreira-Santos, Fernando; Lago, Lissandra Dal; de Azambuja, Evandro; Pimentel, Francisco Luís; Piccart-Gebhart, Martine; Razavi, Darius

2014-01-01

Background Information is vital to cancer patients. Physician–patient communication in oncology presents specific challenges. The aim of this study was to evaluate self-reported information of cancer patients in ambulatory care at a comprehensive cancer centre and examine its possible association with patients’ demographic and clinical characteristics. Patients and methods This study included adult patients with solid tumours undergoing chemotherapy at the Institute Jules Bordet’s Day Hospital over a ten-day period. EORTC QLQ-C30 and QLQ-INFO25 questionnaires were administered. Demographic and clinical data were collected. Descriptive and inferential statistics were used. Results 101 (99%) fully completed the questionnaires. They were mostly Belgian (74.3%), female (78.2%), with a mean age of 56.9 ± 12.8 years. The most frequent tumour was breast cancer (58.4%). Patients were well-informed about the disease and treatments, but presented unmet information domains. The Jules Bordet patients desired more information on treatment side effects, long-term outcome, nutrition, and recurrence symptoms. Patients on clinical trials reported having received less information about their disease and less written information than patients outside clinical trials. Higher information levels were associated with higher quality of life (QoL) scores and higher patient satisfaction. Conclusion Patients were satisfied with the information they received and this correlated with higher QoL, but they still expressed unmet information wishes. Additional studies are required to investigate the quality of the information received by patients enrolled in clinical trials. PMID:24834120

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

PubMed

Poort, Hanneke; Verhagen, Constans A H H V M; Peters, Marlies E W J; Goedendorp, Martine M; Donders, A Rogier T; Hopman, Maria T E; Nijhuis-van der Sanden, Maria W G; Berends, Thea; Bleijenberg, Gijs; Knoop, Hans

2017-01-28

Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.

Effects of Anma therapy (Japanese massage) on health-related quality of life in gynecologic cancer survivors: A randomized controlled trial.

PubMed

Donoyama, Nozomi; Satoh, Toyomi; Hamano, Tetsutaro; Ohkoshi, Norio; Onuki, Mamiko

2018-01-01

Anma therapy (Japanese massage therapy, AMT) significantly reduces the severity of physical complaints in survivors of gynecologic cancer. However, whether this reduction of severity is accompanied by improvement in health-related quality of life is unknown. Forty survivors of gynecologic cancer were randomly allocated to either an AMT group that received one 40-min AMT session per week for 8 weeks or a no-AMT group. We prospectively measured quality of life by using the Japanese version of the European Organization for Research and Treatment of Cancer QLQ-C30 version 3.0 (EORTC QLQ-C30) at baseline and at 8-week follow-up. The QLQ-C30 response rate was 100%. Hospital Anxiety Depression Scale (HADS), Profile of Mood States (POMS), and Measure of Adjustment to Cancer were also prespecified and prospectively evaluated. The QLQ-C30 Global Health Status and Quality of Life showed significant improvement at 8 weeks (P = 0.042) in the AMT group compared with the no-AMT group, and the estimated mean difference reached a minimal clinically important difference of 10 points (10.4 points, 95% CI = 1.2 to 19.6). Scores on fatigue and insomnia showed significant improvement in the AMT group compared with the no-AMT group (P = 0.047 and 0.003, respectively). There were no significant between-group improvements in HADS anxiety and depression scales; however, POMS-assessed anger-hostility showed significant improvement in the AMT group compared with the no-AMT group (p = 0.028). AMT improved health-related quality of life in gynecologic cancer survivors. AMT can be of potential benefit for applications in oncology.

A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration: Interim Results

PubMed Central

Rezk, Youssef A; Hurley, Karen E; Carter, Jeanne; Dao, Fanny; Bochner, Bernard H; Aubey, Janice J; Caceres, Aileen; Einstein, M. Heather; Abu-Rustum, Nadeem R; Barakat, Richard R; Chi, Dennis S; Maker, Vicky

2014-01-01

Purpose Little prospective data exist on quality of life (QOL) after pelvic exenteration (PE). This ongoing study prospectively examines the QOL-changes following this radical procedure using a comprehensive battery of psychological instruments. Methods Since 2005, enrolled patients were interviewed (EORTC QLQ-C30, EORTC QLQ-CR38, EORTC QLQ-BLM30, BFI, BPI-SF, IADL, CES-D, IES-R) preoperatively and at 3, 6, and 12 months after PE for physical/psychological symptoms. Data were examined using repeated measure ANOVA. Results Sixteen women (3 anterior, 1 posterior, and 12 total PE’s), with more than one year of follow up, completed all scheduled interviews. Median age was 58 years (28–76). Overall QOL (F=6.3, p<0.02), ability to perform instrumental daily activities (F=6.8, p<0.02), body image (F=11.9, p<0.00) and sexual function (F=8.0, p<0.01) all declined at 3 months but were near baseline by 12 months after PE. Although, overall, physical function followed a similar trend (F=14.8, p<0.00), it did not return to baseline. At the 12-month interview, patients reported increased gastrointestinal symptoms (F=8.9, p<0.01) but significantly less stress-related ideation (F=6.1, p<0.03) compared to baseline. Pain levels did not change significantly during the study period (F=0.4, p<0.74). Conclusions Although patients report lingering gastrointestinal symptoms and some persistent decline in physical function after PE, most adjust well, returning to almost baseline functioning within a year. Providers can counsel patients that many, though not all, symptoms in the first 3 months following exenteration are likely to improve as they adapt to their changed health status. These preliminary results await confirmation of a larger analysis. PMID:23063761

Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial.

PubMed

Lee, Chee Khoon; Novello, Silvia; Rydén, Anna; Mann, Helen; Mok, Tony

2018-05-07

Purpose Capturing patient-reported outcome data is important for evaluating the overall clinical benefits of new cancer therapeutics. We assessed self-reported symptoms of advanced non-small-cell lung cancer in patients treated with osimertinib or chemotherapy in the AURA3 phase III trial. Patients and Methods Patients completed the European Organisation for Research and Treatment of Cancer 13-item Quality of Life Questionnaire-Lung Cancer Module (EORTC QLQ-LC13) questionnaire on disease-specific symptoms and the EORTC 30-item Core Quality of Life Questionnaire (EORTC QLC-C30) on general cancer symptoms, functioning, global health status, and quality of life. We assessed differences between treatments in time to deterioration of individual symptoms and odds of improvement (a deterioration or improvement was defined as a change in score from baseline of ≥ 10). Hazard ratios (HRs) were calculated using a log-rank test stratified by ethnicity; odds ratios (ORs) were assessed using logistic regression adjusted for ethnicity. Results At baseline, the questionnaires were completed by 82% to 88% of patients, and 30% to 70% had individual key symptoms. Time to deterioration was longer with osimertinib than with chemotherapy for cough (HR, 0.74; 95% CI, 0.53 to 1.05), chest pain (HR, 0.52; 95% CI, 0.37 to 0.73), and dyspnea (HR, 0.42; 95% CI, 0.31 to 0.58). The proportion of symptomatic patients with improvement in global health status and quality of life was higher with osimertinib (80 [37%] of 215) than with chemotherapy (23 [22%] of 105; OR, 2.11; 95% CI, 1.24 to 3.67; P = .007). Proportions were also higher for appetite loss (OR, 2.50; 95% CI, 1.31 to 4.84) and fatigue (OR, 1.96; 95% CI, 1.20 to 3.22). Conclusion Time to deterioration of key symptoms was longer with osimertinib than with chemotherapy, and a higher proportion of patients had improvement in global health status and QoL, demonstrating improved patient outcomes with osimertinib.

Effect of cosmetic outcome on quality of life after breast cancer surgery.

PubMed

Kim, M K; Kim, T; Moon, H G; Jin, U S; Kim, K; Kim, J; Lee, J W; Kim, J; Lee, E; Yoo, T K; Noh, D-Y; Minn, K W; Han, W

2015-03-01

Studies regarding the effects of aesthetic outcomes after breast cancer surgery on quality of life (QoL) have yielded inconsistent results. This study analyzed the aesthetic outcomes and QoL of women who underwent breast conserving surgery (BCS) or total mastectomy with immediate reconstruction (TMIR) using objective and validated methods. QoL questionnaires (EORTC QLQ-C30, BR23, and HADs) were administered at least 1 year after surgery and adjuvant therapy to 485 patients who underwent BCS, 46 who underwent TMIR, and 87 who underwent total mastectomy (TM) without reconstruction. Aesthetic results were evaluated using BCCT.core software and by a panel of physicians. Patients' body image perception was assessed using the body image scale (BIS). QoL outcomes, including for social and role functioning, fatigue, pain, body image, and arm symptoms, were significantly better in the BCS and TMIR groups than in the TM group (p<0.05 each). BIS was significantly better in the BCS than in the TM or TMIR group (p<0.001 each). In the BCS and TMIR groups, general QoL factors were not significantly associated with objective cosmetic outcomes, except for body image in the QLQ-BR23. In contrast, patients with poorer BIS score reported lower QoL in almost all items of the QLQ-C30, BR23, and HADS (p<0.05 each). In conclusion, BCS and TMIR enhanced QoL compared with TM. Among BCS and TMIR patients, objectively measured cosmetic results did not affect general QoL. Self-perception of body image seems to be more important for QoL after breast cancer surgery. Copyright © 2014 Elsevier Ltd. All rights reserved.

Quality of life in Arab women with breast cancer: a review of the literature.

PubMed

Haddou Rahou, Bouchra; El Rhazi, Karima; Ouasmani, Fatima; Nejjari, Chakib; Bekkali, Rachid; Montazeri, Ali; Mesfioui, Abdelhalem

2016-04-27

Quality of life has become an important concept in cancer care. Among the quality of lifestudies in cancer patients, breast cancer has received most attention. This review reports on quality of life in Arab patients with breast cancer. The search was conducted using inclusion and exclusion criteria and in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The databases consulted were PubMed, Sciences Direct, Index Medicus for Wordl Health Organization Eastern Mediterranean, African Journals Online and African Index Medicus. Thirteen articles from eight countries met the inclusion criteria. The EORTC quality of life questionnaires (QLQ-C30 and QLQ-BR23) were the most used instrument (7 out of 13). The results showed that good scores of global health were recorded at Arab women living in United Arab Emirates (mean score = 74.6) compared to other countries. The results indicated that there was a difference in quality of life scores and its associated factors among Arab women with breast cancer. This paper is the first that reviewed published research on quality of life among Arab women with breast cancer. We found that insufficient results-related information is available.

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma†

PubMed Central

Al-Batran, S.-E.; Van Cutsem, E.; Oh, S. C.; Bodoky, G.; Shimada, Y.; Hironaka, S.; Sugimoto, N.; Lipatov, O. N.; Kim, T.-Y.; Cunningham, D.; Rougier, P.; Muro, K.; Liepa, A. M.; Chandrawansa, K.; Emig, M.; Ohtsu, A.; Wilke, H.

2016-01-01

Background The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine–platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov NCT01170663. PMID:26747859

Quality of Life After Palliative Radiation Therapy for Patients With Painful Bone Metastases: Results of an International Study Validating the EORTC QLQ-BM22

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zeng Liang; Chow, Edward, E-mail: edward.chow@sunnybrook.ca; Bedard, Gillian

2012-11-01

Purpose: Radiation therapy (RT) is an effective method of palliating painful bone metastases and can improve function and reduce analgesic requirements. In advanced cancer patients, quality of life (QOL) is the primary outcome of interest over traditional endpoints such as survival. The purpose of our study was to compare bone metastasis-specific QOL scores among patients who responded differently to palliative RT. Methods and Materials: Patients receiving RT for bone metastases across 6 countries were prospectively enrolled from March 2010-January 2011 in a trial validating the QLQ-BM22 and completed the QLQ-BM22 and the core measure (QLQ-C30) at baseline and after 1more » month. Pain scores and analgesic intake were recorded, and response to RT was determined according to the latest published guidelines. The Kruskal-Wallis nonparametric and Wilcoxon rank sum tests compared changes in QOL among response groups. A Bonferroni-adjusted P<.003 indicated statistical significance. Results: Of 79 patients who received palliative RT, 59 were assessable. Partial response, pain progression, and indeterminate response were observed in 22, 8, and 29 patients, respectively; there were no patients with a complete response. Patients across all groups had similar baseline QOL scores apart from physical functioning (patients who progressed had better initial functioning). One month after RT, patients who responded had significant improvements in 3 of 4 QLQ-BM22 domains (painful site, P<.0001; painful characteristic, P<.0001; and functional interference, P<.0001) and 3 QLQ-C30 domains (physical functioning, P=.0006; role functioning, P=.0026; and pain, P<.0001). Patients with progression in pain had significantly worse functional interference (P=.0007) and pain (P=.0019). Conclusions: Patients who report pain relief after palliative RT also have better QOL with respect to bone metastasis-specific issues. The QLQ-BM22 and QLQ-C30 are able to discriminate among patients with varying responses and are recommended for use in future bone metastasis clinical trials.« less

Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nascimento, Mariana, E-mail: mari1980hemato@yahoo.com.br; Aguilar-Nascimento, José Eduardo; Caporossi, Cervantes

Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10{sup 8} colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scoresmore » of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.« less

Does fear of cancer recurrence differ between cancer types? A study from the population-based PROFILES registry.

PubMed

van de Wal, Marieke; van de Poll-Franse, Lonneke; Prins, Judith; Gielissen, Marieke

2016-07-01

Knowledge of factors associated with fear of cancer recurrence (FCR) may inform intervention development and improve patient care. The aims were (1) to compare FCR severity between cancer types and (2) to identify associations between FCR, demographics, medical characteristics, information provision and health-related quality of life. Cross-sectional data were obtained from the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. We included stage I and II survivors diagnosed with melanoma (n = 469), colorectal cancer (n = 861), endometrial cancer (n = 688), thyroid cancer (n = 218), Hodgkin (n = 103) and non-Hodgkin lymphoma (n = 276). Cancer survivors completed questionnaires on FCR (Impact of Cancer scale - Health Worries subscale), satisfaction with information provision (European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC-QLQ) INFO25, satisfaction scale) and health-related quality of life (EORTC-QLQ C30, Short Form 36-item). A total of 2615 survivors completed the Impact of Cancer scale - Health Worries subscale. No significant differences in FCR severity were found between any of the cancer types (p = 0.063). A younger age, female gender, stage II disease, a shorter time since diagnosis, scheduled follow-up appointments and comorbidity were associated with higher FCR (p < 0.01). Satisfaction with information provision was negatively correlated with FCR severity (r = -0.16, p < 0.05). Demographic and medical factors accounted for 6% of explained variance in FCR. The full model, also including health-related quality of life, explained 15% and 19%, respectively. Fear of cancer recurrence seems to be a universal concern of cancer survivors rather than a cancer type-specific problem. Gender, age and medical factors were identified as risk factors. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Adapted ice cream as a nutritional supplement in cancer patients: impact on quality of life and nutritional status.

PubMed

Casas, Francese; León, Concha; Jovell, Esther; Gómez, Joana; Corvitto, Angelo; Blanco, Remei; Alfaro, Jordi; Ángel Seguí, Miguel; Saigí, Eugeni; Massanés, Toni; Sala, Carme; Librán, Anna; Arcusa, Angels

2012-01-01

The aim of this study was to assess the impact of adapted ice cream as a dietary supplement on the quality of life (QLQ) of malnourished patients with cancer. We present an exploratory prospective observational study comparing two patterns of nutrition in cancer patients admitted during the study period who presented malnutrition disorders: adapted ice cream (Group I: 39 patients) and nutritional supplements (Group II: 31 patients). Patients were selected from two different hospitals from the same Oncologic Institute. QLQ was evaluated with the Hospital Anxiety and Depression Scale (HADS) and QLQ of the European Organization for Research and Treatment of Cancer (EORTC QLQ C30). Nutrition was determined by the PG-SGA test. HADS showed significant differences in anxiety (p = 0.023) and depression (p = 0.011) at the end of the study only in Group I. QLQ-C30 revealed statistically significant differences in baseline measures of global dimension between the two groups (Group I: 40.64-56.36 CI; Group II: 25.70-43.11 CI; p = 0.017). Differences were also present in the social dimension (Group I: 77.42-93.51 CI; Group II: 55.85-82.85 CI; p = 0.039). Statistically significant differences were observed between the two groups at the end of the study in the global scale: Group I had 49.36-63.88 CI and Group II had 33.05-51.88 CI (p = 0.016), and in the fatigue scale: Group I had 36.19-53.83 CI and Group II had mean = 65.87, 52.50-79.23 CI (p = 0.007). The administration of ice cream could cover, in part, the social aspect of food and improve QLQ in malnourished cancer patients. These results are encouraging and deserve further confirmation.

Impact of Radiotherapy on Psychological, Financial, and Sexual Aspects in Postmastectomy Carcinoma Breast Patients: A Prospective Study and Management.

PubMed

Sharma, Neelam; Purkayastha, Abhishek

2017-01-01

The aim of this study was to assess the impact of radiotherapy (RT) on psychological, financial, and sexual aspects in postmastectomy carcinoma breast patients affecting their quality of life (QOL) before, during, and after RT with a strong emphasis on their management and rehabilitation aspects. A cross-sectional study carried out in a specialized institution, comprising sixty women. Two standardized questionnaires European Organization for Research and Treatment of Cancer (EORTC) 30-item Quality of Life Questionnaire and Quality of Life Questionnaire breast cancer-23 (QLQ-BR23) for health-related quality, translated and validated for the Hindi language were used. The scores' manual of the EORTC was used to calculate the domain scores of the questionnaires. According to the first questionnaire, the emotional function was most affected even at onset of RT treatment and it was worst at the completion of RT treatment with a mean score of 63.75. The global QOL score was also worst at the end of radiation treatment with a mean score of 32.36, while the score 3 months after completion of treatment was 68.16. The symptoms with the highest scores were insomnia with a worst scoring at completion of treatment (29.99), fatigue (26.57), and pain (23.05). According to the QLQ-BR23, the mean score for side effects such as sexual functioning was minimum 0.55 at the completion of RT, which improved to 11.66 on the first follow-up after 3 months. Mean future perspective score which was 57.22 before the start of RT which was reduced to 50.55 at completion, which means that many women experience side effects of RT and impaired sexual satisfaction. Women with breast cancer showed changes in the following domains: financial, emotional, sexual satisfaction, and future prospects. The most frequently mentioned symptoms were fatigue, insomnia, and pain.

Patient information in radiation oncology: a cross-sectional pilot study using the EORTC QLQ-INFO26 module

PubMed Central

Adler, Johannes; Paelecke-Habermann, Yvonne; Jahn, Patrick; Landenberger, Margarete; Leplow, Bernd; Vordermark, Dirk

2009-01-01

Background The availability of alternative sources of information, e. g. the internet, may influence the quantity and quality of information cancer patients receive regarding their disease and treatment. The purpose of the present study was to assess perception of information in cancer patients during radiotherapy as well as media preferences and specifically the utilization of the internet. Methods In a cross-sectional, single-centre study 94 patients currently undergoing radiotherapy were asked to complete two questionnaires. The EORTC QLQ-INFO26 module was used to assess the quality and quantity of information received by patients in the areas disease, medical tests, treatment, other services, different places of care and how to help themselves, as well as qualitative aspects as helpfulness of and satisfaction with this information. The importance of different media, in particular the internet, was investigated by a nine-item questionnaire. Results The response rate was n = 72 patients (77%). Patients felt best informed concerning medical tests (mean ± SD score 79 ± 22, scale 0-100) followed by disease (68 ± 21). Treatment (52 ± 24) and different places of care and other services (30 ± 36 and 30 ± 30, respectively) ranked last. 37% of patients were very satisfied and 37% moderately satisfied with the amount of information received, 61% wished more information. Among eight media, brochures, television and internet were ranked as most important. 41% used the internet themselves or via friends or family, mostly for research of classic and alternative treatment options. Unavailability and the necessity of computer skills were most mentioned obstacles. Conclusion In a single-center pilot study, radiotherapy patients indicated having received most information about medical tests and their disease. Patients very satisfied with their information had received the largest amount of information. Brochures, television and internet were the most important media. Individual patient needs should be considered in the development of novel information strategies. PMID:19785759

Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study.

PubMed

Marra-Lopez Valenciano, Carlos; Bolado Concejo, Federico; Marín Serrano, Eva; Millastre Bocos, Judith; Martínez-Moneo, Emma; Pérez Rodríguez, Esperanza; Francisco González, María; Del Pozo-García, Andrés; Hernández Martín, Anaiansi; Labrador Barba, Elena; Orera Peña, María Luisa; de-Madaria, Enrique

2018-02-01

Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m 2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0μg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Health-related quality of life, personality and choice of coping are related in renal cell carcinoma patients.

PubMed

Beisland, Elisabeth; Beisland, Christian; Hjelle, Karin M; Bakke, August; Aarstad, Anne K H; Aarstad, Hans J

2015-01-01

To investigate whether health-related quality of life (HRQoL) depends on psychosocial factors, rather than on factors related to the cancer treatment, this study explored the associations between HRQoL, personality, choice of coping and clinical parameters in surgically treated renal cell carcinoma (RCC) patients. After exclusions (e.g. death, dementia), 260 patients were found to be eligible and invited to participate. The response rate was 71%. HRQoL was determined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), personality by the Eysenck Personality Inventory and coping by the COPE Questionnaire. Given tumour treatment, TNM stage and patient-reported comorbidity were also determined. The HRQoL indices were also summarized in general quality of life/health, functional sum and symptom sum scores. EORTC C30 sum scores were negatively associated with the personality trait of neuroticism [common variance (CV) 19-36%]. Avoidant choice of coping inversely accounted for 9-18% of the total HRQoL variance, while reported coping by humour was to some extent negatively associated with HRQoL score (CVmax 4%). Indeed, all of the quality of life indices except for one were significantly negatively correlated with neuroticism and avoidance coping. Patients with low HRQoL due to treatment, secondary to flank or open surgery, reported a closer association between problem-focused choice of coping and HRQoL than the other patients. Moreover, present comorbidities were uniquely associated with a lowered HRQoL. HRQoL is related to treatment-related factors in RCC patients, but shown here to be more strongly associated with psychological factors and present comorbidity. These findings suggest that attention should be paid to supportive treatment of RCC patients.

Quality of life-related outcomes from a patient-tailored integrative medicine program: experience of Russian-speaking patients with cancer in Israel.

PubMed

Sharabi, Ilanit Shalom; Levin, Anna; Schiff, Elad; Samuels, Noah; Agour, Olga; Tapiro, Yehudith; Lev, Efraim; Keinan-Boker, Lital; Ben-Arye, Eran

2016-10-01

Complementary/integrative medicine (CIM) is increasingly being integrated with standard supportive cancer care. The effects of CIM on quality of life (QOL) during chemotherapy need to be examined in varied socio-cultural settings. We purpose to explore the impact of CIM on QOL-related outcomes among Russian-speaking (RS) patients with cancer. RS patients undergoing chemotherapy receiving standard supportive care were eligible. Patients in the treatment arm were seen by an integrative physician (IP) and treated within a patient-tailored CIM program. Symptoms and QOL were assessed at baseline, at 6, and at 12 weeks with the Edmonton Symptom Assessment Scale (ESAS), the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Of 70 patients referred to the treatment arm, 50 (71.4 %) underwent IP assessment and CIM treatments. Of 51 referred to the control arm, 38 (76 %) agreed to participate. At 6 weeks, CIM-treated patients reported improved ESAS scores for fatigue (P = 0.01), depression (P = 0.048), appetite (P = 0.008), sleep (P < 0.0001), and general wellbeing (P = 0.004). No improvement was observed among controls. Between-group analysis found CIM-treated patients had improved sleep scores on ESAS (P = 0.019) and EORTC (P = 0.007) at 6 weeks. Social functioning improved between 6 and 12 weeks (EORTC, P = 0.02), and global health status/QOL scale from baseline to 12 weeks (EORTC, P = 0.007). A patient-tailored CIM treatment program may improve QOL-related outcomes among RS patients undergoing chemotherapy. Integrating CIM in conventional supportive care needs to address cross-cultural aspects of care. The study protocol was registered at ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT01860365 ).

Quality of life in head and neck cancer patients after surgical resection: translation into Cantonese and validation of the EORTC QLQ-H&N35.

PubMed

Bower, W F; Vlantis, A C; Chung, T M L; Cheung, S K C; Bjordal, K; van Hasselt, C A

2009-07-01

High convergent and discriminant validity between subscales was achieved after the translation of EORTC QLQ-H&N35 into Cantonese. Most subscales were assessing distinct components of quality of life (QoL). The study aimed to translate the EORTC QLQ-H&N35 cancer module into Cantonese and to confirm validity and reliability for use in a Hong Kong head and neck (H&N) cancer population. An ethnocentric forward-backward translation of EORTC QLQ-H&N35 was conducted by bilingual head and neck health professionals. Discrepancies were identified and problematic wording and concepts revised. Further review preceded pilot testing in 119 postoperative H&N cancer patients. Internal consistency within each subscale, convergent and discriminant validity to check the item relevance and item representativeness within and between subscales were examined. Mean and standard deviations of each subscale and single item and Cronbach's alpha coefficients for subscales were calculated. Six of seven subscales achieved standard reliability (Cronbach's alpha coefficient >0.7). Correlation coefficients between an item and its own subscale were significantly higher than the coefficients with other subscales. Scaling success was found in all subscales. Pearson's correlation coefficient between subscales was <0.70, except between the subscales swallowing and trouble with social eating (r = 0.795), and speech problems and social contact (r = 0.754).

Deriving a preference-based utility measure for cancer patients from the European Organisation for the Research and Treatment of Cancer’s Quality of Life Questionnaire C30: a confirmatory versus exploratory approach

PubMed Central

Costa, Daniel SJ; Aaronson, Neil K; Fayers, Peter M; Grimison, Peter S; Janda, Monika; Pallant, Julie F; Rowen, Donna; Velikova, Galina; Viney, Rosalie; Young, Tracey A; King, Madeleine T

2014-01-01

Background Multi attribute utility instruments (MAUIs) are preference-based measures that comprise a health state classification system (HSCS) and a scoring algorithm that assigns a utility value to each health state in the HSCS. When developing a MAUI from a health-related quality of life (HRQOL) questionnaire, first a HSCS must be derived. This typically involves selecting a subset of domains and items because HRQOL questionnaires typically have too many items to be amendable to the valuation task required to develop the scoring algorithm for a MAUI. Currently, exploratory factor analysis (EFA) followed by Rasch analysis is recommended for deriving a MAUI from a HRQOL measure. Aim To determine whether confirmatory factor analysis (CFA) is more appropriate and efficient than EFA to derive a HSCS from the European Organisation for the Research and Treatment of Cancer’s core HRQOL questionnaire, Quality of Life Questionnaire (QLQ-C30), given its well-established domain structure. Methods QLQ-C30 (Version 3) data were collected from 356 patients receiving palliative radiotherapy for recurrent/metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter informed by the established QLQ-C30 structure and views of both patients and clinicians on which are the most relevant items. Dimensions determined by EFA or CFA were then subjected to Rasch analysis. Results CFA results generally supported the proposed QLQ-C30 structure (comparative fit index =0.99, Tucker–Lewis index =0.99, root mean square error of approximation =0.04). EFA revealed fewer factors and some items cross-loaded on multiple factors. Further assessment of dimensionality with Rasch analysis allowed better alignment of the EFA dimensions with those detected by CFA. Conclusion CFA was more appropriate and efficient than EFA in producing clinically interpretable results for the HSCS for a proposed new cancer-specific MAUI. Our findings suggest that CFA should be recommended generally when deriving a preference-based measure from a HRQOL measure that has an established domain structure. PMID:25395875

Cross-cultural differences in information disclosure evaluated through the EORTC questionnaires.

PubMed

Arraras, Juan Ignacio; Greimel, Eva; Chie, Wei-Chu; Sezer, Orhan; Bergenmar, Mia; Costantini, Anna; Young, Teresa; Vlasic, Karin Kuljanic; Velikova, Galina

2013-02-01

Informational needs among cancer patients are similar, but the degree of information disclosure in different cultural areas varies. In this paper, we present the results of a cross-cultural study on information received. The EORTC information questionnaire, EORTC QLQ-INFO25, was administered during the treatment process. This questionnaire evaluates the information that patients report they have received. Cross-cultural differences in information have been evaluated using statistical tests such as Kruskall-Wallis and multivariate models with covariates to account for differences in clinical and demographic characteristics across areas. Four hundred and fifty-one patients from three cultural areas, North-Middle Europe, South Europe, and Taiwan, were included in the study. Significant differences among the three cultural areas appeared in eight QLQ-INFO25 dimensions: information about the disease; medical tests; places of care; written information; information on CD/tape/video; satisfaction; wish for more information; and information helpfulness. North-Middle Europe patients received more written information (mean = 67.2 (North) and 33.8 (South)) and South Europe patients received more information on different places of care (mean = 24.7 (North) and 35.0 (South)). Patients from North-Middle Europe and South Europe received more information than patients from Taiwan about the disease (mean = 57.9, 60.6, and 47.1, respectively) and medical tests (70.9, 70.4, and 54.5), showed more satisfaction (64.8, 70.2, and 35.0), and considered the information more helpful (71.9, 73.9, and 50.4). These results were confirmed when adjusting for age, education, and disease stage. There are cross-cultural differences in information received. Some of these differences are based on the characteristics of each culture. Copyright © 2011 John Wiley & Sons, Ltd.

Effects of sociodemographic, treatment variables, and medical characteristics on quality of life of patients with maxillectomy restored with obturator prostheses.

PubMed

Artopoulou, Ioli Ioanna; Karademas, Evangelos C; Papadogeorgakis, Nikolaos; Papathanasiou, Ioannis; Polyzois, Gregory

2017-12-01

Restoration of maxillary defects resulting from tumor ablative surgery presents a difficult challenge, with both functional and esthetic issues. Whether rehabilitation with an obturator prosthesis could significantly contribute to improved quality of life in patients with maxillary resection has been scarcely studied, with relatively small study samples. The purpose of this survey study was to assess the overall functioning of the obturator prosthesis and the effect of specific sociodemographic, medical, and treatment variables on obturator functioning and quality of life in patients with maxillectomy. Global quality of life (QOL) and satisfaction with the obturator prosthesis of 57 patients who underwent maxillectomy and prosthetic rehabilitation at the National and Kapodistrian University of Athens were assessed using 3 questionnaires: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30), the EORTC QLQ-HN35, and the obturator functioning scale. The data were analyzed using the Kruskal-Wallis 1-way ANOVA on ranks, hierarchical multiple regression analysis, and the Spearman rank order correlation (α=.05). Satisfactory functioning of the obturator prosthesis was the most significant predictor of improved QOL (P<.05). QOL was significantly related to additional treatments (P<.05), the size of the primary tumor (P<.05), and the size of the maxillectomy defect (P<.05). The most significant predictors of good obturator functioning were additional treatments (P<.01), age at the time of surgery (P<.05), presence of mandibular teeth (P<.05), and previous maxillary removable prosthetic experience (P<.05). Obturator functioning scale appearance and insertion subscales (r=0.47, P<.01), followed by speech (r=0.42, P<.01), were significantly related to better QOL. A well-functioning obturator prosthesis was the most significant determinant for improved QOL in patients with maxillary resection. Age at the time of surgery, adjuvant treatments, presence of mandibular teeth, and previous maxillary removable prosthetic experience were the most significant predictors for better obturator functioning, whereas the size of the maxillectomy defect had a significant effect on QOL but did not influence the functional outcome. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Cancer-related fatigue and depression in breast cancer patients postchemotherapy: Different associations with optimism and stress appraisals.

PubMed

Levkovich, Inbar; Cohen, Miri; Pollack, Shimon; Drumea, Karen; Fried, Georgeta

2015-10-01

Symptoms of depression and cancer-related fatigue (CRF) are common among breast cancer patients postchemotherapy and may seriously impair quality of life (QoL). This study aimed to assess the relationship between depression and CRF in breast cancer patients postchemotherapy and to examine their relationships to optimism and to threat and challenge appraisals. Participants included 95 breast cancer patients (stages 1-3) 1 to 6 months after completion of chemotherapy. Patients submitted personal and medical details and completed the following: physical symptom questionnaires (EORTC QLQ-C30, and QLQ-BR23), a symptoms of depression questionnaire (CES-D), the Fatigue Symptom Inventory (FSI), the Life Orientation Test (LOT-R), and a stress appraisals questionnaire. We found levels of depression, CRF, and appraisals of cancer as a threat to bemoderate and levels of optimism and appraisals of cancer as a challenge to be high. Depression and CRF were positively associated. A multivariate regression analysis revealed that 51% of the CRF variancewas explained; physical symptoms and threat appraisal were significantly associated with CRF. A 67% of the CRF variance of depression was explained; challenge and threat appraisals were significantly associated with depression [corrected]. Although CRF and depression were often experienced simultaneously and both were found to be higher among individuals who gave higher appraisals of cancer as a threat, only depression was related to optimism and challenge appraisals, while CRF was related mainly to intensity of physical symptoms. The different pattern of associations between optimism and appraisals warrants further clinical attention as well as future study.

Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy.

PubMed

Campone, Mario; Beck, J Thaddeus; Gnant, Michael; Neven, Patrick; Pritchard, Kathleen I; Bachelot, Thomas; Provencher, Louise; Rugo, Hope S; Piccart, Martine; Hortobagyi, Gabriel N; Nunzi, Martina; Heng, Daniel Y C; Baselga, José; Komorowski, Anna; Noguchi, Shinzaburo; Horiguchi, Jun; Bennett, Lee; Ziemiecki, Ryan; Zhang, Jie; Cahana, Ayelet; Taran, Tetiana; Sahmoud, Tarek; Burris, Howard A

2013-11-01

Everolimus (EVE)+exemestane (EXE; n = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (n = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR(+)) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE + EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL. HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall. Clinicaltrials.gov: NCT00863655. Progression-free survival, survival, response rate, safety, and HRQOL. Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE + EXE and PBO + EXE for QL2 (LSM difference = -1.91; 95% CI = -4.61, 0.78), BRBS (LSM difference = -0.18; 95% CI = -1.98, 1.62), or BRAS (LSM difference = -0.42; 95% CI = -2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE + EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO + EXE. HRQOL data were not collected after disease progression. These analyses confirm that EVE + EXE provides clinical benefit without adversely impacting HRQOL in patients with HR(+) ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.

Could Objective Tests Be Used to Measure Fatigue in Patients With Advanced Cancer?

PubMed

Schvartsman, Gustavo; Park, Minjeong; Liu, Diane D; Yennu, Sriram; Bruera, Eduardo; Hui, David

2017-08-01

Assessment of cancer-related fatigue is currently based on patient-reported outcomes. We asked whether objective assessments, such as muscle strength and nutritional markers, can be used as surrogate measures of cancer-related fatigue. We examined the association among three fatigue scales, muscle strength, and nutritional markers in patients with advanced cancer. In this prospective study, we enrolled hospitalized cancer patients who had been seen in palliative care consultation at MD Anderson Cancer Center. We assessed fatigue using three fatigue scales-the Brief Fatigue Inventory (BFI), the Edmonton Symptom Assessment System (ESAS), and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)-and determined their association with objective assessments, including handgrip strength, maximal inspiratory pressure, lean body mass, phase angle, and albumin. Spearman's correlation test was used to assess associations. Among 222 patients, the mean age was 55 years; 59% were women. The median overall survival was 106 days. The total BFI score had weak association with handgrip strength (ρ = -0.18, P = 0.007) and no association with the remaining objective measures. ESAS fatigue and EORTC fatigue showed similar findings. Total BFI had moderate-to-strong association with ESAS (ρ = 0.54, P < 0.0001) and EORTC (ρ = 0.60, P < 0.0001) fatigue. Our study showed that subjective assessment of fatigue based on patient-reported outcomes correlates only weakly with muscle strength and nutritional markers; thus, patient-reported outcomes remain the gold standard for fatigue assessment. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112.

PubMed

Muers, M F; Rudd, R M; O'Brien, M E R; Qian, W; Hodson, A; Parmar, M K B; Girling, D J

2004-02-01

The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma. Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N. During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC. The planned phase III trial is feasible.

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma.

PubMed

Al-Batran, S-E; Van Cutsem, E; Oh, S C; Bodoky, G; Shimada, Y; Hironaka, S; Sugimoto, N; Lipatov, O N; Kim, T-Y; Cunningham, D; Rougier, P; Muro, K; Liepa, A M; Chandrawansa, K; Emig, M; Ohtsu, A; Wilke, H

2016-04-01

The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. NCT01170663. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial.

PubMed

Kumagai, Koshi; Kjellin, Ann; Tsai, Jon A; Thorell, Anders; Granqvist, Staffan; Lundell, Lars; Håkanson, Bengt

2014-01-01

The optimal anti-reflux procedure after Heller cardiomyotomy for oesophageal achalasia remains unclear. The most commonly used procedure is the anterior partial fundoplication according to Dor, although during recent years the posterior counterpart (Toupet) has become popular. Patients with newly diagnosed achalasia and referred for cardiomyotomy were randomised to receive either an anterior or partial posterior fundoplication following a classical cardiomyotomy. The effect of surgery was assessed during the first postoperative year by Eckardt scores, EORTC QLQ-OES18 scores and HRQL questionnaires. Timed barium oesophagogram (TBO) and ambulatory 24-h pH monitoring were performed to determine oesophageal emptying and the degree of reflux control, respectively. Forty-two patients were randomised into Dor (n = 20) and Toupet (n = 22) groups. Eckardt scores improved dramatically with both procedures, but the EORTC QLQ-OES18 (functional scales) scores revealed significantly better relative improvements in the Toupet group compared to the Dor repair (P = 0.044). Corresponding advantages in favour of Toupet were observed postoperatively in the percentage of oesophageal emptying at TBO (P = 0.011 in height and P = 0.018 in area), an effect not observed in the Dor group. There were no other significant differences recorded between the study groups concerning HRQL evaluations and objective assessment of gastro-oesophageal acid reflux. A partial posterior fundoplication after cardiomyotomy seems to achieve more improvement in oesophageal emptying and EORTC QLQ-OES18 functional scale scores than the anterior fundoplication. Otherwise no differences between the two anti-reflux repairs were noted. ClinicalTrials.gov Identifier: NCT01933373. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

New insights in symptom assessment: the Chinese Versions of the Memorial Symptom Assessment Scale Short Form (MSAS-SF) and the Condensed MSAS (CMSAS).

PubMed

Lam, Wendy Wing Tak; Law, Chi Ching; Fu, Yiu Tung; Wong, Kam Hung; Chang, Victor T; Fielding, Richard

2008-12-01

There are very few symptom assessment instruments in Chinese. We present the validity and reliability of the Memorial Symptom Assessment Scale Short Form (MSAS-SF) and the Condensed Form MSAS (CMSAS) in Chinese cancer patients. The Chinese version of the 32-item MSAS-SF, a self-report measure for assessing symptom distress and frequency in cancer patients, was administered to 256 Chinese patients with colorectal cancer at a clinical oncology outpatient unit. Highly prevalent symptoms included worrying (59%), dry mouth (54%), lack of energy (54%), feeling sad (48%), feeling irritable (48%), and pain (41%). Both the MSAS-SF and CMSAS demonstrated good validity and reliability. For the MSAS-SF subscales, Cronbach alphas ranged from 0.84 to 0.91, and for CMSAS subscales, from 0.79 to 0.87. Moderate-to-high correlations of MSAS-SF and CMSAS subscales with appropriate European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 subscales (0.42-0.71, Ps<0.001) indicated acceptable convergent validity. Low correlations with the Rosenberg Self-Esteem and Optimism Scale (0.22, P<0.001) indicated divergent validity. MSAS subscales varied as expected with other Chinese scales--the Chinese Health Questionnaire (CHQ) and the Life Orientation Scale. Construct validity of both MSAS versions was demonstrated by effective differentiation between clinically distinct patient groups (Karnofsky scores <80% vs. > or =80% [P<0.001]; no active treatment vs. active treatment [P<0.002-0.034]; CHQ-12 scores < or =4 vs. CHQ-12 scores >4 [P<0.001]). The Number of Symptoms subscale correlated appropriately with the EORTC QLQ-C30 function (-0.46 to -0.60, P<0.001) and symptom scales (0.31-0.64, P<0.001). The average time to complete the MSAS-SF was six minutes. The Chinese versions of the MSAS-SF and CMSAS are valid and practical measures. Further validation is needed for Chinese patients with other cancer types and with other symptom instruments.

Decline in Tested and Self-Reported Cognitive Functioning After Prophylactic Cranial Irradiation for Lung Cancer: Pooled Secondary Analysis of Radiation Therapy Oncology Group Randomized Trials 0212 and 0214

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gondi, Vinai, E-mail: vgondi@chicagocancer.org; University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin; Paulus, Rebecca

Purpose: To assess the impact of prophylactic cranial irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and atmore » 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results: Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P<.0001) and 12 months (odds ratio 3.44, 95% confidence interval 1.84-6.44, P<.0001). Decline on HVLT-Recall at 6 and 12 months was also associated with PCI (P=.002 and P=.002, respectively) but was not closely correlated with decline in SRCF at the same time points (P=.05 and P=.86, respectively). Conclusions: In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.« less

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30: factorial models to Brazilian cancer patients

PubMed Central

Campos, Juliana Alvares Duarte Bonini; Spexoto, Maria Cláudia Bernardes; da Silva, Wanderson Roberto; Serrano, Sergio Vicente; Marôco, João

2018-01-01

ABSTRACT Objective To evaluate the psychometric properties of the seven theoretical models proposed in the literature for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), when applied to a sample of Brazilian cancer patients. Methods Content and construct validity (factorial, convergent, discriminant) were estimated. Confirmatory factor analysis was performed. Convergent validity was analyzed using the average variance extracted. Discriminant validity was analyzed using correlational analysis. Internal consistency and composite reliability were used to assess the reliability of instrument. Results A total of 1,020 cancer patients participated. The mean age was 53.3±13.0 years, and 62% were female. All models showed adequate factorial validity for the study sample. Convergent and discriminant validities and the reliability were compromised in all of the models for all of the single items referring to symptoms, as well as for the “physical function” and “cognitive function” factors. Conclusion All theoretical models assessed in this study presented adequate factorial validity when applied to Brazilian cancer patients. The choice of the best model for use in research and/or clinical protocols should be centered on the purpose and underlying theory of each model. PMID:29694609

Fatigue as a Driver of Overall Quality of Life in Cancer Patients.

PubMed

McCabe, Ryan M; Grutsch, James F; Braun, Donald P; Nutakki, Swetha B

2015-01-01

This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain--a validated surrogate variable for overall cancer patient well-being. A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients' quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated.

Fatigue as a Driver of Overall Quality of Life in Cancer Patients

PubMed Central

McCabe, Ryan M.; Grutsch, James F.; Braun, Donald P.; Nutakki, Swetha B.

2015-01-01

Background This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain—a validated surrogate variable for overall cancer patient well-being. Methods A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Findings Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients’ quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. Interpretation By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated. PMID:26070133

Decision-making in adult thalassemia patients undergoing unrelated bone marrow transplantation: quality of life, communication and ethical issues.

PubMed

Caocci, G; Pisu, S; Argiolu, F; Giardini, C; Locatelli, F; Vacca, A; Orofino, M G; Piras, E; De Stefano, P; Addari, M C; Ledda, A; La Nasa, G

2006-01-01

Bone marrow transplantation (BMT) represents a potentially curative treatment of thalassemia. For patients without an HLA-identical sibling donor, recourse to an unrelated donor is a practicable option but the candidates and their families are faced with a difficult decision. They can either choose to continue the supportive therapy, with no chance of definitive cure, or they accept the mortality risk of BMT in the hope of obtaining a definitive resolution of the disease. We investigated the communication strategies and the post transplantation quality of life (QoL) in 19 adult thalassemia patients surviving after an unrelated donor BMT. The patients were given two questionnaires: a questionnaire to evaluate pre-transplantation communication factors and the EORTC QLQ-C30 questionnaire to assess global QoL. All patients were satisfied with the communication modalities employed by the physicians. The global post transplantation QoL in our patient cohort was found to be good. The approach used in this study may offer a contribution to understanding the decision-making process leading to the choice of a treatment with a high mortality risk for a chronic, non-malignant disease. Finally, some ethical issues of this therapeutic approach are briefly addressed.

Worsening of rest-activity circadian rhythm and quality of life in female breast cancer patients along progression of chemotherapy cycles.

PubMed

Sultan, Armiya; Choudhary, Vivek; Parganiha, Arti

2017-01-01

Chemotherapy and its associated side effects can induce the disruption of circadian rest-activity rhythm and may have negative consequences on health-related quality of life (HRQoL) of cancer patients. In the current study, repeated-measures cross-sectional design was implemented to determine the status of circadian rest-activity rhythm and to assess the HRQoL of newly diagnosed female breast cancer patients those were planned to receive six cycles of chemotherapy. Rest activity and HRQoL were assessed in twenty-five patients during chemotherapy cycles 1st (C1), 3rd (C3), and 6th (C6) immediately after they reported to the outdoor ward of the Regional Cancer Center, Pt. J.N.M. Medical College, Dr. B.R. Ambedkar Memorial Hospital, Raipur, India. Wrist actigraphs for consecutive spans of 3-4 days were used to record the rest-activity rhythm, and its parameters were computed with the help of Cosinor Rhythmometry. Quality of life (QoL) parameters were assessed using EORTC QLQ-C30 and QLQ-BR23. Results revealed that average scores of all rhythm parameters, such as MESOR, amplitude, acrophase, rhythm quotient, circadian quotient, peak activity, dichotomy index, and autocorrelation coefficient; and all functional scales of QLQ-C30, such as physical, role, emotional, cognitive, and social, and global quality of life statistically significantly decreased with the increasing number of chemotherapy cycles (C1 to C3 and C6). Scores of symptom scales of QLQ-C30, such as fatigue, pain, dyspnoea, insomnia, appetite loss, and diarrhea increased significantly from C1 to C6. Among the QLQ-BR23 scales, scores of sexual functioning, sexual enjoyment, breast symptoms, and arm symptoms significantly decreased, whereas scores of systemic therapy side effects, and upset by hair loss significantly increased across the chemotherapy cycles. We conclude that rest-activity rhythm disrupted and HRQoL of breast cancer patients worsened along the increasing number of chemotherapy cycles. We suggest that along with the treatment protocol, level of disruption of these parameters should be assessed and managed with the proper interventions that prominently include timing of the chemotherapy administration. The latter is pivotal for maintenance of these parameters, which are likely to enhance the physiological ability of patients for better treatment responses and may improve the overall QoL and survival of the patients.

[Quality of life in patients with urolithiasis depending on methods of drainage of the upper urinary tract].

PubMed

Doronchuk, D N; Trapeznikova, M F; Dutov, V V

2010-01-01

A sociological study was made of quality of life of 60 patients with nephrostomic drainage and 71 patients with an ureteral stent according to standard international questionnaires SF-36 and EORTC QLQ-C30, version 3.0. It was found that both internal and external drain significantly aggravate quality of life in the same degree. Younger patients of both groups suffered less. Quality of life was higher in both groups in drainage duration up to 1 month (p < 0.05), in 1 to 6 month draining quality of life is worse in both groups. Internal drainage is worse tolerated by males aged 25-44 years and elderly women aged 60-75 years, especially in long-term drain (over 6 months). Internal drainage is worse tolerated by elderly females (60-75 years of age) and senile women (over 75 years) in 6 month and longer drainage. The study of large number of patients revealed significant differences in quality of life in patients with nephrostomic drain and ureteral stent.

High-intensity interval training and hyperoxia during chemotherapy: A case report about the feasibility, safety and physical functioning in a colorectal cancer patient.

PubMed

Freitag, Nils; Weber, Pia Deborah; Sanders, Tanja Christiane; Schulz, Holger; Bloch, Wilhelm; Schumann, Moritz

2018-06-01

We conducted a case study to examine the feasibility and safety of high-intensity interval training (HIIT) with increased inspired oxygen content in a colon cancer patient undergoing chemotherapy. A secondary purpose was to investigate the effects of such training regimen on physical functioning. A female patient (51 years; 49.1 kg; 1.65 m; tumor stage: pT3, pN2a (5/29), pM1a (HEP), L0, V0, R0) performed 8 sessions of HIIT (5 × 3 minutes at 90% of Wmax, separated by 2 minutes at 45% Wmax) with an increased inspired oxygen fraction of 30%. Patient safety, training adherence, cardiorespiratory fitness (peak oxygen uptake and maximal power output during an incremental cycle ergometer test), autonomous nervous function (i.e., heart rate variability during an orthostatic test) as well as questionnaire-assessed quality of life (EORTC QLQ-C30) were evaluated before and after the intervention.No adverse events were reported throughout the training intervention and a 3 months follow-up. While the patient attended all sessions, adherence to total training time was only 51% (102 of 200 minutes; mean training time per session 12:44 min:sec). VO2peak and Wmax increased by 13% (from 23.0 to 26.1 mL min kg) and 21% (from 83 to 100 W), respectively. Heart rate variability represented by the root mean squares of successive differences both in supine and upright positions were increased after the training by 143 and 100%, respectively. The EORTC QLQ-C30 score for physical functioning (7.5%) as well as the global health score (10.7%) improved, while social function decreased (17%). Our results show that a already short period of HIIT with concomitant hyperoxia was safe and feasible for a patient undergoing chemotherapy for colon cancer. Furthermore, the low overall training adherence of only 51% and an overall low training time per session (∼13 minutes) was sufficient to induce clinically meaningful improvements in physical functioning. However, this case also underlines that intensity and/or length of the HIIT-bouts might need further adjustments to increase training compliance.

Effect of Neoadjuvant Chemoradiotherapy on Health-Related Quality of Life in Esophageal or Junctional Cancer: Results From the Randomized CROSS Trial.

PubMed

Noordman, Bo Jan; Verdam, Mathilde G E; Lagarde, Sjoerd M; Hulshof, Maarten C C M; van Hagen, Pieter; van Berge Henegouwen, Mark I; Wijnhoven, Bas P L; van Laarhoven, Hanneke W M; Nieuwenhuijzen, Grard A P; Hospers, Geke A P; Bonenkamp, Johannes J; Cuesta, Miguel A; Blaisse, Reinoud J B; Busch, Olivier R; Ten Kate, Fiebo J W; Creemers, Geert-Jan M; Punt, Cornelis J A; Plukker, John Th M; Verheul, Henk M W; Spillenaar Bilgen, Ernst J; van Dekken, Herman; van der Sangen, Maurice J C; Rozema, Tom; Biermann, Katharina; Beukema, Jannet C; Piet, Anna H M; van Rij, Caroline M; Reinders, Janny G; Tilanus, Hugo W; Steyerberg, Ewout W; van der Gaast, Ate; Sprangers, Mirjam A G; van Lanschot, J Jan B

2018-01-20

Purpose To compare pre-agreed health-related quality of life (HRQOL) domains in patients with esophageal or junctional cancer who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery or surgery alone. Secondary aims were to examine the effect of nCRT on HRQOL before surgery and the effect of surgery on HRQOL. Patients and Methods Patients were randomly assigned to nCRT (carboplatin plus paclitaxel with concurrent 41.4-Gy radiotherapy) followed by surgery or surgery alone. HRQOL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and -Oesophageal Cancer Module (QLQ-OES24) questionnaires pretreatment and at 3, 6, 9, and 12 months postoperatively. The nCRT group also received preoperative questionnaires. Physical functioning (PF; QLQ-C30) and eating problems (EA; QLQ-OES24) were chosen as predefined primary end points. Predefined secondary end points were global QOL (GQOL; QLQ-C30), fatigue (FA; QLQ-C30), and emotional problems (EM; QLQ-OES24). Results A total of 363 patients were analyzed. No statistically significant differences in postoperative HRQOL were found between treatment groups. In the nCRT group, PF, EA, GQOL, FA, and EM scores deteriorated 1 week after nCRT (Cohen's d: -0.93, P < .001; 0.47, P < .001; -0.84, P < .001; 1.45, P < .001; and 0.32, P = .001, respectively). In both treatment groups, all end points declined 3 months postoperatively compared with baseline (Cohen's d: -1.00, 0.33, -0.47, -0.34, and 0.33, respectively; all P < .001), followed by a continuous gradual improvement. EA, GQOL, and EM were restored to baseline levels during follow-up, whereas PF and FA remained impaired 1 year postoperatively (Cohen's d: 0.52 and -0.53, respectively; both P < .001). Conclusion Although HRQOL declined during nCRT, no effect of nCRT was apparent on postoperative HRQOL compared with surgery alone. In addition to the improvement in survival, these findings support the view that nCRT according to the Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study-regimen can be regarded as a standard of care.

Health-related quality of life in long-term survivors of unresectable locally advanced non-small cell lung cancer.

PubMed

Ran, Juntao; Wang, Jingbo; Bi, Nan; Jiang, Wei; Zhou, Zongmei; Hui, Zhouguang; Liang, Jun; Feng, Qinfu; Wang, Luhua

2017-12-02

Heath-related quality of life (HRQoL) among survivors with unresectable locally-advanced non-small cell lung cancer (LA-NSCLC) treated with radiotherapy and chemotherapy still is not clear. The current study were performed to determine HRQoL for long-term survivors with unresectable LA-NSCLC and to identify risk factors for poor HRQoL. Among patients with LA-NSCLC receiving radiotherapy and chemotherapy between January 2006 and December 2010, 82 long-term survivors beyond 5 years were identified in this cross-sectional study. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and the lung cancer-specific questionnaire QLQ-LC13 were employed to gather information on HRQoL. HRQoL scores were compared between different subgroups to analyze factors related to HRQoL. Fifty-five out of 82 (67%) long-term survivors completed the HRQoL survey. They reported a mild reduction in global health status and physical and emotional functioning. Fatigue, dyspnea, coughing, and financial difficulties ranked the highest scores in the symptom scales. Analysis of risk factors for HRQoL showed age, exercise, smoking status, and treatment regimen were associated with global health status and functional scores, while age, gender, radiation pneumonitis, weight loss, and exercise were associated with symptom scores. This study provides the first description of the HRQoL of long-term LA-NSCLC survivors receiving radiotherapy and chemotherapy who may experience a relatively high HRQoL. Factors related to poorer HRQoL are potential targets for intervention.

Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project.

PubMed

Quintana, José M; Gonzalez, Nerea; Anton-Ladislao, Ane; Redondo, Maximino; Bare, Marisa; Fernandez de Larrea, Nerea; Briones, Eduardo; Escobar, Antonio; Sarasqueta, Cristina; Garcia-Gutierrez, Susana; Aguirre, Urko

2016-07-08

Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients. a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention. In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models. The identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions. ClinicalTrials.gov Identifier: NCT02488161 . Registration date: June 16, 2015.

Geriatric oncology: comparing health related quality of life in head and neck cancer patients.

PubMed

Silveira, Augusta P; Gonçalves, Joaquim; Sequeira, Teresa; Ribeiro, Cláudia; Lopes, Carlos; Monteiro, Eurico; Pimentel, Francisco L

2011-01-13

Population ageing is increasing the number of people annually diagnosed with cancer worldwide, once most types of tumours are age-dependent. High-quality healthcare in geriatric oncology requires a multimodal approach and should take into account stratified patient outcomes based on factors other than chronological age in order to develop interventions able to optimize oncology care.This study aims to evaluate the Health Related Quality of Life in head and neck cancer patients and compare the scores in geriatric and younger patients. Two hundred and eighty nine head and neck cancer patients from the Oncology Portuguese Institute participated in the Health Related Quality of Life assessment. Two patient groups were considered: the geriatric (≥ 65 years old, n = 115) and the younger (45-60 years old, n= 174). The EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were used. Head and neck cancer patients were mostly males, 77.4% within geriatric group and 91.4% among younger patients group.The most frequent tumour locations were similar in both groups: larynx, oral cavity and oropharynx - base of the tongue.At the time of diagnosis, most of younger male patients were at disease stage III/IV (55.9%) whereas the majority of younger female patients were at disease stage I/II (83.4%). The geriatric patient distribution was found to be similar in any of the four disease stages and no gender differences were observed.We found that age (geriatrics scored generally worse), gender (females scored generally worse), and tumour site (larynx tumours denounce more significant problems between age groups) clearly influences Health Related Quality of Life perceptions. Geriatric oncology assessments signalize age-independent indicators that might guide oncologic geriatric care optimization. Decision-making in geriatric oncology must be based on tumour characteristics and chronological age but also on performance status evaluation, co-morbidity, and patient reported outcomes assessment.

Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial

PubMed Central

2013-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. Methods/design This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient’s global impression of change and adverse events. Safety will be assessed at each visit. Discussion The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA. Trial registration Clinical Research Information Service: KCT0000506 PMID:23945074

Early experience with laparoscopic extralevator abdominoperineal excision within an enhanced recovery setting: analysis of short-term outcomes and quality of life

PubMed Central

Vaughan-Shaw, PG; King, AT; Cheung, T; Beck, NE; Knight, JS; Nichols, PH; Nugent, KP; Pilkington, SA; Smallwood, JA; Mirnezami, AH

2011-01-01

INTRODUCTION Conventional abdominoperineal excision for low rectal cancer has a higher local recurrence and reduced survival compared to anterior resection. An extralevator abdominoperineal excision (ELAPE) may improve outcome through removal of increased tissue in the distal rectum. Experience with ELAPE is limited and no studies have reported on quality of life (QOL) following this procedure. We describe a minimally invasive approach to ELAPE within an enhanced recovery programme, and present short-term results and QOL analyses. METHODS All laparoscopic ELAPEs were included in a prospective database. Demographics, intra-operative and post-operative outcomes were evaluated. Postoperative QOL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29. RESULTS Thirteen laparoscopic ELAPEs were performed over a two-year period. All were enrolled in an enhanced recovery programme. The median age was 76. The median tumour height was 20mm (range: 0–50mm) from the dentate line and all patients received neoadjuvant treatment. The median duration of surgery was 300 minutes (range: 120–488 minutes), the mean blood loss was 150ml and one procedure was converted to open surgery. There was no circumferential resection margin involvement or tumour perforation. The median duration of use of intravenous fluid, patient controlled analgesia and urinary catheterisation was 2, 2 and 2.5 days respectively and the median length of hospital stay was 7.5 days. Two patients developed perineal wound dehiscence. QOL analysis revealed high global health status (90.8), physical (91.3), emotional (98.3) and social functioning (100) scores, which compared favourably with EORTC reference values and published QOL scores following conventional abdominoperineal excision. CONCLUSIONS Laparoscopic ELAPE within an enhanced recovery setting is a feasible and safe approach with acceptable short-term outcomes and post-operative quality of life. PMID:21929915

Quality of Life and Survival Outcome for Patients With Nasopharyngeal Carcinoma Receiving Three-Dimensional Conformal Radiotherapy vs. Intensity-Modulated Radiotherapy-A Longitudinal Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fang, F.-M.; Kaohsiung Chang Gung Head and Neck Oncology Group, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung Hsien, Taiwan; Chien, C.-Y.

2008-10-01

Purpose: To investigate the changes of quality of life (QoL) and survival outcomes for patients with nasopharyngeal carcinoma (NPC) treated by three-dimensional conformal radiotherapy (3D-CRT) vs. intensity-modulated radiotherapy (IMRT). Methods and Materials: Two hundred and three newly diagnosed NPC patients, who were curatively treated by 3D-CRT (n = 93) or IMRT (n = 110) between March 2002 and July 2004, were analyzed. The distributions of clinical stage according to American Joint Committee on Cancer 1997 were I: 15 (7.4%), II: 78 (38.4%), III: 74 (36.5%), and IV: 36 (17.7%). QoL was longitudinally assessed by the European Organization for Research andmore » Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H and N35 questionnaires at the five time points: before RT, during RT (36 Gy), and 3 months, 12 months, and 24 months after RT. Results: The 3-year locoregional control, metastasis-free survival, and overall survival rates were 84.8%, 76.7%, and 81.7% for the 3D-CRT group, respectively, compared with 84.2%, 82.6%, and 85.4% for the IMRT group (p value > 0.05). A general trend of maximal deterioration in most QoL scales was observed during RT, followed by a gradual recovery thereafter. There was no significant difference in most scales between the two groups at each time point. The exception was that patients treated by IMRT had a both statistically and clinically significant improvement in global QoL, fatigue, taste/smell, dry mouth, and feeling ill at the time point of 3 months after RT. Conclusions: The potential advantage of IMRT over 3D-CRT in treating NPC patients might occur in QoL outcome during the recovery phase of acute toxicity.« less

Patient-reported outcomes in a phase iii study of everolimus versus placebo in patients with metastatic carcinoma of the kidney that has progressed on vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy.

PubMed

Beaumont, Jennifer L; Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients.

Patient-Reported Outcomes in a Phase III Study of Everolimus Versus Placebo in Patients with Metastatic Carcinoma of the Kidney That Has Progressed on Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

PubMed Central

Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J.; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

Purpose. A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Methods. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index—Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Results. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. Conclusions. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients. PMID:21459902

Psychometric properties and measurement equivalence of the English and Chinese versions of the Beck Anxiety Inventory in patients with breast cancer.

PubMed

Ke, Yu; Ng, Terence; Yeo, Hui Ling; Shwe, Maung; Gan, Yan Xiang; Chan, Alexandre

2017-02-01

There is a lack of psychometric data for both the English and Chinese versions of Beck Anxiety Inventory (BAI) to support its usage among breast cancer patients. This study examined the psychometric properties and measurement equivalence of the English and Chinese versions of BAI among breast cancer patients in Singapore. Patients were recruited from two major cancer centers in Singapore. The criterion and construct validity of BAI was assessed by its correlation strength with (1) the emotional functioning subdomain of EORTC QLQ-C30 and (2) constructs related to anxiety, namely fatigue, dyspnea, and quality of life. The known-group validity was assessed according to the patients' breast cancer stage, religious beliefs, and emotional functioning levels. The internal consistency of the BAI domains was evaluated using Cronbach's alpha coefficient. Regression analysis was performed to compare the BAI total and domain scores between the two language versions. Data from 244 patients (144 English-speaking and 100 Chinese-speaking) were analyzed. For both language versions, the BAI total scores correlated moderately with the EORTC QLQ-C30 emotional functioning subdomain (r = -0.655 and -0.601). Correlations with fatigue, quality of life, and dyspnea were moderate (|r| = 0.456-0.606). Patients with poorer emotional functioning reported higher anxiety levels, establishing known-group validity. All BAI domains demonstrated satisfactory internal consistencies (α = 0.74-0.87), except for the panic domain (α = 0.57-0.61). Possible measurement equivalence between the language versions was established. Both English and Chinese versions of BAI are valid, reliable, and possibly equivalent for future use.

Clinician-observed and patient-reported toxicities and their association with poor tolerance to therapy in older patients with head and neck or lung cancer treated with curative radiotherapy.

PubMed

Moon, Dominic H; Chera, Bhishamjit S; Deal, Allison M; Wang, Yue; Muss, Hyman B; VanderWalde, Noam A

2018-06-11

The agreement between clinician- and patient-reported toxicities and their association with poor tolerance to therapy were assessed in an older population receiving curative radiotherapy (RT). Patients ≥ 65 years old with newly-diagnosed head and neck or lung cancer receiving curative RT ± chemotherapy were enrolled on a prospective, observational study. Agreement between clinician (CTCAEv4.02) and patient (PRO-CTCAE, EORTC QLQ-C30) report of toxicities were assessed at baseline, during treatment, and post-treatment. The association of clinician- and patient-reported symptoms with poor tolerance to therapy (defined as hospitalization, >3-day treatment delay, change in treatment regimen, or death) was assessed. Among 45 patients, median age was 71, 60% had head and neck cancer, and 47% received concurrent chemotherapy with RT. In comparing CTCAE vs PRO-CTCAE, there was good agreement at baseline except for fatigue, anorexia, and pain, where clinicians under-reported the severity. The discrepancy increased during treatment with clinicians reporting lower severity in ≥50% of matched pairs for 4/10 symptoms assessed. At follow-up, clinicians under-reported severity in ≥50% of pairs for 7/10 symptoms. CTCAE vs EORTC QLQ-C30 mirrored these findings. Patient-reported symptoms of nausea and dysphagia at 2 weeks and clinician-observed symptoms of nausea and dysphagia at 4 weeks were associated with poor tolerance to therapy. Clinicians under-report toxicities during and after curative RT in older patients with head and neck or lung cancer. Select toxicities reported by patients early in treatment and clinicians later in treatment were associated with poor tolerance to cancer therapy, providing valuable complementary information. Copyright © 2018 Elsevier Inc. All rights reserved.

Cost-utility analysis of adjuvant therapies for breast cancer in Iran.

PubMed

Bastani, Peivand; Kiadaliri, Aliasghar Ahmad

2012-04-01

The aim of this study was to evaluate the cost-utility of Docetaxel with doxorubicin and cyclophosphamide (TAC) and 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) in node-positive breast cancer patients in the south of Iran. A double blind study was done on a cohort of 100 patients suffering from breast cancer with node-positive over 8 months in the radiotherapy center of Namazi hospital, Shiraz-Iran. Health-related quality of life was assessed using questionnaire (QLQ-C30) from European Organization for Research and Treatment of Cancer (EORTC). QLQ-C30 scale scores were mapped to 15D and EuroQol 5D utilities to measure the quality-adjusted life-years (QALYs).Third party payer point of view was applied to measure and value the cost of treatments. Cost data were extracted from hospital and health insurance organizations. Robustness of the results was checked through a two way sensitivity analysis. TAC was associated with higher deterioration in HRQoL during treatment and higher improvements over 4 months follow-up. On average, the cost of treatment per patient in TAC was 15 times higher than FAC (p < .001). In overall, TAC was resulted in lower QALYs and higher cost over study period. FAC was a dominant option versus TAC in short-term. The higher improvement in HRQoL over follow-up in TAC may not compensate the more intensive deterioration caused during treatment in short-term. The short time horizon of study may limit the generalizability of our findings and, hence, there is a need to conduct long-term economic evaluation studies whenever data is available to inform decision making.

Spiritual therapy to improve the spiritual well-being of Iranian women with breast cancer: a randomized controlled trial.

PubMed

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir; Jafari, Nooshin

2013-01-01

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were assessed using Functional Assessment of Chronic Illness Therapy Spiritual Well-being scale (FACIT-Sp12) and cancer quality-of-life questionnaire (QLQ-C30), respectively. t-test, Paired t-test, pearson's correlation, and hierarchical regression analyses were used for analysis using Predictive Analytic software (PASW, version 18) for Windows. Results. After six spiritual therapy sessions, the mean spiritual well-being score from 29.76 (SD = 6.63) to 37.24 (SD = 3.52) in the intervention group (P < 0.001). There was a significant difference between arms of study (F = 22.91, P < 0.001). A significant positive correlation was detected between meaning and peace with all subscales of functional subscales on European Organization for Research and Treatment of Cancer quality of Life (EORTC QLQ-C30) (P < 0.05). Hierarchical regression analyses of participants indicated that the study arm, pain, and financial impact were significant predictors of spiritual well-being and overall QOL. Social functioning was another significant predictor of spiritual well-being. Conclusion. The results of this randomized controlled trial study suggest that participation in spiritual therapy program is associated with improvements in spiritual well-being and QOL. Targeted interventions to acknowledge and incorporate spiritual needs into conventional treatment should be considered in caring of Iranian patients with breast cancer.

Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G).

PubMed

Smith, Adam B; Cocks, Kim; Parry, David; Taylor, Matthew

2014-04-01

The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs. A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist. Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust. The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.

The influence of symptoms on quality of life among patients who have undergone oesophageal cancer surgery.

PubMed

Ha, Seo-In; Kim, Kyunghee; Kim, Ji-Su

2016-10-01

After oesophagectomy, anatomical changes and loss of function induce various symptoms that may affect quality of life (QoL) in oesophageal cancer patients. The purpose of this study was to identify the factors influencing QoL in Korean patients who have undergone oesophageal cancer surgery. This was a cross-sectional study of a convenience sample consisting of 120 surgery patients with oesophageal cancer. We used the EORTC QLQ-C30 and EORTC QLQ-OES18 to measure participants' oesophageal cancer-related symptoms and QoL. Multiple regression analyses were applied to analyse to the relationship between cancer-related symptoms and QoL. The average score of oesophageal cancer-related symptoms was 19.28 points, and the most common symptom was reflux. The mean score for global health status/QoL was 60.55. There were significant differences in the functional and symptom subscales according to financial burden, operation type (procedure), and treatment period. Dysphagia most affected global health status/QoL, and eating problems most affected the functional and symptom subscales. Dysphagia and eating problems were confirmed to be the most common symptoms affecting the QoL of patients who had undergone oesophageal cancer surgery. These results can be used to aid in the development of strategies to better manage symptoms in these patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Post-WBRT cognitive impairment and hippocampal neuronal depletion measured by in vivo metabolic MR spectroscopy: Results of prospective investigational study.

PubMed

Pospisil, Petr; Kazda, Tomas; Hynkova, Ludmila; Bulik, Martin; Dobiaskova, Marie; Burkon, Petr; Laack, Nadia N; Slampa, Pavel; Jancalek, Radim

2017-03-01

The aim of this prospective study is to evaluate post-whole brain radiotherapy (WBRT) changes in hippocampal concentration of N-acetylaspartate (h-tNAA) as a marker of neuronal loss and to correlate those changes to neurocognitive function. Thirty-five patients with brain metastases underwent baseline single slice multi-voxel MR spectroscopy (MRS) examination for measurement of hippocampal h-tNAA together with baseline battery of neurocognitive tests focused on memory (Auditory Verbal Learning Test and Brief Visuospatial Memory Test - Revised) as well as quality of life questionnaires (EORTC QLQ-C30 a EORTC QLQ-BN20). Eighteen patients completed follow-up evaluation four months after standard WBRT (2 laterolateral fields, 10×3.0Gy, 6MV photons) and were included in this analysis. MRS and cognitive examinations were repeated and compared to baseline measurements. Statistically significant decreases in h-tNAA were observed in the right (8.52-7.42mM; -12.9%, 95%CI: -7.6 to -16.4%) as well as in the left hippocampus (8.64-7.60mM; -12%, 95%CI: -7.9 to -16.2%). Statistically significant decline was observed in all AVLT and BVMT-R subtests with exception of AVLT_Recognition. Quality of life declined after WBRT (mean Δ -14.1±20.3 points in transformed 0-100 point scale; p=0.018) with no correlation to changes in hippocampal metabolite concentrations. Moderate positive correlation was observed between left h-tNAA concentration decrease and AVLT_TR decline (r=+0.32; p=0.24) as well as with AVLT_DR (r=+0.33; p=0.22) decline. Changes in right h-tNAA/Cr negatively correlated with AVLT_DR (r=-0.48; p=0.061). No correlation between right hippocampus h-tNAA and memory decline (AVLT) was observed. Our results suggest hippocampal NAA concentrations decline after WBRT and MRS may be a useful biomarker for monitoring neuronal loss after radiotherapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Quality of life assessment in advanced cancer patients treated at home, an inpatient unit, and a day care center

PubMed Central

Leppert, Wojciech; Majkowicz, Mikolaj; Forycka, Maria; Mess, Eleonora; Zdun-Ryzewska, Agata

2014-01-01

Aim of the study To assess quality of life (QoL) in cancer patients treated at home, at an in-patient palliative care unit (PCU), and at a day care center (DCC). Patients and methods QoL was assessed in advanced cancer patients at baseline and after 7 days of symptomatic treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL), the Edmonton Symptom Assessment System (ESAS), and the Karnofsky Performance Status (KPS) scale. Results A total of 129 patients completed the study, with 51 patients treated at home, 51 patients treated at the PCU, and 27 patients at DCC. In the EORTC QLQ-C15-PAL, improvement in functional and symptom scales was observed except in physical functioning and fatigue levels; patients at DCC had a better physical functioning, global QoL, appetite, and fatigue levels. In the ESAS, improvement in all items was found except for drowsiness levels, which was stable in patients treated at DCC and deteriorated in home and PCU patients. Higher activity, better appetite and well-being, and less drowsiness were observed in patients treated at DCC. KPS was better in DCC patients compared to those treated at home and at the PCU; the latter group deteriorated. Conclusions QoL improved in all patient groups, with better results in DCC patients and similar scores in those staying at home and at the PCU. Along with clinical assessment, baseline age, KPS, physical and emotional functioning may be considered when assigning patients to care at a DCC, PCU, or at home. PMID:24855379

A cross-cultural convergent parallel mixed methods study of what makes a cancer-related symptom or functional health problem clinically important.

PubMed

Giesinger, Johannes M; Aaronson, Neil K; Arraras, Juan I; Efficace, Fabio; Groenvold, Mogens; Kieffer, Jacobien M; Loth, Fanny L; Petersen, Morten Aa; Ramage, John; Tomaszewski, Krzysztof A; Young, Teresa; Holzner, Bernhard

2018-02-01

In this study, we investigated what makes a symptom or functional impairment clinically important, that is, relevant for a patient to discuss with a health care professional (HCP). This is the first part of a European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group project focusing on the development of thresholds for clinical importance for the EORTC QLQ-C30 questionnaire and its corresponding computer-adaptive version. We conducted interviews with cancer patients and HCPs in 6 European countries. Participants were asked to name aspects of a symptom or problem that make it clinically important and to provide importance ratings for a predefined set of aspects (eg, need for help and limitations of daily functioning). We conducted interviews with 83 cancer patients (mean age, 60.3 y; 50.6% men) and 67 HCPs. Participants related clinical importance to limitations of everyday life (patients, 65.1%; HCPs, 77.6%), the emotional impact of a symptom/problem (patients, 53.0%; HCPs, 64.2%), and duration/frequency (patients, 51.8%; HCPs, 49.3%). In the patient sample, importance ratings were highest for worries by partner or family, limitations in everyday life, and need for help from the medical staff. Health care professionals rated limitations in everyday life and need for help from the medical staff to be most important. Limitations in everyday life, need for (medical) help, and emotional impact on the patient or family/partner were found to be relevant aspects of clinical importance. Based on these findings, we will define anchor items for the development of thresholds for clinical importance for the EORTC measures in a Europe-wide field study. Copyright © 2017 John Wiley & Sons, Ltd.

The effects of virgin coconut oil (VCO) as supplementation on quality of life (QOL) among breast cancer patients.

PubMed

Law, Kim Sooi; Azman, Nizuwan; Omar, Eshaifol Azam; Musa, Muhammad Yusri; Yusoff, Narazah Mohd; Sulaiman, Siti Amrah; Hussain, Nik Hazlina Nik

2014-08-27

Breast cancer is the most common cancer amongst Malaysian women. Both the disease and its treatment can disrupt the lives of the woman and adversely affect all aspects of life and thus can alter a woman's quality of life. The aim of this study was to examine the effect of virgin coconut oil (VCO) on the quality of life (QOL) of patients diagnosed with breast cancer. This was a prospective study of breast cancer patients admitted into the Oncology Unit of Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia. The sample consisted of 60 patients with stage III and IV breast cancer allocated to either an intervention group (n = 30) or a control group (n = 30) using a simple random table. QOL was evaluated from the first cycle of chemotherapy to the sixth cycle, and data were collected using a validated Bahasa Malaysia version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-C30) and its breast-specific module (QLQ-BR 23). The mean age of breast cancer patients was 50.2 (SD = 13.5) years. There were significant mean score differences for functioning and global QOL between groups (α < 0.01). The intervention group also had better scores for symptoms including fatigue, dyspnea, sleep difficulties, and loss of appetite compared to the control group. Although there are deteriorations for sexual enjoyment, the intervention group exhibited improvement in breast functioning and symptom scores for body image, sexual function, future perspective, breast symptoms, and systemic therapy side effects. VCO consumption during chemotherapy helped improve the functional status and global QOL of breast cancer patients. In addition, it reduced the symptoms related to side effects of chemotherapy.

Quality of life in relation to tamoxifen or exemestane treatment in postmenopausal breast cancer patients: a Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial side study.

PubMed

van Nes, J G H; Fontein, D B Y; Hille, E T M; Voskuil, D W; van Leeuwen, F E; de Haes, J C J M; Putter, H; Seynaeve, C; Nortier, J W R; van de Velde, C J H

2012-07-01

Tamoxifen and aromatase inhibitors are associated with side effects which can significantly impact quality of life (QoL). We assessed QoL in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial and compared these data with reported adverse events in the main database. 2,754 Dutch postmenopausal early breast cancer patients were randomized between 5 years of exemestane, or tamoxifen (2.5-3 years) followed by exemestane (2.5-2 years). 742 patients were invited to participate in the QoL side study and complete questionnaires at 1 (T1) and 2 (T2) years after start of endocrine treatment. Questionnaires comprised the EORTC QLQ-C30 and BR23 questionnaires, supplemented with FACT-ES questions. 543 patients completed questionnaires at T1 and 454 patients (84%) at T2. Overall QoL and most functioning scales improved over time. The only clinically relevant and statistically significant difference between treatment types concerned insomnia; exemestane-treated patients reported more insomnia than tamoxifen-treated patients. Discrepancy was observed between QoL issue scores reported by the patients and adverse events reported by physicians. Certain QoL issues are treatment- and/or time-specific and deserve attention by health care providers. There is a need for careful inquiry into QoL issues by those prescribing endocrine treatment to optimize QoL and treatment adherence.

Income and health-related quality of life among prostate cancer patients over a one-year period after radical prostatectomy: a linear mixed model analysis.

PubMed

Klein, Jens; Lüdecke, Daniel; Hofreuter-Gätgens, Kerstin; Fisch, Margit; Graefen, Markus; von dem Knesebeck, Olaf

2017-09-01

To examine income-related disparities in health-related quality of life (HRQOL) over a one-year period after surgery (radical prostatectomy) and its contributory factors in a longitudinal perspective. Evidence of associations between income and HRQOL among patients with prostate cancer (PCa) is sparse and their explanations still remain unclear. 246 males of two German hospitals filled out a questionnaire at the time of acute treatment, 6 and 12 months later. Age, partnership status, baseline disease and treatment factors, physical and psychological comorbidities, as well as treatment factors and adverse effects at follow-up were additionally included in the analyses to explain potential disparities. HRQOL was assessed with the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 core questionnaire and the prostate-specific QLQ-PR25. A linear mixed model for repeated measures was calculated. The fixed effects showed highly significant income-related inequalities regarding the majority of HRQOL scales. Less affluent PCa patients reported lower HRQOL in terms of global quality of life, all functional scales and urinary symptoms. After introducing relevant covariates, some associations became insignificant (physical, cognitive and sexual function), while others only showed reduced estimates (global quality of life, urinary symptoms, role, emotional and social function). In particular, mental disorders/psychological comorbidity played a relevant role in the explanation of income-related disparities. One year after surgery, income-related disparities in various dimensions of HRQOL persist. With respect to economically disadvantaged PCa patients, the findings emphasize the importance of continuous psychosocial screening and tailored interventions, of patients' empowerment and improved access to supportive care.

What Patients Can Tell Us: Topic Analysis for Social Media on Breast Cancer

PubMed Central

Bringay, Sandra; Lavergne, Christian; Mollevi, Caroline; Opitz, Thomas

2017-01-01

Background Social media dedicated to health are increasingly used by patients and health professionals. They are rich textual resources with content generated through free exchange between patients. We are proposing a method to tackle the problem of retrieving clinically relevant information from such social media in order to analyze the quality of life of patients with breast cancer. Objective Our aim was to detect the different topics discussed by patients on social media and to relate them to functional and symptomatic dimensions assessed in the internationally standardized self-administered questionnaires used in cancer clinical trials (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core 30 [QLQ-C30] and breast cancer module [QLQ-BR23]). Methods First, we applied a classic text mining technique, latent Dirichlet allocation (LDA), to detect the different topics discussed on social media dealing with breast cancer. We applied the LDA model to 2 datasets composed of messages extracted from public Facebook groups and from a public health forum (cancerdusein.org, a French breast cancer forum) with relevant preprocessing. Second, we applied a customized Jaccard coefficient to automatically compute similarity distance between the topics detected with LDA and the questions in the self-administered questionnaires used to study quality of life. Results Among the 23 topics present in the self-administered questionnaires, 22 matched with the topics discussed by patients on social media. Interestingly, these topics corresponded to 95% (22/23) of the forum and 86% (20/23) of the Facebook group topics. These figures underline that topics related to quality of life are an important concern for patients. However, 5 social media topics had no corresponding topic in the questionnaires, which do not cover all of the patients’ concerns. Of these 5 topics, 2 could potentially be used in the questionnaires, and these 2 topics corresponded to a total of 3.10% (523/16,868) of topics in the cancerdusein.org corpus and 4.30% (3014/70,092) of the Facebook corpus. Conclusions We found a good correspondence between detected topics on social media and topics covered by the self-administered questionnaires, which substantiates the sound construction of such questionnaires. We detected new emerging topics from social media that can be used to complete current self-administered questionnaires. Moreover, we confirmed that social media mining is an important source of information for complementary analysis of quality of life. PMID:28760725

What Patients Can Tell Us: Topic Analysis for Social Media on Breast Cancer.

PubMed

Tapi Nzali, Mike Donald; Bringay, Sandra; Lavergne, Christian; Mollevi, Caroline; Opitz, Thomas

2017-07-31

Social media dedicated to health are increasingly used by patients and health professionals. They are rich textual resources with content generated through free exchange between patients. We are proposing a method to tackle the problem of retrieving clinically relevant information from such social media in order to analyze the quality of life of patients with breast cancer. Our aim was to detect the different topics discussed by patients on social media and to relate them to functional and symptomatic dimensions assessed in the internationally standardized self-administered questionnaires used in cancer clinical trials (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core 30 [QLQ-C30] and breast cancer module [QLQ-BR23]). First, we applied a classic text mining technique, latent Dirichlet allocation (LDA), to detect the different topics discussed on social media dealing with breast cancer. We applied the LDA model to 2 datasets composed of messages extracted from public Facebook groups and from a public health forum (cancerdusein.org, a French breast cancer forum) with relevant preprocessing. Second, we applied a customized Jaccard coefficient to automatically compute similarity distance between the topics detected with LDA and the questions in the self-administered questionnaires used to study quality of life. Among the 23 topics present in the self-administered questionnaires, 22 matched with the topics discussed by patients on social media. Interestingly, these topics corresponded to 95% (22/23) of the forum and 86% (20/23) of the Facebook group topics. These figures underline that topics related to quality of life are an important concern for patients. However, 5 social media topics had no corresponding topic in the questionnaires, which do not cover all of the patients' concerns. Of these 5 topics, 2 could potentially be used in the questionnaires, and these 2 topics corresponded to a total of 3.10% (523/16,868) of topics in the cancerdusein.org corpus and 4.30% (3014/70,092) of the Facebook corpus. We found a good correspondence between detected topics on social media and topics covered by the self-administered questionnaires, which substantiates the sound construction of such questionnaires. We detected new emerging topics from social media that can be used to complete current self-administered questionnaires. Moreover, we confirmed that social media mining is an important source of information for complementary analysis of quality of life. ©Mike Donald Tapi Nzali, Sandra Bringay, Christian Lavergne, Caroline Mollevi, Thomas Opitz. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 31.07.2017.

Restoration of voice function by using biological feedback in laryngeal and hypopharyngeal carcinoma patients

NASA Astrophysics Data System (ADS)

Choinzonov, E. L.; Balatskaya, L. N.; Chizhevskaya, S. Yu.; Meshcheryakov, R. V.; Kostyuchenko, E. Yu.; Ivanova, T. A.

2016-08-01

The aim of the research is to develop and introduce a new technique of post-laryngectomy voice rehabilitation of laryngeal and hypopharyngeal carcinoma patients. The study involves comparing and analyzing 82 cases of voice function restoration by using biological feedback based on mathematical modeling of voice production. The advantage of the modern technology-based method in comparison with the conventional one is proved. Restoration of voice function using biofeedback allows taking into account patient's abilities, adjusting parameters of voice trainings, and controlling their efficiency in real-time mode. The data obtained indicate that the new method contributes to the rapid inclusion of self-regulation mechanisms of the body and results in the overall success rate of voice rehabilitation in totally laryngectomized patients reaching 92%, which reduces the rehabilitation period to 18 days, compared to 86% and 38 days in the control group, respectively. Restoration of disturbed functions after successful treatment is an important task of rehabilitation and is crucial in terms of the quality of cancer patients' lives. To assess life quality of laryngeal cancer patients, the EORTC Quality of Life Core Questionnaire (QLQ-C30), and head and neck module (QLQ-H&N35) were used. The analyzed results proved that the technique of biofeedback voice restoration significantly improves the quality of life of laryngectomized patients. It allows reducing the number of disabled people, restoring patients' ability to work-related activities, and significantly improving social adaptation of these patients.

Quality of life measures in glioma patients with different grades: A preliminary study.

PubMed

Mahalakshmi, P; Vanisree, A J

2015-01-01

Plethora of information exists in the literature on pathology of the glioma while prevailing research data on quality-of-life (QOL) of glioma patients marks dearth thus demanding more studies. In this study, we examined the QOL of different grades of glioma patients among the Chennai population in India. A total of 162 patients with different grades of glioma enrolled from August 2007 to February 2011, at their first contact to Department of Neurology and Neurosurgery, Government General Hospital, Chennai, India were included and their QOL was assessed by European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQc-30), EORTC brain cancer module (QLQ BN-20). Both low and high grade glioma (LGG and HGG) patients had poor mean scores in social functioning (87.0), physical functioning (82.0) and emotional functioning (75.2) and role functioning (58.9). The mean scores on cognitive functioning (61.9) and global QOL (60.3) were better. Age, Karnofsky performance status, World Health Organization grades showed significant associations with all functional scales. The percentage values were higher for symptoms of fatigue (76.9%), pain (71.5%), financial difficulties (77.6%) and appetite loss (38.46%) in both LGG and HGG. Similarly, with respect to QLQ-BN20 domains, HGG patients showed more symptoms than low grade with a significant correlation in communication deficit problems (P = 0.02), headache (P = 0.04), seizures (P < 0.01), hair loss (P < 0.05) than the other symptoms. This initial assessment suggests that an increasing burden of symptoms exists, with poor QOL and survival, which has become a major concern in different grades of glioma patients.

No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions--results from a randomised blinded trial.

PubMed

Sharp, Lena; Finnilä, Kristina; Johansson, Hemming; Abrahamsson, Marie; Hatschek, Thomas; Bergenmar, Mia

2013-08-01

The purpose of this blinded, randomized clinical trial was to compare two topical agents (Calendula Weleda cream vs. Essex cream) in reducing the risk of severe acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast cancer. The primary endpoint was the difference in proportion of patients with ARSR, assessed with the Radiation Therapy Oncology Group/The Organization for Research and Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at follow-up. The secondary endpoints included patient reported outcome measures; Quality of Life Questionnaire (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms from the irradiated area (visual analogue scale). Patients' experiences and adherence to the topical agents were also evaluated. A total of 420 patients were randomised and 411 were analysed. With the exception of previous chemotherapy, the treatment groups were well balanced, both regarding treatment- and patient-related factors. The incidence of severe ARSR (RTOG/EORTC grade ≤2) at the follow-up visit was 23% (n = 45) in the Calendula group and 19% (n = 38) in the Essex group. We found no difference in severe ARSR between the groups at any point of assessment. The patients reported low levels of skin related symptoms and no statistically significant differences between the groups were found. No differences in ARSR between patients randomised to Calendula or Essex cream was found. ARSR seem to be a relatively limited problem, probably more influenced by treatment related factors than by choice of skin care products in this patient group. Copyright © 2012 Elsevier Ltd. All rights reserved.

Impacts of treatments on the quality of life among esophageal squamous cell carcinoma patients.

PubMed

Chen, C-Y; Hsieh, V C-R; Chang, C-H; Chen, P-R; Liang, W-M; Pan, S-C; Shieh, S-H

2017-10-01

This study aims to investigate the effects of treatments on the quality of life for patients with esophageal squamous cell carcinoma patients diagnosed at early and late stages. From a medical center in central Taiwan, patients who had been diagnosed with esophageal squamous cell carcinoma from February 2007 and March 2011 were recruited. Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Quality of Life Questionnaire Oesophageal 18 (QLQ-OES18), quality of life scores for 105 esophageal squamous cell carcinoma patients were obtained and assessed. Multivariate analysis was performed on the quality of life scores after stratification by cancer stage. Among early-stage esophageal squamous cell carcinoma patients, those received only surgery (S-only) performed better in physical and social functioning compared with patients who underwent surgery and concurrent chemoradiotherapy (S+CCRT) (β = 9.0, P = 0.03; β = 12.1, P = 0.04, respectively). For those that received only concurrent chemoradiotherapy (CCRT-only), they performed worse in role and emotional functioning relative to S+CCRT patients (β = -17.2, P = 0.02; β = -15.7, P = 0.05, respectively). Among late-stage patients, CCRT-only treatment gave insignificantly better global health status and functional scale scores and less severe symptoms compared to the S+CCRT option. Better functional scores and less aggravated symptoms are observed in early-stage esophageal squamous cell carcinoma patients who received surgery-only treatment relative to those that underwent both surgery and chemoradiotherapy. For late-stage esophageal cancer patients, the measured difference of quality of life is not significant between CCRT-only and S+CCRT treatments. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Association between unmet needs and quality of life in hospitalised cancer patients no longer receiving anti-cancer treatment.

PubMed

Bužgová, R; Hajnová, E; Sikorová, L; Jarošová, D

2014-09-01

Assessing the quality of life and unmet needs of cancer patients is an integral part of palliative care. This cross-sectional study sought to determine whether there is an association between quality of life and unmet needs, anxiety and depression in cancer patients who are no longer receiving anti-cancer treatment. The sample consisted of 93 patients from the oncology department at the University Hospital in Ostrava for whom further cancer treatment had been terminated as ineffective in halting the progression of their cancer. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Patient Needs Assessment in Palliative Care (PNAP) questionnaire, and the Hospital Anxiety and Depression Scale (HADS) were used to collect data. The overall quality of life score was quite low at 46. Most unmet needs were defined in terms of physical, psychological or spiritual needs. Correlations were found between impaired quality of life and lower Karnofsky scores (r = 0.50); increased physical (r = 0.52), psychological (r = 0.44) and spiritual (r = 0.36) needs; and higher levels of anxiety (r = -0.30) and depression (r = -0.68). Effective management of patients' physical (pain, fatigue and depression), psychological and spiritual needs may improve their quality of life. © 2014 John Wiley & Sons Ltd.

Impact of Preoperative Radiotherapy on General and Disease-Specific Health Status of Rectal Cancer Survivors: A Population-Based Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thong, Melissa S.Y., E-mail: M.Thong@uvt.nl; Comprehensive Cancer Centre South, Eindhoven; Mols, Floortje

Purpose: To date, few studies have evaluated the impact of preoperative radiotherapy (pRT) on long-term health status of rectal cancer survivors. Using a population-based sample, we assessed the impact of pRT on general and disease-specific health status of rectal cancer survivors up to 10 years postdiagnosis. The health status of older ({>=}75 years old at diagnosis) pRT survivors was also compared with that of younger survivors. Methods and Materials: Survivors identified from the Eindhoven Cancer Registry treated with surgery only (SU) or with pRT between 1998 and 2007 were included. Survivors completed the Short Form-36 (SF-36) health survey questionnaire andmore » the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 38 (EORTC QLQ-CR38) questionnaire. The SF-36 and EORTC QLQ-CR38 (sexuality subscale) scores of the survivors were compared to an age- and sex-matched Dutch normal population. Results: A total of 340 survivors (response, 85%; pRT survivors, 71%) were analyzed. Overall, survivors had similar general health status. Both short-term (<5 years) and long-term ({>=}5 years) pRT survivors had significantly poorer body image and more problems with gastrointestinal function, male sexual dysfunction, and defecation than SU survivors. Survivors had comparable general health status but greater sexual dysfunction than the normal population. Older pRT survivors had general and disease-specific health status comparable to that of younger pRT survivors. Conclusions: For better survivorship care, rectal cancer survivors could benefit from increased clinical and psychological focus on the possible long-term morbidity of treatment and its effects on health status.« less

Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Klein, Jonathan, E-mail: jonathan.klein@rmp.uhn.on.ca; Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario; Dawson, Laura A.

Purpose: To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver. Methods and Materials: Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were alsomore » treated. Results: The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients. Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively. Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival. Conclusions: Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants comparison against other liver-directed therapies.« less

Assessment of early and late dysphagia using videofluoroscopy and quality of life questionnaires in patients with head and neck cancer treated with radiation therapy.

PubMed

Erkal, Eda Yirmibeşoğlu; Canoğlu, Doğu; Kaya, Ahmet; Aksu, Görkem; Sarper, Binnaz; Akansel, Gür; Meydancı, Tülay; Erkal, Haldun Sükrü

2014-06-14

The aim of this study was to evaluate dysphagia in patients with head and neck cancer (HNC) undergoing three-dimensional conformal radiation therapy using objective and subjective tools simultaneously and to associate the clinical correlates of dysphagia with dosimetric parameters. Twenty patients were included in the study. The primary tumor and the involved lymph nodes (LN) were treated with 66-70 Gy, the uninvolved LN were treated with 46-50 Gy. Six swallowing structures were identified: the superior pharyngeal constrictor muscle (SPCM), the middle pharyngeal constrictor muscle (MPCM), the inferior pharyngeal constrictor muscle (IPCM), the base of tongue (BOT), the larynx and the proximal esophageal sphincter (PES). Dysphagia was evaluated using videofluoroscopy and European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30) and supplemental EORTC QoL module for HNC (QLQ-H&N35). The evaluations were performed before treatment, at 3 months and at 6 months following treatment. On objective evaluation, the Dmax for the larynx and the sub-structures of the PCM were correlated with impaired lingual movement, BOT weakness and proximal esophageal stricture at 3 months, whereas the V65, the V70and the Dmax for the larynx was correlated with BOT weakness and the V65, the V70, the Dmax or the Dmean for the sub-structures of the PCM were correlated with impaired lingual movement, BOT weakness, reduced laryngeal elevation, reduced epiglottic inversion and aspiration at 6 months following treatment. On subjective evaluation, the V60, the Dmax and the Dmean for SPCM were correlated with QoL scores for HNSO at 3 months, whereas the V70 for SPCM were correlated with QoL scores for HNPA and the V60, the V65, the V70, the Dmax and the Dmean for SPCM were correlated with QoL scores for HNSO at 6 months following treatment. The use of multiple dysphagia-related endpoints to complement eachother rather than to overlap with one another, as well as the use of multiple evaluations over time to represent a scale of early to late findings might provide a better insight in terms of the association of the clinical correlates of dysphagia with the dose-volume data for the dysphagia-related anatomical structures.

Quality of life in Malaysian colorectal cancer patients.

PubMed

Wan Puteh, Sharifa Ezat; Saad, Natrah Mohd; Aljunid, Syed Mohd; Abdul Manaf, Mohd Rizal; Sulong, Saperi; Sagap, Ismail; Ismail, Fuad; Muhammad Annuar, Muhd Azrif

2013-04-01

The rapidly increasing of incidence colorectal cancer (CRC) in Malaysia and the introduction of new treatments that prolong survival advocating treatment outcome measures such as patients' quality of life (QOL) are evaluated in this study. The study aims to determine QOL in CRC patients according to cancer stage and age. A cross-sectional study was performed from June to December 2011 at four public tertiary hospitals. The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire Core-30 (EORTC QLQ C-30) questionnaire was used through face-to-face interview and the medical records of 160 respondents were reviewed. The mean age of respondents was 58.47 ± 12.04 years with 57.5% of respondents being male and 42.5% female. The majority of respondents were in CRC stages III and IV. Median global health status (GHS) score was 83.33 (IQR 16.67). Sikhs and Indians had a higher median GHS score compared to other ethnicities (Kruskal-Wallis, χ(2)  = 12.12, p = 0.007). Emotional, cognitive and social functions were higher in respondents with earlier stage of disease (Kruskal-Wallis, χ2 = 6.06, 6.36, 10.58, p = 0.048, 0.042, 0.005). Median pain, dyspnea, diarrhea and financial implication scores were significantly higher in advanced stage of disease (Kruskal-Wallis, χ(2)  = 9.31, 6.26,6.77, 7.28, p = 0.010, 0.044,0.034,0.026). Median diarrhea score (p = 0.012) was significantly different between age groups. Emotional, cognitive and social functions deteriorate with advanced stage of disease. Patients with advanced stage disease experience more pain, dyspnea, diarrhea and financial implications. A systematic screening program to detect cases as early as possible is essential nationwide. Copyright © 2013 Wiley Publishing Asia Pty Ltd.

Intensity of Anxiety and Depression in Patients with Lung Cancer in Relation to Quality of Life.

PubMed

Polański, Jacek; Chabowski, Mariusz; Chudiak, Anna; Uchmanowicz, Bartosz; Janczak, Dariusz; Rosińczuk, Joanna; Mazur, Grzegorz

2018-01-01

Psychological factors, such as the anxiety and depression, which often occur in patients with lung cancer might negatively influence their quality of life. The aim of the study was to evaluate the effect of anxiety and depression in lung cancer patients on quality of life. The study included 180 lung patients of the mean age of 62.7 ± 9.7 years. The following scales were employed in the study: Quality of Life Questionnaire QLQ-C30 and LC13 scale, and Hospital Anxiety and Depression scale (HADS). The overall score of quality of life measured by QLQ-C30 was 47.1 ± 23.4 points on a hundred-point scale. Anxiety was diagnosed in 67 patients (37.2%) and depression in 75 patients (41.7%) by HADS. Quality of life was significantly worse in case of anxiety and depression (p < 0.05), which negatively influenced both functional and symptom intensity scales measured with QLQ-C30 and QLQ-LC13. We conclude that early identification of anxiety and depression may help in therapeutic decision-making and may be a useful predictive factor in lung cancer patients.

Reflexology in the management of chemotherapy induced peripheral neuropathy: A pilot randomized controlled trial.

PubMed

Kurt, Seda; Can, Gulbeyaz

2018-02-01

The current experimental study aimed to evaluate the effectiveness of reflexology on the management of symptoms and functions of chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. This study was conducted as a randomized controlled trial in 60 patients (30 experimental and 30 control patients) who had chemotherapy-induced Grade II-IV peripheral neuropathy complaints from July 2013 to November 2015. Data were collected using the patient identification form, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN-20) form, and BPI (used for related chemotherapy-induced peripheral neuropathy symptoms). The majority of the patients were being treated for gastrointestinal or breast cancer and were primarily receiving Eloxatine- or taxane-based treatment. It was found that reflexology applications did not lead to differences in either group in terms of peripheral neuropathy severity and incidence (p > 0.05) and only led to improvement in sensory functions in the experimental group (p < 0.05). It was determined that reflexology is not an effective method in the management of patients' activity levels, walking ability etc. and motor, autonomic functions related CIPN, but reflexology is effective method in the management of patients' sensory functions related CIPN. Key Words: Peripheral neuropathy, reflexology, chemotherapy, EORTC QLQ-CIPN-20, BPI. Copyright © 2017 Elsevier Ltd. All rights reserved.

Undergoing Diagnostic Evaluation for Possible Cancer Affects the Health-Related Quality of Life in Patients Presenting with Non-Specific Symptoms

PubMed Central

Moseholm, Ellen; Rydahl-Hansen, Susan; Lindhardt, Bjarne Ørskov

2016-01-01

Aim Undergoing diagnostic evaluation for possible cancer can affect health-related quality of life (HRQoL). The aims of this study were to examine the HRQoL in patients undergoing a diagnostic evaluation for possible cancer due to non-specific symptoms and further to investigate the impact of socio-demographic and medical factors associated with HRQoL at the time of diagnosis. Methods This was a prospective, multicenter survey study that included patients who were referred for a diagnostic evaluation due to non-specific cancer symptoms. Participants completed the EORTC-QLQ-C30 quality of life scale before and after completing the diagnostic evaluation. The baseline and follow-up EORTC-QLQ-C30 scores were compared with reference populations. The impact of socio-demographic and medical factors on HRQoL at follow-up was explored by bootstrapped multivariate linear regression. Results A total of 838 patients participated in the study; 680 (81%) also completed follow-up. Twenty-two percent of the patients received a cancer diagnosis at the end of follow-up. Patients presented initially with a high burden of symptoms, less role and emotional functioning and a lower global health/QoL. Most domains improved after diagnosis and no clinically important difference between baseline and follow-up scores was found. Patients reported effects on HRQoL both at baseline and at follow-up compared with the Danish reference population and had similar scores as a cancer reference population. Co-morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis. Conclusions Patients with non-specific symptoms reported an affected HRQoL while undergoing a diagnostic evaluation for possible cancer. Morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis. PMID:26840866

Undergoing Diagnostic Evaluation for Possible Cancer Affects the Health-Related Quality of Life in Patients Presenting with Non-Specific Symptoms.

PubMed

Moseholm, Ellen; Rydahl-Hansen, Susan; Lindhardt, Bjarne Ørskov

2016-01-01

Undergoing diagnostic evaluation for possible cancer can affect health-related quality of life (HRQoL). The aims of this study were to examine the HRQoL in patients undergoing a diagnostic evaluation for possible cancer due to non-specific symptoms and further to investigate the impact of socio-demographic and medical factors associated with HRQoL at the time of diagnosis. This was a prospective, multicenter survey study that included patients who were referred for a diagnostic evaluation due to non-specific cancer symptoms. Participants completed the EORTC-QLQ-C30 quality of life scale before and after completing the diagnostic evaluation. The baseline and follow-up EORTC-QLQ-C30 scores were compared with reference populations. The impact of socio-demographic and medical factors on HRQoL at follow-up was explored by bootstrapped multivariate linear regression. A total of 838 patients participated in the study; 680 (81%) also completed follow-up. Twenty-two percent of the patients received a cancer diagnosis at the end of follow-up. Patients presented initially with a high burden of symptoms, less role and emotional functioning and a lower global health/QoL. Most domains improved after diagnosis and no clinically important difference between baseline and follow-up scores was found. Patients reported effects on HRQoL both at baseline and at follow-up compared with the Danish reference population and had similar scores as a cancer reference population. Co-morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis. Patients with non-specific symptoms reported an affected HRQoL while undergoing a diagnostic evaluation for possible cancer. Morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis.

Quality of life and psychological well-being of breast cancer survivors in Jordan.

PubMed

Abu-Helalah, Munir; Al-Hanaqta, Motasem; Alshraideh, Hussam; Abdulbaqi, Nada; Hijazeen, Jameel

2014-01-01

Breast cancer is the most common cancer among Jordanians. Breast cancer patients suffer from several negative consequences after treatment and these include pain, fatigue, sexual problems, appearance and body image concerns, with psychological dysfunction. This could affect the patient quality of life and psychological well-being. To the best of our knowledge, there is no published quantitative data on the quality of life and psychological well-being of breast cancer patients in Jordan. The objective of this study was to obtain such data and assess predictors with calculated scores. In this cross-sectional study conducted among breast cancer patients in Jordan diagnosed in 2009 and 2010, assessment was performed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Breast Module (QLQ-BR23) and the Hospital Anxiety and Depression Scale (HADS). Clinical, demographic and psychosocial indicators that could predict patient quality of life scores were collected. The number of patients interviewed was 236 (mean age=50.7±10.7 years). The mean Global Health score for the QLQ-C30 was 63.7±20.2 SD. Among functional scales, "social functioning" scored the highest (mean=78.1±28.6 SD), whereas "emotional functioning" scored the lowest (mean=59.0±SD 33.5). For the QLQ-BR23, the worst scores within the functional scales were for "body image" (mean=52.1±36.8 SD) and "future perspective" (mean=52.9±38.5 SD) . The worst symptom was "upset by hair loss" (mean=69.8±43.0). The mean HADS scores was 18.±9.0 SD. Out of study participants, 53% scored abnormal on the anxiety scale and 45% on the depression scale. Severe depression and severe anxiety were detected among 8% and 14% of study participants, respectively. Statistically significant predictors for individual scores were similar to those reported in published studies, such as the presence of recurrence since baseline, family history of cancer, low educational status, current social problems, extent of the disease, presence of financial difficulties, and employment status. Breast cancer survivors in Jordan have overall good quality of life scores when compared with patients from Western countries. However, their psychological wellbeing is more impaired. There is an urgent need for psychosocial support programs and psychological screening and consultation for breast cancer patients at hospitals of the Ministry of Health in Jordan.

The effects on anxiety and quality of life of breast cancer patients following completion of the first cycle of chemotherapy

PubMed Central

Charalambous, Andreas; Kaite, Charis P; Charalambous, Melanie; Tistsi, Theologia; Kouta, Christiana

2017-01-01

Objectives: Breast cancer patients as part of their treatment need to undergo various forms of chemotherapy. This is considered as a burdensome experience for many patients often leading to significant levels of anxiety. The aim of the study was to explore the anxiety levels and any correlations to the quality of life of women with breast cancer that were undergoing chemotherapy. Methods: This was a cross-sectional study utilizing an explanatory sequential design. Data were collected from 355 women with breast cancer with the Self Anxiety Scale, the EORTC QLQ-C30, the EORTC QLQ-BR23 and sociodemographic questionnaires. Further insight to patients’ experiences was given through 12 in-depth interviews. Results: Anxiety scores ranged between 24 and 75 (45.7 ± 10.11), with 44% reporting serious or/and intense anxiety. The results revealed statistically significant differences on patients’ anxiety levels depending on their source of support. Overall, patients’ global health-related quality of life was found to be low to average 55.91 ± 17.94. The results showed low emotional functioning (49.30 ± 29.12), low role functions (56.34 ± 27.50) and low sexual functioning (24.93 ± 20.75). Patients also reported experiencing problems with fatigue (49.04 ± 29.12), insomnia (44.32 ± 32.97), hair loss (48.25 ± 38.32) and arm symptoms (36.53 ± 23.71). Patients being solely supported by the family experienced higher anxiety levels (p < 0.001) and lower quality of life (p < 0.001). There was a statistically significant negative correlation between anxiety and quality of life (r = −0.623, p < 0.001). Statistically significant differences were also found in relation to demographics, anxiety and quality of life. The interviews provided further evidence on the impact of anxiety on patients’ lives. Conclusion: The time following the completion of the first cycle of chemotherapy is associated with anxiety and lower quality of life levels in breast cancer patients. Healthcare providers should consider the supportive healthcare needs from the beginning of chemotherapy in patients to optimize their conventional and supportive healthcare outcomes. PMID:28694967

Quality of life of patients from rural and urban areas in Poland with head and neck cancer treated with radiotherapy. A study of the influence of selected socio-demographic factors.

PubMed

Depta, Adam; Jewczak, Maciej; Skura-Madziała, Anna

2017-10-01

The quality of life (QoL) experienced by cancer patients depends both on their state of health and on sociodemographic factors. Tumours in the head and neck region have a particularly adverse effect on patients psychologically and on their social functioning. The study involved 121 patients receiving radiotherapy treatment for head and neck cancers. They included 72 urban and 49 rural residents. QoL was assessed using the questionnaires EORTC-QLQ-C30 and QLQ-H&N35. The data were analysed using statistical methods: a χ 2 test for independence and a multinomial logit model. The evaluation of QoL showed a strong, statistically significant, positive dependence on state of health, and a weak dependence on sociodemographic factors and place of residence. Evaluations of financial situation and living conditions were similar for rural and urban residents. Patients from urban areas had the greatest anxiety about deterioration of their state of health. Rural respondents were more often anxious about a worsening of their financial situation, and expressed a fear of loneliness. Studying the QoL of patients with head and neck cancer provides information concerning the areas in which the disease inhibits their lives, and the extent to which it does so. It indicates conditions for the adaptation of treatment and care methods in the healthcare system which might improve the QoL of such patients. A multinomial logit model identifies the factors determining the patients' health assessment and defines the probable values of such assessment.

Determinants and implications of cancer patients' psychosocial needs.

PubMed

Ernstmann, N; Neumann, M; Ommen, O; Galushko, M; Wirtz, M; Voltz, R; Hallek, M; Pfaff, H

2009-11-01

Cancer patients often experience distress. However, the majority of newly diagnosed patients gradually adapt to the crisis. When symptoms of distress and anxiety persist over months, patients require psychosocial support. The aim of the present study was to determine the proportion of cancer patients who indicate the need for psychosocial support and to identify sociodemographic, psychological and illness-related factors predicting the need for psychosocial support in a German sample. The cross-sectional retrospective study was administered to 710 cancer patients who had been inpatients at the University Hospital of Cologne. The response rate was 49.5%. Patients suffering from bronchial, oesophageal, colorectal, breast, prostate and skin cancer participated in the study. The severity of depressive symptoms was assessed using the German version of the Major Depression Inventory. The level of anxiety was assessed with the state subscale of the German version of the State-Trait Anxiety Inventory. To measure the functional aspects of health-related quality of life, the scales "physical functioning", "role functioning", "emotional functioning", "cognitive functioning" and "role functioning" of the European Organisation for Research and Treatment of Cancer QLQ-C30 Questionnaire (EORTC QLQ-C30) were used. Of the cancer patients, 18.9% indicate an unmet need for psychosocial support and 9.5% are actually using psychosocial services. In a multiple logistic regression, significant indicators of the need for psychosocial support are gender [p = 0.014; standardised effect coefficient (sc) = 1.615] and emotional functioning (p < 0.001; sc = 1.533). The estimated model has a specificity of 92.2% and a sensitivity of 54.0%. Almost a third of the cancer patient population indicates an unmet need for psychosocial support or is actually using psychosocial services. Emotional functioning is a central predictor of the requirement for psychosocial support. Women are emotionally more affected than men and need more psychosocial support. The prognostic validity of the severity of depression and anxiety is limited.

The international phase 4 validation study of the EORTC QLQ-SWB32: A stand-alone measure of spiritual well-being for people receiving palliative care for cancer.

PubMed

Vivat, B; Young, T E; Winstanley, J; Arraras, J I; Black, K; Boyle, F; Bredart, A; Costantini, A; Guo, J; Irarrazaval, M E; Kobayashi, K; Kruizinga, R; Navarro, M; Omidvari, S; Rohde, G E; Serpentini, S; Spry, N; Van Laarhoven, H W M; Yang, G M

2017-11-01

The EORTC Quality of Life Group has just completed the final phase (field-testing and validation) of an international project to develop a stand-alone measure of spiritual well-being (SWB) for palliative cancer patients. Participants (n = 451)-from 14 countries on four continents; 54% female; 188 Christian; 50 Muslim; 156 with no religion-completed a provisional 36-item measure of SWB plus the EORTC QLQ-C15-PAL (PAL), then took part in a structured debriefing interview. All items showed good score distribution across response categories. We assessed scale structure using principal component analysis and Rasch analysis, and explored construct validity, and convergent/divergent validity with the PAL. Twenty-two items in four scoring scales (Relationship with Self, Relationships with Others, Relationship with Someone or Something Greater, and Existential) explained 53% of the variance. The measure also includes a global SWB item and nine other items. Scores on the PAL global quality-of-life item and Emotional Functioning scale weakly-moderately correlated with scores on the global SWB item and two of the four SWB scales. This new validated 32-item SWB measure addresses a distinct aspect of quality-of-life, and is now available for use in research and clinical practice, with a role as both a measurement and an intervention tool. © 2017 John Wiley & Sons Ltd.

A comprehensive geriatric assessment screening questionnaire (CGA-GOLD) for older people undergoing treatment for cancer.

PubMed

Whittle, A K; Kalsi, T; Babic-Illman, G; Wang, Y; Fields, P; Ross, P J; Maisey, N R; Hughes, S; Kwan, W; Harari, D

2017-09-01

Oncology services do not routinely assess broader needs of older people with cancer. This study evaluates a comprehensive geriatric assessment and comorbidity screening questionnaire (CGA-GOLD) covering evidence-based domains and quality of life (EORTC-QLQ-C30). Patients aged 65+ attending oncology services were recruited into (1) Observational cohort (completed CGA-GOLD, received standard oncology care), (2) Intervention cohort (responses categorised 'low-risk', 'high-risk', 'possible need' by geriatricians). N = 417 observational patients (1002 invited by post, 418 consented, age 73.9 ± 5.4) completed CGA-GOLD in 11.7 ± 7.9 min, 86.3% required no assistance, 3.1% overall missing responses. Multiple problems reported: hypertension (18.1%), diabetes (16.9%), dyspnoea on flat surfaces (27.6%), polypharmacy (46%), difficulty walking (14.9%), fatigue (40.5%), living alone (30.9%), social isolation (11.2%), recent functional dependence (27.8%), urinary incontinence (21.4%), falls (13.3%). 237/239 intervention patients completed CGA-GOLD and consecutive subsets examined. The doctor and nurse specialist independently identified same need level in 87.3% (high inter-rater reliability kappa = 0.80), taking 1-2 min per questionnaire. Need level remained unchanged following hospital notes review against responses in 90% (75/83). 'Possible need' patients were telephoned with change in 29% (16/55) to low-risk and none to high-risk, confirming high need was not being missed. CGA-GOLD screening questionnaire was acceptable to older patients, feasibly administered in NHS cancer services, described comorbidities, CGA and QOL needs, and reliably identified higher risk patients requiring further input for optimal cancer treatment. © 2016 John Wiley & Sons Ltd.

A pilot study of minocycline for the prevention of paclitaxel-associated neuropathy: ACCRU study RU221408I.

PubMed

Pachman, Deirdre R; Dockter, Travis; Zekan, Patricia J; Fruth, Briant; Ruddy, Kathryn J; Ta, Lauren E; Lafky, Jacqueline M; Dentchev, Todor; Le-Lindqwister, Nguyet Anh; Sikov, William M; Staff, Nathan; Beutler, Andreas S; Loprinzi, Charles L

2017-11-01

Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Given that extensive animal data suggest that minocycline may prevent chemotherapy-induced neurotoxicity, the purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and the P-APS. Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks and were randomized to receive minocycline 200 mg on day 1 followed by 100 mg twice daily or a matching placebo. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy to measure P-APS and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment, to measure CIPN. Forty-seven patients were randomized. There were no remarkable differences noted between the minocycline and placebo groups for the overall sensory neuropathy score of the EORTC QLQ-CIPN20 or its individual components, which evaluate tingling, numbness and shooting/burning pain in hands and feet. However, patients taking minocycline had a significant reduction in the daily average pain score attributed to P-APS (p = 0.02). Not only were no increased toxicities reported with minocycline, but there was a significant reduction in fatigue (p = 0.02). Results of this pilot study do not support the use of minocycline to prevent CIPN, but suggest that it may reduce P-APS and decrease fatigue; further study of the impact of this agent on those endpoints may be warranted.

Correlates of existential well-being and their association with health-related quality of life in breast cancer survivors compared with the general population.

PubMed

Shin, Hae Won; Noh, Dong Young; Lee, Eun Sook; Nam, Seok Jin; Park, Byeong Woo; Ahn, Sei Hyun; Yun, Young Ho

2009-11-01

The aim was to evaluate the correlates of existential well-being (EWB) and investigate the relationship between EWB and health-related quality of life (HRQOL) according to the McGill Quality of Life Questionnaire (MQOL) in breast cancer survivors (BCS) and in the general population. BCS (N = 1,933) recruited from five large hospitals completed a mailed survey, which included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30), Quality of Life Questionnaire Breast Cancer Module (QLQ-BR23) and the MQOL. Reference data were derived from a representative sample of the Korean adult population composed of 500 women selected by a nationwide random route technique. Multiple logistic regression analysis showed that members of the general population with a lower educational status were more likely to report poor EWB. However, among BCS, correlates that were associated with poor EWB included lower monthly income, lower educational status, unemployment and comorbidities. Almost all factors listed on the HRQOL questionnaire were correlated with EWB in BCS as well as in the general population (P < 0.001). Factors listed on the QLQ-C30 that were correlated to a clinically meaningful extent with EWB in the general population included physical functioning, nausea and vomiting, and appetite loss, whereas among BCS, insomnia and distress over hair loss were meaningfully correlated with EWB. Compared with general population, BCS showed different EWB correlates and distinct associations with HRQOL findings. Our data suggest that socio-economic status and comorbidities influence on their EWB.

[Dance/movement therapy in oncological rehabilitation].

PubMed

Mannheim, Elana G; Helmes, Almut; Weis, Joachim

2013-01-01

Dance/movement therapy may be defined as a psychosocial and body-oriented art therapy, which uses dance for the expression of emotional and cognitive issues. Dance/movement therapy is an important intervention for cancer patients to enhance coping strategies. There are only few studies investigating dance therapy with cancer patients. The present study investigates effects of dance/movement therapy (n = 115) in the setting of inpatient rehabilitation based on a pre-post design with a control group as well as a follow-up 3 months later. Standardized questionnaires measuring quality of life, anxiety and depression, and self-concept (EORTC QLQ-C30, HADS, FSKN) were used. In addition, at the end of the inpatient rehabilitation program subjective expectations of the dance/movement therapy and the patients' subjective evaluation of the benefits of the intervention were measured by a new developed questionnaire. As process factors of dance/movement therapy, expression of emotions, enhancement of self-esteem, development of the personality, vitality, getting inner balance, and getting in touch with the body have been identified. In terms of quality of life and psychological well-being, the results showed significant improvements with medium to large effect sizes. Even though those effects may not be attributed to the intervention alone, the analysis of the data and the patients' subjective statements help to reveal therapeutic factors and process characteristics of dance/movement therapy within inpatient rehabilitation. Copyright © 2013 S. Karger AG, Basel.

Quality of life and need for care in patients with an ostomy: a survey of 2647 patients of the Berlin OStomy-Study (BOSS).

PubMed

Braumann, Chris; Müller, Verena; Knies, Moritz; Aufmesser, Birgit; Schwenk, Wolfgang; Koplin, Gerold

2016-12-01

Although ostomies are sometimes necessary, it is unclear which type of ostomy is advantageous for quality of life (QoL). In an observational study of 2647 patients, QoL after colostomy (CS) and small bowel stoma (SBS) formation was evaluated. The European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30 and CR-38 questionnaires were used. Patient characteristics, retrospective information about the ostomy and previous treatments, and current stoma-related complications were recorded. All questionnaires were distributed and collected by stoma therapists at the homecare company PubliCare®. In all, 1790 patients had a CS, and 756 had an SBS. The mean Global Health Score (mGHS-a general QoL indicator) was 52.33 in CS and 49.40 in SBS patients (p = 0.004), but the effect size (Cohen's d) was 0.1. In SBS patients, all functional scores were lower and most of the symptom scores were higher. QoL differed significantly for CS and SBS patients, but the effect size was marginal. The care of certain patient groups, particularly (female) patients who receive emergency surgeries, must be improved. More professional education and guidance are necessary for a larger proportion of patients. This survey provided reference data for quality of life in patients with an ostomy.

Health-related Quality of Life as Studied by EORTC QLQ and Voice Handicap Index Among Various Patients With Laryngeal Disease.

PubMed

Karlsen, Tom; Sandvik, Lorentz; Heimdal, John-Helge; Hjermstad, Marianne Jensen; Aarstad, Anne Kari Hersvik; Aarstad, Hans Jørgen

2017-03-01

Patients with voice-related disorders are often treated by a multidisciplinary team including assessment by patient-reported outcome measures. The present paper aims at documenting the importance of including general health-related quality of life (HRQoL) measures to clinical investigations. The participants (N = 80 larynx cancer, N = 32 recurrent palsy, N = 23 dysfunctional, N = 75 degenerative/inflammation, N = 19 various) were included consecutively at the laryngology clinic at Haukeland University Hospital. In addition, HRQoL data were included from one national group with laryngectomies (N = 105), one group with various patients formerly treated for head and neck squamous cell carcinoma (N = 96), and one population-based reference group (N = 1956). Obtained were the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ), the Voice Handicap Index (VHI), and the Eysenck Personality Inventory (EPI) neuroticism scores. By analysis of variance, we have determined significant dependence of groups analyzing the sum global QoL/health index (F = 9.47; P <0.001), the functional HRQoL sum score (F 5,2373  = 7.14, P <0.001), and the symptom sum HRQoL scores (F 7,2381  = 8.13; P <0.001). In particular, patients with recurrent palsy and laryngeal cancer had lowered HRQoL. At the index levels, in particular dyspnea scores, were scored depending on larynx disease group (F 7,2288  = 24.4; P <0.001). The VHI score correlated with the EORTC H&N35 "speech" index with a common variance of 52%. VHI scores correlated with level of neuroticism with 8% common variance (P <0.001) and EORTC scores with 22% (P <0.001). In particular, among patients with voice-related disease, those with recurrent palsy and laryngeal cancer had lower HRQoL. Furthermore, the HRQoL and VHI scores were inversely tied to neuroticism. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.

PubMed

Anota, Amélie; Mariet, Anne-Sophie; Maingon, Philippe; Joly, Florence; Bosset, Jean-François; Guizard, Anne-Valérie; Bittard, Hugues; Velten, Michel; Mercier, Mariette

2016-12-06

Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach's α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.

Course of chemotherapy-induced peripheral neuropathy and its impact on health-related quality of life among ovarian cancer patients: A longitudinal study.

PubMed

Bonhof, Cynthia S; Mols, Floortje; Vos, M Caroline; Pijnenborg, Johanna M A; Boll, Dorry; Vreugdenhil, Gerard; Ezendam, Nicole P M; van de Poll-Franse, Lonneke V

2018-06-01

Chemotherapy-induced peripheral neuropathy (CIPN) presents itself as sensory peripheral neuropathy (SPN) or motor peripheral neuropathy (MPN). Our aim was to examine the course of SPN and MPN, and their impact on health-related quality of life (HRQoL) among ovarian cancer patients. All newly diagnosed ovarian cancer patients from twelve hospitals in the South of the Netherlands were eligible for participation. Patients (N=174) completed questions on CIPN (EORTC QLQ-OV28) and HRQoL (EORTC QLQ-C30) after initial treatment and at 6, 12, and 24months (response rates were 70%, 71%, 58%, and 43% respectively). Generalized linear mixed models showed that among chemotherapy-treated patients (N=98), SPN levels were stable over time. For MPN, symptoms significantly improved at 12months. At 2years, 13% still reported high SPN. Also, 11% still reported high MPN. Regarding HRQoL, patients with high SPN reported a worse physical, role, emotional, social, and cognitive functioning compared to those with low SPN. Moreover, those who changed from low to high SPN over time worsened on physical functioning. For MPN, a worse global quality of life and a worse functioning was reported among patients with high MPN. Also, those who changed from low to high MPN over time worsened on global quality of life and on physical, role, social, and cognitive functioning. Among chemotherapy-treated ovarian cancer patients, SPN levels were stable over time. In contrast, MPN symptoms significantly improved at 12months. These symptoms seriously impacted HRQoL. Future studies should examine the impact of different treatment decisions and alterations on CIPN, so recommendations can be made to reduce CIPN (prevalence). Copyright © 2018 Elsevier Inc. All rights reserved.

Small-cell lung cancer patients are just 'a little bit' tired: response shift and self-presentation in the measurement of fatigue.

PubMed

Westerman, Marjan J; The, Anne-Mei; Sprangers, Mirjam A G; Groen, Harry J M; van der Wal, Gerrit; Hak, Tony

2007-06-01

Response shift has gained increasing attention in the measurement of health-related quality of life (QoL) as it may explain counter-intuitive findings as a result of adaptation to deteriorating health. To search for response shift type explanations to account for counter-intuitive findings in QoL measurement. Qualitative investigation of the response behaviour of small-cell lung cancer (SCLC) patients (n = 23) in the measurement of fatigue with The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) question 'were you tired'. Interviews were conducted at four points during 1st line chemotherapy: at the start of chemotherapy, 4 weeks later, at the end of chemotherapy, and 6 weeks later. Patients were asked to 'think aloud' when filling in the questionnaire. Fifteen patients showed discrepancies between their answer to the EORTC question 'were you tired' and their level of fatigue spontaneously reported during the interview. These patients chose the response options 'not at all' or 'a little' and explained their answers in various ways. In patients with and without discrepancies, we found indications of recalibration response shift (e.g. using a different comparison standard over time) and of change in perspective (e.g. change towards a more optimistic perspective). Patients in the discrepancy group reported spontaneously how they dealt with diagnosis and treatment, i.e. by adopting protective and assertive behaviour and by fighting the stigma. They distanced themselves from the image of the stereotypical cancer patient and presented themselves as not suffering and accepting fatigue as consequence of treatment. In addition to response shift, this study suggests that 'self-presentation' might be an important mechanism affecting QoL measurement, particularly during phases when a new equilibrium needs to be found.

Small-cell lung cancer patients are just ‘a little bit’ tired: response shift and self-presentation in the measurement of fatigue

PubMed Central

The, Anne-Mei; Sprangers, Mirjam A. G.; Groen, Harry J. M.; van der Wal, Gerrit; Hak, Tony

2007-01-01

Background Response shift has gained increasing attention in the measurement of health-related quality of life (QoL) as it may explain counter-intuitive findings as a result of adaptation to deteriorating health. Objective To search for response shift type explanations to account for counter-intuitive findings in QoL measurement. Methods Qualitative investigation of the response behaviour of small-cell lung cancer (SCLC) patients (n = 23) in the measurement of fatigue with The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) question ‘were you tired’. Interviews were conducted at four points during 1st line chemotherapy: at the start of chemotherapy, 4 weeks later, at the end of chemotherapy, and 6 weeks later. Patients were asked to ‘think aloud’ when filling in the questionnaire. Results Fifteen patients showed discrepancies between their answer to the EORTC question ‘were you tired’ and their level of fatigue spontaneously reported during the interview. These patients chose the response options ‘not at all’ or ‘a little’ and explained their answers in various ways. In patients with and without discrepancies, we found indications of recalibration response shift (e.g. using a different comparison standard over time) and of change in perspective (e.g. change towards a more optimistic perspective). Patients in the discrepancy group reported spontaneously how they dealt with diagnosis and treatment, i.e. by adopting protective and assertive behaviour and by fighting the stigma. They distanced themselves from the image of the stereotypical cancer patient and presented themselves as not suffering and accepting fatigue as consequence of treatment. Conclusion In addition to response shift, this study suggests that ‘self-presentation’ might be an important mechanism affecting QoL measurement, particularly during phases when a new equilibrium needs to be found. PMID:17450423

Spiritual well-being and quality of life in Iranian women with breast cancer undergoing radiation therapy.

PubMed

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir

2013-05-01

Psychological distress and morbidity are common consequences of diagnosis and treatment of breast cancer and associated with poor quality of life (QOL). Spiritual well-being is an important aspect of QOL, but little is known about the spiritual well-being and its relationship with QOL in patients of different cultures such as Iranian Muslim patients. The aim of this study was to investigate the association of QOL and spirituality among patients with breast cancer undergoing radiation therapy. This was a cross-sectional study which was conducted in the Breast Cancer Research Center of St. S. Al-Shohada Hospital, Isfahan, Iran. Spiritual well-being was measured using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp12). The European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and its supplementary breast cancer questionnaire (QLQ-BR23) were used to assess the quality of life of patients. Descriptive analysis, Pearson's correlation, and multiple regression analysis were performed for statistical assessment. In all, 68 patients fulfilled the study's inclusion criteria and were interviewed. The mean global QOL was 41.42 (SD = 18.02), and the mean spiritual well-being was 28.41 (SD = 6.95). There was a significant positive correlation between general QOL and total spiritual well-being scores. Also, spiritual well-being, social functioning, pain, and arm symptoms were significant predictors of global QOL. The results of this study provide evidence that breast cancer survivors in Iran experience a poor quality of life across a broad spectrum of health domains, particularly social, emotional, and spiritual, indicating that psychosocial-spiritual support should be considered in caring for patients with breast cancer.

Quality of life of patients from rural and urban areas in Poland with head and neck cancer treated with radiotherapy. A study of the influence of selected socio-demographic factors

PubMed Central

Jewczak, Maciej; Skura-Madziała, Anna

2017-01-01

Introduction The quality of life (QoL) experienced by cancer patients depends both on their state of health and on sociodemographic factors. Tumours in the head and neck region have a particularly adverse effect on patients psychologically and on their social functioning. Material and methods The study involved 121 patients receiving radiotherapy treatment for head and neck cancers. They included 72 urban and 49 rural residents. QoL was assessed using the questionnaires EORTC-QLQ-C30 and QLQ-H&N35. The data were analysed using statistical methods: a χ2 test for independence and a multinomial logit model. Results The evaluation of QoL showed a strong, statistically significant, positive dependence on state of health, and a weak dependence on sociodemographic factors and place of residence. Evaluations of financial situation and living conditions were similar for rural and urban residents. Patients from urban areas had the greatest anxiety about deterioration of their state of health. Rural respondents were more often anxious about a worsening of their financial situation, and expressed a fear of loneliness. Conclusions Studying the QoL of patients with head and neck cancer provides information concerning the areas in which the disease inhibits their lives, and the extent to which it does so. It indicates conditions for the adaptation of treatment and care methods in the healthcare system which might improve the QoL of such patients. A multinomial logit model identifies the factors determining the patients’ health assessment and defines the probable values of such assessment. PMID:29181080

The course of health-related quality of life in head and neck cancer patients treated with chemoradiation: a prospective cohort study.

PubMed

Verdonck-de Leeuw, Irma M; Buffart, Laurien M; Heymans, Martijn W; Rietveld, Derek H; Doornaert, Patricia; de Bree, Remco; Buter, Jan; Aaronson, Neil K; Slotman, Ben J; Leemans, C René; Langendijk, Johannes A

2014-03-01

To evaluate the course of health-related quality of life (HRQOL) from diagnosis to 2 years follow-up in patients with head and neck cancer (HNSCC) treated with chemoradiation (CRT). 164 patients completed the EORTC QLQ-C30 and QLQ-H&N35 questionnaires 1 week before and 6 weeks and 6, 12, 18, and 24 months after CRT. Patients were compared to a reference group. A linear mixed-model analysis was used to assess changes in HRQOL over time, and whether this was associated with age, gender, comorbidity, and tumor sublocation. Significant differences for the majority of HRQOL scales were observed between patient and reference group at baseline, and follow-up. The course of HRQOL was different for survivors compared to non-survivors. In survivors, improvement over time was observed (in global quality of life, physical, role, and social function, fatigue, pain, swallowing, speech, social eating, and social contacts), while in non-survivors the pattern over time was either no changes in HRQOL or a deterioration (in physical function, social eating and contacts). In both survivors and non-survivors, emotional functioning improved after treatment, but deteriorated in the longer term. Patients with comorbidity reported worse physical function, and patients with oral/oropharyngeal cancer (compared to hypopharyngeal/laryngeal cancer) reported more oral pain and sexual problems, but fewer speech problems. The course of HRQOL of HNSCC patients during the first 2 years after CRT is different for survivors compared to non-survivors and is associated with comorbidity and tumor subsite. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Quality of life after whole brain radiotherapy compared with radiosurgery of the tumor bed: results from a randomized trial.

PubMed

Kepka, L; Tyc-Szczepaniak, D; Osowiecka, K; Sprawka, A; Trąbska-Kluch, B; Czeremszynska, B

2018-02-01

A recent randomized trial (NCT01535209) demonstrated no difference in neurocognitive function between stereotactic radiotherapy of the tumor bed (SRT-TB) and whole brain radiotherapy (WBRT) in patients with resected single brain metastasis. Patients treated with SRT-TB had lower overall survival compared with the WBRT arm. Here, we compared the health-related quality of life (HRQOL) in patients who received WBRT vs. SRT-TB. A self-reported questionnaire was used to assess HRQOL (EORTC QLQ-C30 with the QLQ-BN20 module) before RT, 2 months after RT, and every 3 months thereafter. HRQOL results are presented as mean scores and compared between groups. Of 59 randomized patients, 37 (64%) were eligible for HRQOL analysis, 15 received SRT-TB, and 22 had WBRT. There were no differences between groups in global health status and main function scales/symptoms (except for drowsiness and appetite loss, which were worse with WBRT 2 months after RT). Global health status decreased 2 and 5 months after RT, but significantly only for SRT-TB (p = 0.025). Physical function decreased significantly 5 months after SRT-TB (p = 0.008). Future uncertainty worsened after RT, but significantly only for SRT-TB after 2 months (p = 0.036). Patients treated with WBRT had significant worsening of appetite, hair loss, and drowsiness after treatment. Despite higher symptom burden after WBRT attributed to the side effects of RT (such as appetite loss, drowsiness, and hair loss), global health status, physical functioning, and future uncertainty favored WBRT compared with SRT-TB. This may be related to the compromised brain tumor control with omission of WBRT.

Pancreatitis Quality of Life Instrument: A Psychometric Evaluation.

PubMed

Wassef, Wahid; DeWitt, John; McGreevy, Kathleen; Wilcox, Mel; Whitcomb, David; Yadav, Dhiraj; Amann, Stephen; Mishra, Girish; Alkaade, Samer; Romagnuolo, Joseph; Stevens, Tyler; Vargo, John; Gardner, Timothy; Singh, Vikesh; Park, Walter; Hartigan, Celia; Barton, Bruce; Bova, Carol

2016-08-01

Chronic pancreatitis is a significant medical problem that impacts a large number of patients worldwide. In 2014, we developed a disease-specific instrument for the evaluation of quality of life in this group of patients: pancreatitis quality of life instrument (PANQOLI). The goal of this study was to evaluate its psychometric properties: its reliability and its construct validity. This is a cross-sectional multi-center study that involved 12 pancreatic disease centers. Patients who met the inclusion/exclusion criteria for chronic pancreatitis were invited to participate. Those who accepted were asked to complete seven questionnaires/instruments. Only patients who completed the PANQOLI were included in the study. Its reliability and its construct validity were tested. A total of 159 patients completed the PANQOLI and were included in the study. They had a mean age of 49.03, 49% were male, and 84% were Caucasian. Six of the 24 items on the scale were removed because of lack of inter-item correlation, redundancy, or lack of correlation to quality of life issues. The final 18-item scale had excellent reliability (Cronbach's alpha coefficient: 0.914) and excellent construct validity with good correlation to generic quality of life instruments (SF-12 and EORTC QLQ-C30/QLQ-PAN26) and lack of correlation to non-quality of life instruments (MAST and DAST). Through exploratory factor analysis, the PANQOLI was found to consist of four subscales: emotional function scale, role function scale, physical function scale, and "self-worth" scale. PANQOLI is the first disease-specific instrument to be developed and validated for the evaluation of quality of life in chronic pancreatitis patients. It has a unique subscale for "self-worth" that differentiates it from other generic instruments. Studies are currently under way to evaluate its use in other populations not included in this study.

Cancer-related symptoms predict psychological wellbeing among prostate cancer survivors: results from the PiCTure study.

PubMed

Sharp, Linda; O'Leary, Eamonn; Kinnear, Heather; Gavin, Anna; Drummond, Frances J

2016-03-01

Prostate cancer treatments are associated with a range of symptoms and physical side-effects. Cancer can also adversely impact on psychological wellbeing. Because many prostate cancer-related symptoms and side-effects are potentially modifiable, we investigated associations between symptoms and psychological wellbeing among prostate cancer survivors. Postal questionnaires were distributed to men diagnosed with prostate cancer 2-18 years previously identified through cancer registries. General and prostate cancer-specific symptoms were assessed using the EORTC QLQ-C30 and QLQ-PR25, with higher symptom scores indicating more/worse symptomatology. Psychological wellbeing was assessed by the DASS-21. Associations between symptoms and each outcome were investigated using multivariate logistic regression, controlling for socio-demographic and clinical factors. A total 3348 men participated (response rate = 54%). Seventeen percent (95%CI 15.2%-17.9%), 16% (95%CI 15.1%-17.8%) and 11% (95%CI 9.5%-11.8%) of survivors scored in the range for depression, anxiety and distress on the DASS scales, respectively. In multivariate models, risk of depression on the DASS scale was significantly higher in men with higher urinary and androgen deprivation therapy (ADT)-related symptoms, and higher scores for fatigue, insomnia and financial difficulties. Risk of anxiety on the DASS scale was higher in men with higher scores for urinary, bowel and ADT-related symptoms and fatigue, dyspnoea and financial difficulties. Risk of distress on the DASS scale was positively associated with urinary, bowel and ADT-related symptoms, fatigue, insomnia and financial difficulties. Cancer-related symptoms significantly predict psychological wellbeing among prostate cancer survivors. Greater use of interventions and medications and to alleviate symptoms might improve psychological wellbeing of prostate cancer survivors. Copyright © 2015 John Wiley & Sons, Ltd.

Social inequalities in quality of life in a cohort of women diagnosed with breast cancer in Barcelona (DAMA Cohort).

PubMed

Graells-Sans, Ariadna; Serral, Gemma; Puigpinós-Riera, Rosa

2018-06-01

Breast cancer is a challenge for women's health-related quality of life (QoL), compromising their physical health and emotional well-being. QoL is equally distributed among different social groups. The aim of this study to analyze the impact of clinical characteristics and social determinants of health on the QoL of a cohort of women diagnosed and/or treated for breast cancer between 2003 and 2013 in one of the main hospitals in Barcelona's public health network. We performed a descriptive cross-sectional study in a cohort of 2235 women with various stages of breast cancer at different stages of their disease. Data were obtained using questionnaires QLQ-C30 and QLQ-BR23 from the European Organization for Research and Treatment of Cancer (EORTC), which include a set of functional and symptomatic scales. We conducted descriptive and bivariate analysis using the Chi-Square test and adjusted for relevant variables using logistic regression. The dependent variables were the functional scales of QoL and the independent variables were sociodemographic and clinical variables. We observed significant differences for most QoL functions. Women from the most disadvantaged class, those in social isolation, or those who had suffered relapses showed the poorest results for most of the function scales. In contrast, age had differential effects depending on the function studied. The QoL of women diagnosed with breast cancer is closely linked to both their social and economic status, and to their stage of disease progression. It is necessary to explore interventions that focus on the social determinants of health in order to mitigate their effects on breast cancer survivors' QoL. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Unmet home healthcare needs and quality of life in cancer patients: a hospital-based Turkish sample.

PubMed

Ataman, Gülsen; Erbaydar, Tugrul

2017-07-01

Home healthcare services in Turkey are provided primarily to patients that are bedridden or seriously disabled. There are no such services integrated with hospital services that are specifically designed for cancer patients. The present study aimed to explore the home healthcare needs of cancer patients and their experiences related to unmet home healthcare needs. The study included 394 adult cancer patients who were followed up at the surgical oncology department of a university hospital. A 37-item, study-specific questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for cancer patients (EORTC-QLQ-C30) were administered, and patient clinical records were evaluated. Home healthcare was provided primarily by the patients' immediate family members; the professional home healthcare usage rate was only 2.8%. Patient quality of life (QoL) was negatively affected by cancer, especially those with stage three and four disease. The frequency of the need for home healthcare services due to disease-related health problems during the 30 days prior to administration of the questionnaires was as follows: pain (62.9%), surgical wound care (44.9%), injection of therapeutics (52.3%), gastrointestinal complaints (51.8%), anxiety (87.1%), psychosocial assistance (77.2%) and information about cancer (94.4%). In the absence of home healthcare services, the patients primarily used institutional healthcare services to meet their needs; otherwise, their needs were not met. The physical and psychosocial problems that cancer patients experience could be solved in most cases by professional home healthcare services. Hospital-integrated home healthcare services might not only improve cancer patient QoL but might also increase the effectiveness of hospital-based healthcare services. © 2017 John Wiley & Sons Ltd.

Quality of Life in Patients with Bladder Cancer Undergoing Ileal Conduit: A Comparison of Women Versus Men

PubMed Central

SIRACUSANO, SALVATORE; D’ELIA, CAROLINA; CERRUTO, MARIA ANGELA; SALEH, OMAR; SERNI, SERGIO; GACCI, MAURO; CICILIATO, STEFANO; SIMONATO, ALCHIEDE; PORCARO, ANTONIO; DE MARCO, VINCENZO; TALAMINI, RENATO; TOFFOLI, LAURA; VISALLI, FRANCESCO; NIERO, MAURO; LONARDI, CRISTINA; IMBIMBO, CIRO; VERZE, PAOLO; MIRONE, VINCENZO; RACIOPPI, MARCO; IAFRATE, MASSIMO; CACCIAMANI, GIOVANNI; DE MARCHI, DAVIDE; BASSI, PIERFRANCESCO; ARTIBANI, WALTER

2018-01-01

Background/Aim: Studies comparing health-related quality of life (HR-QoL) between patients who underwent radical cystectomy (RC) and those who underwent a different form of urinary diversion has not reached yet univocal and reliable conclusions. The aim of our study was to evaluate bladder-specific long-term HR-QoL after radical cystectomy and ileal conduit. Patients and Methods: A multicenter study was carried out on 145 consecutive patients (112 males and 33 females) undergoing RC and ileal conduit (IC). HR-QoL assessment was conducted using Italian versions of European Organisation for Research and Treatment of Cancer QLQ-C30 and EORTC BLM-30 questionnaires. Results: Our data showed that women who underwent IC presented greater problems than men in cognitive functioning (mean score±SD: 77.3±27.9 vs. 87.8±18.6) as well in future perspective (score: 42.4±34.4 vs. 21.9±24.6). Nevertheless, men undergoing IC had more problems in sexual functioning than women (score: 23.3±24.5 vs. 7.0±20.3) (all p<0.05). Conclusion: In our series, female patients presented a greater burden than male patients in cognitive functioning as well in future perspective, but lower concerns with regard to sexual function. PMID:29275311

[Perineal colostomy with antegrade continence enemas as an alternative after abdominoperineal resection for low rectal cancer].

PubMed

Penninckx, F; D'Hoore, A; Vanden Bosch, A

2005-06-01

Some young and active patients requiring abdominoperineal resection for rectum cancer ask for an alternative of an abdominal colostomy. We analysed the results after a combination of a perineal colostomy and antegrade continence enemas (ACE). Fifteen patients have been operated between 1999 and 2004. Follow-up was >six months in 12 patients with a mean of two years and with a maximum of 55 months. The QLQ-C30 (version 3) and CR 38 questionnaires of the EORTC have been used to evaluate quality of life aspects. Five out of 15 patients presented complications: infection of the caecal conduit (2), small bowel obstruction (1), prolapse of the perineal colostomy (1), eventration (1), urologic complications (2). ACE are still used by all patients. The volume needed was 400 ml and duration of irrigation was 30 minutes (15-45 minutes). The median score for faecal incontinence was 0 ; faecal pseudocontinence was obtained by 7/12 patients. The scores for all aspects of functioning were excellent, as well as the score for body image. The general health status and quality of life were estimated at 75% from normal value. The procedure is simple and can be performed in one operative session. A perineal colostomy with ACE seems to be a valuable and less expensive alternative for an abdominal colostomy, and certainly for total anorectal reconstruction.

Quality of Life in Patients with Bladder Cancer Undergoing Ileal Conduit: A Comparison of Women Versus Men.

PubMed

Siracusano, Salvatore; D'Elia, Carolina; Cerruto, Maria Angela; Saleh, Omar; Serni, Sergio; Gacci, Mauro; Ciciliato, Stefano; Simonato, Alchiede; Porcaro, Antonio; DE Marco, Vincenzo; Talamini, Renato; Toffoli, Laura; Visalli, Francesco; Niero, Mauro; Lonardi, Cristina; Imbimbo, Ciro; Verze, Paolo; Mirone, Vincenzo; Racioppi, Marco; Iafrate, Massimo; Cacciamani, Giovanni; DE Marchi, Davide; Bassi, Pierfrancesco; Artibani, Walter

2018-01-01

Studies comparing health-related quality of life (HR-QoL) between patients who underwent radical cystectomy (RC) and those who underwent a different form of urinary diversion has not reached yet univocal and reliable conclusions. The aim of our study was to evaluate bladder-specific long-term HR-QoL after radical cystectomy and ileal conduit. A multicenter study was carried out on 145 consecutive patients (112 males and 33 females) undergoing RC and ileal conduit (IC). HR-QoL assessment was conducted using Italian versions of European Organisation for Research and Treatment of Cancer QLQ-C30 and EORTC BLM-30 questionnaires. Our data showed that women who underwent IC presented greater problems than men in cognitive functioning (mean score±SD: 77.3±27.9 vs. 87.8±18.6) as well in future perspective (score: 42.4±34.4 vs. 21.9±24.6). Nevertheless, men undergoing IC had more problems in sexual functioning than women (score: 23.3±24.5 vs. 7.0±20.3) (all p<0.05). In our series, female patients presented a greater burden than male patients in cognitive functioning as well in future perspective, but lower concerns with regard to sexual function. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Evaluation of Quality of Life at Progression in Patients with Soft Tissue Sarcoma.

PubMed

Hudgens, Stacie; Forsythe, Anna; Kontoudis, Ilias; D'Adamo, David; Bird, Ashley; Gelderblom, Hans

2017-01-01

Introduction . Soft Tissue Sarcoma (STS) is a rare malignancy of mesodermal tissue, with international incidence estimates between 1.8 and 5 per 100,000 per year. Understanding quality of life (QoL) and the detrimental impact of disease progression is critical for long-term care and survival. Objectives . The primary objective was to explore the relationship between disease progression and health-related quality of life (HRQoL) using data from Eisai's study (E7389-G000-309). Methods . This was a 1 : 1 randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin versus dacarbazine in patients with advanced STS. The QoL analysis was conducted for the baseline and progression populations using the European Organization for Research and Treatment of Cancer 30-item core QoL questionnaire (EORTC QLQ-C30). Results . There were no statistical differences between the two treatment arms at baseline for any domain ( p > 0.05; n = 452). Of the 399 patients who experienced disease progression (unadjusted and adjusting for histology), dacarbazine patients had significantly lower Global Health Status, Physical Functioning scores, and significantly worse Nausea and Vomiting, Insomnia, and Appetite Loss ( p < 0.05). Conclusions . These results indicate differences in HRQoL overall and at progression between dacarbazine and eribulin patients, with increases in symptom severity observed among dacarbazine patients.

Quality of life and psychological well-being of colorectal cancer survivors in Jordan.

PubMed

Abu-Helalah, Munir Ahmad; Alshraideh, Hussam Ahmad; Al-Hanaqta, Motasem Mohammad; Arqoub, Kamal Hasan

2014-01-01

Colorectal ranked first among cancers reported in males and ranked second amongst females in Jordan, accounting for 12.7% and 10.5% of cancers in males and females, respectively. Colorectal cancer patients can suffer several consequences after treatment that include pain and fatigue, constipation, stoma complications, sexual problems, appearance and body-image concerns as well as psychological dysfunction. There is no published quantitative data on the health-related quality of life and psychological wellbeing of Jordanian colorectal cancer survivors. This project was a cross-sectional study of colorectal cancer survivors diagnosed in 2009 and 2010. Assessment was performed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the colorectal cancer specific module (EORTC QLQ-CR 29) and the Hospital Anxiety and Depression Scale (HADS). Data on potential predictors of scores were also collected. A total of 241 subjects completed the study with mean age of 56.7±13.6. Males represented 52.3% of study participants. A majority of participants reported good to high overall health; the mean Global health score was 79.74± 23.31 with only 6.64% of study participants scoring less than 33.3%. The striking result in this study was that none of the study participants participated in a psychosocial support group; only 4 of them (1.7%) were even offered such support. The mean scores for HADS, depression score, and anxiety score were 8.25±9, 4.35±4.9 and 3.9±4.6, respectively. However, 77.1% of study participants were within the normal category for the depression score and 81.7% were within this category for anxiety score; 5.4% of participants had severe anxiety and 5.4% of them had severe depression. Patients with colorectal cancer in Jordan have a good quality of life and psychological wellbeing scores when compared with patients from western countries. None of the colorectal cancer patients managed at the Ministry of Health received any formal counselling, or participated in psychological or social support programmes. This highlights the urgent need for a psychosocial support programme, psychological screening and consultations for patients diagnosed with colorectal cancer at the Ministry of Health Hospitals.

The psychological context of quality of life: a psychometric analysis of a novel idiographic measure of bladder cancer patients' personal goals and concerns prior to surgery

PubMed Central

2011-01-01

Background Over the past two decades, there has been an increasing focus on quality of life outcomes in urological diseases. Patient-reported outcomes research has relied on structured assessments that constrain interpretation of the impact of disease and treatments. In this study, we present content analysis and psychometric evaluation of the Quality of Life Appraisal Profile. Our evaluation of this measure is a prelude to a prospective comparison of quality of life outcomes of reconstructive procedures after cystectomy. Methods Fifty patients with bladder cancer were interviewed prior to surgery using the Quality of Life Appraisal Profile. Patients also completed the EORTC QLQ-C30 and demographics. Analysis included content coding of personal goal statements generated by the Appraisal Profile, examination of the relationship of goal attainment to content, and association of goal-based measures with QLQ-C30 scales. Results Patients reported an average of 10 personal goals, reflecting motivational themes of achievement, problem solving, avoidance of problems, maintaining desired circumstances, letting go of roles and responsibilities, acceptance of undesirable situations, and attaining milestones. 503 goal statements were coded using 40 different content categories. Progress toward goal attainment was positively correlated with relationships and activities goals, but negatively correlated with health concerns. Associations among goal measures provided evidence for construct validity. Goal content also differed according to age, gender, employment, and marital status, lending further support for construct validity. QLQ-C30 functioning and symptom scales were correlated with goal content, but not with progress toward goal attainment, suggesting that patients may calibrate progress ratings relative to their specific goals. Alternately, progress may reflect a unique aspect of quality of life untapped by more standard scales. Conclusions The Brief Quality of Life Appraisal Profile was associated with measures of motivation, goal content and progress, as well as relationships with demographic and standard quality of life measures. This measure identifies novel concerns and issues in treating patients with bladder cancer, necessary for a more comprehensive evaluations of their health-related quality of life. PMID:21324146

Determinants of patient satisfaction in ambulatory oncology: a cross sectional study based on the OUT-PATSAT35 questionnaire

PubMed Central

2011-01-01

Background The aim of this study was to identify factors associated with satisfaction with care in cancer patients undergoing ambulatory treatment. We investigated associations between patients' baseline clinical and socio-demographic characteristics, as well as self-reported quality of life, and satisfaction with care. Methods Patients undergoing ambulatory chemotherapy or radiotherapy in 2 centres in France were invited, at the beginning of their treatment, to complete the OUT-PATSAT35, a 35 item and 13 scale questionnaire evaluating perception of doctors, nurses and aspects of care organisation. Additionally, for each patient, socio-demographic variables, clinical characteristics and self-reported quality of life using the EORTC QLQ-C30 questionnaire were recorded. Results Among 692 patients included between January 2005 and December 2006, only 6 were non-responders. By multivariate analysis, poor perceived global health strongly predicted dissatisfaction with care (p < 0.0001). Patients treated by radiotherapy (vs patients treated by chemotherapy) reported lower levels of satisfaction with doctors' technical and interpersonal skills, information provided by caregivers, and waiting times. Patients with primary head and neck cancer (vs other localisations), and those living alone were less satisfied with information provided by doctors, and younger patients (< 55 years) were less satisfied with doctors' availability. Conclusions A number of clinical of socio-demographic factors were significantly associated with different scales of the satisfaction questionnaire. However, the main determinant was the patient's global health status, underlining the importance of measuring and adjusting for self-perceived health status when evaluating satisfaction. Further analyses are currently ongoing to determine the responsiveness of the OUT-PATSAT35 questionnaire to changes over time. PMID:22204665

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery.

PubMed

Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

2012-11-01

The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based "STAR" (Symptom Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient's assessment of STAR's usefulness was measured via an exit survey. Forty-nine patients completed the study. The procedures included the following: hysterectomy±staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. Copyright © 2012 Elsevier Inc. All rights reserved.

Quality of Life in Patients With Advanced Cancer: Differential Association With Performance Status and Systemic Inflammatory Response.

PubMed

Laird, Barry J A; Fallon, Marie; Hjermstad, Marianne J; Tuck, Sharon; Kaasa, Stein; Klepstad, Pål; McMillan, Donald C

2016-08-10

Quality of life is a key component of cancer care; however, the factors that determine quality of life are not well understood. The aim of this study was to examine the relationship between quality of life parameters, performance status (PS), and the systemic inflammatory response in patients with advanced cancer. An international biobank of patients with advanced cancer was analyzed. Quality of life was assessed at a single time point by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30). PS was assessed by using the Eastern Cooperative Oncology Group (ECOG) classification. Systemic inflammation was assessed by using the modified Glasgow Prognostic Score (mGPS), which combines C-reactive protein and albumin. The relationship between quality of life parameters, ECOG PS, and the mGPS was examined. Data were available for 2,520 patients, and the most common cancers were GI (585 patients [22.2%]) and pulmonary (443 patients [17.6%]). The median survival was 4.25 months (interquartile range, 1.36 to 12.9 months). Increasing mGPS (systemic inflammation) and deteriorating PS were associated with deterioration in quality-of-life parameters (P < .001). Increasing systemic inflammation was associated with deterioration in quality-of-life parameters independent of PS. Systemic inflammation was associated with quality-of-life parameters independent of PS in patients with advanced cancer. Further investigation of these relationships in longitudinal studies and investigations of possible effects of attenuating systemic inflammation are now warranted. © 2016 by American Society of Clinical Oncology.

Methodological study to evaluate the psychometric properties of FACIT-CD in a sample of Brazilian women with cervical intraepithelial neoplasia.

PubMed

Fregnani, Cristiane Menezes Sirna; Fregnani, José Humberto Tavares Guerreiro; Longatto-Filho, Adhemar

2017-10-16

The occurrence of cervical intraepithelial neoplasia (CIN) is associated with changes in health-related quality of life, including psychological factors, such as fear and shame, and changes in sexuality and sexual satisfaction, such as decreased sexual desire and frequency of sexual intercourse. Personal relationships are the most affected because CIN is sexually transmitted and many women tend to blame their partner for disease transmission. The aim of this study was to evaluate the psychometric properties of the FACIT-CD questionnaire in Brazilian women diagnosed with CIN. The properties of the FACIT-CD questionnaire were tested on a sample of 439 women seen at the Department of Prevention of Barretos Cancer Hospital, including 329 patients who were diagnosed with CIN and 110 women who were not diagnosed with the disease. The analysed parameters included internal consistency (Cronbach's alpha), reproducibility (intraclass correlation coefficient), structural validity, convergent validity (correlation with the SF-12 and EORTC QLQ-CX24 questionnaires), discriminant validity (according to disease status, and self-rating of health), sensitivity, and responsiveness. The Cronbach alpha values ​​of the FACIT-CD scales were higher than 0.70 with the exception of the relationship scale (0.66). The FACIT-CD reproducibility was satisfactory, with variation in the intraclass correlation coefficients ranging between 0.50 and 0.83, although the 95% confidence interval (CI) was lower than 0.40 (0.33-0.64) on the treatment satisfaction scale. Regarding structural validity, only one item on the physical well-being scale was not kept in the original domain. The expected correlations between the FACIT-CD and SF-12 were not confirmed, whereas the correlations between the FACIT-CD and EORTC QLQ-CX24 were confirmed. The questionnaire was able to discriminate the groups according to disease status and self-rating of health. The sensitivity was low for the relationship scale and moderate for the other scales. The responsiveness of the FACIT-CD questionnaire varied between the groups that denominate the self-perception of health as no change, improvement or worsening. Our results are encouraging and indicate that the FACIT-CD questionnaire is a promising tool for the analysis of the quality of life of women with CIN.

Frequency of fibromyalgia syndrome in breast cancer patients.

PubMed

Akkaya, Nuray; Atalay, Nilgün Simsir; Selcuk, Selin Taflan; Alkan, Hakan; Catalbas, Necdet; Sahin, Füsun

2013-04-01

We aimed to determine the frequency of fibromyalgia syndrome (FM) in operated breast cancer patients and to research the relationship between FM and the severity of fatigue and quality of life in these breast cancer patients. The demographic data of 101 operated breast cancer patients were recorded. The patients who had pain were then classified as having regional pain (RP), widespread pain without FM (WP), and widespread pain with FM (WFM). The FM diagnosis was based on the American College of Rheumatology (ACR) criteria. The severity of fatigue was evaluated with the Brief Fatigue Inventory, the disease impact was evaluated with the Fibromyalgia Impact Questionnaire (FIQ), and the quality of life was evaluated with the European Organization for Research on Treatment of Cancer questionnaire Quality of Life-C30 (EORTC-QoL-C30). There was no pain in 38 (37.6%) patients, whereas there was pain in 63 (62.4%) patients (N = 42, 41.6% had RP, N = 21, 20.8% had WP). Ten (9.9%) of the entire patient cohort were diagnosed as having FM according to the ACR criteria. There were no differences among the 3 groups in respect to demographic characteristics when patients were classified as RP (N = 42), WP (N = 11), and WFM (N = 10) groups. While there were negative correlations between the FIQ and EORTC-QoL-C30-function score (r = -0.727) and EORTC-QoL-C30-global score (r = -0.488), there was a positive correlation between the FIQ and EORTC-QoL-C30-symptom score (r = 0.726). We note that the frequency of FM in the operated breast cancer patients in this study was higher than that reported in normal populations in the literature. Also, we found that the presence of FM had negative effects on the quality of life of the breast cancer patients. Accordingly, in the evaluation of widespread pain and complaints of fatigue in long-surviving breast cancer patients, after metastatic disease is excluded, the probability of FM should be kept in mind, so that appropriate treatment can be initiated to improve their functional status and quality of life.

Response shift in quality of life assessment among cancer patients: A study from Iran

PubMed Central

Hosseini, Bayan; Nedjat, Saharnaz; Zendehdel, Kazem; Majdzadeh, Reza; Nourmohammadi, Azam; Montazer, Ali

2017-01-01

Background: During the course of disease, particularly of chronic diseases, changes in internal standards cause certain changes in the estimation of quality of life (QOL). These changes indicate the phenomenon of ‘response shift’. The present study aimed at assessing response shift in different scales of QOL in Iranian cancer patients. Methods: To assess response shift through the ‘then test’ approach, we asked 211 cancer patients to complete the EORTC QLQ-C30 questionnaire at pretest (at the beginning of the study), posttest (3 months later), and then test (administered immediately after the posttest). Paired t test and Cohen’s effect size were used for comparison. Results: Response shift was significant in all 4 scales under study, i.e. fatigue, pain, emotional functioning, and general QOL (p<0.001). Fatigue, pain, and global QOL have deteriorated significantly with then test approach and emotional function was significantly improved. Conclusion: We observed a response shift in Iranian cancer patients in our study. Thus, in light of the multifactorial nature of QOL and the effect of the response shift bias on different aspects of QOL changes, it is of utmost importance to keep this bias in mind when interpreting the results and managing cancer patients’ treatment regimens. PMID:29951421

Positive factors associated with quality of life among Chinese patients with renal carcinoma: a cross-sectional study.

PubMed

Liu, Jiao; Gong, Da-Xin; Zeng, Yu; Li, Zhen-Hua; Kong, Chui-Ze

2018-01-01

Quality of life and positive psychological variables has become a focus of concern in patients with renal carcinoma. However, the integrative effects of positive psychological variables on the illness have seldom been reported. The aims of this study were to evaluate the quality of life and the integrative effects of hope, resilience and optimism on the quality of life among Chinese renal carcinoma patients. A cross-sectional study was conducted at the First Hospital of China Medical University. 284 participants completed questionnaires consisting of demographic and clinical characteristics, EORTC QLQ-C30, Adult Hope Scale, Resilience Scale-14 and Life Orientation Scale-Revised from July 2013 to July 2014. Pearson's correlation and hierarchical regression analyses were performed to explore the effects of related factors. Hope, resilience and optimism were significantly associated with quality of life. Hierarchical regression analyses indicated that hope, resilience and optimism as a whole accounted for 9.8, 24.4 and 21.9% of the variance in the global health status, functioning status and symptom status, respectively. The low level of quality of life for Chinese renal carcinoma patients should receive more attention from Chinese medical institutions. Psychological interventions to increase hope, resilience and optimism may be essential to enhancing the quality of life of Chinese cancer patients.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Evaluating the impact of spirituality on the quality of life, anxiety, and depression among patients with cancer: an observational transversal study.

PubMed

Chaar, Emile Abou; Hallit, Souheil; Hajj, Aline; Aaraj, Racha; Kattan, Joseph; Jabbour, Hicham; Khabbaz, Lydia Rabbaa

2018-02-16

Spiritual well-being was found to have some protective effect against end-of life despair in cancer patients. We aimed at assessing the impact of spirituality on the quality of life, depression, and anxiety of Lebanese cancer patients. Our observational transversal monocentric study was conducted between January and April 2016 among a convenient sample of 115 Lebanese cancer patients admitted to Hôtel-Dieu de France Hospital (HDF), Beirut-Lebanon. In addition to socio-demographic and clinical data, three questionnaires were used: EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 3rd version), FACIT-Sp-12 (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; The 12-item Spiritual Well-Being Scale, 4th version), and HADS (Hospital Anxiety and Depression Scale). Eighteen patients taking anxiolytic and/or antidepressants were not included in the analysis. The remaining 97 patients were analyzed. Better emotional and cognitive functioning was seen in patients with higher meaning, peace, faith, and total FACIT scores. Meaning, peace, and total FACIT scores were also higher among patients with better global health status and quality of life. Anxiety as well as depression was significantly associated to all spiritual well-being factors. Spirituality can improve quality of life and decrease the incidence of anxiety and depression in cancer patients. Our results highlight the need to incorporate spiritual care in healthcare systems.

Quality of Life and Its Association with Physical Activity among Different Types of Cancer Survivors.

PubMed

Tang, Furong; Wang, Jiwei; Tang, Zheng; Kang, Mei; Deng, Qinglong; Yu, Jinming

2016-01-01

The main goal of this study was to compare the quality of life (QOL) and its association with physical activity (PA) among patients diagnosed with different types of cancer. Based on the results, we tentatively present suggestions for the cancer health care model. A cross-sectional study was conducted with 2915 cancer survivors recruited from multi-community cancer rehabilitation centers, all of which were affiliated with the Shanghai Cancer Rehabilitation Club. We collected data including socio-demographic characteristics and information about PA. All the subjects included were asked to complete the European Organization for Research and Treatment Quality of Life Questionnaires (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy-General Questionnaire (FACT-G). Multiple linear regression models were employed to control the potential confounding factors. Lung cancer survivors reported the worst dyspnea. Colorectal cancer survivors claimed the highest level of constipation and diarrhea. Liver cancer survivors indicated greatest loss of appetite and financial difficulties. Generally, survivors with PA tended to reported better QOL, although these associations among liver cancer survivors were not statistically significant. Moreover, survivors of all cancer types who performed PA did not report significant lower level of constipation or diarrhea. The relationship between PA frequency and QOL among cancer survivors remained unexplored. Both QOL and its association with PA vary among survivors of different cancer types. The detailed results can assist clinicians and public health practitioners with improving health care management.

Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study.

PubMed

Baco, Eduard; Gelet, Albert; Crouzet, Sébastien; Rud, Erik; Rouvière, Olivier; Tonoli-Catez, Hélène; Berge, Viktor; Chapelon, Jean-Yves; Eggesbø, Heidi B

2014-10-01

To report the oncological and functional outcomes of hemi salvage high-intensity focused ultrasound (HSH) in patients with unilateral radiorecurrent prostate cancer. Between 2009 and 2012, 48 patients were prospectively enrolled in two European centres. Inclusion criteria were biochemical recurrence (BCR) after primary radiotherapy (RT), positive magnetic resonance imaging and ≥1 positive biopsy in only one lobe. BCR was defined using Phoenix criteria (a rise by ≥2 ng/mL above the nadir prostate specific antigen [PSA] level). The following schemes and criteria for functional outcomes were used: Ingelman-Sundberg score using International Continence Society (ICS) questionnaire (A and B), International prostate symptom score (IPSS), International Index of Erectile Function-5 (IIEF-5) points, the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ C-30). HSH was performed under spinal or general anaesthesia using the Ablatherm® Integrated Imaging device. Patients with obstructive voiding symptoms at the time of treatment underwent an endoscopic bladder neck resection or incision during the same anaesthesia to prevent the risk of postoperative obstruction. After HSH the mean (sd) PSA nadir was 0.69 (0.83) ng/mL at a median (interquartile range) follow-up of 16.3 (10.5-24.5) months. Disease progression occurred in 16/48 (33%). Of these, four had local recurrence in the untreated lobe and four bilaterally, six developed metastases, and two had rising PSA levels without local recurrence or radiological confirmed metastasis. Progression-free survival rates at 12, 18, and 24 months were 83%, 64%, and 52%. Severe incontinence occurred in four of the 48 patients (8%), eight (17%) required one pad a day, and 36/48 (75%) were pad-free. The ICS questionnaire showed a mean (sd) deterioration from 0.7 (2.0) to 2.3 (4.5) for scores A and 0.6 (1.4) to 1.6 (3.0) for B. The mean (sd) IPSS and erectile function (IIEF-5) scores decreased from a mean (sd) of 7.01 (5.6) to 8.6 (5.1) and from 11.2 (8.6) to 7.0 (5.8), respectively. The mean (sd) EORTC QLC-30 scores before and after HSH were 35.7 (8.6) vs 36.8 (8.6). HSH is a feasible therapeutic option in patients with unilateral radiorecurrent prostate cancer, which offers limited urinary and rectal morbidity, and preserves health-related quality of life. © 2013 The Authors. BJU International © 2013 BJU International.

Evaluation of cross-cultural adaptation and measurement properties of breast cancer-specific quality-of-life questionnaires: a systematic review.

PubMed

Oliveira, Indiara Soares; da Cunha Menezes Costa, Lucíola; Fagundes, Felipe Ribeiro Cabral; Cabral, Cristina Maria Nunes

2015-05-01

To assess the procedures of translation, cross-cultural adaptation, and measurement properties of breast cancer-specific quality-of-life questionnaires. Searches were conducted in the databases MEDLINE, EMBASE, CINAHL, and SciELO using the keywords: "Questionnaires," "Quality of life," and "Breast cancer." The studies were analyzed in terms of methodological quality according to the guidelines for the procedure of cross-cultural adaptation and the quality criteria for measurement properties of questionnaires. We found 24 eligible studies. Most of the articles assessed the translation and measurement properties of the instrument EORTC QLQ-BR23. Description about translation and cross-cultural adaptation was incomplete in 11 studies. Translation and back translation were the most tested phases, and synthesis of the translation was the most omitted phase in the articles. Information on assessing measurement properties was provided incompletely in 23 articles. Internal consistency was the most tested property in all of the eligible articles, but none of them provided information on agreement. Construct validity was adequately tested in only three studies that used the FACT-B and QLQ-BR23. Eight articles provided information on reliability; however, only four found positive classification. Responsiveness was tested in four articles, and ceiling and floor effects were tested in only three articles. None of the instruments showed fully adequate quality. There is limited evidence on cross-cultural adaptations and measurement properties; therefore, it is recommended that caution be exercised when using breast cancer-specific quality-of-life questionnaires that have been translated, adapted, and tested.

Development of the EORTC QLQ-CAX24, A Questionnaire for Cancer Patients With Cachexia.

PubMed

Wheelwright, Sally J; Hopkinson, Jane B; Darlington, Anne-Sophie; Fitzsimmons, Deborah F; Fayers, Peter; Balstad, Trude R; Bredart, Anne; Hammerlid, Eva; Kaasa, Stein; Nicolatou-Galitis, Ourania; Pinto, Monica; Schmidt, Heike; Solheim, Tora S; Strasser, Florian; Tomaszewska, Iwona M; Johnson, Colin D

2017-02-01

Cachexia is commonly found in cancer patients and has profound consequences; yet there is only one questionnaire that examines the patient's perspective. To report a rigorously developed module for patient self-reported impact of cancer cachexia. Module development followed published guidelines. Patients from across the cancer cachexia trajectory were included. In Phase 1, health-related quality of life (HRQOL) issues were generated from a literature review and interviews with patients in four countries. The issues were revised based on patient and health care professional (HCP) input. In Phase 2, questionnaire items were formulated and translated into the languages required for Phase 3, the pilot phase, in which patients from eight countries scored the relevance and importance of each item, and provided qualitative feedback. A total of 39 patients and 12 HCPs took part in Phase 1. The literature review produced 68 HRQOL issues, with 22 new issues arising from the patient interviews. After patient and HCP input, 44 issues were formulated into questionnaire items in Phase 2. One hundred ten patients took part in Phase 3. One item was reworded, and 20 items were deleted as a consequence of patient feedback. The QLQ-CAX24 is a cancer cachexia-specific questionnaire, comprising 24 items, for HRQOL assessment in clinical trials and practice. It contains five multi-item scales (food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline) and four single items. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Symptoms of depression and anxiety as predictors of physical functioning in breast cancer patients. A prospective study using path analysis.

PubMed

Faller, Hermann; Strahl, André; Richard, Matthias; Niehues, Christiane; Meng, Karin

2017-12-01

Although symptoms of depression and anxiety are linked to health-related quality of life (HRQoL), the nature of this relationship remained unclear. We therefore aimed to examine, in a prospective study, both possible directions of impact in this relationship. To avoid conceptual and measurement overlap between depressive and anxiety symptoms, on the one hand, and HRQoL, on the other hand, we focused on the physical functioning component of HRQoL. We conducted a secondary analysis of a prospective cohort study with 436 female breast cancer patients (mean age 51 years). Both at baseline and after 12 months, we measured symptoms of depression and anxiety with the four-item Patient Heath Questionnaire (PHQ-4) and physical functioning with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Using path analysis, we estimated (1) the predictive value of symptoms of depression/anxiety for subsequent physical functioning and (2) the predictive value of physical functioning for subsequent symptoms of depression/anxiety, in the same model. Baseline symptoms of depression/anxiety predicted 1-year levels of physical functioning (depression: standardized β =  -.09, p = .024; anxiety: standardized β =  -.10, p = .009), while the reciprocal paths linking baseline physical functioning to subsequent depressive and anxiety symptoms were not significant, adjusting for the baseline scores of all outcome variables. Depressive and anxiety symptoms were predictors of the physical functioning component of HRQoL. Thus, if this relation is causal, treating breast cancer patients' depressive and anxiety symptoms may have a favorable impact on their self-reported physical functioning.

Cost-Utility of "Doxorubicin and Cyclophosphamide" versus "Gemcitabine and Paclitaxel" for Treatment of Patients with Breast Cancer in Iran.

PubMed

Hatam, Nahid; Askarian, Mehrdad; Javan-Noghabi, Javad; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2015-01-01

A cost-utility analysis was performed to assess the cost-utility of neoadjuvant chemotherapy regimens containing doxorubicin and cyclophosphamide (AC) versus paclitaxel and gemcitabine (PG) for locally advanced breast cancer patients in Iran. This cross-sectional study in Namazi hospital in Shiraz, in the south of Iran covered 64 breast cancer patients. According to the random numbers, the patients were divided into two groups, 32 receiving AC and 32 PG. Costs were identified and measured from a community perspective. These items included medical and non-medical direct and indirect costs. In this study, a data collection form was used. To assess the utility of the two regimens, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) was applied. Using a decision tree, we calculated the expected costs and quality adjusted life years (QALYs) for both methods; also, the incremental cost-effectiveness ratio was assessed. The results of the decision tree showed that in the AC arm, the expected cost was 39,170 US$ and the expected QALY was 3.39 and in the PG arm, the expected cost was 43,336 dollars and the expected QALY was 2.64. Sensitivity analysis showed the cost effectiveness of the AC and ICER=-5535 US$. Overall, the results showed that AC to be superior to PG in treatment of patients with breast cancer, being less costly and more effective.

Traditional Chinese Medicine treatment as maintenance therapy in advanced non-small-cell lung cancer: A randomized controlled trial.

PubMed

Jiang, Yi; Liu, Ling-Shuang; Shen, Li-Ping; Han, Zhi-Fen; Jian, Hong; Liu, Jia-Xiang; Xu, Ling; Li, He-Gen; Tian, Jian-Hui; Mao, Zhu-Jun

2016-02-01

Maintenance therapy for patients with advanced non-small-cell lung cancer (NSCLC) is an increasingly hot topic in the field of clinical NSCLC research. This study aimed to evaluate the effects of Traditional Chinese Medicine (TCM) treatment as maintenance therapy on time to progression (TTP), quality of life (QOL), overall survival (OS) and 1-year survival rate in patients with advanced NSCLC. This study was conducted as a randomized, controlled, open-label trial. 64 non-progressive patients who responded to initial therapy were randomized 1:1 to the TCM arm (treated with herbal injection (Cinobufacini, 20ml/d, d1-d10), herbal decoction (d1-d21) and Chinese acupoint application (d1-d21), n=32) or to the chemotherapy arm (treated with pemetrexed (non-squamous NSCLC, 500mg/m(2), d1), docetaxel (75mg/m(2), d1) or gemcitabine (1250mg/m(2), d1 and d8), n=32). Each therapy cycle was 21 days. They were repeated until disease progression, unacceptable toxicity, or until the patients requested therapy discontinuation. The primary end point was TTP; the secondary end points were QOL, OS and 1-year survival rate. "Intention-to-treat" analysis included all randomized participants. TCM treatment prolonged median TTP for 0.7 months compared with chemotherapy, but it was not statistically significant (3.0 months vs. 2.3 months, P=0.114). Median OS time for TCM treatment did not offer a significant advantage over for chemotherapy (21.5 months vs. 18.8 months, P=0.601). 1-year survival rate of TCM treatment significantly improved than that of chemotherapy (78.1% vs. 53.1%, P=0.035). TCM treatment can significantly improve QOL when compared to chemotherapy as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 QOL instruments. TCM maintenance treatment had similar effects on TTP and OS compared with maintenance chemotherapy, but it improved patients' QOL and had higher 1-year survival rate. TCM Maintenance treatment is a promising option for advanced NSCLC patients without progression following first-line chemotherapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Spiritual Well-Being for Increasing Life Expectancy in Palliative Radiotherapy Patients: A Questionnaire-Based Study.

PubMed

Hematti, Simin; Baradaran-Ghahfarokhi, Milad; Khajooei-Fard, Rasha; Mohammadi-Bertiani, Zohreh

2015-10-01

Spiritual well-being in patients with an advanced cancer has been found to positively correlate with subjective well-being, lower pain levels, hope and positive mood states, high self-esteem, social competence, purpose in life, and overall quality of life. In this regard, Quran recitation is stated to be an efficient way to increase patient spirituality and also to handle life's everyday challenges. The aim of this study was to investigate the effects of listening, reading, and watching the text of the Holy Quran, called (in this study) Quran recitation, for increasing life expectancy (LE) in palliative radiotherapy patients admitted to Radiotherapy Department of Seyed alshohada Hospital, Isfahan, Iran. A questionnaire-based study was carried out on a total of 89 palliative radiotherapy patients between March 2012 and June 2012. Informed consent was obtained. The patients were requested to complete a standardized questionnaire which was designed based on the European Organization for Research and Treatment of Cancer C30 Scale Quality of Life Questionnaire (EORTC C30 Scale QLQ). A computer program (SPSS version 16.0, Chicago, IL, USA) was used, and data were analyzed by the Wilcoxon test and Spearman's rank correlation. All hypotheses were tested using a criterion level of P = 0.05. There was a significant difference for frequency and duration of Quran recitation among patients, before and after the diagnosis of their cancer (P = 0.03). Using the Spearman's rank correlation, it was found that there was a correlation between Quran recitation and subjective well-being (r = 0.352, P < 0.001). Moreover, there was a correlation between Quran recitation and increasing LE (r = 0.311, P < 0.003). More than 60% of the patients stated that more frequent recitation would lead to more LE and/or greater reassurance. On the basis of the present work, listening, reading, and watching the text of the Holy Quran are useful for increasing LE in palliative radiotherapy patients admitted to Radiotherapy Department. In other words, a benefit of Quran recitation on outcome of radiotherapy for palliative radiotherapy patients was found.

Perceived communication between physicians and breast cancer patients as a predicting factor of patients' health-related quality of life: a longitudinal analysis.

PubMed

Trudel, Julie G; Leduc, Nicole; Dumont, Serge

2014-05-01

Communication between cancer patients and healthcare providers is recognized as an important aspect of these patients' health-related quality of life (HRQOL). Nevertheless, no study has examined whether perceived communication between physicians and breast cancer patients is a determining factor in their HRQOL along the disease's trajectory. This longitudinal study aimed to ascertain whether such communication influenced the HRQOL of such women at three points in time. The sample consisted of 120 French-speaking women with stage I or II breast cancer aged 18 years or over (mean = 55 years) who underwent a lumpectomy with adjuvant treatment. The women filled out questionnaires at three different times: around the time of diagnosis, halfway through radiotherapy and at follow-up. Either at the hospital or at home, they completed demographic and medical data questionnaires, the Medical Outcomes Study-Social Support Survey, an HRQOL questionnaire (EORTC QLQ-C30/BR23) and the Medical Communication Competence Scale. Generalized estimated equations analyses indicated that the women's perceptions of their own communication skills towards physicians had a greater impact on their HRQOL than the women's perception of physicians' communication skills. The women had better global health and better role, emotional, cognitive and sexual functioning as well as fewer side effects and symptoms during radiotherapy and at follow-up when they perceived themselves as competent communicators at diagnosis and during radiotherapy. The results underscore the importance for breast cancer patients of being proactive in information seeking and in the socio-emotional aspect of their relationship with physicians to enhance their HRQOL. Copyright © 2013 John Wiley & Sons, Ltd.

Impact of healthy eating practices and physical activity on quality of life among breast cancer survivors.

PubMed

Mohammadi, Shooka; Sulaiman, Suhaina; Koon, Poh Bee; Amani, Reza; Hosseini, Seyed Mohammad

2013-01-01

Following breast cancer diagnosis, women often attempt to modify their lifestyles to improve their health and prevent recurrence. These behavioral changes typically involve diet and physical activity modification. The aim of this study was to determine association between healthy eating habits and physical activity with quality of life among Iranian breast cancer survivors. A total of 100 Iranian women, aged between 32 to 61 years were recruited to participate in this cross-sectional study. Eating practices were evaluated by a validated questionnaire modified from the Women's Healthy Eating and Living (WHEL) study. Physical activity was assessed using the International Physical Activity Questionnaire (IPAQ). A standardized questionnaire by the European Organization of Research and Treatment of Cancer Quality of Life and its breast cancer module (EORTC QLQ-C30/+BR-23) were applied to determine quality of life. Approximately 29% of the cancer survivors were categorized as having healthy eating practices, 34% had moderate eating practices and 37% had poor eating practices based on nutrition guidelines. The study found positive changes in the decreased intake of fast foods (90%), red meat (70%) and increased intake of fruits (85%) and vegetables (78%). Generally, breast cancer survivors with healthy eating practices had better global quality of life, social, emotional, cognitive and role functions. Result showed that only 12 women (12%) met the criteria for regular vigorous exercise, 22% had regular moderate-intensity exercise while the majority (65%) had low-intensity physical activity. Breast cancer survivors with higher level of physical activity had better emotional and cognitive functions. Healthy eating practices and physical activity can improve quality of life of cancer survivors. Health care professionals should promote good dietary habits and physical activity to improve survivors' health and quality of life.

Review of HaNDLE-on-QoL: a database of published papers that use questionnaires to report quality of life in patients with cancer of the head and neck.

PubMed

Wotherspoon, R J; Kanatas, A N; Rogers, S N

2018-02-01

HaNDLE-on-QoL (Head And Neck Database Listing Evidence on QoL) is a searchable database that comprises abstracts of papers that have used questionnaires to report on quality of life (QoL) in patients with cancer of the head and neck. It can be searched by title, first author, year of publication, words used in the abstract, site of cancer, study design, and questionnaires used. The aim of this paper was to summarise its contents. In May 2017 we searched the website using the criteria above. It contained 1498 papers (including 149 reviews), and the number is increasing each year. Most studies concerned a combination of subsites in the head and neck (n=871); 180 focused specifically on oral sites, and 109 on the larynx. The commonest topics were swallowing (n=353), speech (n=299), pain (n=292), emotions (n=226), and depression (n=193). Nearly all the papers concerned function or predictors of health-related QoL (HRQoL), but 98 were clinical or randomised controlled trials. The site included over 250 questionnaires of which the most common were the European Organisation for Research and Treatment of Cancer C30 (EORTC-C30, n=369), the EORTC-head and neck 35 (EORTC H&N35, n=353), and the University of Washington Quality of Life (UWQoL) (n=276). HaNDLE-on-QoL highlights the complexity of QoL after treatment and the diversity and range of the studies. It is a useful point of reference for those involved in clinical practice or research. Copyright © 2017 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Long-term prospective longitudinal evaluation of emotional distress and quality of life in cervical cancer patients who remained disease-free 2-years from diagnosis.

PubMed

Mantegna, Giovanna; Petrillo, Marco; Fuoco, Gilda; Venditti, Laura; Terzano, Serena; Anchora, Luigi Pedone; Scambia, Giovanni; Ferrandina, Gabriella

2013-03-18

A long-term prospective assessment of QoL in cervical cancer patients is still lacking. Here, we provide the first 2-years prospective, longitudinal study evaluating emotional distress and QoL in early stage (ECC) and locally advanced (LACC) cervical cancer patients who remained disease-free 2-years from diagnosis. The questionnaires: Hospital Anxiety and Depression Scale (HADS), Global Health Status items of EORTC QLQ-C30 (GHS), and EORTC QLQ-CX24 (CX24) have been administered by a dedicated team of psycho-oncologists, administered at baseline, and after 3, 6, 12 and 24 months from surgery The Generalized Linear Model for repeated measure was used to analyze modifications of QoL measures over time. In both groups, an early reduction of the percentage of patients with anxiety levels ≥11 was observed at the 3-month evaluation (ECC: 25.7% at baseline Vs 14.7% after 3 months, p value=0.001; LACC: 22.2% at baseline Vs 15.4% after 3 months, p value=0.001). Despite this favorable trend, after 2 years from diagnosis, 11.9% of ECC and 15.6% of LACC patients still showed an anxiety score ≥11. No significant changes over time were observed in term of Depression levels. Focusing on QoL issues, mean GHS and Sexual Activity scores showed an improvement over time in both groups compared to baseline (GHS: 5.7% difference for ECC, p value=0.001, and 11.0% in LACC, p value=0.001; SXA: 13.9% difference for ECC, p value=0.001; and 6.1% in LACC, p value=0.008). On the other hand, Body Image mean scores were significantly impaired by chemoradiation administration in LACC patients, without long-term recovery (7.5% difference, p value=0.001). Finally, in both groups, lymphedema (LY) and menopausal symptoms (MS) showed an early worsening which persisted 2-year after surgery (LY: 19.5% difference for ECC, p value=0.014, and 27.3% in LACC, p value=0.001; MS: 14.4% difference for ECC, p value=0.004, and 16.0% in LACC, p value=0.002). Despite a significant improvement over time, elevated anxiety levels are still detectable at 24 months after surgery in approximately 10% of cervical cancer patients. Much more attention should be focused on surgical/medical approaches able to minimize the negative impact of lymphedema and menopausal symptoms on QoL.

Complete resection of contrast-enhancing tumor volume is associated with improved survival in recurrent glioblastoma—results from the DIRECTOR trial

PubMed Central

Suchorska, Bogdana; Weller, Michael; Tabatabai, Ghazaleh; Senft, Christian; Hau, Peter; Sabel, Michael C.; Herrlinger, Ulrich; Ketter, Ralf; Schlegel, Uwe; Marosi, Christine; Reifenberger, Guido; Wick, Wolfgang; Tonn, Jörg C.; Wirsching, Hans-Georg

2016-01-01

Background The role of reoperation for recurrent glioblastoma (GBM) remains unclear. Prospective studies are lacking. Here, we studied the association of clinical outcome with extent of resection upon surgery for recurrent GBM in the patient cohort of DIRECTOR, a prospective randomized multicenter trial comparing 2 dose-intensified temozolomide regimens at recurrence of GBM. Methods We analyzed prospectively collected clinical and imaging data from the DIRECTOR cohort (N = 105). Volumetric analysis was performed on gadolinium contrast-enhanced MRI as well as fluid attenuated inversion recovery/T2 MRI and correlated with PFS after initial progression (PFS2) and post-recurrence survival (PRS). Quality of life was monitored by the EORTC QLQ-C30 and QLQ-BN20 questionnaires at 8-week intervals. Results Seventy-one patients received surgery at first recurrence. Prognostic factors, including age, MGMT promoter methylation, and Karnofsky performance score, were balanced between patients with and without reoperation. Outcome in patients with versus without surgery at recurrence was similar for PFS2 (2.0 mo vs 1.9 mo, P = .360) and PRS (11.4 mo vs 9.8 mo, P = .633). Among reoperated patients, post-surgery imaging was available in 59 cases. In these patients, complete resection of contrast-enhancing tumor (N = 40) versus residual detection of contrast enhancement (N = 19) was associated with improved PRS (12.9 mo [95% CI: 11.5–18.2] vs 6.5 mo [95% CI: 3.6–9.9], P < .001) and better quality of life. Incomplete tumor resection was associated with inferior PRS compared with patients who did not undergo surgery (6.5 vs 9.8 mo, P = .052). Quality of life was similar in these 2 groups. Conclusion Surgery at first recurrence of GBM improves outcome if complete resection of contrast-enhancing tumor is achieved. PMID:26823503

Proxy assessment of health-related quality of life in african american and white respondents with prostate cancer: perspective matters.

PubMed

Pickard, A Simon; Lin, Hsiang-Wen; Knight, Sara J; Knight, Sara L; Sharifi, Roohollah; Wu, Zhigang; Hung, Shih-Ying; Witt, Whitney P; Chang, Chih-Hung; Bennett, Charles L

2009-02-01

An emerging issue in the proxy literature is whether specifying different proxy viewpoints contributes to different health-related quality of life (HRQL) assessments, and if so, how might each perspective be informative in medical decision making. The aims of this study were to determine if informal caregiver assessments of patients with prostate cancer differed when prompted from both the patient perspective (proxy-patient) and their own viewpoint (proxy-proxy), and to identify factors associated with differences in proxy perspectives (ie, the intraproxy gap). Using a cross-sectional design, prostate cancer patients and their informal caregivers were recruited from urology clinics in the Jesse Brown Veterans Affairs Healthcare System in Chicago. Dyads assessed HRQL using the EQ-5D visual analog scale (VAS) and EORTC QLQ-C30. Of 87 dyads, most caregivers were female (83%) and were spouses/partners (58%). Mean difference scores between proxy-patient and proxy-proxy perspectives were statistically significant for QLQ-C30 physical and emotional functioning, and VAS (all P < 0.05), with the proxy-patient perspective closer to patient self-report. Emotional functioning had the largest difference, mean 6.0 (SD 12.8), an effect size = 0.47. Factors weakly correlated with the intraproxy gap included relationship (spouse) and proxy gender for role functioning, and health literacy (limited/functional) for physical functioning (all P < 0.05, 0.20 < r < 0.35). Meaningful differences between proxy-patient and proxy-proxy perspectives on mental health were consistent with a conceptual framework for understanding proxy perspectives. Prompting different proxy viewpoints on patient health could help clinicians identify patients who may benefit from clinical intervention.

Proxy Assessment of Health-Related Quality of Life in African American and White Respondents With Prostate Cancer

PubMed Central

Pickard, A. Simon; Lin, Hsiang-Wen; Knight, Sara J.; Sharifi, Roohollah; Wu, Zhigang; Hung, Shih-Ying; Witt, Whitney P.; Chang, Chih-Hung; Bennett, Charles L.

2011-01-01

Objectives An emerging issue in the proxy literature is whether specifying different proxy viewpoints contributes to different health-related quality of life (HRQL) assessments, and if so, how might each perspective be informative in medical decision making. The aims of this study were to determine if informal caregiver assessments of patients with prostate cancer differed when prompted from both the patient perspective (proxy-patient) and their own viewpoint (proxy-proxy), and to identify factors associated with differences in proxy perspectives (ie, the intraproxy gap). Research Design and Methods Using a cross-sectional design, prostate cancer patients and their informal caregivers were recruited from urology clinics in the Jesse Brown Veterans Affairs Healthcare System in Chicago. Dyads assessed HRQL using the EQ-5D visual analog scale (VAS) and EORTC QLQ-C30. Results Of 87 dyads, most caregivers were female (83%) and were spouses/partners (58%). Mean difference scores between proxy-patient and proxy-proxy perspectives were statistically significant for QLQ-C30 physical and emotional functioning, and VAS (all P < 0.05), with the proxy-patient perspective closer to patient self-report. Emotional functioning had the largest difference, mean 6.0 (SD 12.8), an effect size = 0.47. Factors weakly correlated with the intraproxy gap included relationship (spouse) and proxy gender for role functioning, and health literacy (limited/functional) for physical functioning (all P < 0.05, 0.20 < r < 0.35). Conclusions Meaningful differences between proxy-patient and proxy-proxy perspectives on mental health were consistent with a conceptual framework for understanding proxy perspectives. Prompting different proxy viewpoints on patient health could help clinicians identify patients who may benefit from clinical intervention. PMID:19169118

Quality of life and nutritional consequences after aboral pouch reconstruction following total gastrectomy for gastric cancer: randomized controlled trial CCG1101.

PubMed

Ito, Yuichi; Yoshikawa, Takaki; Fujiwara, Michitaka; Kojima, Hiroshi; Matsui, Takanori; Mochizuki, Yoshinari; Cho, Haruhiko; Aoyama, Toru; Ito, Seiji; Misawa, Kazunari; Nakayama, Hiroshi; Morioka, Yuki; Ishiyama, Akiharu; Tanaka, Chie; Morita, Satoshi; Sakamoto, Junichi; Kodera, Yasuhiro

2016-07-01

Total gastrectomy has detrimental effects on postoperative nutritional status and quality of life (QOL), but it is often unavoidable in the treatment of gastric cancer. Roux-en-Y (RY) is the most common reconstruction method following total gastrectomy. Trials to explore other means of reconstruction have been conducted but have failed to identify a method that is globally accepted. Aboral pouch reconstruction (AP), in which an anisoperistaltic jejunal pouch is created in the Y limb of the RY reconstruction, is considered effective and technically feasible. A prospective randomized trial was conducted to compare AP with RY. Gastric cancer patients requiring total gastrectomy for R0 resection were randomly assigned during surgery to receive either RY (n = 51) or AP (n = 49). Postoperative QOL as assessed by the EORTC QLQ-C30 and STO22, body composition, and morbidity were compared between the two reconstruction methods. The physical functioning score of the QLQ-C30 was selected as the primary endpoint. The incidences of postoperative complications were similar between the two groups (29 % in the RY group and 27 % in the AP group). No significant difference was observed in the physical functioning score, and the superiority of AP was demonstrated only for the nausea and vomiting score at 12 months (p = 0.041) and the reflux score at 1 month (p = 0.036). No significant differences were observed in body composition or serum biochemistry. Although AP was safely implemented, no increased benefits in nutritional or QOL-related parameters were observed for this method over RY within 12 months postoperatively.

Impact of age, comorbidity and symptoms on physical function in long-term breast cancer survivors (CALGB 70803)

PubMed Central

Cohen, Harvey Jay; Lan, Lan; Archer, Laura; Kornblith, Alice B.

2012-01-01

Purpose The purpose of this study was to assess the impact of aging, comorbidities and symptoms on physical function in patients surviving 20 years since adjuvant treatment for breast cancer. Patients & Methods Patients were originally treated on CALGB 7581 (from 1975–1980), a randomized trial of three adjuvant therapies and reassessed (153 of 193 eligible survivors) 20 years from the onset of therapy for physical function and symptoms by the EORTC QLQ-C30 and comorbidities by the OARS questionnaire. Results The average age at reassessment was 64.5 years. 66% of patients had at least two comorbidities and 22% had four or more, but relatively little interference with activities. Older patients had greater multimorbidity. Physical function was generally high and comparable to matched population norms. Older patients had greater difficulty with strenuous activities. For every increase in number of comorbidities, physical function score decreased by 5.1 (p<.001). Symptoms were also frequent (80%) and correlated strongly with decreases in function (0–100u scale) (p <.001), to an even greater degree than comorbidities. Conclusion Very long-term cancer survivors have changes in physical function and symptoms largely consistent with their aging suggesting that the impact of cancer and its treatment is attenuated over time and largely replaced by the impact of age-related comorbidities and functional decline. PMID:22707996

Health-related quality of life during adjuvant treatment for breast cancer among postmenopausal women.

PubMed

Browall, Maria; Ahlberg, Karin; Karlsson, Per; Danielson, Ella; Persson, Lars-Olof; Gaston-Johansson, Fannie

2008-07-01

The purpose of the present study was twofold: first, to describe changes of Health-Related Quality of Life (HRQoL) during the adjuvant treatment among postmenopausal women with breast cancer; second, in the same population to identify the best predictors of Overall Quality of Life (QoL) after treatment, from perceived functioning, symptoms, emotional distress and clinical/demographic variables measured at baseline. The study group was 150 women (> or = 55 years of age) scheduled for adjuvant chemotherapy (CT, n=75) or radiotherapy (RT, n=75). They were examined before (baseline), during and after completing the treatment. Data about QoL, perceived functioning, symptoms and emotional distress were collected with the European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30, BR23 and Hospital Anxiety and Depression Scale (HADS) questionnaires. The general finding was that the adjuvant treatments were associated with decrease in overall QoL, physical and role functioning, anxiety and body image, as well as with increase in fatigue, dyspnoea, pain, nausea/vomiting, constipation and systemic therapy side effects measured over time. For women receiving CT, better emotional functioning and less pain at baseline predicted better overall QoL at the end of the treatment. For women receiving RT, better physical and emotional functioning, less breast symptoms and lower tumour stage at baseline predicted better overall QoL at the end of the treatment.

Use of complementary and alternative medicine by lymphoma survivors in South Korea.

PubMed

Kim, Kisook; Kim, Soo Hyun; Ok, Oh Nam; Kim, Im-Ryung; Lee, Suyeon; Kim, So Hee; Kim, Won Seog; Ryu, Min-Hee; Lee, Moon Hee

2018-04-01

We aimed to examine the experience of complementary and alternative medicine (CAM) use and its association with health-related quality of life (HRQOL) in lymphoma survivors in South Korea. The participants were 869 lymphoma survivors from three hospitals in South Korea, all diagnosed with lymphoma at least 24 months prior to participation. Self-reported questionnaires were used to assess CAM use. The questionnaire addressed types of CAM used, sources of information about CAM, reason for CAM use, satisfaction with CAM use, discussion of CAM use with doctors, experience of side effects, costs of CAM use, and intentions to continue using CAM. HRQOL was measured with the EORTC QLQ-C30. Of the 869 participants, 42.2% had experience using CAM, and there were statistically significant differences among CAM users and non-users in terms of sex, religion, and time since diagnosis. A special diet (e.g., ginseng, chitosan, mixed cereals) was the most commonly used type of CAM, and most CAM users (82.1%) were satisfied with their CAM use. Most CAM users (77.5%) did not discuss the use of CAM with their doctors, and only 9.2% reported any side effects from CAM. CAM users showed significantly lower HRQOL scores than did non-users. A significant number of lymphoma survivors in Korea have used CAM, and most CAM users are satisfied with their CAM use. Oncology nurses should be aware of the range of CAM use among patients and reflect their responses in their treatment and/or follow-up care. Copyright © 2018 Elsevier Ltd. All rights reserved.

Exercise intervention for the treatment of trismus in head and neck cancer.

PubMed

Pauli, Nina; Fagerberg-Mohlin, Bodil; Andréll, Paulin; Finizia, Caterina

2014-04-01

The aim of this study was to investigate the impact of structured exercise with jaw mobilizing devices on trismus and its effect on trismus symptomatology and health-related quality of life (HRQL) in head and neck (H&N) cancer patients. Fifty patients with H&N cancer and trismus, i.e. maximum interincisal opening (MIO) ≤ 35 mm participated in a structured intervention program with jaw exercise. The patients in the intervention group underwent a 10-week exercise program with regular follow-up. A control group comprising of 50 patients with trismus and H&N cancer were matched to the intervention group according to gender, tumor location, tumor stage, comorbidity and age. HRQL and trismus-related symptoms were assessed. The mean MIO improvement was 6.4 mm (4.8-8.0) and 0.7 (-0.3-1.7) mm in the intervention group and control group respectively, three months post-intervention commencement (p < 0.001). The intervention group demonstrated a statistically significant improvement in Role functioning, Social functioning and Global quality of life (EORTC QLQ C30) and in all Gothenburg Trismus Questionnaire (GTQ) domains, i.e. jaw-related problems (p < 0.001), eating limitation (p < 0.05) and muscular tension (p < 0.001). We found that a structured jaw exercise program was effective and improved the mouth opening capacity significantly. The objective effect on trismus (MIO) was also reflected in the patient-reported outcome questionnaires where the patients who underwent the structured exercise program after cancer treatment reported improvements in HRQL and less trismus-related symptoms compared to the control group.

Types of reactions to malignant disease in view of V.E. Frankl philosophy.

PubMed

Majkowicz, Mikolaj; Pankiewicz, Piotr; Zdun-Ryzewska, Agata; Podolska, Magdalena Z

2014-01-01

The purpose of this work was to find out whether there is interdependence between the patients- assessments of biological, psychological, psychosocial and spiritual levels. 590 subjects, both ill and healthy, were examined by appropriate means and asked to consider their level of fear, depression (Hospital Anxiety and Depression Scale - Modification), aggression, quality of life (EORTC QLQ-C30 questionnaire), and the purpose and meaning of life (The "PURPOSE in Life Test" - PIL questionnaire). Three groups of patients were established with the help of statistical procedures. The first group encompassed the healthy subjects, whereas the second and third included those that were ill. Although the subjects estimated their level of physical fitness and general quality of life similarly, there were some essential differences in their disease-associated reactions (i.e. the groups adjusted differently - the second group poorly and the third well). The majority of people suffering from cancer were well adapted to the early stages of the disease. As cancer progressed the percentage of those that adjusted poorly rose. However, even in the terminal stage some of the patients, about 1/3, still belonged to the group of those that were quite well adjusted. Established meaning of life, system of values, and personal religion were factors that helped to adapt. There was no connection between the patients' assessments of their biological level and other (psychological, psychosocial, spiritual) levels. We can distinguish groups of patients that judge their physical condition similarly and still vary in the assessment of their emotional state or meaning of life.

Late Patient-Reported Toxicity After Preoperative Radiotherapy or Chemoradiotherapy in Nonresectable Rectal Cancer: Results From a Randomized Phase III Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Braendengen, Morten, E-mail: mortbrae@medisin.uio.no; Department of Oncology and Pathology, Karolinska Institutet, Stockholm; Tveit, Kjell Magne

Purpose: Preoperative chemoradiotherapy (CRT) is superior to radiotherapy (RT) in locally advanced rectal cancer, but the survival gain is limited. Late toxicity is, therefore, important. The aim was to compare late bowel, urinary, and sexual functions after CRT or RT. Methods and Materials: Patients (N = 207) with nonresectable rectal cancer were randomized to preoperative CRT or RT (2 Gy Multiplication-Sign 25 {+-} 5-fluorouracil/leucovorin). Extended surgery was often required. Self-reported late toxicity was scored according to the LENT SOMA criteria in a structured telephone interview and with questionnaires European Organisation for Research and Treatment of Cancer (EORTC) Quality of Lifemore » Questionnaire (QLQ-C30), International Index of Erectile Function (IIEF), and sexual function -vaginal changes questionnaire (SVQ). Results: Of the 105 patients alive in Norway and Sweden after 4 to 12 years of follow-up, 78 (74%) responded. More patients in the CRT group had received a stoma (73% vs. 52%, p = 0.09). Most patients without a stoma (7 of 12 in CRT group and 9 of 16 in RT group) had incontinence for liquid stools or gas. No stoma and good anal function were seen in 5 patients (11%) in the CRT group and in 11 (30%) in the RT group (p = 0.046). Of 44 patients in the CRT group, 12 (28%) had had bowel obstruction compared with 5 of 33 (15%) in the RT group (p = 0.27). One-quarter of the patients reported urinary incontinence. The majority of men had severe erectile dysfunction. Few women reported sexual activity during the previous month. However, the majority did not have concerns about their sex life. Conclusions: Fecal incontinence and erectile dysfunction are frequent after combined treatment for locally advanced rectal cancer. There was a clear tendency for the problems to be more common after CRT than after RT.« less

Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial.

PubMed

Twelves, Chris; Cortés, Javier; O'Shaughnessy, Joyce; Awada, Ahmad; Perez, Edith A; Im, Seock-Ah; Gómez-Pardo, Patricia; Schwartzberg, Lee S; Diéras, Véronique; Yardley, Denise A; Potter, David A; Mailliez, Audrey; Moreno-Aspitia, Alvaro; Ahn, Jin-Seok; Zhao, Carol; Hoch, Ute; Tagliaferri, Mary; Hannah, Alison L; Rugo, Hope S

2017-05-01

Health-related quality of life (HRQoL) enhances understanding of treatment effects that impact clinical decision-making. Although the primary end-point was not achieved, the BEACON (BrEAst Cancer Outcomes with NKTR-102) trial established etirinotecan pegol, a long-acting topoisomerase-1 (TOP1) inhibitor, as a promising therapeutic for patients with advanced/metastatic breast cancer (MBC) achieving clinically meaningful benefits in median overall survival (OS) for patients with stable brain metastases, with liver metastases or ≥ 2 sites of metastatic disease compared to treatment of physician's choice (TPC). Reported herein are the findings from the preplanned secondary end-point of HRQoL. HRQoL, assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) (version 3.0) supplemented by the breast cancer-specific Quality of Life Questionnaire (QLQ-BR23), was evaluated post randomisation in 733 of 852 patients with either anthracycline-, taxane- and capecitabine-pretreated locally recurrent or MBC randomised to etirinotecan pegol (n = 378; 145 mg/m 2 every 3 weeks (q3wk)) or single-agent TPC (n = 355). Patients completed assessments at screening, every 8 weeks (q8wk) during treatment, and end-of-treatment. Changes from baseline were analysed, and the proportions of patients achieving differences (≥5 points) in HRQoL scores were compared. Differences were seen favouring etirinotecan pegol up to 32 weeks for global health status (GHS) and physical functioning scales (P < 0.02); numerical improvement was reported in other functional scales. The findings from HRQoL symptom scales were consistent with adverse event profiles; etirinotecan pegol was associated with worsening gastrointestinal symptoms whereas TPC was associated with worsened dyspnoea and other systemic side-effects. Analysis of GHS and physical functioning at disease progression showed a decline in HRQoL in both treatment arms, with a mean change from baseline of -9.4 and -10.8 points, respectively. There was evidence of benefit associated with etirinotecan pegol compared with current standard of care agents in multiple HRQoL measurements, including global health status and physical functioning, despite worse gastrointestinal symptoms (e.g. diarrhoea). Patients in both arms had a decline in HRQoL at disease progression. NCT01492101. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Reporting combined outcomes with Trifecta and survival, continence, and potency (SCP) classification in 337 patients with prostate cancer treated with image-guided hypofractionated radiotherapy.

PubMed

Jereczek-Fossa, Barbara A; Zerini, Dario; Fodor, Cristiana; Santoro, Luigi; Maucieri, Andrea; Gerardi, Marianna A; Vischioni, Barbara; Cambria, Raffaella; Garibaldi, Cristina; Cattani, Federica; Vavassori, Andrea; Matei, Deliu V; Musi, Gennaro; De Cobelli, Ottavio; Orecchia, Roberto

2014-12-01

To report the image-guided hypofractionated radiotherapy (hypo-IGRT) outcome for patients with localised prostate cancer according to the new outcome models Trifecta (cancer control, urinary continence, and sexual potency) and SCP (failure-free survival, continence and potency). Between August 2006 and January 2011, 337 patients with cT1-T2N0M0 prostate cancer (median age 73 years) were eligible for a prospective longitudinal study on hypo-IGRT (70.2 Gy/26 fractions) in our Department. Patients completed four questionnaires before treatment, and during follow-up: the International Index of Erectile Function-5 (IIEF-5), the International Prostate Symptom Score (IPSS), and the European Organization for Research and Treatment of Cancer prostate-cancer-specific Quality of Life Questionnaires (QLQ) QLQ-PR25 and QLQ-C30. Baseline and follow-up patient data were analysed according to the Trifecta and SCP outcome models. Cancer control, continence and potency were defined respectively as no evidence of disease, score 1 or 2 for item 36 of the QLQ-PR25 questionnaire, and total score of >16 on the IIEF-5 questionnaire. Patients receiving androgen-deprivation therapy (ADT) at any time were excluded. Trifecta criteria at baseline were met in 72 patients (42% of all ADT-free patients with completed questionnaires). Both at 12 and 24 months after hypo-IGRT, 57% of the Trifecta patients at baseline were still meeting the Trifecta criteria (both oncological and functional success according to the SCP model). The main reason for failing the Trifecta criteria during follow-up was erectile dysfunction: in 18 patients after 6 months follow-up, in 12 patients after 12 months follow-up, and in eight patients after 24 months. Actuarial 2-year Trifecta failure-free survival rate was 44% (95% confidence interval 27-60%). In multivariate analysis no predictors of Trifecta failure were identified. Missing questionnaires was the main limitation of the study. The Trifecta and SCP classifications can be used as tools to report RT outcome. © 2013 The Authors. BJU International © 2013 BJU International.

Development and evaluation of oral Cancer quality-of-life questionnaire (QOL-OC).

PubMed

Nie, Min; Liu, Chang; Pan, Yi-Chen; Jiang, Chen-Xi; Li, Bao-Ru; Yu, Xi-Jie; Wu, Xin-Yu; Zheng, Shu-Ning

2018-05-03

In this study scales and items for the Oral Cancer Quality-of-life Questionnaire (QOL-OC) were designed and the instrument was evaluated. The QOL-OC was developed and modified using the international definition of quality of life (QOL) promulgated by the European Organization for Research and Treatment of Cancer (EORTC) and analysis of the precedent measuring instruments. The contents of each item were determined in the context of the specific characteristics of oral cancer. Two hundred thirteen oral cancer patients were asked to complete both the EORTC core quality of life questionnaire (EORTC QLC-C30) and the QOL-OC. Data collected was used to conduct factor analysis, test-retest reliability, internal consistency, and construct validity. Questionnaire compliance was relatively high. Fourteen of the 213 subjects accepted the same tests after 24 to 48 h demonstrating a high test-retest reliability for all five scales. Overall internal consistency surpasses 0.8. The outcome of the factor analysis coincides substantially with our theoretical conception. Each item shows a higher correlation coefficient within its own scale than the others which indicates high construct validity. QOL-OC demonstrates fairly good statistical reliability, validity, and feasibility. However, further tests and modification are needed to ensure its applicability to the quality-of-life assessment of Chinese oral cancer patients.

Postoperative quality-of-life assessment in patients with spine metastases treated with long-segment pedicle-screw fixation.

PubMed

Bernard, Florian; Lemée, Jean-Michel; Lucas, Olivier; Menei, Philippe

2017-06-01

OBJECTIVE In recent decades, progress in the medical management of cancer has been significant, resulting in considerable extension of survival for patients with metastatic disease. This has, in turn, led to increased attention to the optimal surgical management of bone lesions, including metastases to the spine. In addition, there has been a shift in focus toward improving quality of life and reducing hospital stay for these patients, and many minimally invasive techniques have been introduced with the aim of reducing the morbidity associated with more traditional open approaches. The goal of this study was to assess the efficacy of long-segment percutaneous pedicle screw stabilization for the treatment of instability associated with thoracolumbar spine metastases in neurologically intact patients. METHODS This study was a retrospective review of data from a prospective database. The authors analyzed cases in which long-segment percutaneous pedicle screw fixation was performed for the palliative treatment of thoracolumbar spinal instability due to spinal metastases in neurologically intact patients. All of the patients included in the study underwent surgery between January 2014 and May 2015 at the authors' institution. Postoperative radiation therapy was planned within 10 days following the stabilization in all cases. Clinical and radiological follow-up assessments were planned for 3 days, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Outcome was assessed by means of standard postoperative evaluation and oncological and spinal quality of life measures (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 [EORTC QLQ-C30] and Oswestry Disability Index [ODI], respectively). Moreover, 5 patients were given an activity monitoring device for recording the distance walked daily; preoperative and postoperative daily distances were compared. RESULTS Data from 17 cases were analyzed. There were no complications, and patients showed improvement in pain level and quality of life from the early postoperative period on. The mean ODI score was 62.7 (range 40-84) preoperatively, 35.4 (range 24-59) on postoperative Day 3, and 46.1 (range 30-76) at 3 weeks, 37.6 (range 25-59) at 6 weeks, 34.0 (range 24-59) at 3 months, 39.1 (range 22-64) at 6 months, and 30.0 (range 20-55) at 1 year after screw placement. The mean ODI was significantly improved in the first 45 days (p < 0.001). Improvement was also evident in scores for functional and symptomatic scales of the EORTC QLQ-C30. All patients underwent postoperative radiation therapy within 10 days (mean 7.5). All patients (n = 5) with an activity monitoring device showed improvement in daily walking distance. CONCLUSIONS Less-invasive palliative treatment for advanced spinal metastases is promising as part of a multidisciplinary approach to the care of patients with metastatic disease. The results of this study indicate that percutaneous surgery may allow for rapid improvement in quality of life and walking ability for patients with thoracolumbar instability due to spine metastases. Long-segment percutaneous screw fixation followed by early radiation therapy appears to be a safe and effective treatment option for providing solid and durable stability and improved quality of life for these patients.

Differences in health related quality of life in the randomised ARTSCAN study; accelerated vs. conventional radiotherapy for head and neck cancer. A five year follow up.

PubMed

Nyqvist, Johanna; Fransson, Per; Laurell, Göran; Hammerlid, Eva; Kjellén, Elisabeth; Franzén, Lars; Söderström, Karin; Wickart-Johansson, Gun; Friesland, Signe; Sjödin, Helena; Brun, Eva; Ask, Anders; Nilsson, Per; Ekberg, Lars; Björk-Eriksson, Thomas; Nyman, Jan; Lödén, Britta; Lewin, Freddi; Reizenstein, Johan; Lundin, Erik; Zackrisson, Björn

2016-02-01

Health related quality of life (HRQoL) was assessed in the randomised, prospective ARTSCAN study comparing conventional radiotherapy (CF) with accelerated radiotherapy (AF) for head and neck cancer. 750 patients with squamous cell carcinoma (of any grade and stage) in the oral cavity, oro-, or hypopharynx or larynx (except T1-2, N0 glottic carcinoma) without distant metastases were randomised to either conventional fractionation (2 Gy/day, 5 days/week in 49 days, total dose 68 Gy) or accelerated fractionation (1.1+2.0 Gy/day, 5 days/week in 35 days, total dose 68 Gy). HRQoL was assessed with EORTC QLQ-C30, QLQ-H&N35 and HADS at baseline, at end of radiotherapy (eRT) and at 3 and 6 months and 1, 2 and 5 years after start of treatment. The AF group reported HRQoL was significantly lower at eRT and at 3 months for most symptoms, scales and functions. Few significant differences were noted between the groups at 6 months and 5 years. Scores related to functional oral intake never reached baseline. In comparison to CF, AF has a stronger adverse effect on HRQoL in the acute phase. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

PubMed Central

Delforge, Michel; Minuk, Leonard; Eisenmann, Jean-Claude; Arnulf, Bertrand; Canepa, Letizia; Fragasso, Alberto; Leyvraz, Serge; Langer, Christian; Ezaydi, Yousef; Vogl, Dan T.; Giraldo-Castellano, Pilar; Yoon, Sung-Soo; Zarnitsky, Charles; Escoffre-Barbe, Martine; Lemieux, Bernard; Song, Kevin; Bahlis, Nizar Jacques; Guo, Shien; Monzini, Mara Silva; Ervin-Haynes, Annette; Houck, Vanessa; Facon, Thierry

2015-01-01

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients’ health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide. PMID:25769541

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.

PubMed

Delforge, Michel; Minuk, Leonard; Eisenmann, Jean-Claude; Arnulf, Bertrand; Canepa, Letizia; Fragasso, Alberto; Leyvraz, Serge; Langer, Christian; Ezaydi, Yousef; Vogl, Dan T; Giraldo-Castellano, Pilar; Yoon, Sung-Soo; Zarnitsky, Charles; Escoffre-Barbe, Martine; Lemieux, Bernard; Song, Kevin; Bahlis, Nizar Jacques; Guo, Shien; Monzini, Mara Silva; Ervin-Haynes, Annette; Houck, Vanessa; Facon, Thierry

2015-06-01

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide. Copyright© Ferrata Storti Foundation.

Quality of life, lifestyle behavior and employment experience: a comparison between young and midlife survivors of gynecology early stage cancers.

PubMed

Bifulco, G; De Rosa, N; Tornesello, M L; Piccoli, R; Bertrando, A; Lavitola, G; Morra, I; Di Spiezio Sardo, A; Buonaguro, F M; Nappi, C

2012-03-01

To evaluate differences and changes in quality of life (QoL), lifestyle behavior and employment experience of young in comparison to midlife adults in response to early stage gynecologic cancer diagnoses. 263 patients, divided into two age groups (Group A: ≤ 45 and Group B: >45 years), were interviewed on their QoL, lifestyle behavior (dietary habits, tobacco and alcohol use, physical activity) and employment experience (employment status and working time) at diagnosis and within 4 years from the treatment. The QoL was evaluated by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) and its specific modules for each cancer type (in particular endometrium, cervix, ovarian and breast). Global health status was significantly different between the two groups. In the younger age group a more relevant cancer interference on family life and social activities and a greater impact on perception of health status have been observed. Young women were more affected by fatigue, constipation, gastrointestinal symptoms, lymphedema, poor body image and impaired sexuality. Cancer diagnosis had a major negative impact on employment of younger patients. Conversely, younger patients had overall better health behavior. They reported a higher daily intake of fruits and vegetables, along with lower alcohol consumption, furthermore they were a little more physically active than midlife adults. To enhance quality of life and to promote healthy lifestyle behavior of female cancer patients, particularly in younger age, it is essential to assure multidisciplinary approaches with specific medical intervention and psychosocial supports. Indeed, midlife adults seem to have a more rapid adaptive tendency to return towards levels of well-being, following cancer diagnosis and treatment, than younger patients. Copyright © 2011 Elsevier Inc. All rights reserved.

A Feasibility Study of Moxibustion for Treating Anorexia and Improving Quality of Life in Patients With Metastatic Cancer: A Randomized Sham-Controlled Trial.

PubMed

Jeon, Ju-Hyun; Cho, Chong-Kwan; Park, So-Jung; Kang, Hwi-Joong; Kim, Kyungmin; Jung, In-Chul; Kim, Young-Il; Lee, Suk-Hoon; Yoo, Hwa-Seung

2017-03-01

The aim of this study was to determine the feasibility, acceptability, and safety of using moxibustion for treating anorexia and improving quality of life in patients with metastatic cancer. We conducted a randomized sham-controlled trial of moxibustion. Sixteen patients with metastatic cancer were recruited from Daejeon, South Korea. The patients were randomly placed into a true or a sham moxibustion group and received 10 true or sham moxibustion treatments administered to the abdomen (CV12, CV8, CV4) and legs (ST36) over a 2-week period. Outcome measures included interest in participating in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with the treatment plan (ie, attendance at treatment sessions). Clinical outcomes included results of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), answers on the European Organization for Research and Treatment of Cancer 30-item core quality of life (EORTC QLQ-C30) questionnaires, scores on the visual analogue scale (VAS), and the results from blood tests and a safety evaluation. Moxibustion was an acceptable intervention in patients with metastatic cancer. Compliance with the treatment protocol was high, with 11 patients completing all 10 treatments. No serious adverse events related to moxibustion occurred, but 4 patients in the true moxibustion group reported mild rubefaction, which disappeared in a few hours. This study suggests that moxibustion may be safely used to treat anorexia and improve quality of life in patients with metastatic cancer. However, further research is needed to confirm this result.

Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: Health-related quality of life final analysis from the Florence phase 3 trial.

PubMed

Meattini, Icro; Saieva, Calogero; Miccinesi, Guido; Desideri, Isacco; Francolini, Giulio; Scotti, Vieri; Marrazzo, Livia; Pallotta, Stefania; Meacci, Fiammetta; Muntoni, Cristina; Bendinelli, Benedetta; Sanchez, Luis Jose; Bernini, Marco; Orzalesi, Lorenzo; Nori, Jacopo; Bianchi, Simonetta; Livi, Lorenzo

2017-05-01

Accelerated partial breast irradiation (APBI) represents a valid option for selected early breast cancer (BC). We recently published the 5-year results of the APBI-IMRT-Florence phase 3 randomised trial (NCT02104895), showing a very low rate of disease failure, with acute and early-late toxicity in favour of APBI. We present the early and 2-year follow-up health-related quality of life (HRQoL) results. Eligible patients were women aged more than 40 years with early BC suitable for breast-conserving surgery. APBI consisted of 30 Gy in five fractions delivered with IMRT technique. Standard whole breast irradiation (WBI) consisted of 50 Gy in 25 fractions plus a 10 Gy in five fractions boost on tumour bed. A total of 520 patients were enrolled in the phase 3 trial. Overall, 205 patients (105 APBI and 100 WBI) fully completed all the given questionnaires and were therefore included in the present analysis. As HRQoL assessment, patients were asked to complete the European Organisation for Research and Treatment of Cancer QLQ-C30, and the BR23 questionnaires at the beginning (T0), at the end (T1) and after 2 years from radiation (T2). No significant difference between the two arms at QLQ-C30 and BR23 scores emerged at T0. Global health status (p = 0.0001), and most scores of the functional and symptom scales of QLQ-C30 at T1 showed significant differences in favour of the APBI arm. Concerning the BR23 functional and symptom scales, the body image perception, future perspective and breast and arm symptoms were significantly better in the APBI group. Similar significant results emerged at T2: significant differences in favour of APBI emerged for GHS (p = 0.0001), and most functional and symptom QLQ-C30 scales. According to QLQ-BR23 module, among the functional scales, the body image perception and the future perspective were significantly better in the APBI group (p = 0.0001), whereas among the symptom scales significant difference emerged by breast and arm symptoms with better outcomes in APBI arm (p < 0.01). Early BC treated with APBI showed an improved short-term, and 2-year follow-up HRQoL outcome as compared with WBI. Early BC treated with APBI showed an improved short-term, and 2-year follow-up HRQoL outcome as compared with WBI. APBI should be strongly considered in the treatment choice for selected low-risk patients. Mature local control results from ongoing adequately powered randomised trials are awaited. Copyright © 2017 Elsevier Ltd. All rights reserved.

Parotid Gland Sparing With Helical Tomotherapy in Head-and-Neck Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Voordeckers, Mia, E-mail: mia.voordeckers@uzbrussel.be; Farrag, Ashraf; Assiut University

Purpose: This study evaluated the ability of helical tomotherapy to spare the function of the parotid glands in patients with head-and-neck cancer by analyzing dose-volume histograms, salivary gland scintigraphy, and quality of life assessment. Methods and Materials: Data from 76 consecutive patients treated with helical tomotherapy (Hi-Art Tomotherapy) at University Hospital Brussel were analyzed. During planning, priority was given to planning target volume (PTV) coverage: {>=}95% of the dose must be delivered to {>=}95% of the PTV. Elective nodal regions received 54 Gy (1.8 Gy/fraction). A dose of 70.5 Gy (2.35 Gy/fraction) was prescribed to the primary tumor and pathologicmore » lymph nodes (simultaneous integrated boost scheme). Objective scoring of salivary excretion was performed by salivary gland scintigraphy. Subjective scoring of salivary gland function was evaluated by the European Organization for Research and Treatment of Cancer quality of life questionnaires Quality of Life Questionnaire-C30 (QLQ-C30) and Quality of Life Questionnaire-Head and Neck 35 (H and N35). Results: Analysis of dose-volume histograms (DVHs) showed excellent coverage of the PTV. The volume of PTV receiving 95% of the prescribed dose (V95%) was 99.4 (range, 96.3-99.9). DVH analysis of parotid gland showed a median value of the mean parotid dose of 32.1 Gy (range, 17.5-70.3 Gy). The median parotid volume receiving a dose <26 Gy was 51.2%. Quality of life evaluation demonstrated an initial deterioration of almost all scales and items in QLQ-C30 and QLQ-H and N35. Most items improved in time, and some reached baseline values 18 months after treatment. Conclusion: DVH analysis, scintigraphic evaluation of parotid function, and quality of life assessment of our patient group showed that helical tomotherapy makes it possible to preserve parotid gland function without compromising disease control. We recommend mean parotid doses of <34 Gy and doses <26 Gy to a maximum 47% of the parotid volume as planning goals. Intensity-modulated radiotherapy should be considered as standard treatment in patients with head-and-neck cancer.« less

Pilot-testing the French version of a provisional European organisation for research and treatment of cancer (EORTC) measure of spiritual well-being for people receiving palliative care for cancer.

PubMed

Lucette, A; Brédart, A; Vivat, B; Young, T

2014-03-01

Spiritual well-being is increasingly recognised as an important aspect of patients' quality of life when living with a potentially life-limiting illness such as cancer. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a measure for assessing spiritual well-being cross-culturally for people receiving palliative care for cancer. The pilot-testing phase of the study explored potential problems related to the content and administration of a provisional version of this measure. The French version was pilot-tested with 12 patients in a palliative and supportive day care unit in Paris. Participants were asked to complete the measure and the EORTC QLQ-C15-PAL before being interviewed about their responses. The administration of the measure enabled participants to express the difficulties and existential concerns they experienced. The items were not considered intrusive, despite the sensitive topic of the measure. This article considers difficulties with items pertaining to 'religion' and 'spirituality' in the context of French culture. Overall, this measure appears to enhance holistic care, by providing caregivers with a means of broaching spirituality issues, a topic otherwise difficult to discuss in the context of palliative care. © 2013 John Wiley & Sons Ltd.

The Association Between Pain and Quality of Life for Patients With Cancer in an Outpatient Clinic, an Inpatient Oncology Ward, and Inpatient Palliative Care Units.

PubMed

Mikan, Fukiko; Wada, Makoto; Yamada, Michiko; Takahashi, Ayaka; Onishi, Hideki; Ishida, Mayumi; Sato, Kazuki; Shimizu, Sachiko; Matoba, Motohiro; Miyashita, Mitsunori

2016-09-01

This study was designed to clarify the association between pain and quality of life (QOL) of Japanese patients with cancer using a cancer-specific QOL scale (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C15-PAL) in 3 care settings (outpatient, inpatient, and palliative care units [PCUs]). We examined the above-mentioned purpose for the total of 404 patients. In outpatients, physical, emotional functioning (EF), and global health status/QOL (QL item) were significantly correlated with average pain, and their correlation coefficients were -0.37 to -0.46 (P < .0001). In inpatients, they were -0.33 (P = .006), -0.26 (P = .030), and -0.31 (P = .012). In the PCU patients, they were -0.12 (P = .316), -0.30 (P = .009), and -0.28 (P = .015). Patients' pain had an association with physical and emotional QOL, and the association was smaller in the PCU patients than the others. © The Author(s) 2016.

Quality of life in women following various surgeries of body manipulation: organ transplantation, mastectomy, and breast reconstruction.

PubMed

Pérez-San-Gregorio, M Angeles; Fernández-Jiménez, Eduardo; Martín-Rodríguez, Agustín; Borda-Más, Mercedes; Rincón-Fernández, M Esther

2013-09-01

This study aimed to determine biopsychosocial differences (anxious-depressive symptomatology and quality of life) among three groups of patients who underwent surgical interventions related to body manipulation, as well as to assess the clinical significance of these results versus reference values. Four groups were compared: women who underwent organ transplant (n = 26), mastectomy for breast cancer (n = 36), breast reconstruction (n = 36), and general population (n = 608). The Hospital Anxiety and Depression Scale and the EORTC QLQ-C30 were used. Women who underwent mastectomy showed the highest anxious-depressive symptomatology and quality-of-life impairment in comparison to the remaining groups, and they also displayed the most clinically significant deterioration in the majority of dimensions (large effect sizes). In contrast, the group with implantation of a healthy organ (transplantation) only showed higher biopsychosocial impairment than the group with reconstruction of an organ (breast reconstruction) in gastrointestinal dysfunctions and in the global self-perception of health.

Attachment orientations of Greek cancer patients in palliative care. A validation study of the Experiences in Close Relationships scale (ECR-M16).

PubMed

Tsilika, Eleni; Parpa, Efi; Galanopoulou, Natasa; Gennimata, Vasiliki; Mosa, Eftychia; Galanos, Antonis; Mystakidou, Kyriaki

2016-01-01

Health-care professionals may serve as attachment figures, nevertheless little research has been made in the palliative context. The psychometric properties of the brief ECR-M16 in Greek cancer patients were explored. The ECR-M16 was translated into Greek (G-ECR-M16), and was administered to 100 patients before starting palliative care and 7 days later to test its stability. Patients (N=35) also completed the EORTC QLQ-C30 scales. Cronbach's alphas for the discomfort for closeness, anxiety and avoidance scales were 0.871, 0.762, and 0.761, respectively. Test-retest reliability was very satisfactory (p< 0.0005). Factor analysis yielded three factors (58.75% of the variance). Known-groups validity showed that discomfort with closeness had a statistically significant correlation with advanced disease stage (p=0.022). The G-ECR-M16 is a valid research tool for the attachment patterns' impact in Greek cancer patients.

Impact of cancer anorexia-cachexia syndrome on health-related quality of life and resource utilisation: A systematic review.

PubMed

Tarricone, Rosanna; Ricca, Giada; Nyanzi-Wakholi, Barbara; Medina-Lara, Antonieta

2016-03-01

Cancer anorexia-cachexia syndrome (CACS) negatively impacts patients' quality of life (QoL) and increases the burden on healthcare resources. To review published CACS data regarding health-related QOL (HRQoL) and its economic impact on the healthcare system. Searches were conducted in MEDLINE, EMBASE, DARE, and NHS EED databases. A total of 458 HRQoL and 189 healthcare resources utilisation abstracts were screened, and 42 and 2 full-text articles were included, respectively. The EORTC QLQ-C30 and FAACT instruments were most favoured for assessing HRQOL but none of the current tools cover all domains affected by CACS. Economic estimates for managing CACS are scarce, with studies lacking a breakdown of healthcare resource utilisation items. HRQoL instruments that can better assess and incorporate all the domains affected by CACS are required. Rigorous assessment of costs and benefits of treatment are needed to understand the magnitude of the impact of CACS. Copyright © 2016. Published by Elsevier Ireland Ltd.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

PubMed

Dueck, Amylou C; Mendoza, Tito R; Mitchell, Sandra A; Reeve, Bryce B; Castro, Kathleen M; Rogak, Lauren J; Atkinson, Thomas M; Bennett, Antonia V; Denicoff, Andrea M; O'Mara, Ann M; Li, Yuelin; Clauser, Steven B; Bryant, Donna M; Bearden, James D; Gillis, Theresa A; Harness, Jay K; Siegel, Robert D; Paul, Diane B; Cleeland, Charles S; Schrag, Deborah; Sloan, Jeff A; Abernethy, Amy P; Bruner, Deborah W; Minasian, Lori M; Basch, Ethan

2015-11-01

To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Early whole brain radiotherapy in primary CNS lymphoma: negative impact on quality of life in the randomized G-PCNSL-SG1 trial.

PubMed

Herrlinger, Ulrich; Schäfer, Niklas; Fimmers, Rolf; Griesinger, Frank; Rauch, Michael; Kirchen, Heinz; Roth, Patrick; Glas, Martin; Bamberg, Michael; Martus, Peter; Thiel, Eckhard; Korfel, Agnieszka; Weller, Michael

2017-09-01

In the randomized G-PCNSL-SG-1 trial, the addition of whole brain radiotherapy (45 Gy) to high-dose methotrexate (HD-MTX)-based chemotherapy (early WBRT arm) did not prolong overall survival (OS) as compared to HD-MTX-based chemotherapy alone (no early WBRT arm) in primary CNS lymphoma (PCNSL) patients. To determine whether WBRT might lead to quality of life (QoL)-relevant late neurotoxicity, this trial prospectively monitored QoL. QoL measurements were performed using the EORTC-QLQ-C30 and BN20 questionnaires and combined with repeated Mini Mental State Examinations (MMSE). Exploratory data analysis included the 318 patients in the per-protocol population. In year 2 after randomization, cognitive functioning and global health status were reduced in the early WBRT arm as compared to the no early WBRT arm (p = 0.004 and p = 0.022, respectively). Also, fatigue (p = 0.037), appetite loss (p = 0.006) and hair loss (p = 0.002) were more intense in the early WBRT arm. MMSE testing revealed lower values (p = 0.002) in the early WBRT arm. A mixed model analysis of longitudinal data additionally showed differences favoring the no early WBRT arm in 15 of 26 dimensions of QoL. The analysis of subjective QoL questionnaires and objective MMSE testing revealed that QoL and cognition were conserved in the arm without early WBRT. Thus, even though it was an exploratory analysis, the results of G-PCNSL-SG1 challenge the place of WBRT in the primary therapy of PCNSL.

Systematic review and meta-analysis of non RCT's on health related quality of life after radical cystectomy using validated questionnaires: Better results with orthotopic neobladder versus ileal conduit.

PubMed

Cerruto, M A; D'Elia, C; Siracusano, S; Gedeshi, X; Mariotto, A; Iafrate, M; Niero, M; Lonardi, C; Bassi, P; Belgrano, E; Imbimbo, C; Racioppi, M; Talamini, R; Ciciliato, S; Toffoli, L; Rizzo, M; Visalli, F; Verze, P; Artibani, W

2016-03-01

The current literature on the impact of different urinary diversions on patients' health related quality of life (HR-QoL) showed a marginally better quality of life scores of orthotopic neobladder (ONB) compared to ileal conduit (IC). The aim of this study was to update the review of all relevant published studies on the comparison between ONB and IC. Studies were identified by searching multiple literature databases, including MEDLINE, CINAHL, the Cochrane Library, PubMed Data were synthesized using meta-analytic methods conformed to the PRISMA statement. The current meta-analysis was based on 18 papers that reported a HR-QoL comparison between IC and ONB using at least a validate questionnaire. Pooled effect sizes of combined QoL outcomes for IC versus ONB showed a slight, but not significant, better QoL in patients with ONB (Hedges' g = 0.150; p = 0.066). Patients with ileal ONB showed a significant better QoL than those with IC (Hedges' g = 0.278; p = 0.000); in case series with more than 65% males, ONB group showed a slight significant better QoL than IC (Hedges' g = 0.190; p = 0.024). Pooled effects sizes of all EORTC-QLQ-C30 aspects showed a significant better QoL in patients with ONB (Hedges' g = 0.400; p = 0.0000). This meta-analysis of not-randomized comparative studies on the impact of different types of urinary diversions on HR-QoL showed demonstrated a significant advantage of ileal ONB compared to IC in terms of HR-QoL. Copyright © 2015 Elsevier Ltd. All rights reserved.

The impact of prostate cancer diagnosis and treatment decision-making on health-related quality of life before treatment onset.

PubMed

Cuypers, Maarten; Lamers, Romy E D; Cornel, Erik B; van de Poll-Franse, Lonneke V; de Vries, Marieke; Kil, Paul J M

2018-04-01

The objective of this study is to test if patients' health-related quality of life (HRQoL) declines after prostate biopsy to detect Pca, and after subsequent treatment decision-making in case Pca is confirmed, and to test whether personality state and traits are associated with these potential changes in HRQoL. Patients who were scheduled for prostate biopsy to detect Pca (N = 377) filled out a baseline questionnaire about HRQoL (EORTC QLQ-C30 and PR25), "big five" personality traits (BFI-10), optimism (LOT-r), and self-efficacy (Decision Self-efficacy Scale) (t0). Patients with confirmed Pca (N = 126) filled out a follow-up questionnaire on HRQoL within 2 weeks after treatment was chosen but had not yet started (t1). HRQoL declined between t0 and t1, reflected in impaired role and cognitive functioning, and elevated fatigue, constipation, and prostate-specific symptoms. Sexual activity and functioning improved. Baseline HRQoL scores were unrelated to the selection of a particular treatment, but for patients who chose a curative treatment, post-decision HRQoL showed a greater decline compared to patients who chose active surveillance. Optimism was associated with HRQoL at baseline; decisional self-efficacy was positively associated with HRQoL at follow-up. No associations between HRQoL and the "big five" personality traits were found. Patients who have undergone prostate biopsy and treatment decision-making for Pca experience a decline in HRQoL. Choosing treatment with a curative intent was associated with greater decline in HRQoL. Interventions aimed at optimism and decision self-efficacy could be helpful to reduce HRQoL impairment around the time of prostate biopsy and treatment decision-making.

Long-term Quality of Life After Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy for Pseudomyxoma Peritonei: A Prospective Longitudinal Study.

PubMed

Stearns, Adam T; Malcomson, Lee; Punnett, Grant; Abudeeb, Haytham; Aziz, Omer; Selvasekar, Chelliah R; Fulford, Paul E; Wilson, Malcolm S; Renehan, Andrew G; O'Dwyer, Sarah T

2018-04-01

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are an established treatment for pseudomyxoma peritonei (PMP), but it is a major surgical procedure and may be associated with long-term morbidity. To date, health-related quality-of-life (HRQL) data among survivors are lacking. A two-period qualitative study investigated patients undergoing CRS-HIPEC for PMP at a national peritoneal tumor center between 2003 and 2011. First, the European Organization for Research and Treatment (EORTC)-QLQ C30 HRQL questionnaire was used longitudinally preoperatively and at postoperative months 3, 6, 9, 12, 18, and 24, then yearly thereafter. Second, it was updated in 2016 as a cross-sectional study. Both studies were compared with age- and sex-matched reference populations (one-way t tests). A total of 553 longitudinal HRQL questionnaires were completed for 137 patients, truncated at 60 months. In the 2016 update, 85 responses were received from 103 survivors (mean follow-up period, 8.11 years). Patients' physical, role, and social function scores were impaired until 12 months postoperatively, after which the scores did not differ significantly from those of with reference populations. Similarly, fatigue, appetite loss, insomnia, and financial difficulties worsened significantly compared with reference populations in the first 12-months and then normalized. In contrast, impaired cognitive function (82.3 vs 88.5; P = 0.017), constipation (13.7 vs 7.3; P = 0.032), and diarrheal symptoms (15.1 vs 4.9; P = 0.0006) persisted through both periods. Global health scores did not differ significantly from those of the reference population. Beyond 12 months postoperatively, CRS-HIPEC for PMP is associated with a good quality of life except for some cognitive functional impairment and bowel disturbances.

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

PubMed

García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

2018-01-08

Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

Does quality of life impact the decision to pursue stem cell transplantation for elderly patients with advanced MDS?

PubMed

El-Jawahri, A; Kim, H T; Steensma, D P; Cronin, A M; Stone, R M; Watts, C D; Chen, Y-B; Cutler, C S; Soiffer, R J; Abel, G A

2016-08-01

The factors that influence utilization of reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (HCT) among medically fit older patients with advanced myelodysplastic syndromes (MDS) are largely unknown. The MDS Transplant-Associated Outcomes (MDS-TAO) study is an ongoing prospective observational study at the Dana-Farber Cancer Institute and Massachusetts General Hospital that enrolls transplant-eligible fit patients aged 60-75 years with advanced MDS and follows them through RIC HCT vs non-HCT treatment. In this analysis of 127 patients enrolled from May 2011 to June 2014, we examined the influence of age, gender, cytogenetics, International Prognostic Scoring System (IPSS) category, performance status, distance from HCT center and baseline patient-reported quality of life (QOL) from the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) on the likelihood of receiving RIC HCT using competing risk regression modeling. With a median follow-up of 16 months, 44 patients (35%) had undergone RIC HCT. In multivariable analyses, age (hazard ratio (HR) 0.87 per year, 95% confidence interval (CI): 0.81-0.92, P<0.001) and higher IPSS (intermediate-2/high; HR 2.29, 95% CI: 1.25-4.19, P=0.007) were significantly predictive of receipt of RIC HCT; neither global QOL score nor any QOL subscales scores were predictive. These data suggest that baseline patient-reported QOL has little influence on the decision to undergo RIC HCT for older patients with advanced MDS.

The influence of simultaneous integrated boost, hypofractionation and oncoplastic surgery on cosmetic outcome and PROMs after breast conserving therapy.

PubMed

Lansu, J T P; Essers, M; Voogd, A C; Luiten, E J T; Buijs, C; Groenendaal, N; Poortmans, P M H

2015-10-01

We retrospectively investigated the possible influence of a simultaneous integrated boost (SIB), hypofractionation and oncoplastic surgery on cosmetic outcome in 125 patients with stage I-II breast cancer treated with breast conserving therapy (BCT). The boost was given sequentially (55%) or by SIB (45%); fractionation was conventional (83%) or hypofractionated (17%); the surgical technique was a conventional lumpectomy (74%) or an oncoplastic technique (26%). We compared cosmetic results subjectively using a questionnaire independently completed by the patient and by the physician and objectively with the BCCT.core software. Independent-samples T-tests were used to compare outcome in different groups. Patients also completed the EORTC QLQ C30 and BR23. Univariate analyses indicated no significant differences of the cosmetic results (P ≤ 0.05) for the type of boost or fractionation. However, the conventional lumpectomy group scored significantly better than the oncoplastic group in the BCCT.core evaluation, without a significant difference in the subjective cosmetic evaluation. Quality of life outcome was in favour of SIB, hypofractionation and conventional surgery. Our study indicates that the current RT techniques seem to be safe for cosmetic outcome and quality of life. Further investigation is needed to verify the possible negative influence of oncoplastic surgery on the cosmetic outcome and the quality of life as this technique is especially indicated for patients with an unfavourable tumour/breast volume ratio. Copyright © 2015 Elsevier Ltd. All rights reserved.

Quality of life in patients with muscle invasive and non-muscle invasive bladder cancer.

PubMed

Singer, S; Ziegler, C; Schwalenberg, T; Hinz, A; Götze, H; Schulte, T

2013-05-01

Compared to the literature on other malignancies, data on quality of life (QoL) in bladder cancer are sparse. This study sought answers to the following questions: In what QoL domains do patients with bladder cancer differ from the general population? Do patients with radical cystectomy differ in QoL compared to those who received conservative treatment? Do patients with neobladder generally have better QoL compared to patients with other diversion methods? At the beginning of inpatient rehabilitation, N = 823 patients with bladder cancer were assessed. Data of a representative community sample (N = 2037) were used for comparison. The questionnaire EORTC QLQ-C30 was used to measure QoL. Multivariate linear regression models were computed to investigate differences between groups. Patients with both non-muscle invasive and muscle invasive bladder cancer reported significantly more problems and worse functioning than the general population. Radiotherapy is associated with clinically relevant more pain, dyspnoea, constipation, appetite loss and decreased social functioning while chemotherapy is associated more with dyspnoea. Cystectomy patients reported more fatigue, appetite loss and decreased role functioning. Male patients ≥70 years with conduit experienced more sleep and emotional problems. These effects of urinary diversion were not observed in women and younger patients. Patients with bladder cancer experience various QoL concerns at the beginning of inpatient rehabilitation. These problems can partly be explained by the type of treatment the patients receive. Type of urinary diversion is relevant for QoL in subgroups of patients.

Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma – a randomized, controlled pilot study

PubMed Central

2012-01-01

Background Mistletoe (Viscum album L.) extracts are widely used in complementary cancer therapy. Aim of this study was to evaluate safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer. Patients and Methods 32 operated gastric cancer patients (stage Ib or II) who were waiting for oral chemotherapy with the 5-FU prodrug doxifluridine were randomized 1:1 to receive additional therapy with aVQ or no additional therapy. aVQ was injected subcutaneously three times per week from postoperative day 7 to week 24 in increasing doses. EORTC QLQ-C30 and -STO22 Quality of Life questionnaire, differential blood count, liver function tests, various cytokine levels (tumor necrosis factor (TNF)-alpha, interleukin (IL)-2), CD 16+/CD56+ and CD 19+ lymphocytes were analyzed at baseline and 8, 16 and 24 weeks later. Results Global health status (p <0.01), leukocyte- and eosinophil counts (p ≤0.01) increased significantly in the treatment group compared to the control group. Diarrhea was less frequently reported (7% vs. 50%, p=0.014) in the intervention group. There was no significant treatment effect on levels of TNF-alpha, IL-2, CD16+/CD56+ and CD 19+ lymphocytes and liver function tests measured by ANOVA. Conclusion Additional treatment with aVQ is safe and was associated with improved QoL of gastric cancer patients. ClinicalTrials.Gov Registration number NCT01401075. PMID:23033982

Quality of life and toxicity in breast cancer patients using adjuvant TAC (docetaxel, doxorubicin, cyclophosphamide), in comparison with FAC (doxorubicin, cyclophosphamide, 5-fluorouracil).

PubMed

Hatam, N; Ahmadloo, N; Ahmad Kia Daliri, A; Bastani, P; Askarian, M

2011-07-01

The aim of this study was to compare two regimens of chemotherapy in patients with breast cancer, including FAC (doxorubicin, cyclophosphamide, and 5-fluorouracil) and TAC (docetaxel, doxorubicin and cyclophosphamide); and analyze the toxicity of these treatments and observe patient's health-related quality of life. Health-related quality of life was assessed for up to 4 months (from the beginning to the end of chemotherapy cycles), using European organization and cancer treatment quality of life questionnaire (EORTC) QLQ-C30. A group of 100 patients, with node-positive breast cancer were studied in order to compare the toxicity of adjuvant therapy TAC with FAC and the subsequent effects on the patient's quality of life. After a 4-month follow-up of patients, our findings showed that despite having the same mean score of QOL at the start of adjuvant chemotherapy, the QOL in TAC arm was decreased more as a result of the higher range of toxicity in TAC regimen. In spite of increase in disease-free patients who received TAC regimen and increase their survival rate, there is significant toxicity and decrease in QOL in TAC protocol compare to FAC protocol. Using prophylactic granulocyte colony stimulating factor (G-CSF) along with increased education aimed at improving patient's knowledge and also the provision of a supportive group involving psychiatrics and patients that have successfully experienced the same treatment may be helpful.

Quality of life after cancer-How the extent of impairment is influenced by patient characteristics.

PubMed

Peters, Elisabeth; Mendoza Schulz, Laura; Reuss-Borst, Monika

2016-10-10

Although this effect is well known, tailored treatment methods have not yet been broadly adopted. The aim of this study was to identify those patient characteristics that most influence the impairment of quality of life and thus to identify those patients who need and can benefit most from specific intervention treatment. 1879 cancer patients were given the EORTC QLQ C-30 questionnaire at the beginning and end of their inpatient rehabilitation. Patients' scores were compared to those of 2081 healthy adults (Schwarz and Hinz, Eur J Cancer 37:1345-1351, 2001). Furthermore, differences in quality of life corresponding to sex, age, tumor site, TNM stage, interval between diagnosis and rehabilitation, and therapy method were examined. Compared to the healthy population, the study group showed a decreased quality of life in all analyzed domains. This difference diminished with increasing age. Women reported a lower quality of life then men in general. Patients with prostate cancer showed the least impairment in several domains. Patients having undergone chemotherapy as well as radiotherapy were impaired the most. Surprisingly, TNM stage and interval between diagnosis and rehabilitation did not significantly influence quality of life. Global quality of life and all functional domains significantly improved after a 3-week rehabilitation program. Despite an individualized and increasingly better tolerable therapy, the quality of life of cancer patients is still considerably impaired. However, systematic screening of psychosocial aspects of cancer, e.g. quality of life, could enable improved intervention.

Weight loss and quality of life in patients surviving 2 years after gastric cancer resection.

PubMed

Climent, M; Munarriz, M; Blazeby, J M; Dorcaratto, D; Ramón, J M; Carrera, M J; Fontane, L; Grande, L; Pera, M

2017-07-01

Malnutrition is common in patients undergoing gastric cancer resection, leading to weight loss, although little is known about how this impacts on health-related quality of life (HRQL). This study aimed to explore the association between HRQL and weight loss in patients 2 years after curative gastric cancer resection. Consecutive patients undergoing curative gastric cancer resection and surviving at least 2 years without disease recurrence were recruited. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the specific module for gastric cancer (STO22) before and 2 years postoperatively and associations between HRQL scores and patients with and without ≥ 10% body weight loss (BWL) were examined. A total of 76 patients were included, of whom 51 (67%) had BWL ≥10%. At 2 years postoperatively, BWL ≥10% was associated with deterioration of all functional aspects of quality of life, with persistent pain (21.6%), diarrhoea (13.7%) and nausea/vomiting (13.7%). By contrast, none of the patients with BWL <10% experienced severe nausea/vomiting, pain or diarrhoea. Disabling symptoms occurred more frequently in patients with ≥10% BWL than in those with <10% BWL, with a relevant negative impact on HRQL. A cause-effect relationship between weight loss and postoperative outcome remains unsolved. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Iyengar-Yoga Compared to Exercise as a Therapeutic Intervention during (Neo)adjuvant Therapy in Women with Stage I-III Breast Cancer: Health-Related Quality of Life, Mindfulness, Spirituality, Life Satisfaction, and Cancer-Related Fatigue.

PubMed

Lötzke, Désirée; Wiedemann, Florian; Rodrigues Recchia, Daniela; Ostermann, Thomas; Sattler, Daniel; Ettl, Johannes; Kiechle, Marion; Büssing, Arndt

2016-01-01

This study aims to test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with breast cancer. In a randomized controlled trial 92 women with breast cancer undergoing oncological treatment were randomly enrolled for a yoga intervention (YI) (n = 45) or for a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t 0) and after the intervention (t 1) as well as 3 months after finishing intervention (t 2) using standardized questionnaires. Life satisfaction and fatigue improved under PEI (p < 0.05) but not under YI (t 0 to t 2). Regarding quality of life (EORTC QLQ-C30) a direct effect (t 0 to t 1; p < 0.001) of YI was found on role and emotional functioning, while under PEI only emotional functioning improved. Significant improvements (p < 0.001) were observed at both t 1 and t 2 also for symptom scales in both groups: dyspnea, appetite loss, constipation, and diarrhea. There was no significant difference between therapies for none of the analyzed variables neither for t 1 nor for t 2. During chemotherapy, yoga was not seen as more helpful than conventional therapeutic exercises. This does not argue against its use in the recovery phase.

Iyengar-Yoga Compared to Exercise as a Therapeutic Intervention during (Neo)adjuvant Therapy in Women with Stage I–III Breast Cancer: Health-Related Quality of Life, Mindfulness, Spirituality, Life Satisfaction, and Cancer-Related Fatigue

PubMed Central

Lötzke, Désirée; Wiedemann, Florian; Rodrigues Recchia, Daniela; Ostermann, Thomas; Sattler, Daniel; Ettl, Johannes; Kiechle, Marion; Büssing, Arndt

2016-01-01

This study aims to test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with breast cancer. In a randomized controlled trial 92 women with breast cancer undergoing oncological treatment were randomly enrolled for a yoga intervention (YI) (n = 45) or for a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t 0) and after the intervention (t 1) as well as 3 months after finishing intervention (t 2) using standardized questionnaires. Life satisfaction and fatigue improved under PEI (p < 0.05) but not under YI (t 0 to t 2). Regarding quality of life (EORTC QLQ-C30) a direct effect (t 0 to t 1; p < 0.001) of YI was found on role and emotional functioning, while under PEI only emotional functioning improved. Significant improvements (p < 0.001) were observed at both t 1 and t 2 also for symptom scales in both groups: dyspnea, appetite loss, constipation, and diarrhea. There was no significant difference between therapies for none of the analyzed variables neither for t 1 nor for t 2. During chemotherapy, yoga was not seen as more helpful than conventional therapeutic exercises. This does not argue against its use in the recovery phase. PMID:27019663

Phase III study of the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and specific complementary outpatient module (EORTC OUT-PATSAT7).

PubMed

Brédart, A; Anota, A; Young, T; Tomaszewski, K A; Arraras, J I; Moura De Albuquerque Melo, H; Schmidt, H; Friend, E; Bergenmar, M; Costantini, A; Vassiliou, V; Hureaux, J; Marchal, F; Tomaszewska, I M; Chie, W-C; Ramage, J; Beaudeau, A; Conroy, T; Bleiker, E; Kulis, D; Bonnetain, F; Aaronson, N K

2018-01-01

Advances in cancer care delivery require revision and further development of questionnaires assessing patients' perceived quality of care. This study pre-tested the revised EORTC satisfaction with cancer care core questionnaire applicable in both the cancer inpatient and outpatient settings, and its new, outpatient-specific complementary module. The process of revision, development of the extended application, and pre-testing of these questionnaires was based on phases I to III of the "EORTC Quality of Life Group Module Development Guidelines." In phase III, patients in 11 countries in four European regions, South America and Asia completed provisional versions of the questionnaires. Fifty-seven relevant issues selected from literature reviews and input from experts were operationalized into provisional items, and subsequently translated into ten languages. Assessment of understanding, acceptability, redundancy and relevance by patients (n = 151) from oncology inpatient wards, and outpatient chemotherapy, radiotherapy and consultation settings, led to retention of, deletion of and merging of 40, 14 and 6 items respectively. Cronbach's alpha coefficients for hypothesized questionnaire scales were above 0.80. Our results provide preliminary support for the 33-item EORTC Satisfaction with cancer care core questionnaire and the 7-item complementary module specific for the outpatient care setting. A large scale phase IV cross-cultural psychometric study is now underway. © 2017 John Wiley & Sons Ltd.

Adult self-image and well-being after testicular cancer: The role of agency and meaning.

PubMed

Ryan, Sean J; Hoyt, Michael A

2018-08-01

Cancer during young adulthood can limit the extent to which one adopts an adult self-image. However, the relationship of adult self-image to cancer-related adjustment remains unexplored. The current study examines relationships of adult self-image and social/emotional well-being and job-related problems in young testicular cancer survivors. Factors thought to facilitate future-oriented goals (i.e. agency and meaning) are examined as intermediary processes. Testicular cancer survivors (N = 171) between the ages of 18 and 29 completed questionnaire measures of adult self-image, agency, sense of meaning and indicators of adjustment. Social and emotional well-being were measured by the Functional Assessment of Cancer Therapy-General. Job problems were assessed using the EORTC's testicular cancer supplement (EORTC QLQ-TC26). Path model results revealed direct associations of survivors' adult self-image with social (β = .20, p < .05), but not emotional well-being (β = .14, p < .01). Both agency and meaning mediated the relationship of adult self-image and well-being indicators. Finally, the relationship between adult self-image and job problems was only significant for those who were employed or in school (β = -.19, p < .05). Assessment of adult self-image might be useful in identifying risk for poor adjustment. Interventions that target agency and meaning might facilitate developmental goals.

Assessment of the quality of life and sexual functions of patients followed-up for non-muscle invasive bladder cancer: preliminary results of the prospective-descriptive study.

PubMed

Bolat, Deniz; Çelik, Serdar; Aydın, Mehmet Erhan; Aydoğdu, Özgü; Günlüsoy, Bülent; Değirmenci, Tansu; Dinçel, Çetin

2018-03-09

The aim of this study is to evaluate sexual functions and quality life of patients who are followed- up for non-muscle invasive bladder cancer (NMIBC). Between March 2015-June 2016, 50 patients underwent cystoscopy for NMIBC. At the end of the 1 st year follow-up patients were assessed for sexual functions using 5-item version of the International Sexual Function Index (IIEF-5) for male and the Female Sexual Function Index(FSFI) for female; for quality of life (QoL) by the European Organisation for Research and Treatment of Cancer-Non-Muscle Invasiv Bladder Cancer Quality of Life Questionnaire (EORTC QLQ-NMIBC24) and for emotional status by Beck depression inventory. There were 44 male and 6 female patients with the mean age of 57.6±11.5 years. Twenty patients received intravesical treatment after transurethral resection of bladder tumour (TURBT). The mean Beck (10.7±9.5) IIEF-5 (15.6±5.9), FSFI (19.2±10.9), and the EORTC-QLQ NMBIC 24 (38.2±7.7) scores of the patients were determined as indicated. Among the patients, 42 (84%) of them were not feeling bad about their bladder tumors and 37 (74%) were not worrying about their daily lives. Moreover, 12 (24%) patients were not interested with sexuality, while 27 (54%) of them did not feel comfortable about sexual sincerity. Interestingly, 27 patients receiving intravesical treatment were concerned that the treatment they received for prevention of recurrence and progression of bladder tumor infect their partners during sexual intercourse. NMIBC affects patients' sexual functions and QoL negatively. Therefore during the follow-up of these patients, it is important to inform these patients accurately about their treatments to be applied and predicted complications in the follow up period.

Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

PubMed

Costantini, Massimo; Rabitti, Elisa; Beccaro, Monica; Fusco, Flavio; Peruselli, Carlo; La Ciura, Pietro; Valle, Alessandro; Suriani, Cinzia; Berardi, Maria Alejandra; Valenti, Danila; Mosso, Felicita; Morino, Piero; Zaninetta, Giovanni; Tubere, Giorgio; Piazza, Massimo; Sofia, Michele; Di Leo, Silvia; Higginson, Irene J

2016-02-26

There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

Cocreated Smartphone App to Improve the Quality of Life of Adolescents and Young Adults with Cancer (Kræftværket): Protocol for a Quantitative and Qualitative Evaluation

PubMed Central

Elsbernd, Abbey; Hjerming, Maiken; Visler, Camilla; Hjalgrim, Lisa Lyngsie; Niemann, Carsten Utoft; Boisen, Kirsten

2018-01-01

Background Adolescents and young adults with cancer face significant challenges during the course of their medical treatment and recovery from illness. Many adolescents and young adults struggle with long-term complications in the physical, psychosocial, economic, and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of apps on smartphones and tablets. To create a successful mHealth intervention for adolescents and young adults, youth input and feedback is essential. The process of cocreation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for adolescents and young adults with cancer, “Kræftværket.” Objective The objective of this paper is to describe the protocol for the evaluation of the Kræftværket app, a prototype app designed via cocreation, to support and improve health-related quality of life for adolescents and young adults with cancer. Methods The Kræftværket app has three primary features, (1) a symptom and activity diary, (2) a supportive communication network between app users, and (3) a “one-stop shop” information bank with practical information as well as links to patient organizations and other resources. The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 adolescents and young adults aged 15 to 29 years, selected for equal representation amongst age group and treatment status. Patients will be allowed to utilize the app over the course of six weeks and will complete a baseline and follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) health-related quality of life inventory. In addition, participant focus group interviews will be conducted according to a semistructured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample of 50 adolescents and young adults aged 15-29 years selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Results Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. Conclusions It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting adolescents and young adult oncology patients in the digital world. Registered Report Identifier RR1-10.2196/10098 PMID:29748162

Cocreated Smartphone App to Improve the Quality of Life of Adolescents and Young Adults with Cancer (Kræftværket): Protocol for a Quantitative and Qualitative Evaluation.

PubMed

Elsbernd, Abbey; Hjerming, Maiken; Visler, Camilla; Hjalgrim, Lisa Lyngsie; Niemann, Carsten Utoft; Boisen, Kirsten; Pappot, Helle

2018-05-10

Adolescents and young adults with cancer face significant challenges during the course of their medical treatment and recovery from illness. Many adolescents and young adults struggle with long-term complications in the physical, psychosocial, economic, and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of apps on smartphones and tablets. To create a successful mHealth intervention for adolescents and young adults, youth input and feedback is essential. The process of cocreation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for adolescents and young adults with cancer, "Kræftværket." The objective of this paper is to describe the protocol for the evaluation of the Kræftværket app, a prototype app designed via cocreation, to support and improve health-related quality of life for adolescents and young adults with cancer. The Kræftværket app has three primary features, (1) a symptom and activity diary, (2) a supportive communication network between app users, and (3) a "one-stop shop" information bank with practical information as well as links to patient organizations and other resources. The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 adolescents and young adults aged 15 to 29 years, selected for equal representation amongst age group and treatment status. Patients will be allowed to utilize the app over the course of six weeks and will complete a baseline and follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) health-related quality of life inventory. In addition, participant focus group interviews will be conducted according to a semistructured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample of 50 adolescents and young adults aged 15-29 years selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting adolescents and young adult oncology patients in the digital world. RR1-10.2196/10098. ©Abbey Elsbernd, Maiken Hjerming, Camilla Visler, Lisa Lyngsie Hjalgrim, Carsten Utoft Niemann, Kirsten Boisen, Helle Pappot. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.05.2018.

Beneficial Effects of Pranic Meditation on the Mental Health and Quality of Life of Breast Cancer Survivors.

PubMed

Castellar, Juarez I; Fernandes, César A; Tosta, C Eduardo

2014-07-01

Breast cancer survivors frequently present long-lasting impairments, caused either by the disease or its treatment, capable of compromising their emotional health and quality of life. Meditation appears to be a valuable complementary measure for overcoming some of these impairments. The purpose of the present investigation was to assess the effect of pranic meditation on the quality of life and mental health of breast cancer survivors. This study was a prospective single-arm observational study using before and after measurements. The subjects were 75 women submitted either to breast cancer therapy or to posttherapy control who agreed to practice pranic meditation for 20 minutes, twice a day, during 8 weeks, after receiving a formal training. The quality of life of the practitioners was assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC BR-023 questionnaires, and the mental health status by the Goldberg's General Health Questionnaire. After 8 weeks of pranic meditation practice, the subjects showed a significant improvement of their quality of life scores that included physical (P = .0007), role (P = .01), emotional (P = .002), and social functioning (P = .004), as well as global health status (P = .005), fatigue (P < .0001), pain (P = .007), sleep disturbances (P = .01), body image (P = .001), arm symptoms (P = .007), and breast symptoms (P = .002). They also showed a reduction of the side effects of systemic therapy (P = .02) and being upset by hair loss (P = .02). Moreover, meditation was associated with improvement of the mental health parameters of the practitioners that included psychic stress (P = .001), death ideation (P = .02), performance diffidence (P = .001), psychosomatic disorders (P = .02), and severity of mental disorders (P = .0003). The extension of the meditation period from 8 to 15 weeks caused no substantial extra benefits in practitioners. The results of this pilot study showed that breast cancer survivors presented significant benefits related to their mental health and quality of life scores after a short period of practice of pranic meditation, consisting of simple and easy-to-learn exercises. However, because of the limitations of the study, further research is required using a more rigorous experimental design to ascertain whether pranic meditation may be an acceptable adjunct therapy for cancer patients. © The Author(s) 2014.

Fatigue, insomnia and hot flashes after definitive radiochemotherapy and image-guided adaptive brachytherapy for locally advanced cervical cancer: An analysis from the EMBRACE study.

PubMed

Smet, Stéphanie; Pötter, Richard; Haie-Meder, Christine; Lindegaard, Jacob C; Schulz-Juergenliemk, Ina; Mahantshetty, Umesh; Segedin, Barbara; Bruheim, Kjersti; Hoskin, Peter; Rai, Bhavana; Huang, Fleur; Cooper, Rachel; van Limbergen, Erik; Tanderup, Kari; Kirchheiner, Kathrin

2018-04-04

To evaluate the pattern of manifestation of fatigue, insomnia and hot flashes within the prospective, observational, multi-center EMBRACE study. Morbidity was prospectively assessed according to CTCAE v.3 and patient-reported outcome with EORTC QLQ-C30/CX24 at baseline and regular follow-up. Analyses of crude incidence, prevalence rates and actuarial estimates were performed. A total of 1176 patients were analyzed with a median follow-up of 27 months. At baseline, CTCAE G1/G2 prevalence rates for fatigue were 29%/6.2%, for insomnia 18%/3.1% and for hot flashes 7.9%/1.6% with respective 3-year prevalence rates of 29%/6.8%, 17%/4.4% and 19%/5.9%. Similar patterns of manifestation were seen in patient-reported EORTC outcomes. The 3-year actuarial estimates for G ≥ 3 CTCAE fatigue, insomnia and hot flashes were 5.5%, 4.7% and 1.9%. Younger age was associated with significantly higher risk for fatigue, insomnia and hot flashes. Fatigue, insomnia and hot flashes occurred mainly in the mild to moderate range. Fatigue and insomnia were already present before treatment and showed minor fluctuations or recovery during follow-up, whereas hot flashes showed a considerable increase after treatment. More research is needed to evaluate contributing risk factors in order to define intervention strategies. Copyright © 2018 Elsevier B.V. All rights reserved.

Role of original and modified Frey's procedures in chronic pancreatitis.

PubMed

Tan, Chun-Lu; Zhang, Hao; Yang, Min; Li, Shao-Jun; Liu, Xu-Bao; Li, Ke-Zhou

2016-12-21

To retrospectively review patients with chronic pancreatitis (CP) treated with Frey's procedures between January 2009 and January 2014. A retrospective review was performed of patients with CP treated with Frey's procedures between January 2009 and January 2014 in the Department of Pancreatic Surgery. A cross-sectional study of postoperative pain relief, quality of life (QoL), and alcohol and nicotine abuse was performed by clinical interview, letters and telephone interview in January 2016. QoL of patients was evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0. The patients were requested to fill in the questionnaires by themselves via correspondence or clinical interview. A total of 80 patients were enrolled for analysis, including 44 who underwent the original Frey's procedure and 36 who underwent a modified Frey's procedure. The mean age was 46 years in the original group and 48 years in the modified group. Thirty-five male patients (80%) were in the original group and 33 (92%) in the modified group. There were no differences in the operating time, blood loss, and postoperative morbidity and mortality between the two groups. The mean follow-up was 50.3 mo in the original group and 48.7 mo in the modified group. There were no differences in endocrine and exocrine function preservation between the two groups. The original Frey's procedure resulted in significantly better pain relief, as shown by 5-year follow-up ( P = 0.032), better emotional status ( P = 0.047) and fewer fatigue symptoms ( P = 0.028). When stratifying these patients by the M-ANNHEIM severity index, no impact was found on pain relief after the two types of surgery. The original Frey's procedure is as safe as the modified procedure, but the former yields better pain relief. The severity of CP does not affect postoperative pain relief.

Cloud-Based Service Information System for Evaluating Quality of Life after Breast Cancer Surgery.

PubMed

Kao, Hao-Yun; Wu, Wen-Hsiung; Liang, Tyng-Yeu; Lee, King-The; Hou, Ming-Feng; Shi, Hon-Yi

2015-01-01

Although recent studies have improved understanding of quality of life (QOL) outcomes of breast conserving surgery, few have used longitudinal data for more than two time points, and few have examined predictors of QOL over two years. Additionally, the longitudinal data analyses in such studies rarely apply the appropriate statistical methodology to control for censoring and inter-correlations arising from repeated measures obtained from the same patient pool. This study evaluated an internet-based system for measuring longitudinal changes in QOL and developed a cloud-based system for managing patients after breast conserving surgery. This prospective study analyzed 657 breast cancer patients treated at three tertiary academic hospitals. Related hospital personnel such as surgeons and other healthcare professionals were also interviewed to determine the requirements for an effective cloud-based system for surveying QOL in breast cancer patients. All patients completed the SF-36, Quality of Life Questionnaire (QLQ-C30) and its supplementary breast cancer measure (QLQ-BR23) at baseline, 6 months, 1 year, and 2 years postoperatively. The 95% confidence intervals for differences in responsiveness estimates were derived by bootstrap estimation. Scores derived by these instruments were interpreted by generalized estimating equation before and after surgery. All breast cancer surgery patients had significantly improved QLQ-C30 and QLQ-BR23 subscale scores throughout the 2-year follow-up period (p<0.05). During the study period, QOL generally had a negative association with advanced age, high Charlson comorbidity index score, tumor stage III or IV, previous chemotherapy, and long post-operative LOS. Conversely, QOL was positively associated with previous radiotherapy and hormone therapy. Additionally, patients with high scores for preoperative QOL tended to have high scores for QLQ-C30, QLQ-BR23 and SF-36 subscales. Based on the results of usability testing, the five constructs were rated on a Likert scale from 1-7 as follows: system usefulness (5.6±1.8), ease of use (5.6±1.5), information quality (5.4±1.4), interface quality (5.5±1.4), and overall satisfaction (5.5±1.6). The current trend in clinical medicine is applying therapies and interventions that improve QOL. Therefore, a potentially vast amount of internet-based QOL data is available for use in defining patient populations that may benefit from therapeutic intervention. Additionally, before undergoing breast conserving surgery, patients should be advised that their postoperative QOL depends not only on the success of the surgery, but also on their preoperative functional status.

Cloud-Based Service Information System for Evaluating Quality of Life after Breast Cancer Surgery

PubMed Central

Kao, Hao-Yun; Wu, Wen-Hsiung; Liang, Tyng-Yeu; Lee, King-The; Hou, Ming-Feng; Shi, Hon-Yi

2015-01-01

Objective Although recent studies have improved understanding of quality of life (QOL) outcomes of breast conserving surgery, few have used longitudinal data for more than two time points, and few have examined predictors of QOL over two years. Additionally, the longitudinal data analyses in such studies rarely apply the appropriate statistical methodology to control for censoring and inter-correlations arising from repeated measures obtained from the same patient pool. This study evaluated an internet-based system for measuring longitudinal changes in QOL and developed a cloud-based system for managing patients after breast conserving surgery. Methods This prospective study analyzed 657 breast cancer patients treated at three tertiary academic hospitals. Related hospital personnel such as surgeons and other healthcare professionals were also interviewed to determine the requirements for an effective cloud-based system for surveying QOL in breast cancer patients. All patients completed the SF-36, Quality of Life Questionnaire (QLQ-C30) and its supplementary breast cancer measure (QLQ-BR23) at baseline, 6 months, 1 year, and 2 years postoperatively. The 95% confidence intervals for differences in responsiveness estimates were derived by bootstrap estimation. Scores derived by these instruments were interpreted by generalized estimating equation before and after surgery. Results All breast cancer surgery patients had significantly improved QLQ-C30 and QLQ-BR23 subscale scores throughout the 2-year follow-up period (p<0.05). During the study period, QOL generally had a negative association with advanced age, high Charlson comorbidity index score, tumor stage III or IV, previous chemotherapy, and long post-operative LOS. Conversely, QOL was positively associated with previous radiotherapy and hormone therapy. Additionally, patients with high scores for preoperative QOL tended to have high scores for QLQ-C30, QLQ-BR23 and SF-36 subscales. Based on the results of usability testing, the five constructs were rated on a Likert scale from 1–7 as follows: system usefulness (5.6±1.8), ease of use (5.6±1.5), information quality (5.4±1.4), interface quality (5.5±1.4), and overall satisfaction (5.5±1.6). Conclusions The current trend in clinical medicine is applying therapies and interventions that improve QOL. Therefore, a potentially vast amount of internet-based QOL data is available for use in defining patient populations that may benefit from therapeutic intervention. Additionally, before undergoing breast conserving surgery, patients should be advised that their postoperative QOL depends not only on the success of the surgery, but also on their preoperative functional status. PMID:26422018

Translation and validation of the Cancer-Related Fatigue Scale in Greek in a sample of patients with advanced prostate cancer.

PubMed

Charalambous, Andreas; Kaite, Charis; Constantinou, Marianna; Kouta, Christiana

2016-12-02

To translate and validate the Cancer-Related Fatigue (CRF) Scale in the Greek language. A cross-sectional descriptive design was used in order to translate and validate the CRF Scale in Greek. Factor analyses were performed to understand the psychometric properties of the scale and to establish construct, criterion and convergent validity. Outpatients' oncology clinics of two public hospitals in Cyprus. 148 patients with advanced prostate cancer undergoing chemotherapy. The Cancer Fatigue Scale (CFS) had good stability (test-retest reliability r=0.79, p<0.001) and good internal consistency (Cronbach's α coefficient for all 15 items α=0.916). Furthermore, the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value) was found to be 0.743 and considered to be satisfactory (>0.5). The correlations between the CFS physical scale (CFS-FS scale) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 physical subscales were found to be significant (r=-0.715). The same occurred between CFS cognitive and EORTC cognitive subscale (r=-0.579). Overall, the criterion validity was verified. The same occurs for the convergent validity of the CFS since all correlations with the Global Health Status (q29-q30) were found to be significant. This is the first validation study of the CRF Scale in Greek and warrant of its use in the assessment of prostate cancer patient's related fatigue. However, further testing and validation is needed in the early stages of the disease and in patients in later chemotherapy cycles. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Translation and validation of the Cancer-Related Fatigue Scale in Greek in a sample of patients with advanced prostate cancer

PubMed Central

Kaite, Charis; Constantinou, Marianna; Kouta, Christiana

2016-01-01

Objective To translate and validate the Cancer-Related Fatigue (CRF) Scale in the Greek language. Design A cross-sectional descriptive design was used in order to translate and validate the CRF Scale in Greek. Factor analyses were performed to understand the psychometric properties of the scale and to establish construct, criterion and convergent validity. Setting Outpatients' oncology clinics of two public hospitals in Cyprus. Participants 148 patients with advanced prostate cancer undergoing chemotherapy. Results The Cancer Fatigue Scale (CFS) had good stability (test–retest reliability r=0.79, p<0.001) and good internal consistency (Cronbach's α coefficient for all 15 items α=0.916). Furthermore, the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value) was found to be 0.743 and considered to be satisfactory (>0.5). The correlations between the CFS physical scale (CFS-FS scale) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 physical subscales were found to be significant (r=−0.715). The same occurred between CFS cognitive and EORTC cognitive subscale (r=−0.579). Overall, the criterion validity was verified. The same occurs for the convergent validity of the CFS since all correlations with the Global Health Status (q29–q30) were found to be significant. Conclusions This is the first validation study of the CRF Scale in Greek and warrant of its use in the assessment of prostate cancer patient's related fatigue. However, further testing and validation is needed in the early stages of the disease and in patients in later chemotherapy cycles. PMID:27913557

Two-stage autotransplantation of human submandibular gland: a novel approach to treat postradiogenic xerostomia.

PubMed

Hagen, Rudolf; Scheich, Matthias; Kleinsasser, Norbert; Burghartz, Marc

2016-08-01

Xerostomia is a persistent side effect of radiotherapy (RT), which severely reduces the quality of life of the patients affected. Besides drug treatment and new irradiation strategies, surgical procedures aim for tissue protection of the submandibular gland. Using a new surgical approach, the submandibular gland was autotransplanted in 6 patients to the patient's forearm for the period of RT and reimplanted into the floor of the mouth 2-3 months after completion of RT. Saxon's test was performed during different time points to evaluate patient's saliva production. Furthermore patients had to answer EORTC QLQ-HN35 questionnaire and visual analog scale. Following this two-stage autotransplantation, xerostomia in the patients was markedly reduced due to improved saliva production of the reimplanted gland. Whether this promising novel approach is a reliable treatment option for RT patients in general should be evaluated in further studies.

Psychometric properties of the Persian version of satisfaction with care EORTC-in-patsat32 questionnaire among Iranian cancer patients.

PubMed

Pishkuhi, Mahin Ahmadi; Salmaniyan, Soraya; Nedjat, Saharnaz; Zendedel, Kazem; Lari, Mohsen Asadi

2014-01-01

Cancers impose an increasing burden on health of the populations and individuals, but little is known about cancer patient satisfaction with care. The aim of this study was to assess the psychometric properties of the Persian version of European Organisation for Research and Treatment of Cancer (EORTC) In-Patsat32, as a recently developed questionnaire to assess cancer patient satisfaction with care and information provided during hospital admission. Complying with EORTC protocols, the Persian version of Inpatsat32 was translated and piloted in a small group of patients, then applied to 380 cancer patients admitted to different oncology wards in Tehran. Validity (convergent, discriminant, and divergent) and reliability of the tool was assessed through using multitrait analysis, factor analysis, intraclass correlations, Chronbach's alpha and test-retest (on a sample of 70 patients). Good acceptance and high sensitivity of the questionnaire with low floor and ceiling effects were recognized, indicating power of the instrument to detect differences between groups with heterogeneous levels of satisfaction. Multitrait scaling analyses supported the convergent validity of the majority of scales (correlation coefficient >0.4) and favorable discriminant validity (item own scale correlation >0.8). There was no correlation between In-patsat32 scales and the EORTC-C30, which measures different concepts, confirming divergent validity of the tool. Internal consistency for all domains was high (α>0.70) except for the hospital access score and the test-retest reliability was excellent (r=0.86-0.96). There was a weak responsiveness to change except for nurses technical skills. Principle component analysis confirmed five domains with much improved internal consistency (α>0.9). The Persian version of the EORTC-in-patsat32 module is a reliable and valid instrument to measure cancer patient satisfaction with care received during their hospitalization period and can be utilized in clinical cancer research.

Predictors of quality of life of cancer patients, their children, and partners.

PubMed

Götze, Heide; Ernst, Jochen; Brähler, Elmar; Romer, Georg; von Klitzing, Kai

2015-07-01

The objective of this study is to assess the quality of life (QOL) of cancer patients and their family members over 1-year period post therapy. We evaluated QOL in cancer patients (N = 161) (Short Form-8 Health Survey (SF-8), European Organization for Research and Treatment of Cancer 30- Item Core Quality of Life Questionnaire (EORTC QLQ-C30)), their partners (N = 110) (SF-8), and their children (N = 115) (KIDSCREEN-27) using a longitudinal design (t1: post therapy, t2: 6 months after t1, t3: 12 months after t1). Multiple regression models were employed to examine factors related to QOL. After cancer therapy, impairments in the patients' QOL were found primarily in emotional and social areas and also in role functions. We found the highest symptom burden in fatigue (M = 45.21), sleep disturbances (M = 41.04), and financial difficulties (M = 39.2). Partners had lower mental QOL compared with the general population at each assessment point (p < 0.05). No significant difference was found in physical QOL between partners and the general population (p > 0.05). Social support, full-time employment, tumor stage 0-2, time since diagnosis <1 year, and lower levels of anxiety and depression were associated with better QOL in patients. Full-time employment, social support, and lower levels of anxiety and depression had a significant impact on the partners' QOL. Higher levels of anxiety and depression in patients (p = 0.006) adversely influenced children's QOL. Family members' QOL is overall stable over time indicating the need for professional psychosocial support for those family members with low QOL. For the children, new measures are needed to better examine the experience with parental cancer. Copyright © 2014 John Wiley & Sons, Ltd.

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

PubMed Central

2012-01-01

Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study. PMID:22937765

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Sagap, Ismail; Zakaria, Jasiah; Blazeby, Jane M; Law, Chee Wei

2012-09-03

Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers' guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study.

Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study.

PubMed

Thaler, Josef; Karthaus, Meinolf; Mineur, Laurent; Greil, Richard; Letocha, Henry; Hofheinz, Ralf; Fernebro, Eva; Gamelin, Erick; Baños, Ana; Köhne, Claus-Henning

2012-09-29

Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported. Here we report additional descriptive tolerability and quality of life data from this trial. Integument-related toxicities and quality of life were analysed; toxicities were graded using modified National Cancer Institute Common Toxicity Criteria. Kaplan-Meier estimates of time to and duration of first integument-related toxicity were prepared. Quality of life was measured using EuroQoL EQ-5D and EORTC QLQ-C30. Best overall response was analysed by skin toxicity grade and baseline quality of life. Change in quality of life was analysed by skin toxicity severity. 154 patients were enrolled (WT KRAS n = 86; mutant KRAS n = 59); most (98%) experienced integument-related toxicities (most commonly rash [42%], dry skin [40%] and acne [36%]). Median time to first integument-related toxicity was 8 days; median duration was 334 days. Overall, proportionally more patients with grade 2+ skin toxicity responded (56%) compared with those with grade 0/1 (29%). Mean overall EQ-5D health state index scores (0.81 vs. 0.78), health rating scores (72.5 vs. 71.0) and QLQ-C30 global health status scores (65.8 vs. 66.7) were comparable at baseline vs. safety follow-up (8 weeks after completion), respectively and appeared unaffected by skin toxicity severity. First-line panitumumab plus FOLFIRI has acceptable tolerability and appears to have little impact on quality of life, despite the high incidence of integument-related toxicity. ClinicalTrials.gov NCT00508404.

Associations between education and physical functioning and pain in adult Danish cancer survivors.

PubMed

Winther, Dorte; Nygaard, Tina K; Horsbøl, Trine A; Kjær, Trille; Vedsted, Peter; Johansen, Christoffer; Hovaldt, Hanna B; Sandager, Mette; Dalton, Susanne O

2017-02-01

Late effects after cancer diagnosis and treatment are common, but only few studies have examined the role of social factors in developing these late effects. The aim of this study was to examine the association between educational level and physical function and pain among cancer survivors two years after diagnosis. The study population consisted of adult Danish patients with a first-time cancer diagnosis who were sent a questionnaire in 2010 and followed up in 2012. In total, 4346 returned the first questionnaire shortly after diagnosis and 2568 returned the follow-up questionnaire. After exclusion of 177 due to missing information, we included 2391 cancer survivors in the analyses. Physical function and pain were measured using the EORTC QLQ-C30. Linear regression analyses were conducted separately for men and women, and adjusted for demographic and clinical characteristics. Additionally, analyses were stratified on comorbidity. Differences in mean scores according to educational level were small. Physical function was better in women with medium (2.8; 95% CI 0.1;5.4) and higher education (3.4; 95% CI 0.9;5.9) compared to women with short education. In contrast, men with medium education reported lower physical function (-2.9; 95% CI -5.7;-0.1) than men with short education. Compared to women with short education, we found lower pain scores among women with medium (-5.0; 95% CI -8.7;-1.4) and higher education (-3.4; 95% CI -6.7;0.0). Similarly, men with higher education experienced lower pain score (-3.4; 95% CI -6.9;0.1) than men with short education. The role of educational level differed between those with and without comorbidity. Educational level is slightly associated with physical function and pain among cancer survivors. However, mean differences in this study were small and below what is considered clinically relevant.

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

PubMed

Philip, Errol J; Nelson, Christian; Temple, Larissa; Carter, Jeanne; Schover, Leslie; Jennings, Sabrina; Jandorf, Lina; Starr, Tatiana; Baser, Ray; DuHamel, Katherine

2013-10-01

Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all P<0.01). Body image, anxiety, and cancer-specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated. For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients. © 2013 International Society for Sexual Medicine.

Quality of life of older rectal cancer patients is not impaired by a permanent stoma.

PubMed

Orsini, R G; Thong, M S Y; van de Poll-Franse, L V; Slooter, G D; Nieuwenhuijzen, G A P; Rutten, H J T; de Hingh, I H J T

2013-02-01

The current study was undertaken to investigate the impact of a stoma on the HRQL with a special focus on age. Using the Eindhoven Cancer Registry, rectal cancer patients diagnosed between 1998 and 2007 in 4 hospitals were identified. All patients underwent TME surgery. Survivors were approached to complete the SF-36 and EORTC QLQ-C38 questionnaires. HRQL scores of the four groups, stratified by stoma status (stoma/no stoma) and age at operation (<70 and ≥ 70), were compared. The SF-36 and the QLQ-CR38 sexuality subscale scores of the survivors were compared with an age- and sex-matched Dutch norm population. Median follow-up of 143 patients was 3.4 years. Elderly had significantly worse physical function (p = 0.0003) compared to younger patients. Elderly (p = 0.005) and patients without a stoma (p = 0.009) had worse sexual functioning compared to younger patients and patients with a stoma. Older males showed more sexual dysfunction (p = 0.01) when compared to younger males. In comparison with the normative population, elderly with a stoma had worse physical function (p < 0.01), but slightly better mental health (p < 0.05). Elderly without a stoma had better emotional role function (p < 0.01), and younger patients had worse sexual functioning and enjoyment (both p < 0.0001). Older patients with a stoma have comparable HRQL to older patients without a stoma or the normative population, indicating the feasibility of a permanent stoma for elderly patients with a low situated rectal carcinoma. The negative impact of treatment on sexual functioning as found in the current study calls for further attention to alleviate this problem in sexually active patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

The efficacy of Life Review Therapy combined with Memory Specificity Training (LRT-MST) targeting cancer patients in palliative care: A randomized controlled trial.

PubMed

Kleijn, Gitta; Lissenberg-Witte, Birgit I; Bohlmeijer, Ernst T; Steunenberg, Bas; Knipscheer-Kuijpers, Kitty; Willemsen, Vincent; Becker, Annemarie; Smit, Egbert F; Eeltink, Corien M; Bruynzeel, Anna M E; van der Vorst, Maurice; de Bree, Remco; Leemans, C René; van den Brekel, Michiel W M; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

2018-01-01

The aim of this study was to evaluate the efficacy of an intervention combining Life Review Therapy (LRT) and Memory Specificity Training (MST) (LRT-MST) to improve ego-integrity and despair among cancer patients in palliative care. In this multicentre randomized controlled trial, cancer patients in palliative care were randomized to the intervention group (LRT-MST; n = 55) or waiting-list control group (n = 52). LRT-MST is a 4-session home-based psychological intervention that aims to retrieve specific positive memories, to re-evaluate life events and to reconstruct the story of a patient's life, including the diagnosis of incurable cancer. Outcome measures were ego-integrity and despair (NEIS), psychological distress, anxiety and depression (HADS), quality of life (EORTC QLQ-C15-PAL), and specificity of the autobiographical memory (AMT). NEIS, HADS and EORTC QLQ-C15-PAL were assessed at baseline (T0), 1 month later (post-treatment; T1), and at 1 month follow-up (T2). AMT was assessed at T0 and T1. Linear mixed models (intention to treat) were used to assess group differences in changes over time. Independent samples t-tests were used to assess group differences at T0, T1, and T2, and effect sizes (ES) were calculated at T1 and T2. The course of ego-integrity (not despair) improved significantly over time (p = .007) in the intervention group compared to the waiting-list control group, with moderate, but insignificant, effect sizes at T1 (ES = .42) and T2 (ES = .48). Compliance rate was 69% and total dropout rate was 28%, both primarily related to disease progression and death. LRT-MST seems effective among cancer patients in palliative care to improve the course of ego-integrity.

Health-Related Quality of Life in Locally Advanced Cervical Cancer Patients After Definitive Chemoradiation Therapy Including Image Guided Adaptive Brachytherapy: An Analysis From the EMBRACE Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kirchheiner, Kathrin, E-mail: kathrin.kirchheiner@meduniwien.ac.at; Pötter, Richard; Christian Doppler Laboratory for Medical Radiation Research for Radiation Oncology, Medical University of Vienna, Vienna

Purpose: This study analyzed functioning and symptom scores for longitudinal quality of life (QoL) from patients with locally advanced cervical cancer who underwent definitive chemoradiation therapy with image guided adaptive brachytherapy in the EMBRACE study. Methods and Materials: In total, 744 patients at a median follow-up of 21 months were included. QoL was prospectively assessed using European Organization for Research and Treatment of Cancer Quality of Life core module 30 (EORTC QLQ-C30) and EORTC cervical cancer module 24 (CX24) questionnaires at baseline, then every 3 months during the first year, every 6 months in the second and third years, and finally yearly thereaftermore » in patients with no evidence of disease. Outcomes were evaluated over time and compared to those from an age-matched female reference population. Results: General QoL and emotional and social functioning were impaired at baseline but improved during the first 6 months after treatment, to reach a level comparable to that of the reference population, whereas cognitive functioning remained impaired. Both social and role functioning showed the lowest scores at baseline but which increased after treatment to reach a plateau at 6 months and then declined slightly at 3 and 4 years. The overall symptom experience was elevated at baseline and decreased to a level within the range of that of the reference population. Similarly, tumor-related symptoms (eg, pain, appetite loss, and constipation), which were present before treatment, decreased substantially at the first follow-up after treatment. Several treatment-related symptoms developed either immediately after and persisted over time (diarrhea, menopausal symptoms, peripheral neuropathy, and sexual functioning problems) or developed gradually after treatment (lymphedema and dyspnea). Conclusions: This longitudinal prospective QoL analysis showed that patients' general QoL and functioning were impaired before treatment compared to those of reference data. Several tumor-related symptoms resolved after treatment, and functioning and general QoL returned to that of the level of the reference population, indicating a transient impact of diagnosis and treatment. However, several treatment-related symptoms and problems did develop and persist, either immediately or gradually after treatment.« less

Chronic fatigue in Hodgkin lymphoma survivors and associations with anxiety, depression and comorbidity

PubMed Central

Daniëls, L A; Oerlemans, S; Krol, A D G; Creutzberg, C L; van de Poll-Franse, L V

2014-01-01

Background: Fatigue is a frequent and persistent problem among Hodgkin lymphoma (HL) survivors. We investigated the prevalence of clinically relevant fatigue in HL survivors and the relation between fatigue and anxiety and depression. Methods: Fatigue was measured through the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Fatigue Assessment Scale (FAS). Anxiety and depression were measured with the Hospital Anxiety and Depression Scale. Questionnaires were mailed to 267 HL survivors. Results were compared with a Dutch age-matched normative population. Results: Response rate was 68% (median age 46 years, mean time since diagnosis 4.6 years). Prevalence of fatigue was significantly higher among HL survivors than in the norm population (FAS 41% vs 23%, QLQ-C30 43% vs 28%), as were fatigue levels. There was a significant association between fatigue, anxiety and depression. Of the HL survivors with high symptom levels of depression, 97% also reported fatigue. In multivariate analysis, depression was strongly associated with high levels of fatigue and, to a lesser extent, anxiety and comorbidity. Conclusions: Prevalence rates of fatigue are significantly higher in HL survivors than in the general population and differences are clinically relevant. Depression and anxiety were strongly associated with high levels of fatigue. Reducing fatigue levels by treatment of depression and anxiety should be further explored. PMID:24434433

Impact of esophagectomy for cancer on patients' occupational status.

PubMed

Pinto, E; Cavallin, F; Alfieri, R; Saadeh, L M; Mantoan, S; Cagol, M; Castoro, C; Scarpa, M

2016-01-01

The aim of our study was to investigate the impact of esophagectomy for cancer on patients' occupational status. All 109 consecutive patients presenting with esophageal cancer to the Surgical Oncology Unit of the Veneto Institute of Oncology Padua (Italy) between November 1, 2009 and March 15, 2012, were included in the study. Information on occupational status at diagnosis and at 1 year after esophagectomy was retrieved. Health-related quality of life was evaluated at discharge after surgery using selected aspects of the EORTC QLQ-C30 questionnaire. Non parametric statistics were used. Sixty-one patients (49.6%) were active workers at diagnosis and 50 of them (82.0%) underwent esophagectomy. Eighteen active workers (18/50, 36.0%) quit their job within one year from esophagectomy. They received jejunostomy more often than patients still working after surgery (50.0% vs. 18.8%, respectively; p = 0.03) and reported lower social functioning at discharge (mean ± SD 63.6 ± 16.4 vs. 80.2 ± 25.6 in others, p = 0.02). Multivariable analysis identified jejunostomy as independent predictor of job-quitting at 1 year after esophagectomy (p = 0.03; OR 4.75, 95% C.I. 1.11-20.39) but not social functioning at discharge (p = 0.21). Patients should be informed that they may experience social and work disability due to cancer treatment and adequate interventions of return-to-work support should be provided. Adequate welfare strategy should be implemented for esophageal cancer survivors, enhancing their role competences and contributing to precision care medicine. Copyright © 2015 Elsevier Ltd. All rights reserved.

Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer.

PubMed

Stockler, Martin R; Hilpert, Felix; Friedlander, Michael; King, Madeleine T; Wenzel, Lari; Lee, Chee Khoon; Joly, Florence; de Gregorio, Nikolaus; Arranz, José Angel; Mirza, Mansoor Raza; Sorio, Roberto; Freudensprung, Ulrich; Sneller, Vesna; Hales, Gill; Pujade-Lauraine, Eric

2014-05-01

To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.

Communication after laryngectomy: an assessment of quality of life.

PubMed

Carr, M M; Schmidbauer, J A; Majaess, L; Smith, R L

2000-01-01

The purpose of this study was to examine quality of life in laryngectomees using different methods of communication. A survey was mailed to all the living laryngectomees in Nova Scotia. Patients were asked to rate their ability to communicate in a number of common situations, to rate their difficulty with several communication problems, and to complete the EORTC QLQ-C30 quality-of-life assessment tool. Sixty-two patients responded (return rate of 84%); 57% were using electrolaryngeal speech, 19% esophageal speech, and 8.5% tracheoesophageal speech. These groups were comparable with respect to age, sex, first language, education level, and years since laryngectomy. There were very few differences between these groups in ability to communicate in social situations and no difference in overall quality of life as measured by these scales. The most commonly cited problem was difficulty being heard in a noisy environment. Despite the fact that tracheoesophageal speech is objectively most intelligible, there does not seem to be a measurable improvement in quality of life or ability to communicate in everyday situations over electrolaryngeal or esophageal speakers.

Health-related quality of life of Iranian breast cancer patients: a meta-analysis and systematic review.

PubMed

Bouya, Salehoddin; Koochakzai, Maryam; Rafiemanesh, Hosein; Balouchi, Abbas; Taheri, Safiyeh; Badakhsh, Mahin; Didehvar, Mahnaz

2018-07-01

Quality of life is the most important psychological factor affecting breast cancer patients. This study aimed to examine the health related quality of life of breast cancer patients in Iran. International (PubMed, Web of science, Scopus and Google scholar) and national (SID, Magiran) databases were searched for related studies to September 2017. The quality of the articles was evaluated using the Hoy tool. Out of 232 initial studies, 18 studies performed on 2263 people were included in the final stage of the study. Based on the EORTC-QLQ-C30 and random effect method, the pooled mean score of quality of life in 1073 people was 57.88 (95% CI 48.26-67.41, I 2 = 97.90%) and the pooled mean score of quality of life based on WHOQOL-BREF in 357 people was 66.79 (95% CI 45.96-87.62, I 2 = 99.50%). According to the results of the study, a moderate level of quality of life in women with breast cancer was indicated. Therefore, the use of multidimensional approaches can improve their quality of life.

Development and validation of the quality care questionnaire -palliative care (QCQ-PC): patient-reported assessment of quality of palliative care.

PubMed

Yun, Young Ho; Kang, Eun Kyo; Lee, Jihye; Choo, Jiyeon; Ryu, Hyewon; Yun, Hye-Min; Kang, Jung Hun; Kim, Tae You; Sim, Jin-Ah; Kim, Yaeji

2018-03-05

In this study, we aimed to develop and validate an instrument that could be used by patients with cancer to evaluate their quality of palliative care. Development of the questionnaire followed the four-phase process: item generation and reduction, construction, pilot testing, and field testing. Based on the literature, we constructed a list of items for the quality of palliative care from 104 quality care issues divided into 14 subscales. We constructed scales of 43 items that only the cancer patients were asked to answer. Using relevance and feasibility criteria and pilot testing, we developed a 44-item questionnaire. To assess the sensitivity and validity of the questionnaire, we recruited 220 patients over 18 years of age from three Korean hospitals. Factor analysis of the data and fit statistics process resulted in the 4-factor, 32-item Quality Care Questionnaire-Palliative Care (QCQ-PC), which covers appropriate communication with health care professionals (ten items), discussing value of life and goals of care (nine items), support and counseling for needs of holistic care (seven items), and accessibility and sustainability of care (six items). All subscales and total scores showed a high internal consistency (Cronbach alpha range, 0.89 to 0.97). Multi-trait scaling analysis showed good convergent (0.568-0.995) and discriminant (0.472-0.869) validity. The correlation between the total and subscale scores of QCQ-PC and those of EORTC QLQ-C15-PAL, MQOL, SAT-SF, and DCS was obtained. This study demonstrates that the QCQ-PC can be adopted to assess the quality of care in patients with cancer.

Does social support from family and friends work as a buffer against reactions to stressful life events such as terminal cancer?

PubMed

Ringdal, Gerd Inger; Ringdal, Kristen; Jordhøy, Marit S; Kaasa, Stein

2007-03-01

To examine the relationship between social support and emotional functioning and stress reactions. Our hypothesis is that patients who reported a high degree of social support will experience better emotional functioning and less serious stress reactions than patients with a low degree of social support. The sample was comprised of 434 patients at the Palliative Medicine Unit (PMU), University Hospital of Trondheim in Norway. The patients completed a questionnaire monthly including questions about social support from the MacAdam's Scale, subjective stress measured by the Impact of Event Scale (IES), and emotional functioning measured by the subscale in the EORTC QLQ-30. Although our hypothesis was not supported at the baseline assessment, it was supported at the second assessment, 2 months later. Patients with high social support reported better emotional functioning and less serious stress reactions, in terms of lower scores on the IES avoidance subscale, than patients with a low degree of social support. SIGNIFICANCE OF THE RESULTS: The mixed findings may indicate that social support has only small effects on emotional functioning and stress reactions. Our results on the second assessment indicate, however, that social support might work as a buffer against reactions toward external stressful events such as terminal cancer.

Reduced fitness and physical functioning are long-term sequelae after curative treatment for esophageal cancer: a matched control study.

PubMed

Gannon, J A; Guinan, E M; Doyle, S L; Beddy, P; Reynolds, J V; Hussey, J

2017-08-01

Reduced physical functioning is common following resections for esophageal cancer; however, objective data on physical performance outcomes in this cohort are rare. The aim of this study was to assess the physical performance and health related quality of life (HRQOL) of disease free survivors and compare findings in a case matched noncancer control group. Twenty-five males (mean (±SD) aged 63 (±6) years) who were over 6 months postesophagectomy and disease-free were compared with 25 controls (60 ± 6 years). Physical functioning was assessed through hand grip strength (dynamometry), exercise capacity (incremental shuttle walk test), physical activity levels (RT3 accelerometer), and body composition (bio-electrical impedance analysis). Health-related quality of life was measured using the EORTC QLQ-C30 questionnaire. Esophageal cancer survivors demonstrated significantly lower fitness (P < 0.001) and time spent in moderate (P < 0.001) and vigorous (P < 0.001) intensity physical activity compared with controls. Global health status and quality of life were similar in both groups (P = 0.245); however, physical and role functioning domains were lower in the cancer survivors (P < 0.001, and P = 0.001, respectively). These data show that disease-free survivors of curative esophageal cancer treatment demonstrate a significant compromise in physical functioning compared with controls, thus highlighting the multiple, complex rehabilitative needs of this cohort. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cross-cultural comparison of breast cancer patients' Quality of Life in the Netherlands and Japan.

PubMed

Fischer, M J; Inoue, K; Matsuda, A; Kroep, J R; Nagai, S; Tozuka, K; Momiyama, M; Weijl, N I; Langemeijer-Bosman, D; Ramai, S R S; Nortier, J W R; Putter, H; Yamaoka, K; Kubota, K; Kobayashi, K; Kaptein, A A

2017-11-01

Cultural differences are hypothesized to influence patients' Quality of Life (QoL) reports. However, there is a lack of empirical cross-cultural studies comparing QoL of patients with cancer. This study aims to compare QoL of women with breast cancer in the Netherlands and Japan, and to investigate the association of QoL with sociodemographic, clinical, and psychological variables (illness perceptions). Dutch (n = 116) and Japanese (n = 148) women with early breast cancer undergoing chemotherapy completed the EORTC QLQ-C30 and Brief Illness Perception Questionnaire immediately before their second cycle of chemotherapy. Dutch women reported poorer Physical, Role, Emotional, and Cognitive functioning than Japanese women. Additionally, illness perceptions were significantly different in Japan and the Netherlands, but these did not vary across treatment type. In Japan, QoL of women receiving AC-chemotherapy was better than that of women receiving FEC-chemotherapy, whereas in the Netherlands, QoL did not vary as a function of chemotherapy. Illness perceptions about symptom severity, adverse consequences, and emotional representations were negatively related to most domains of patients' QoL in both countries. Adding illness perceptions as covariates to the ANOVA analyses rendered the effects of country and treatment type on QoL non-significant. Comparing Dutch and Japanese women with early breast cancer revealed important differences in treatment modalities and illness perceptions which both appear to influence QoL. Perceptions about cancer have been found to vary across cultures, and our study suggests that these perceptions should be considered when performing cross-cultural studies focusing on patient-reported outcomes.

Cost-utility analysis of individual psychosocial support interventions for breast cancer patients in a randomized controlled study.

PubMed

Arving, Cecilia; Brandberg, Yvonne; Feldman, Inna; Johansson, Birgitta; Glimelius, Bengt

2014-03-01

The aim was to explore the cost-utility in providing complementary individual psychosocial support to breast cancer patients compared with standard care (SC). Patients just starting adjuvant therapy (n = 168) at Uppsala University Hospital, Sweden, were consecutively included and randomized into three groups: psychosocial support from a specially trained nurse (INS), from a psychologist (IPS), or SC. Psychological effects and healthcare utilization were monitored during a 2-year period. The hospital billing system provided cost estimates. Quality-adjusted life years (QALYs) were calculated using health-related quality of life data from the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ C-30) translated into the Euro Quality of Life- 5-Dimensional classification. On the basis of the medical cost offset, a cost-utility analysis was performed. Health care utilization was mainly related to the breast cancer diagnosis and treatment. The intervention costs amounted to about €500 or 3% of the total costs. Total health care costs, including interventions cost, were lower in the INS (€18,670) and IPS (€20,419) groups than in the SC group (€25,800). The number of QALYs were also higher in the INS (1.52 QALY) and IPS (1.59 QALY) groups, compared with the SC group (1.43 QALY). The cost-utility analysis revealed that, during adjuvant treatment for breast cancer, the individual psychosocial support interventions provided here was cost effective because the health care costs were lower and QALYs were higher compared to SC alone. Copyright © 2013 John Wiley & Sons, Ltd.

Preservation of duodenal passage as a determinant of short- and long-term quality of life in gastric cancer patients after total gastrectomy.

PubMed

Olesiński, Tomasz; Szpakowski, Marek; Saramak, Piotr; Rutkowski, Andrzej; Jeziorski, Krzysztof

2017-10-01

The aim of this prospective study was to compare subjective and objective quality of life (QoL) of gastric cancer patients after total gastrectomy with and without preservation of the duodenal passage during short- and long-term follow-up. The study included 68 patients, among them 37 (54%) persons subjected to total gastrectomy with Roux-Y reconstruction (R-Y group) and 31 (46%) individuals in whom gastrectomy was followed by formation of Henley-Longmire loop (H-L group). Subjective and objective QoL was determined 1 and 10 years postsurgery. During each visit, subjective QoL was determined with EORTC QLQ-C30 questionnaire, along with markers of nutritional status and self-reported incidence of symptoms specific to postgastrectomy syndrome. The two groups did not differ significantly in terms of their subjective QoL and markers of nutritional status at 1 and 10 years postsurgery, and none of these parameters underwent significant changes between the first and second evaluation. Patients from R-Y group reported subjective weight loss significantly more often during both visits, and individuals from H-L group significantly more often complained on postprandial diarrhea during long-term follow-up. Moreover, both groups showed an increase in the incidence of postprandial vomiting between the first and second evaluation. QoL of gastric cancer patients subjected to total gastrectomy stabilizes at relatively high level within a year from the surgery. Preservation of the duodenal passage does not exert a beneficial effect on both objective and subjective QoL after total gastrectomy.

Awareness of incurable cancer status and health-related quality of life among advanced cancer patients: a prospective cohort study.

PubMed

Lee, Myung Kyung; Baek, Sun Kyung; Kim, Si-Young; Heo, Dae Seog; Yun, Young Ho; Park, Sook Ryun; Kim, Jun Suk

2013-02-01

Many patients near death report an interest in knowing their prognoses. Patients' awareness of disease status may lead to more appropriate care and maintained or improved quality of life. However, it is not known whether advanced cancer patients' awareness of disease status is associated with patients' quality of life. We aimed to examine the effect of patients' awareness of disease status on the health-related quality of life (HRQOL) among advanced cancer patients undergoing palliative chemotherapy. In this prospective cohort study, patients were followed-up at 4-6 weeks and 2-3 months after the initial palliative chemotherapy. Patients' awareness of disease status, and demographic and clinical characteristics were assessed at baseline, and depression and anxiety using the Hospital Anxiety and Depression Scale (HADS) and HRQOL using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were assessed three times. In total, 100 patients with advanced cancer starting palliative chemotherapy were recruited from two tertiary university hospitals and from the Korea National Cancer Center. Patients with advanced cancer undergoing palliative chemotherapy experienced deteriorated HRQOL. Of these, the patients who were aware of their disease status as incurable had significantly higher role (p=0.002), emotional (p=0.025), and social functioning (p=0.002), and lower fatigue (p=0.008), appetite loss (p=0.039), constipation (p=0.032), financial difficulties (p=0.019), and anxiety (p=0.041) compared with patients unaware of disease status. Our findings demonstrate the importance of patients' awareness of disease status to HRQOL.

Evaluation of long-term results and quality of life in patients who underwent rib fixation with titanium devices after trauma.

PubMed

Billè, Andrea; Okiror, Lawrence; Campbell, Aideen; Simons, Jason; Routledge, Tom

2013-06-01

To describe the long-term results, quality of life and chronic pain after chest wall fixation for traumatic rib fracture using a quality of life (QOL) score and a numeric pain score. Retrospective analysis of 10 consecutive patients who underwent surgery for rib fractures after trauma and reconstruction between October 2010 and March 2012. Chest rib fractures were fixed with titanium clips and bars or titanium plates and screws through a posterolateral thoracotomy. Pain was assessed with a numeric pain scale 0-10 and quality of life (QOL) with the EORTC questionnaire QLQ-C30. There were 5 males and 5 females. The median age was 58 years (range 21-80). There were no postoperative deaths. The only postoperative complication observed was a contralateral pleural effusion requiring drainage. Median length of stay of the drain and median length of hospital stay were 2 days (range 0-8) and 4 days (range 1-42 days), respectively. The average follow-up period of operatively managed patients was 14 months (range 8-23.5 months). Seven patients scored the pain as 0, one as 1 (mild), one as 4 (moderate) and one as 8 (severe). Only two patients are taking occasionally pain killers. Only one patient presents severe limitation in his life scoring his QOL as poor. Titanium devices (clips and bars; screws and plates) are effective and safe for repair of rib fractures and showed good long-term results in terms of pain and quality of life after the operation.

Quality of life in patients with recurrent breast cancer after second breast-conserving therapy in comparison with mastectomy: the German experience.

PubMed

Jendrian, Svenja; Steffens, Katharina; Schmalfeldt, Barbara; Laakmann, Elena; Bergelt, Corinna; Witzel, Isabell

2017-06-01

Although some studies suggest that breast-conserving therapy (BCT) shows better psychosocial outcomes than mastectomy in patients with primary breast cancer, little is known about the outcomes of these surgical options in recurrent breast cancer. We investigated differences in overall survival and re-recurrence rates as well as psychosocial outcomes among patients who underwent BCT or mastectomy after the diagnosis of recurrent breast cancer in a single-center setting. 124 of 186 eligible patients who underwent surgical treatment for breast cancer recurrence completed the questionnaires on quality of life (EORTC QLQ-C30 and -BR23), fear of progression (PA-F-KF), anxiety and depression (HADS), and body image (BIS). Women after breast-conserving surgery (n = 46) showed significantly better outcomes than women after mastectomy (n = 61) with respect to body image (P < 0.001 in BIS and p < 0.001 in BR23), social functioning (p = 0.016), emotional functioning (p = 0.028), and role functioning (p = 0.043). There were no significant group differences regarding anxiety, depression, and fear of progression as well as re-recurrence and survival rates. Predictors of good quality of life were partnership (OR 2.46), higher monthly family income (OR 3.54), and higher professional qualification (OR 4.3) in our group of patients. Our results indicate that patients treated with breast-conserving therapy after recurrent breast cancer perceive lower impairments in body image and several aspects of quality of life than patients treated with mastectomy.

Quality of life in Malaysian colorectal cancer patients: a preliminary result.

PubMed

Natrah, M S; Ezat, Sharifa W P; Syed, M A; Rizal, A M Mohd; Saperi, S

2012-01-01

Rapidly increasing colorectal cancer (CRC) incidence in Malaysia and the introduction of cutting edge new treatments, which prolong survival, mean that treatment outcome measures meed to be evaluated, including consideration of patient's quality of life (QoL) assessment. There are limited data on QoL in CRC patients, especially in Malaysia. Therefore, this study was performed focusing on cancer stages and age groups. The cross sectional study was conducted from June to September 2011 at three public tertiary hospitals with the EORTC QLQ C-30 questionnaire in addition to face to face interview and review of medical records of 100 respondents. The mean age was 57.3 (SD 11.9) years with 56.0% are males and 44.0% females, 62% of Malay ethnicity, 30% Chinese, 7% Indian and 1% Sikh. Majority were educated up to secondary level (42%) and 90% respondents had CRC stages III and IV. Mean global health status (GHS) score was 79.1 (SD 21.4). Mean scores for functional status (physical, emotional, role, cognitive, social) rangeds between 79.5 (SD 26.6) to 92.2 (SD 13.7). Mean symptom scores (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnoea, loss of appetite) ranged between 4.00 (SD 8.58) to 20.7 (SD 30.6). Respondents role function significantly deteriorates with increasing stage of the disease (p=0.044). Females had worse symptoms of pain (p=0.022), fatigue (p=0.031) and dyspnoea (p=0.031). Mean insomnia (p=0.006) and diarrhea (p=0.024) demonstrated significant differences between age groups. QOL in CRC patients in this study was comparable to that in other studies done in developed countries. Pain, fatigue and dyspnoea are worse among female CRC patients. Given that functions deteriorates with advanced stage of the disease at diagnosis, a systematic screening programme to detect cases as early as possible is essential nationwide.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial.

PubMed

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial

PubMed Central

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

Objective The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. Materials and Methods The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. Results After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Conclusions Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs. PMID:28331763

Goserelin (Zoladex) or orchiectomy in metastatic prostate cancer? A quality of life and cost-effectiveness analysis.

PubMed

Nygård, R; Norum, J; Due, J

2001-01-01

We have today two treatment alternatives (orchiectomy or LHRH-analogue) in metastatic prostate cancer offering the same expectations of survival. This study documents the quality of life (QoL) and cost-effectiveness of these alternatives. 65 consecutive patients treated at the University Hospital of Tromsø (UHT), Norway, between 1994 and 1999 were registered. At evaluation, 45 patients (LHRH-analogue--15 patients, orchiectomy--30 patients) were alive and included in the QoL-study (EORTC QLQ C-30, QoL 15D). 45 patients were followed-up at the UHT and included in the cost-analysis. Costs were calculated for a 36-month interval and converted to British pounds (1 Pound = 13 NOK). A 5% d.r. was employed. The mean QoL (15D) was 76.4 (orchiectomy) and 72 (LHRH) (0-100 scale). Constipation, urinating problems, fatigue, pain and loss of sexual functioning were the dominant symptoms. The treatment costs per patient treated were 8,895 Pounds (orchiectomy) and 10,937 Pounds (LHRH-analogue). The crossover in cost was located at 25 months. A sensitivity analysis varying discount rate (0-10%), drug charges (25-50% off) and treatment time (12-18 months) did not alter the conclusion. Orchiectomy is the treatment of choice when life expectancy is more than two years.

Socioeconomic status and quality of life in patients with locally advanced head and neck cancer.

PubMed

Tribius, S; Meyer, M S; Pflug, C; Hanken, H; Busch, C-J; Krüll, A; Petersen, C; Bergelt, C

2018-05-07

Socioeconomic aspects play an important role in health care. Patients with locally advanced head and neck cancer (LAHNC) experience detrimental effects on their quality of life (QoL). This prospective study examines QoL differences between patients with different socioeconomic status (SES) after intensity-modulated radiation therapy (IMRT). In all, 161 patients were questioned at the end of IMRT and at 12 and 24 months follow-up using the questionnaires of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 and QLQ-HN35. Patients' QoL 2 years after IMRT was compared to a population reference sample and QoL of patients from lower, middle, and higher social class 2 years after IMRT was analyzed by ANCOVA using baseline QoL (end of radiation treatment) as a covariate. Patients with high SES report worse QoL at the end of IMRT in the domains global health status (-15.2; p = 0.005), role function (-23.8; p = 0.002), and social function (-19.4; p = 0.023) compared to patients with middle and low SES. QoL improved during the first 12 and 24 months. However, 2 years after IMRT, middle and low SES patients report lower QoL in the domains global health status, physical function, and role function, and report a higher general (fatigue, pain, dyspnea) and head and neck cancer-specific symptom burden (pain, swallowing, senses, speech, social eating, opening mouth, and felt ill) than patients with high SES. After IMRT for LAHNC, patients with high SES report worse QoL compared to patients with middle or low SES. There is a marked improvement within the first 24 months in many domains. However, the magnitude of improvement in patients with middle or low SES is significantly smaller compared to patients with high SES.

Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer

PubMed Central

Stockler, Martin R.; Hilpert, Felix; Friedlander, Michael; King, Madeleine T.; Wenzel, Lari; Lee, Chee Khoon; Joly, Florence; de Gregorio, Nikolaus; Arranz, José Angel; Mirza, Mansoor Raza; Sorio, Roberto; Freudensprung, Ulrich; Sneller, Vesna; Hales, Gill; Pujade-Lauraine, Eric

2014-01-01

Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy–Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer. PMID:24687829

Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boer, Stephanie M. de, E-mail: s.m.de_boer.ONCO@lumc.nl; Nout, Remi A.; Jürgenliemk-Schulz, Ina M.

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high–intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed modelsmore » for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.« less

Implementation of a mobile inpatient quality of life (QoL) assessment for oncology nursing.

PubMed

Schuler, Markus K; Trautmann, Freya; Radloff, Mirko; Schmädig, Roman; Hentschel, Leopold; Eberlein-Gonska, Maria; Petzold, Thomas; Vetter, Heike; Oberlack, Sebastian; Ehninger, Gerhard; Schmitt, Jochen

2016-08-01

Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

The impact of treatment on quality of life of patients with head and neck cancer and its association with prognosis.

PubMed

Carrillo, J F; Carrillo, L C; Ramirez-Ortega, M C; Ochoa-Carrillo, F J; Oñate-Ocaña, L F

2016-10-01

Information is scarce regarding the impact of treatment on Health-Related Quality of Life (HRQL) of patients with Head and Neck (H&N) cancers. We assessed the effect of treatment on HRQL and its association with prognosis in H&N cancer. Patients with H&N cancer in whom HRQL was assessed before and after treatment. The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 instruments were used. Association of changes in patients' HRQL after treatment with Loco-Regional Recurrence (LRR) and Overall Survival (OS) was investigated. One hundred sixty patients were included; scales of the baseline assessment of HRQL were moderately associated with LRR and OS, but the impact of treatment on most HRQL scales was strongly associated with OS. By multivariate analysis, baseline assessment of Global Health, Physical, HN Teeth, HN Dry mouth, and HN Cough scales, and impact of treatment on the Physical and Pain scales comprised independent variables associated with LRR. Male gender, positive lymph nodes, baseline assessment of Role, HN Pain, HN Cough, and impact of treatment on Emotion, Pain, Financial, HN Swallowing, HN Social contact, and the interaction of HN Pain-change in Pain scales were associated with OS. Both multivariate models were adjusted by the neoplasm's site of origin. Aside from well-known clinical-pathologic prognostic factors in H&N cancers, HRQL assessment, both prior to and after treatment, provides significant prognostic information and should be measured. Design of therapeutic clinical trials in patients with H&N cancers should consider these novel prognostic factors. Copyright © 2016 Elsevier Ltd, BASO ~ the Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

A novel systemic immune-inflammation index predicts survival and quality of life of patients after curative resection for esophageal squamous cell carcinoma.

PubMed

Wang, Lu; Wang, Cong; Wang, Jiangfeng; Huang, Xiaochen; Cheng, Yufeng

2017-10-01

A novel systemic immune-inflammation index (SII) based on platelet (P), neutrophil (N), and lymphocyte (L) counts has been reported to be associated with clinical outcomes in several solid tumors. We aimed to investigate its prognostic value in esophageal squamous cell carcinoma (ESCC) and the potential relationship with quality of life (QOL). A total of 280 ESCC patients who underwent esophagectomy were enrolled. SII (SII = P × N/L) was calculated on the basis of data obtained within 1 week before surgery. An optimal cut-off value stratified patients into high (≥560) and low (<560) preoperative SII groups. The widely used EORTC QLQ-C30 and QLQ-OES18 were utilized to assess QOL at cancer diagnosis and 36 months after surgery. Generalized estimating equations (GEEs) were used to evaluate the association of SII with QOL. Kaplan-Meier method and Cox proportional regression were used to analyze the prognostic value of SII. Kaplan-Meier analyses revealed that higher SII correlated significantly with poorer overall survival (OS) (p < 0.001) and disease-free survival (DFS) (p < 0.001) in patients with ESCC. Multivariate analysis identified SII as an independent prognostic factor for OS (p < 0.001; HR 2.578; 95% CI 1.625-4.088) and DFS (p < 0.001; HR 2.699; 95% CI 1.726-4.223). In addition, patients with high SII exhibited notably deteriorating QOL (p < 0.05). The preoperative SII is a promising biomarker for predicting survival and QOL of patients with ESCC. It may help to identify the high-risk patients for treatment strategy decisions.

Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.

PubMed

Kataoka, Tomoko; Kiyota, Naomi; Shimada, Takanobu; Funakoshi, Yohei; Chayahara, Naoko; Toyoda, Masanori; Fujiwara, Yutaka; Nibu, Ken-Ichi; Komori, Takahide; Sasaki, Ryohei; Mukohara, Toru; Minami, Hironobu

2016-12-01

Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC+G). Gabapentin was maintained at 900mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC+G (n=11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). Adverse events related to gabapentin were manageable. This pilot study is the first prospective randomized trial of gabapentin for RIM-related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM-related pain is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Do Patients Feel Well Informed in a Radiation Oncology Service?

PubMed

Jimenez-Jimenez, Esther; Mateos, Pedro; Ortiz, Irene; Aymar, Neus; Vidal, Meritxell; Roncero, Raquel; Pardo, Jose; Soto, Carmen; Fuentes, Concepción; Sabater, Sebastià

2018-04-01

Information received by cancer patients has gained importance in recent decades. The aim of this study was to evaluate the perception of information received by oncological patients in a radiotherapy department and to measure the importance of the other information sources. A cross-sectional study was conducted, evaluating patients who received radiotherapy. All the patients were asked two questionnaires: the EORTC QLQ-INFO26 module evaluating their satisfaction with received information, and a questionnaire analyzing other sources of information search. One hundred patients between 27 and 84 years were enrolled. Breast cancer (26 %) was the commonest cancer. Patients felt better informed about the medical tests and secondly about the performed treatment. The younger patients were those who were more satisfied with the information received and patients with no formal education felt less satisfied, with statistically significant differences. Patients did not seek external information; at the most, they asked relatives and other people with cancer. Patients were satisfied with the received information, although a high percentage would like more information. In general, patients did not search for external information sources. Age and educational level seem to influence in the satisfaction with the received information.

Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study)

PubMed Central

Caminiti, Caterina; Iezzi, Elisa; Passalacqua, Rodolfo

2017-01-01

Introduction Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient’s health-related quality of life (HRQoL). Methods and analysis Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centres are exposed to the intervention, and a final epoch when all centres will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. A total of 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. The primary aim is to evaluate the effectiveness of the HQIS versus standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items) questionnaire, at baseline and at 3 months. This outcome was chosen because patients with cancer generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy’s impact as perceived by patients themselves. The HQIS comprises three phases: (1) clinician training—to improve communication-relational skills and instruct on the project; (2) centre support—four on-site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; (3) implementation of Evidence-Based Medicine (EBM) recommendations at the centre. Ethics and dissemination Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, and in peer-reviewed and professional journals intended for policymakers and managers. Trial registration number NCT03008993; Pre-results. PMID:28988170

Association of nutritional status with quality of life in breast cancer survivors.

PubMed

Mohammadi, Shooka; Sulaiman, Suhaina; Koon, Poh Bee; Amani, Reza; Hosseini, Seyed Mohammad

2013-01-01

Nutritional status and dietary intake play a significant role in the prognosis of breast cancer and may modify the progression of disease. The aim of this study was to determine the influence of nutritional status on the quality of life of Iranian breast cancer survivors. Cross-sectional data were collected for 100 Iranian breast cancer survivors, aged 32 to 61 years, attending the oncology outpatient clinic at Golestan Hospital, Ahvaz, Iran. Nutritional status of subjects was assessed by anthropometric measurements, Patient-Generated Subjective Global Assessment (PG-SGA) and three non-consecutive 24-hour diet recalls. The European Organization of Research and Treatment of Cancer Quality of Life form (EORTC QLQ-C30) was used to assess quality of life. Ninety-four percent of the survivors were well-nourished, 6% were moderately malnourished or suspected of being malnourished while none were severely malnourished. Prevalence of overweight and obesity was 86%. Overall, participants had an inadequate intake of vitamin D, E, iron and magnesium according to dietary reference intake (DRI) recommendations. Survivors with better nutritional status had better functioning scales and experienced fewer clinical symptoms. It appears important to provide educational and nutritional screening programs to improve cancer survivor quality of life.

Quality of life of Brazilian and Spanish cancer patients undergoing chemotherapy: an integrative literature review.

PubMed

Sawada, Namie Okino; Nicolussi, Adriana Cristina; de Paula, Juliana Maria; Garcia-Caro, Maria Paz; Marti-Garcia, Celia; Cruz-Quintana, Francisco

2016-01-01

characterize the scientific production of Brazil and Spain in regard to methodological aspects and aspects of health-related quality of life experienced by cancer patients receiving chemotherapy in both countries. integrative literature review was conducted using the following databases: CINAHL, MEDLINE, SCOPUS and CUIDEN and the electronic libraries PubMed and SciELO, conducted in September 2013. a total of 28 papers met the inclusion criteria. The synthesis of knowledge was presented in three categories of analysis: assessment of quality of life in different types of cancer; sociodemographic factors that influenced quality of life; and type of cancer and interventions that improve quality of life. Chemotherapy affects health-related quality of life and the most important factors were: age, sex, chemotherapy protocol, type of surgery, stage of the disease, educational level, and emotional intelligence. Complementary therapies such as acupuncture, guided visualization, prayers and exercise were positive and reduced side effects. the results showed a poor level of evidence, since 86% of the studies were cross-sectional descriptive studies; the instrument most frequently used to measure health-related quality of life was EORTC QLQ C-30 and more studies were conducted in Brazil than in Spain.

Health-related quality of life in rehabilitants with different cancer entities.

PubMed

Lamprecht, J; Thyrolf, A; Mau, W

2017-09-01

The focus of the study is the analysis of changes in health-related quality of life in various cancer entities during and after an inpatient rehabilitation programme. In a multicentre longitudinal study, a total of 211 cancer patients (breast cancer: N = 84; prostate cancer: N = 90; colon cancer: N = 37) were asked about their quality of life (EORTC QLQ-C30; HADS) at the beginning, the end and 3 months after the end of the rehabilitation programme. In different domains of quality of life significant and mostly clinically relevant improvements were found during rehabilitation. The breast and prostate cancer patients improved most in emotional functioning, colon cancer patients in global quality of life. With regard to the severity of symptoms, the fatigue burden improved in breast and colon cancer patients, nausea in the prostate cancer patients. However, they are increases 3 months after rehabilitation. Functional burdens improved 3 months after the end of rehabilitation in the physical domain for all cancer patients. For breast cancer patients, emotional functioning decreased significantly 3 months after rehabilitation. An inpatient oncological rehabilitation programme can lead to an improvement in quality of life. © 2016 John Wiley & Sons Ltd.

Self-perception versus professional assessment of functional outcome after ablative surgery in patients with oral cancer.

PubMed

Beck-Broichsitter, Benedicta E; Huck, Jörn; Küchler, Thomas; Hauke, Daniela; Hedderich, Jürgen; Wiltfang, Jörg; Becker, Stephan T

2017-02-01

The extent of functional impairment after ablative surgery in the orofacial region may be directly reflected in a reduction in Quality of Life. This study intended to compare the patients' perception with an objective functional evaluation of the orofacial system in order to bilaterally distinguish direct influence factors. A total of 45 patients were included in this study and were asked to complete the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) and the Head and Neck 35 Module (H&N 35). Afterward one independent speech therapist evaluated the patients applying the Frenchay Dysarthria Assessment regarding four main categories: mouth opening, tongue motility, swallowing and intelligibility. Comparisons between groups were performed using Whitney-Mann U-Wilcoxon test and calculating Spearman's rho. Overall the professional assessments by the speech therapists revealed significantly higher scores regarding intelligibility, swallowing and mouth opening when compared to the patients' self-perception. Smaller tumor sizes, no bone resection and local reconstruction techniques led to significantly better functional outcomes, when assessed by speech therapists. Swallowing was perceived significantly better by patients in cases of local reconstruction. From the professionals' point of view differences were perceived in more items compared to the patients' self-assessments, who widely experienced a more severe functional impairment. Physicians should take this into account when discussing adverse therapy effects with the patients.

The assessment of fatigue: Psychometric qualities and norms for the Checklist individual strength.

PubMed

Worm-Smeitink, M; Gielissen, M; Bloot, L; van Laarhoven, H W M; van Engelen, B G M; van Riel, P; Bleijenberg, G; Nikolaus, S; Knoop, H

2017-07-01

The Checklist Individual Strength (CIS) measures four dimensions of fatigue: Fatigue severity, concentration problems, reduced motivation and activity. On the fatigue severity subscale, a cut-off score of 35 is used. This study 1) investigated the psychometric qualities of the CIS; 2) validated the cut-off score for severe fatigue and 3) provided norms. Representatives of the Dutch general population (n=2288) completed the CIS. The factor structure was investigated using an exploratory factor analysis. Internal consistency and test-retest reliability were determined. Concurrent validity was assessed in two additional samples by correlating the CIS with other fatigue scales (Chalder Fatigue Questionnaire, MOS Short form-36 Vitality subscale, EORTC QLQ-C30 fatigue subscale). To validate the fatigue severity cut-off score, a Receiver Operating Characteristics analysis was performed with patients referred to a chronic fatigue treatment centre (n=5243) and a healthy group (n=1906). Norm scores for CIS subscales were calculated for the general population, patients with chronic fatigue syndrome (CFS; n=1407) and eight groups with other medical conditions (n=1411). The original four-factor structure of the CIS was replicated. Internal consistency (α=0.84-0.95) and test-retest reliability (r=0.74-0.86) of the subscales were high. Correlations with other fatigue scales were moderate to high. The 35 points cut-off score for severe fatigue is appropriate, but, given the 17% false positive rate, should be adjusted to 40 for research in CFS. The CIS is a valid and reliable tool for the assessment of fatigue, with a validated cut-off score for severe fatigue that can be used in clinical practice. Copyright © 2017. Published by Elsevier Inc.

Effectiveness of an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study

PubMed Central

Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

2017-01-01

Background Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). Material/Methods This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. Results There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: −39.31 vs. self-efficacy: −27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. Conclusions This intervention promoting self-efficacy could increase patients’ own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC. PMID:28832557

Influence of chemoradiotherapy on nutritional status, functional capacity, quality of life and toxicity of treatment for patients with cervical cancer.

PubMed

Aredes, Mariah A; Garcez, Marcelly R; Chaves, Gabriela V

2018-02-21

Assess the influence of chemoradiotherapy on the nutritional status, functional capacity and quality of life (QoL), associating these indicators at baseline with toxicity and interruption of oncologic treatment in women with cervical cancer. Prospective cohort study performed on 49 women diagnosed with cervical cancer, who underwent treatment between August 2015 and January 2016. For data collection, two appointments were conducted by the lead researcher: the first occurred the day before the first chemotherapy session (T0) and the other at the end of chemotherapy session (T1). Nutritional status was measured by anthropometry (weight, height, mid-upper arm circumference and triceps skinfold thickness) and computed tomography (skeletal muscle index-SMI), functional capacity by handgrip strength (HGS) and Karnofsky Performance Status (KPS), and application of QoL questionnaire (EORTC QLQ-C30). The average age was 45 ± 13.8 years and 81.6% of the women were diagnosed in stages II and III. There was significant reduction in HGS, KPS and QoL between T0 and T1, in addition to a significant QoL reduction according to worsening nutritional status. The interruption of chemotherapy was significantly associated with the variables of nutritional status assessed at baseline. Women who interrupted treatment due to acute toxicity also had a significant lower median SMI than those who concluded the treatment and 83% of these patients presented cachexia. Chemoradiotherapy treatment in patients with cervical cancer had changed negative nutritional parameters, function capacity and QoL, and poor nutritional status at baseline was associated with chemotherapy interruption. © 2018 Dietitians Association of Australia.

The relationship of quality of life and distress in prostate cancer patients compared to the general population.

PubMed

Zenger, Markus; Lehmann-Laue, Antje; Stolzenburg, Jens-Uwe; Schwalenberg, Thilo; Ried, Alexander; Hinz, Andreas

2010-06-30

The aim of this study is two-fold. The first part compares quality of life (QoL) data of prostate cancer patients with those of a representative and age-specific sample of the general population and analyzes the influence of cancer related as well as socio-demographic parameters on QoL. Secondly, differences in QoL depending on the experienced psychological distress will be shown both in prostate cancer patients and in the general population. A sample of 265 prostate cancer patients completed both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Hospital Anxiety and Depression Scale (HADS) during their stay in the hospital. A total HADS cut off score of 15 was used to indicate psychological distress and significant emotional concerns in patients and men of the general population. The results of the patients were compared with those of the general population (N=444). Prostate cancer patients reported significantly worse levels of social and emotional functioning as well as more symptoms like insomnia, constipation and diarrhea compared to the general population. Patients and men of the general population with a total HADS score >/=15 reported lower QoL in all sub-scales except for diarrhea in comparison to people without distress. Psychological distress is accompanied by lower QoL and therefore should be taken into consideration when QoL is assessed. Furthermore, clinicians should be trained by professionals to detect distress in their patients and to pay more attention to their emotional concerns, which are strongly associated with the patients' well-being and QoL during their stay in hospital.

The relationship of quality of life and distress in prostate cancer patients compared to the general population

PubMed Central

Zenger, Markus; Lehmann-Laue, Antje; Stolzenburg, Jens-Uwe; Schwalenberg, Thilo; Ried, Alexander; Hinz, Andreas

2010-01-01

Background: The aim of this study is two-fold. The first part compares quality of life (QoL) data of prostate cancer patients with those of a representative and age-specific sample of the general population and analyzes the influence of cancer related as well as socio-demographic parameters on QoL. Secondly, differences in QoL depending on the experienced psychological distress will be shown both in prostate cancer patients and in the general population. Material and Methods: A sample of 265 prostate cancer patients completed both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Hospital Anxiety and Depression Scale (HADS) during their stay in the hospital. A total HADS cut off score of 15 was used to indicate psychological distress and significant emotional concerns in patients and men of the general population. The results of the patients were compared with those of the general population (N=444). Results: Prostate cancer patients reported significantly worse levels of social and emotional functioning as well as more symptoms like insomnia, constipation and diarrhea compared to the general population. Patients and men of the general population with a total HADS score ≥15 reported lower QoL in all sub-scales except for diarrhea in comparison to people without distress. Discussion: Psychological distress is accompanied by lower QoL and therefore should be taken into consideration when QoL is assessed. Furthermore, clinicians should be trained by professionals to detect distress in their patients and to pay more attention to their emotional concerns, which are strongly associated with the patients’ well-being and QoL during their stay in hospital. PMID:20628652

Neurocognitive functioning and health-related quality of life in patients treated with stereotactic radiotherapy for brain metastases: a prospective study

PubMed Central

Habets, Esther J.J.; Dirven, Linda; Wiggenraad, Ruud G.; Verbeek-de Kanter, Antoinette; Lycklama à Nijeholt, Geert J.; Zwinkels, Hanneke; Klein, Martin; Taphoorn, Martin J.B.

2016-01-01

Background Stereotactic radiotherapy (SRT) is expected to have a less detrimental effect on neurocognitive functioning and health-related quality of life (HRQoL) than whole-brain radiotherapy. To evaluate the impact of brain metastases and SRT on neurocognitive functioning and HRQoL, we performed a prospective study. Methods Neurocognitive functioning and HRQoL of 97 patients with brain metastases were measured before SRT and 1, 3, and 6 months after SRT. Seven cognitive domains were assessed. HRQoL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and BN20 questionnaires. Neurocognitive functioning and HRQoL over time were analyzed with linear mixed models and stratified for baseline Karnofsky performance status (KPS), total metastatic volume, and systemic disease. Results Median overall survival of patients was 7.7 months. Before SRT, neurocognitive domain and HRQoL scores were lower in patients than in healthy controls. At group level, patients worsened in physical functioning and fatigue at 6 months, while other outcome parameters of HRQoL and cognition remained stable. KPS < 90 and tumor volume >12.6 cm3 were both associated with worse information processing speed and lower HRQoL scores over 6 months time. Intracranial tumor progression was associated with worsening of executive functioning and motor function. Conclusions Prior to SRT, neurocognitive functioning and HRQoL are moderately impaired in patients with brain metastases. Lower baseline KPS and larger tumor volume are associated with worse functioning. Over time, SRT does not have an additional detrimental effect on neurocognitive functioning and HRQoL, suggesting that SRT may be preferred over whole-brain radiotherapy. PMID:26385615

The assessment of anorexia in patients with cancer: cut-off values for the FAACT-A/CS and the VAS for appetite.

PubMed

Blauwhoff-Buskermolen, S; Ruijgrok, C; Ostelo, R W; de Vet, H C W; Verheul, H M W; de van der Schueren, M A E; Langius, J A E

2016-02-01

Anorexia is a frequently observed symptom in patients with cancer and is associated with limited food intake and decreased quality of life. Diagnostic instruments such as the Anorexia/Cachexia Subscale (A/CS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire and the visual analog scale (VAS) for appetite have been recommended in the assessment of anorexia, but validated cut-off values are lacking. This study aimed to obtain cut-off values of these instruments for the assessment of anorexia in patients with cancer. The FAACT-A/CS and the VAS for appetite were administered to patients with cancer before start of chemotherapy. As reference standard for anorexia, two external criteria were used: (1) a cut-off value of ≥2 on the anorexia symptom scale of the EORTC QLQ C-30 and (2) the question "Do you experience a decreased appetite?" (yes/no). ROC curves were used to examine the optimal cut-off values for the FAACT-A/CS and VAS. A total of 273 patients (58 % male; 64.0 ± 10.6 years) were included. The median score on the FAACT-A/CS was 38 (IQR 32-42) points and 77 (IQR 47-93) points on the VAS. Considering both external criteria, the optimal cut-off value for the FAACT-A/CS was ≤37 (sensitivity (se) 80 %, specificity (sp) 81 %, positive predictive value (PV(+)) 79 %, negative predictive value (PV(-)) 82 %) and for the VAS was ≤70 (se 76 %, sp 83 %, PV(+) 80 %, PV(-) 79 %). For the assessment of anorexia in patients with cancer, our study suggests cut-off values of ≤37 for the FAACT-A/CS and ≤70 for the VAS. Future studies should confirm our findings in other patient samples.

Quality of life in elderly patients with an ostomy - a study from the population-based PROFILES registry.

PubMed

Verweij, N M; Bonhof, C S; Schiphorst, A H W; Maas, H A; Mols, F; Pronk, A; Hamaker, M E

2018-04-01

Ostomies are being placed frequently in surgically treated elderly patients with colorectal cancer (CRC). An insight into the (potential) impact of ostomies on quality of life (QoL) could be useful in patient counselling as well as in the challenging shared treatment decision-making. Patients with CRC diagnosed between 2000 and 2009 and registered in the population-based Eindhoven Cancer Registry received a QoL questionnaire (EORTC QLQ-C30) in 2010. In addition, QoL was compared with an age- and sex-matched normative population. The study included 2299 CRC patients, of whom 494 had an ostomy. No differences were found in reported ostomy-related problems between patients aged ≤65, 66-75 and ≥76 years. Ostomy patients aged 66-75 and ≥76 years reported significantly lower physical functioning compared with those without an ostomy. In the elderly (those aged ≥76 years) ostomates reported a worse physical and social functioning compared with the normative population. All these differences were of small clinical relevance. The impact of an ostomy seems to be more prominent in younger (≤75 years old) ostomates, as they experience more functional limitations and a decrease in global health status compared with younger nonostomy patients and the normative population. Although elderly (≥76 years old) patients with an ostomy report significantly more limitations in functioning compared with a normative population and elderly CRC patients without an ostomy, the clinical relevance of this finding is limited. In contrast, the impact of an ostomy is more prominent in younger patients. Thus, age itself is not a reason for withholding an ostomy. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Implementation and first results of a tablet-based assessment referring to patient-reported outcomes in an inpatient cancer care unit.

PubMed

Schuler, Markus; Trautmann, Freya; Radloff, Mirko; Hentschel, Leopold; Petzold, Thomas; Eberlein-Gonska, Maria; Ehninger, Gerhard; Schmitt, Jochen

2017-04-01

Inclusion of patient-reported outcomes (PROs) in routine cancer care is of key importance for individualized treatment, shared decision making and patient satisfaction. To describe the implementation under routine conditions of an electronic self-administered PRO assessment and comparison of PROs before and after inpatient treatment in oncologic care. In a tablet-based survey PROs on symptom burden, global health status/ quality of life (QoL) and health utility were collected twice (at hospital admission and discharge) in an inpatient oncological setting over a 17-month period using the EORTC QLQ-C30 and EQ-5D questionnaires. Data were linked to the hospital information system (HIS). Patient acceptability, recruitment rates, symptom burden, and clinically meaningful changes in PROs over time were analyzed. From a total of 384 hospitalized patients invited to participate at admission 371 (96.6 %) participated. At discharge, 195 patients were approached for a follow-up assessment, and 192 patients (98.5 %) participated. Despite strong acceptance among patients, recruitment rates were decreasing over time. During the hospital stay clinically meaningful improvements were observed for health utility (33.3 %, n = 64) and global health status/QoL (43.2 %, n = 83). Patients reported a variety of symptoms at admission and discharge. Implementation of PRO assessment in routine care and data integration into the HIS provides valuable information for the entire medical staff as symptom burden is present during the entire hospital stay. Long-term maintenance of PRO assessment in a clinical setting as a prerequisite of value-based healthcare requires continuous involvement of the nursing team, which can only be achieved by allocating resources to this task. Copyright © 2017. Published by Elsevier GmbH.

Oral rehabilitation with dental implants and quality of life following mandibular reconstruction with free fibular flap.

PubMed

Jacobsen, Hans-Christian; Wahnschaff, Falko; Trenkle, Thomas; Sieg, Peter; Hakim, Samer G

2016-01-01

Bony reconstruction of jaw defects using the free fibular flap and dental rehabilitation mostly requires insertion of dental implants within the transferred fibula bone. The aim of this paper was to discuss results of the implant stability with data on the possible benefit for the patient's quality of life after such treatment. For clinical outcome of implants, we evaluated 26 patients with a total number of 94 dental implants after a follow-up period of 12 to 132 months. A group of 38 patients who underwent mandibular reconstruction with free fibular flap could be included in the life-quality study. Evaluation included 23 patients with and 15 patients without implant-borne restoration. The quality of life was assessed using the standard QLQ C-30 questionnaire and the H&N35 module of the European Organisation for Research and Treatment of Cancer (EORTC). Of implants, 94.7 % were stable at the time of investigation and could be used for prosthesis. Patients with dental implants reported improvement of life quality along with better scores in most function and symptom scales; however, only values for global health status (QL2), absence of dyspnea (DY) and absence of feeding tube (HNFE) were significantly better than in the control group. Dental implant insertion in fibula grafts along with implant-borne restoration is a proven concept and might lead to improved quality of life following ablative surgery of the jaw. The effect on the quality of life is not as predictable as on the implant stability. Patients with bony defects of the jaw require bony reconstruction. This allows further masticatory rehabilitation using dental implants and might lead to improved quality of life.

Worse quality of life in young and recently diagnosed breast cancer survivors compared with female survivors of other cancers: A cross-sectional study.

PubMed

Li, Jingmei; Humphreys, Keith; Eriksson, Mikael; Dar, Huma; Brandberg, Yvonne; Hall, Per; Czene, Kamila

2016-12-01

Literature focusing on health-related quality of life (HRQoL) by cancer site among women only is scarce. This study examines HRQoL of breast cancer (BC) survivors compared with female survivors of other cancers, and to understand which subgroups of BC survivors were particularly at risk of reduced HRQoL. We placed emphasis on young (<50 years) and recently diagnosed (≤5 years) survivors, where the deficits in HRQoL were most pronounced. The cross-sectional study consisted of 2,224 BC survivors, 8,504 non-cancer controls and 2,205 other cancer survivors in the Karma study. We examined HRQoL differences using linear regression analyses in the whole cohort and in a subset of young and recently diagnosed BC survivors (n = 242) and female survivors of other cancers (n = 140) with comparable ages at diagnosis (43.6 vs 43.6, p = 0.917) and time since diagnosis (2.3 vs 2.8 years, p < 0.001). HRQoL was assessed using the EORTC QLQ-C30 questionnaire. While only cognitive functioning was significantly compromised in BC survivors compared with survivors of other cancers when women of all ages were included, young BC survivors reported significantly lower HRQoL on multiple functional scales (global quality of life, emotional, role, social and cognitive functioning) and experienced more fatigue and insomnia. BC survivors with any prior medical history of mental disorders reported poorer HRQoL than those without such a history. We also observed a close-knit relationship between tumor and treatment characteristics. BC survivors perform poorly in HRQoL in comparison with female survivors of other cancers. Our results emphasize the importance of age- and gender-appropriate comparison groups. © 2016 UICC.

Effect of Community-Based Occupational Therapy on Health-Related Quality of Life and Engagement in Meaningful Activities of Women with Breast Cancer.

PubMed

Petruseviciene, Daiva; Surmaitiene, Deive; Baltaduoniene, Daiva; Lendraitiene, Egle

2018-01-01

We aimed to evaluate the short-term effects of community-based occupational therapy on health-related quality of life and engagement in meaningful activities among women with breast cancer. An open label randomized controlled trial study design was applied. The participants were members of various societies of women with cancer. In total, 22 women have participated in the study. Participants of the experimental group ( n = 11) participated in a 6-week community-based occupational therapy program and the usual activities of various societies, whereas the control group ( n = 11) women participated in the usual activities of the societies only. 1 of the participants withdrew during the course; therefore 21 completed the study successfully. Participants of both groups were assessed for health-related quality of life and the participants of the experimental group were assessed for engagement in meaningful activities. The evaluation was carried out during the nonacute period of the disease-at the beginning of the study and after 6 weeks. Women of the experimental group demonstrated statistically significantly better scores in the global quality of life, role functions, physical, emotional, cognitive, and social functions, fatigue, insomnia, financial impact, systemic therapy side effects, and breast symptoms scales compared to the control group participants ( p < 0.05) after the 6 weeks, as measured by the EORTC QLQ-C30 questionnaire and its breast cancer module QLQ-BR23 . Furthermore, women of the experimental group demonstrated significant greater engagement in meaningful activities when applying community-based occupational therapy ( p < 0.05), as measured by using the Engagement in Meaningful Activities Survey (EMAS). The evaluation of the associations between the women's engagement in meaningful activities and changes in health-related quality of life showed that greater engagement in meaningful activities was associated with better emotional functions and a lower level of insomnia ( p < 0.05). Based on the results of our study, we recommend applying occupational therapy in the field of community healthcare in order to maintain or improve breast cancer patients' health-related quality of life and suggest involving women into meaningful activities during community-based occupational therapy after clarifying which activities are important to them.

Quality of life in Malay and Chinese women newly diagnosed with breast cancer in Kelantan, Malaysia.

PubMed

Yusuf, Azlina; Ahmad, Zulkifli; Keng, Soon Lean

2013-01-01

Breast cancer is the leading cause of cancer-related death among women in Malaysia. A diagnosis is very stressful for women, affecting all aspects of their being and quality of life. As such, there is little information on quality of life of women with breast cancer across the different ethnic groups in Malaysia. The purpose of this study was to examine the quality of life in Malay and Chinese women newly diagnosed with breast cancer in Kelantan. A descriptive study involved 58 Malays and 15 Chinese women newly diagnosed with breast cancer prior to treatment. Quality of life was measured using the Malay version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast-specific module (QLQ-BR23). Socio-demographic and clinical data were also collected. All the data were analyzed using SPSS version 20.0. Most of the women were married with at least a secondary education and were in late stages of breast cancer. The Malay women had lower incomes (p=0.046) and more children (p=0.001) when compared to the Chinese women. Generally, both the Malay and Chinese women had good functioning quality-of-life scores [mean score range: 60.3-84.8 (Malays); 65.0-91.1 (Chinese)] and global quality of life [mean score 60.3, SD 22.2 (Malays); mean score 65.0, SD 26.6 (Chinese)]. The Malay women experienced more symptoms such as nausea and vomiting (p=0.002), dyspnoea (p=0.004), constipation (p<0.001) and breast-specific symptoms (p=0.041) when compared to the Chinese. Quality of life was satisfactory in both Malays and Chinese women newly diagnosed with breast cancer in Kelantan. However, Malay women had a lower quality of life due to high general as well as breast-specific symptoms. This study finding underlined the importance of measuring quality of life in the newly diagnosed breast cancer patient, as it will provide a broader picture on how a cancer diagnosis impacts multi-ethnic patients. Once health care professionals understand this, they might then be able to determine how to best support and improve the quality of life of these women during the difficult times of their disease and on-going cancer treatments.

Clinical experience with the N-shaped ileal neobladder: assessment of complications, voiding patterns, and quality of life in our series of 58 patients.

PubMed

Joniau, S; Benijts, J; Van Kampen, M; De Waele, M; Ooms, J; Van Cleynenbreugel, B; Van Poppel, H

2005-05-01

The purpose of this retrospective study was to assess complications, voiding patterns, and quality of life in patients with an orthotopic bladder substitution, using an N-shaped ileal neobladder. Between May 1996 and December 2002, 58 patients (52 men and 6 women) underwent an orthotopic ileal neobladder reconstruction after radical cystectomy. The mean age was 47 for the female and 60 for the male patients. In all patients an N-shaped ileal pouch was constructed. This pouch has not yet been described in the literature before. All procedures were performed by the same surgeon (HVP) and the mean follow-up was 38 months. Complications were registered as early (occurring within 3 months) or late (occurring after 3 months), and as pouch-related and non-pouch-related. The patients took part in a pelvic floor re-education programme for as long as they were incontinent. All patients completed a retrospective Quality of Life questionnaire, based on the QLQ-C30 questionnaire, which was validated by the EORTC's Study Group on Quality of Life. In 38% of the patients, early complications occurred, whereas 48% had late complications. The most frequent early complications were diarrhea (24%) and pyelonephritis (9%). Diarrhea was again the most frequently mentioned non-pouch-related complication (19%). The most frequently observed pouch-related late complication was ileo-urethral stenosis. This occurred in five patients. All of these 5 patients were re-operated using a minimally invasive approach. Daytime continence was achieved in 95% of patients and nighttime continence in 66%. Hyper-continence with subsequent need for CISC was observed in 5 out of 6 women (83%) and 0 out of 52 men (0%). The retrospective QoL questionnaire learned that the impact of bladder removal and orthotopic bladder substitution has acceptable impact on patient's everyday life. Diarrhea was mentioned as being the most discomforting complication by most of the patients. We describe a modified orthotopic ileal neobladder: the ileal N-pouch. The functional results with this pouch are good. Complication rates and QoL are comparable with the larger series published by other authors, using different ileal neobladder reconstructions.

[Functional impairment and quality of life after rectal cancer surgery].

PubMed

Mora, Laura; Zarate, Alba; Serra-Aracil, Xavier; Pallisera, Anna; Serra, Sheila; Navarro-Soto, Salvador

2018-01-01

This study determines the quality of life and the anorectal function of these patients. Observational study of two cohorts comparing patients undergoing rectal tumor surgery using TaETM or conventional ETM after a minimum of six months of intestinal transit reconstruction. EORTC-30, EORTC-29 quality of life questionnaires and the anorectal function assessment questionnaire (LARS score) are applied. General variables are also collected. 31 patients between 2011 and 2014: 15 ETM group and 16 TaETM. We do not find statistically significant differences in quality of life questionnaires or in anorectal function. Statistically significant general variables: longer surgical time in the TaETM group. Nosocomial infection and minor suture failure in the TaETM group. The performance of TaETM achieves the same results in terms of quality of life and anorectal function as conventional ETM. Copyright: © 2018 Permanyer.

Development of a hospital-based patient-reported outcome framework for lung cancer patients: a study protocol.

PubMed

Moloczij, Natasha; Gough, Karla; Solomon, Benjamin; Ball, David; Mileshkin, Linda; Duffy, Mary; Krishnasamy, Mei

2018-01-11

Patient-reported outcome (PRO) data is central to the delivery of quality health care. Establishing sustainable, reliable and cost-efficient methods for routine collection and integration of PRO data into health information systems is challenging. This protocol paper describes the design and structure of a study to develop and pilot test a PRO framework to systematically and longitudinally collect PRO data from a cohort of lung cancer patients at a comprehensive cancer centre in Australia. Best-practice guidelines for developing registries aimed at collecting PROs informed the development of this PRO framework. Framework components included: achieving consensus on determining the purpose of the framework, the PRO measures to be included, the data collection time points and collection methods (electronic and paper), establishing processes to safeguard the quality of the data collected and to link the PRO framework to an existing hospital-based lung cancer clinical registry. Lung cancer patients will be invited to give feedback on the PRO measures (PROMs) chosen and the data collection time points and methods. Implementation of the framework will be piloted for 12 months. Then a mixed-methods approach used to explore patient and multidisciplinary perspectives on the feasibility of implementing the framework and linking it to the lung cancer clinical registry, its clinical utility, perceptions of data collection burden, and preliminary assessment of resource costs to integrate, implement and sustain the PRO framework. The PRO data set will include: a quality of life questionnaire (EORTC-QLQ-C30) and the EORTC lung cancer specific module (QLQC-LC-13). These will be collected pre-treatment (baseline), 2, 6 and 12 months post-baseline. Also, four social isolation questions (PROMIS) will be collected at baseline. Identifying and deciding on the overall purpose, clinical utility of data and which PROs to collect from patients requires careful consideration. Our study will explore how PRO data collection processes that link to a clinical data set can be developed and integrated; how PRO systems that are easy for patients to complete and professionals to use in practice can be achieved, and will provide indicative costs of developing and integrating a longitudinal PRO framework into routine hospital data collection systems. This study is not a clinical trial and is therefore not registered in any trial registry. However, it has received human research ethics approval (LNR/16/PMCC/45).

Anxiety, depression, perceived social support and quality of life in Malaysian breast cancer patients: a 1-year prospective study.

PubMed

Ng, Chong Guan; Mohamed, Salina; See, Mee Hoong; Harun, Faizah; Dahlui, Maznah; Sulaiman, Ahmad Hatim; Zainal, Nor Zuraida; Taib, Nur Aishah

2015-12-30

Depression and anxiety are common psychiatric morbidity among breast cancer patient. There is a lack of study examining the correlation between depression, anxiety and quality of life (QoL) with perceived social support (PSS) among breast cancer patients. This study aims to study the level of depression, anxiety, QoL and PSS among Malaysian breast cancer women over a period of 12 months and their associations at baseline, 6 and 12 months. It is a 12 months prospective cohort study. Two hundred and twenty one female patients were included in the study. They were assessed at the time of diagnosis, 6 months and 12 month using Hospital Anxiety and Depression Scale (HADS), Quality-of-Life Questionnaire (QLQ-C30), Version 3.0 of the EORTC Study Group and Multidimensional Scale of Perceived Social Support (MSPSS). The information of age, ethnicity, types of treatment, and staging of cancer were collected. The HADS anxiety and depression subscales scores of the subjects were relatively low. The level of anxiety reduced significantly at 6 and 12 months (Baseline - 6 months, p = 0.002; Baseline - 12 months, p < 0.001). There were no changes in the level of depression over the study period. The global status of QoL and MSPSS scores were relatively high. Correlation between the global status of QoL and MSPSS for the study subjects was positive (Spearman's rho = 0.31-0.36). Global status of QoL and MSPSS scores were negatively correlated with anxiety and depression. Malaysian breast cancer women had relatively better QoL with lower level of anxiety and depression. Perceived social support was an important factor for better QoL and low level of psychological distress. It reflects the importance of attention on activities that enhance and maintain the social support system for breast cancer patients.

Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.

PubMed

Grob, J-J; Amonkar, M M; Martin-Algarra, S; Demidov, L V; Goodman, V; Grotzinger, K; Haney, P; Kämpgen, E; Karaszewska, B; Mauch, C; Miller, W H; Millward, M; Mirakhur, B; Rutkowski, P; Chiarion-Sileni, V; Swann, S; Hauschild, A

2014-07-01

In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial. The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks. This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient. ClinicalTrials.gov Identifier: NCT01227889. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

PubMed Central

2011-01-01

Background To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Methods Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. Results From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. Conclusions In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. Trial registration ClinicalTrials.gov NCT00540800. PMID:21324184

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial.

PubMed

Nuzzo, Francesco; Morabito, Alessandro; Gravina, Adriano; Di Rella, Francesca; Landi, Gabriella; Pacilio, Carmen; Labonia, Vincenzo; Rossi, Emanuela; De Maio, Ermelinda; Piccirillo, Maria Carmela; D'Aiuto, Giuseppe; Thomas, Renato; Rinaldo, Massimo; Botti, Gerardo; Di Bonito, Maurizio; Di Maio, Massimo; Gallo, Ciro; Perrone, Francesco; de Matteis, Andrea

2011-02-16

To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. ClinicalTrials.gov NCT00540800.

Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial.

PubMed

Wienert, Julian; Schwarz, Betje; Bethge, Matthias

2016-07-27

Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors. To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60 years with a Karnofsky Performance Status of ≥70 %, a preliminary positive social-medical prognosis of employability for at least 3 h/day within the next 6 months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients' capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC-QLQ30. Secondary outcome measures are the remaining scales of the EORTC-QLQ30, fatigue, self-rated work ability, disease coping, participation in working life, realization of work-related goals and therapies during rehabilitation, and treatment satisfaction. A positive evaluation of work-related medical rehabilitation in cancer patients is expected due to the promising findings on the effectiveness of such programs for patients with other health conditions. Results may support the dissemination of work-related medical rehabilitation programs in German cancer rehabilitation. German Clinical Trials Register DRKS00007770 . Registered 13 May 2015.

Physical exercise, vegetable and fruit intake and health-related quality of life in Chinese breast cancer survivors: a cross-sectional study.

PubMed

Gong, Xiao-Huan; Wang, Ji-Wei; Li, Jiang; Chen, Xue-Fen; Sun, Li; Yuan, Zheng-Ping; Yu, Jin-Ming

2017-06-01

Breast cancer has long-term effects on health-related quality of life (HRQOL) of cancer survivors after treatment. Few research studies have focused on the association between health behaviors and HRQOL of Chinese breast cancer survivors (BCS). The aim of this study was to examine the separate and combined influence of physical exercise, vegetable and fruit intake on health-related quality of life of BCS. A cross-sectional study was conducted among BCS from April to July 2013, in Shanghai, China. Data were collected using a self-reported questionnaire, which included questions about basic socio-demographic characteristics, health conditions and treatments, health behaviors and HRQOL. HRQOL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) simplified Chinese V3.0 version and the Functional Assessment of Cancer Therapy-General (FACT-G) simplified Chinese 4th version. Multiple linear regression models were performed to estimate the effects of physical exercise, vegetable and fruit intake as well as the effects of health behavior patterns on HRQOL adjusting for potential confounding variables. Exercisers reported significantly higher scores in most HRQOL dimensions than non-exercisers. Participants who ate more than 250 g of vegetables reported significantly higher scores in most HRQOL dimensions than participants who ate equal or less than 250 g of vegetables. Participants who ate fruit every day reported significantly higher scores in all HRQOL dimensions than those who did not eat fruit every day (P Adjusted  ≤ 0.032), except symptom subscales. All subscale scores and total scores of HRQOL, except symptom subscales, were positively associated with the number of adopted healthy lifestyle behaviors (P Trend  ≤ 0.003). Compared to participants who adopted only one healthy behavior, participants who adopted two or three healthy behaviors both reported significantly higher HRQOL scores. Physical exercise, enough vegetable and fruit intake are positively associated with HRQOL of BCS. BCS who adopted several healthy behaviors simultaneously had better HRQOL than one healthy behavior alone. Healthy behaviors, including engagement in exercise, proper diet, especially comprehensive lifestyle behavior interventions, should be valued in improving HRQOL of BCS.

Symptom Prevalence of Patients with Cancer in a Tertiary Cancer Center in Jordan.

PubMed

Alawneh, Alia; Anshasi, Huda; Khirfan, Ghaleb; Yaseen, Hesham; Quran, Anood

2017-01-01

Prevalence of symptoms experienced by patients with cancer was studied in different parts of the world. In Jordan, to the best of our knowledge, there is no published data on the prevalence of symptoms among patients with cancer. The aim of this study is to estimate the prevalence of symptoms among patients with cancer in Jordan. This was a secondary analysis of crosssectional survey that evaluate the psychometric properties of the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) among patients admitted to a tertiary cancer center in Jordan. A total of 175 patients with cancer participated in the study; 51.4% were males, 48.6 % were females, mean age of patients was 50 years. Median number of symptoms per patient was 6, interquartile range was 5-7. The majority of patients (143; 81%) had more than 3 non-pain symptoms each. The most frequently reported symptom was tiredness (82%), whereas the least prevalent symptom was depression (55%). Pain was prevalent in 71% of patients, median severity score was 50%. Patients with cancer suffer from a large constellation of symptoms, frequent assessment with a designated tool can help early identification of these symptoms and subsequent management. This highlights the need for integrated palliative services along with other health care provision.

Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients.

PubMed

Lui, Michelle; Gallo-Hershberg, Daniela; DeAngelis, Carlo

2017-12-22

Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT). The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients. Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal incontinence and abdominal symptoms. Cronbach's alpha was 0.78; kappa ranged from 0.934-0.952, except for abdominal spasms (κ = 0.0455). The positive predictive value was 96.4%, with the minimum score of 1.35 predicting a positive STID occurrence. Patients with moderate or severe diarrhea experience significant decreases in QoL compared to those with no diarrhea. This is the first patient-reported questionnaire that accurately predicts the occurrence and severity of diarrhea in oncology patients via assessing several bowel habit dimensions.

Clinical outcome of using gastric remnant or jejunum or colon conduit in surgery for esophageal carcinoma with previous gastrectomy.

PubMed

Jun, Wang; Wei, Wen; Weibing, Wu; Jing, Xu; Fuxi, Zhen; Xiaoxiang, Xi; Bihong, Lu; Tong, Zhou; Liang, Chen; Jinhua, Luo

2017-05-01

For esophageal carcinoma patients with early gastrectomy, individualized surgical plans-including selection of replacement conduit and operation route based on patient's new lesion and surgical history-can achieve the desired therapeutic effect and improve postoperative life quality. We investigated the outcomes at our institution. The clinical data of 42 esophageal carcinoma patients with early gastrectomy were analyzed retrospectively. Esophagectomy was performed combining replacement with remnant stomach in 16 patients, jejunum in 17, and colon in 9. Esophagectomy combining replacement with gastric remnant got advantages of shorter operation time and less bleeding over that of replacement with jejunum or colon. Gastric remnant group scored higher on the QLQ-C30 questionnaire than jejunum or colon group with respect to overall quality of life, physical function, and social relationships. In QLQ-OES18 questionnaire, the scores of appetite recovery and reflux mitigation were more favorable in remnant stomach group than those in jejunum or colon group. Survival analysis showed no significant difference in survival rate among the patients undergoing replacement with gastric remnant, jejunum, or colon. For esophageal carcinoma patients with early gastrectomy, esophagus-gastric remnant anastomosis possesses advantages of shorter operation time, less surgical trauma, and greater life quality after surgery. © 2017 Wiley Periodicals, Inc.

Ondansetron rapidly dissolving film for the prophylactic treatment of radiation-induced nausea and vomiting-a pilot study.

PubMed

Wong, E; Pulenzas, N; Bedard, G; DeAngelis, C; Zhang, L; Tsao, M; Danjoux, C; Thavarajah, N; Lechner, B; McDonald, R; Cheon, P M; Chow, E

2015-06-01

The purpose of the present study was to investigate the efficacy of an ondansetron rapidly dissolving film (rdf) in the prophylaxis of radiation-induced nausea and vomiting (rinv). Rapidly dissolving film formulations facilitate drug delivery in circumstances in which swallowing the medication might be difficult for the patient. Patients undergoing palliative radiotherapy at risk for rinv were prescribed ondansetron rdf 8 mg twice daily while on treatment and were asked to complete a nausea and vomiting-specific daily diary, the Functional Living Index-Emesis (flie), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C15 Palliative (qlq-C15-pal). Patients were categorized as receiving primary or secondary prophylaxis based on whether they had already experienced emetic episodes. "Overall control" was defined as a maximum increase of 2 episodes of nausea or vomiting from baseline. "Acute phase" was defined as the days during radiation until the first day after radiation; "delayed phase" was defined as days 2-10 after radiation. The study accrued 30 patients. Rates of overall control for nausea and for vomiting during the acute phase in the primary prophylaxis group were 88% and 93% respectively; during the delayed phase, they were 73% and 75%. Rates of overall control for nausea and for vomiting during the acute phase in the secondary prophylaxis group were both 100%; during the delayed phase, they were 50%. The number of nausea and vomiting episodes was found to be significantly correlated with the flie and qlq-C15-pal questionnaires. Ondansetron rdf is effective for the prophylaxis of rinv.

Impact of total pancreatectomy: short- and long-term assessment.

PubMed

Barbier, Louise; Jamal, Wisam; Dokmak, Safi; Aussilhou, Béatrice; Corcos, Olivier; Ruszniewski, Philippe; Belghiti, Jacques; Sauvanet, Alain

2013-11-01

The aim was to assess the outcome of a total pancreatectomy (TP). From 1993 to 2010, 56 patients underwent an elective TP for intraductal papillary mucinous neoplasia (n = 42), endocrine tumours (n = 6), adenocarcinoma (n = 5), metastases (n = 2) and chronic pancreatitis (n = 1). Morbidity and survival were analysed. Long-term survivors were assessed prospectively using quality-of-life (QoL) questionnaires. Five patients developed gastric venous congestion intra-operatively. Post-operative morbidity and mortality rates were 45% and 3.6%, respectively. An anastomotic ulcer occurred in seven patients, but none after proton pump inhibitor therapy. There were five inappropriate TPs according to definitive pathological examination. Overall 3- and 5-year survival rates were 62% and 55% respectively; five deaths were related to TP (two postoperative deaths, one hypoglycaemia, one ketoacidosis and one anastomotic ulcer). Prospective evaluation of 25 patients found that 14 had been readmitted for diabetes and that all had hypoglycaemia within the past month. The glycated haemoglobin (HbA1c) was 7.8% (6.3-10.3). Fifteen patients experienced weight loss. The QLQ-C30 questionnaire showed a decrease in QoL predominantly because of fatigue and diarrhoea, and the QLQ-PAN26 showed an impact on bowel habit, flatulence and eating-related items. Morbidity and mortality rates of TP are acceptable, although diabetes- and TP-related mortality still occurs. Endocrine and exocrine insufficiency impacts on the long-term quality of life. © 2013 International Hepato-Pancreato-Biliary Association.

Quality of life of Brazilian and Spanish cancer patients undergoing chemotherapy: an integrative literature review

PubMed Central

Sawada, Namie Okino; Nicolussi, Adriana Cristina; de Paula, Juliana Maria; Garcia-Caro, Maria Paz; Marti-Garcia, Celia; Cruz-Quintana, Francisco

2016-01-01

Objective: characterize the scientific production of Brazil and Spain in regard to methodological aspects and aspects of health-related quality of life experienced by cancer patients receiving chemotherapy in both countries. Method: integrative literature review was conducted using the following databases: CINAHL, MEDLINE, SCOPUS and CUIDEN and the electronic libraries PubMed and SciELO, conducted in September 2013. Results: a total of 28 papers met the inclusion criteria. The synthesis of knowledge was presented in three categories of analysis: assessment of quality of life in different types of cancer; sociodemographic factors that influenced quality of life; and type of cancer and interventions that improve quality of life. Chemotherapy affects health-related quality of life and the most important factors were: age, sex, chemotherapy protocol, type of surgery, stage of the disease, educational level, and emotional intelligence. Complementary therapies such as acupuncture, guided visualization, prayers and exercise were positive and reduced side effects. Conclusion: the results showed a poor level of evidence, since 86% of the studies were cross-sectional descriptive studies; the instrument most frequently used to measure health-related quality of life was EORTC QLQ C-30 and more studies were conducted in Brazil than in Spain. PMID:27192414

Assessing anxiety and depression with respect to the quality of life in cancer inpatients receiving palliative care.

PubMed

Bužgová, Radka; Jarošová, Darja; Hajnová, Erika

2015-12-01

The study aimed at assessing the presence of anxiety and depression in cancer inpatients receiving palliative care at an oncology department using the Hospital Anxiety and Depression Scale (HADS) and determining whether anxiety and depression contribute to a lower quality of life controlled for pain and illness severity. This cross-sectional study comprised 225 advanced cancer inpatients (a mean age of 65.1 years). Data were collected with the HADS, EORTC QLQ-C30 and Karnofsky Performance Status scale. Anxiety (HADS-a ≥8) was found in 33.9% and depression (HADS-d ≥8) in 47.6% of patients. Higher anxiety scores were observed in patients living with a partner (p = 0.042) and non-religious patients (p = 0.045). Correlations were found between anxiety, depression and all quality of life dimensions (r = 0.31-0.63). Multiple regression analysis showed that anxiety and depression contribute to lower physical and emotional functioning. Patients with anxiety (HADS-a ≥8) and depression (HADS-d ≥8) reported a lower total quality of life (p < 0.01). Management of anxiety and depression in cancer patients receiving palliative care may contribute to improvement in certain quality of life dimensions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.

PubMed

Sandsund, Catherine; Towers, Richard; Thomas, Karen; Tigue, Ruth; Lalji, Amyn; Fernandes, Andreia; Doyle, Natalie; Jordan, Jake; Gage, Heather; Shaw, Clare

2017-08-28

Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold. Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

PubMed

Umbehr, Martin H; Bachmann, Lucas M; Poyet, Cedric; Hammerer, Peter; Steurer, Johann; Puhan, Milo A; Frei, Anja

2018-02-20

No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID. We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID. For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain. The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.

Psychological Correlates of Sexual Dysfunction in Female Rectal and Anal Cancer Survivors: Analysis of Baseline Intervention Data

PubMed Central

Philip, Errol J.; Nelson, Christian; Temple, Larissa; Carter, Jeanne; Schover, Leslie; Jennings, Sabrina; Jandorf, Lina; Starr, Tatiana; Baser, Ray; DuHamel, Katherine

2013-01-01

Introduction Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported and undertreated issue in the field of cancer survivorship. Aim This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. Main Outcomes Measures Quality of life (EORTC-QLQ-C30 & QLQ-CR38), sexual functioning (FSFI) and psychological well-being (BSI Depression/Anxiety, IES-R, CR-38 Body Image). Methods There were 70 female post-treatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. Results Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%) and a median of 4 years post-primary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=−.45 to −.70, all p<.01). Body image, anxiety and cancer-specific post-traumatic distress were notable in their association with subscales of sexual functioning, while a global quality of life measure was largely unrelated. Conclusions For sexually-active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad quality of life assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients. PMID:23551928

Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

PubMed

Caminiti, Caterina; Iezzi, Elisa; Passalacqua, Rodolfo

2017-10-06

Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL). Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centres are exposed to the intervention, and a final epoch when all centres will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. A total of 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. The primary aim is to evaluate the effectiveness of the HQIS versus standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items) questionnaire, at baseline and at 3 months. This outcome was chosen because patients with cancer generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy's impact as perceived by patients themselves. The HQIS comprises three phases: (1) clinician training-to improve communication-relational skills and instruct on the project; (2) centre support-four on-site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; (3) implementation of Evidence-Based Medicine (EBM) recommendations at the centre. Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, and in peer-reviewed and professional journals intended for policymakers and managers. NCT03008993; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

PubMed

Nguyen, Thanh Vân France; Anota, Amélie; Brédart, Anne; Monnier, Alain; Bosset, Jean-François; Mercier, Mariette

2014-01-25

In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients' perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received.

Comparison of health-related quality of life and prostate-associated symptoms after primary and salvage cryotherapy for prostate cancer.

PubMed

Anastasiadis, Aristotelis G; Sachdev, Reena; Salomon, Laurent; Ghafar, Mohamed A; Stisser, Brian C; Shabsigh, Ridwan; Katz, Aaron E

2003-12-01

Recent advances in cryosurgery of the prostate have led to the ability to treat tumors successfully with decreased morbidity. The patients' perspectives of this relatively new technique, however, have not yet been addressed. The purpose of this study was to compare health related quality of life (QoL) as well as prostate-associated symptoms in patients after primary and salvage cryoablation for clinically localized prostate cancer using a self-administered questionnaire. A total of 131 consecutive patients who underwent cryoablation of the prostate between 1997 and 2001 were included in this confidential mailing study. The patients were either (a) patients with localized prostate cancer with contraindications for radical surgery, including patients refusing other forms of therapy, or (b) had locally recurrent prostate cancer after failure of radiation therapy. All patients received 3 months of neoadjuvant androgen deprivation therapy prior to cryosurgery and were surgically treated by the same surgeon using an argon-based system. We used the EORTC QLQ-C30, a commonly used, multidimensional instrument together with a supplementing, prostate-cancer-specific module. Eighty-one of the 131 patients (response rate 62%) returned the questionnaires. The two groups were comparable regarding age (mean age 72.8 vs 70.1 for the primary and the salvage group, respectively; p=0.22). The overall QoL scores were high in both groups. Primary cryotherapy patients fared significantly better regarding physical (p=0.005) and social (p=0.024) functioning compared with salvage cryotherapy patients. The most prominent prostate-related symptom in both patient groups was sexual dysfunction, followed by urinary symptoms, which were significantly more severe in the salvage group (p=0.001). Incontinence rates were 5.9 and 10% in the primary and the salvage group, respectively. Severe erectile dysfunction was reported in 86 and 90% of the primary and the salvage group, respectively. The present study demonstrates that, in selected patients, cryotherapy is a treatment option which has a functional outcome comparable to traditionally used prostate cancer treatments. More information regarding QoL is necessary for appropriate patient counseling and individual decision-making in the presence of various treatment alternatives.

Short-term quality of life in patients undergoing colonic surgery using enhanced recovery after surgery program versus conventional perioperative management.

PubMed

Wang, Hao; Zhu, Dexiang; Liang, Li; Ye, Lechi; Lin, Qi; Zhong, Yunshi; Wei, Ye; Ren, Li; Xu, Jianmin; Qin, Xinyu

2015-11-01

Enhanced recovery after surgery (ERAS) integrates evidence-based interventions to reduce surgical stress and accelerate rehabilitation. Our study was to compare the short-term quality of life (QOL) in patients undergoing open colonic surgery using ERAS program or conventional management. A prospective study of 57 patients using ERAS program and 60 patients using conventional management was conducted. The clinical characteristics of all patients were recorded. QOL was evaluated longitudinally using the questionnaires (EORTC QLQ-C30 and QLQ-CR29) pre- and postoperatively. Generalized estimating equation was used to do the analysis in order to determine the effective impact of correlative factors on the postoperative QOL, including age, sex, BMI, ASA grade, tumor location, tumor size, pTNM stage, recovery program and length of time after surgery. The morbidity in ERAS and control group was 17.5 versus 26.7 % (p = 0.235). The patients in ERAS group had much faster rehabilitation and less hospital stay. In the primary statistical analysis, the scores of global QOL (on POD3, POD6, POD10, POD14, POD21), physical functioning (on POD3, POD6, POD10, POD14, POD21), role functioning (on POD6, POD10, POD14, POD21), emotional functioning (on POD3, POD6, POD10, POD14, POD21), cognitive functioning (on POD3, POD6) and social functioning (on POD3, POD6, POD10, POD14, POD21, POD28) were higher in ERAS group than in control group, which suggested that the patients in ERAS group had a better life status. However, the scores of pain (on POD10, POD14, POD21), appetite loss (on POD3, POD6), constipation (on POD3, POD6, POD10), diarrhea (on POD3, POD10), financial difficulties (on POD10, POD14, POD21), perspective of future health (on POD6, POD10, POD14), gastrointestinal tract problems (on POD3, POD6, POD10) and defecation problems (on POD6, POD10, POD14) were lower in ERAS group than in control group, which revealed that the patients in ERAS group suffered less symptoms. In the further generalized estimating equation analysis, the result showed that recovery program and length of time after surgery had independently positive impact on the patient's postoperative QOL. Short-term QOL in patients undergoing colonic cancer using ERAS program was better than that using conventional management.

Impact of Cardiovascular Counseling and Screening in Hodgkin Lymphoma Survivors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Daniëls, Laurien A., E-mail: l.a.daniels@lumc.nl; Krol, Stijn D.G.; Graaf, Michiel A. de

Purpose: Cardiovascular disease (CVD) is the most common nonmalignant cause of death in Hodgkin lymphoma (HL) survivors, especially after mediastinal irradiation. The role of screening for CVD in HL survivors is unclear, but confrontation with risks of CVD may have a negative influence on health-related quality of life (HRQL). As part of a phase 2 screening study using computed tomography angiography (CTA) among HL survivors, an HRQL analysis was done to evaluate the emotional and practical burden and perceived benefits of screening and the effect of CVD-specific counseling on patient satisfaction. Methods and Materials: Patients who participated in the screeningmore » study also took part in the HRQL study. The impact of undergoing screening was evaluated with a 9-item questionnaire, and impact on HRQL with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire C30, version 3.0. The effect of counseling of CVD on perceived provision of information was evaluated with EORTC INFO-25. All questionnaires were completed at baseline and after screening. Results: Baseline questionnaires were received from 48 participants, and 43 completed questionnaires after screening. Mean age was 47 years, and mean time since diagnosis was 21 years. Of the total, 93% of subjects were content with participating, and 80% did not find the emphasis placed on late effects burdensome, although screening did have a small impact on social functioning and global quality of life. Perceived information on disease, medical tests, and treatment increased significantly after screening (P<.01). Differences were clinically relevant. There were no differences in perceived information between patients with and without screen-detected CVD. Conclusions: Screening was evaluated favorably, whether CTA showed abnormalities or not. Extensive counseling resulted in substantially increased provision of information and improved information satisfaction. Screening by means of CTA and subsequent cardiac intervention was highly valued, and the benefits were felt to outweigh the emotional and practical burden.« less

Impact of cardiovascular counseling and screening in Hodgkin lymphoma survivors.

PubMed

Daniëls, Laurien A; Krol, Stijn D G; de Graaf, Michiel A; Scholte, Arthur J H A; van 't Veer, Mars B; Putter, Hein; de Roos, Albert; Schalij, Martin J; van de Poll-Franse, Lonneke V; Creutzberg, Carien L

2014-09-01

Cardiovascular disease (CVD) is the most common nonmalignant cause of death in Hodgkin lymphoma (HL) survivors, especially after mediastinal irradiation. The role of screening for CVD in HL survivors is unclear, but confrontation with risks of CVD may have a negative influence on health-related quality of life (HRQL). As part of a phase 2 screening study using computed tomography angiography (CTA) among HL survivors, an HRQL analysis was done to evaluate the emotional and practical burden and perceived benefits of screening and the effect of CVD-specific counseling on patient satisfaction. Patients who participated in the screening study also took part in the HRQL study. The impact of undergoing screening was evaluated with a 9-item questionnaire, and impact on HRQL with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire C30, version 3.0. The effect of counseling of CVD on perceived provision of information was evaluated with EORTC INFO-25. All questionnaires were completed at baseline and after screening. Baseline questionnaires were received from 48 participants, and 43 completed questionnaires after screening. Mean age was 47 years, and mean time since diagnosis was 21 years. Of the total, 93% of subjects were content with participating, and 80% did not find the emphasis placed on late effects burdensome, although screening did have a small impact on social functioning and global quality of life. Perceived information on disease, medical tests, and treatment increased significantly after screening (P<.01). Differences were clinically relevant. There were no differences in perceived information between patients with and without screen-detected CVD. Screening was evaluated favorably, whether CTA showed abnormalities or not. Extensive counseling resulted in substantially increased provision of information and improved information satisfaction. Screening by means of CTA and subsequent cardiac intervention was highly valued, and the benefits were felt to outweigh the emotional and practical burden. Copyright © 2014 Elsevier Inc. All rights reserved.

Bowel morbidity following radiochemotherapy and image-guided adaptive brachytherapy for cervical cancer: Physician- and patient reported outcome from the EMBRACE study.

PubMed

Jensen, Nina Boje Kibsgaard; Pötter, Richard; Kirchheiner, Kathrin; Fokdal, Lars; Lindegaard, Jacob Christian; Kirisits, Christian; Mazeron, Renaud; Mahantshetty, Umesh; Jürgenliemk-Schulz, Ina Maria; Segedin, Barbara; Hoskin, Peter; Tanderup, Kari

2018-06-01

This study describes late bowel morbidity prospectively assessed in the multi-institutional EMBRACE study on MRI-guided adaptive brachytherapy in locally advanced cervical cancer (LACC). A total of 1176 patients were analyzed. Physician reported morbidity (CTCAE v.3.0) and patient reported outcome (PRO) (EORTC QLQ C30/CX24) were assessed at baseline and at regular follow-up. At 3/5 years the actuarial incidence of bowel morbidity grade 3-4 was 5.0%/5.9%, including incidence of stenosis/stricture/fistula of 2.0%/2.6%. Grade 1-2 morbidity was pronounced with prevalence rates of 28-33% during follow-up. Diarrhea and flatulence were most frequently reported, significantly increased after 3 months and remained elevated during follow-up. Incontinence gradually worsened with time. PRO revealed high prevalence rates. Diarrhea ≥"a little" increased from 26% to 37% at baseline to 3 months and remained elevated, difficulty in controlling bowel increased from 11% to 26% at baseline to 3 months gradually worsening with time. Constipation and abdominal cramps improved after treatment. Bowel morbidity reported in this large cohort of LACC patients was limited regarding severe/life-threatening events. Mild-moderate diarrhea, flatulence and incontinence were prevalent after treatment with PROs indicating a considerable and clinically relevant burden. Critical knowledge based on the extent and manifestation pattern of treatment-related morbidity will serve future patient management. Copyright © 2018 Elsevier B.V. All rights reserved.

Applying the Longitudinal Model from Item Response Theory to Assess Health-Related Quality of Life in the PRODIGE 4/ACCORD 11 Randomized Trial.

PubMed

Barbieri, Antoine; Anota, Amélie; Conroy, Thierry; Gourgou-Bourgade, Sophie; Juzyna, Beata; Bonnetain, Franck; Lavergne, Christian; Bascoul-Mollevi, Caroline

2016-07-01

A new longitudinal statistical approach was compared to the classical methods currently used to analyze health-related quality-of-life (HRQoL) data. The comparison was made using data in patients with metastatic pancreatic cancer. Three hundred forty-two patients from the PRODIGE4/ACCORD 11 study were randomly assigned to FOLFIRINOX versus gemcitabine regimens. HRQoL was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. The classical analysis uses a linear mixed model (LMM), considering an HRQoL score as a good representation of the true value of the HRQoL, following EORTC recommendations. In contrast, built on the item response theory (IRT), our approach considered HRQoL as a latent variable directly estimated from the raw data. For polytomous items, we extended the partial credit model to a longitudinal analysis (longitudinal partial credit model [LPCM]), thereby modeling the latent trait as a function of time and other covariates. Both models gave the same conclusions on 11 of 15 HRQoL dimensions. HRQoL evolution was similar between the 2 treatment arms, except for the symptoms of pain. Indeed, regarding the LPCM, pain perception was significantly less important in the FOLFIRINOX arm than in the gemcitabine arm. For most of the scales, HRQoL changes over time, and no difference was found between treatments in terms of HRQoL. The use of LMM to study the HRQoL score does not seem appropriate. It is an easy-to-use model, but the basic statistical assumptions do not check. Our IRT model may be more complex but shows the same qualities and gives similar results. It has the additional advantage of being more precise and suitable because of its direct use of raw data. © The Author(s) 2015.

Quality of life and anxiety in women with breast cancer before and after treatment

PubMed Central

Villar, Raquel Rey; Fernández, Salvador Pita; Garea, Carmen Cereijo; Pillado, Mª Teresa Seoane; Barreiro, Vanesa Balboa; Martín, Cristina González

2017-01-01

ABSTRACT Objectives: to determine the quality of life and anxiety in patients with breast cancer and the changes they experience after treatments. Method: prospective study. Breast cancer statistics (n=339, confidence=95%, accuracy= ± 5.32%). The quality of life questionnaires (QLQ) used were QLQ C-30 and QLQ Br23, and the State-Trait Anxiety Inventory (STAI) was used for anxiety. A multivariate analysis was performed to identify variables associated with baseline quality of life and anxiety as well as pre- and post-treatment differences. Authorization was obtained from the Ethics Committee, and informed consent was provided by all patients. Results: the baseline quality of life dimensions with the lowest score were future prospects (46.0/100) and sexual enjoyment (55.7/100). The dimensions with the highest score were body image (94.2/100) and role (93.3/100). The most disturbing symptoms were insomnia, fatigue and concern about hair loss. After treatment, the dimensions of physical function, role, body image, financial concerns and symptomatology worsened, whereas emotional function and future prospects improved. Severe anxiety presented as a state (48.6%) and as a trait (18.2%). The highest baseline state anxiety was associated with married-widowed status and anxiolytic medication. The greatest trait anxiety was associated with an inactive work situation, anxiolytic medication, breast swelling and advanced stage at diagnosis. After treatment, anxiety significantly decreased. Conclusions: After treatment, the quality of life score was positively modified, while state and trait anxiety decreased. PMID:29267541

Quality of life and anxiety in women with breast cancer before and after treatment.

PubMed

Villar, Raquel Rey; Fernández, Salvador Pita; Garea, Carmen Cereijo; Pillado, Mª Teresa Seoane; Barreiro, Vanesa Balboa; Martín, Cristina González

2017-12-21

to determine the quality of life and anxiety in patients with breast cancer and the changes they experience after treatments. prospective study. Breast cancer statistics (n=339, confidence=95%, accuracy= ± 5.32%). The quality of life questionnaires (QLQ) used were QLQ C-30 and QLQ Br23, and the State-Trait Anxiety Inventory (STAI) was used for anxiety. A multivariate analysis was performed to identify variables associated with baseline quality of life and anxiety as well as pre- and post-treatment differences. Authorization was obtained from the Ethics Committee, and informed consent was provided by all patients. the baseline quality of life dimensions with the lowest score were future prospects (46.0/100) and sexual enjoyment (55.7/100). The dimensions with the highest score were body image (94.2/100) and role (93.3/100). The most disturbing symptoms were insomnia, fatigue and concern about hair loss. After treatment, the dimensions of physical function, role, body image, financial concerns and symptomatology worsened, whereas emotional function and future prospects improved. Severe anxiety presented as a state (48.6%) and as a trait (18.2%). The highest baseline state anxiety was associated with married-widowed status and anxiolytic medication. The greatest trait anxiety was associated with an inactive work situation, anxiolytic medication, breast swelling and advanced stage at diagnosis. After treatment, anxiety significantly decreased. After treatment, the quality of life score was positively modified, while state and trait anxiety decreased.

Impact of Response Shift on Time to Deterioration in Quality of Life Scores in Breast Cancer Patients

PubMed Central

Hamidou, Zeinab; Dabakuyo-Yonli, Tienhan S.; Guillemin, Francis; Conroy, Thierry; Velten, Michel; Jolly, Damien; Causeret, Sylvain; Graesslin, Olivier; Gauthier, Mélanie; Mercier, Mariette; Bonnetain, Franck.

2014-01-01

Background This prospective multicenter study aimed to study the impact of the recalibration component of response-shift (RS) on time to deterioration (TTD) in health related quality of life (QoL) scores in breast cancer (BC) patients and the influence of baseline QoL expectations on TTD. Methods The EORTC-QLQ-C30 and BR-23 questionnaires were used to assess the QoL in a prospective multicenter study at inclusion (T0), at the end of the first hospitalization (T1) and, three (T2) and 6 months after the first hospitalization (T3). Recalibration was investigated by the then-test method. QoL expectancy was assessed at diagnosis. Deterioration was defined as a 5-point decrease in QoL scores, considered a minimal clinically important difference (MCID). TTD was estimated using the Kaplan-Meier method. Cox regression analyses were used to identify factors influencing TTD. Results From February 2006 to February 2008, 381 women were included. Recalibration of breast cancer patients' internal standards in the assessment of their QoL had an impact on TTD. Median TTD were significantly shorter when recalibration was not taken into account than when recalibration was taken into account for global health, role-functioning, social-functioning, body-image and side effects of systemic therapy. Cox multivariate analyses showed that for body image, when recalibration was taken into account, radiotherapy was associated with a shorter TTD (HR: 0.60[0.38–0.94], whereas, no significant impact of surgery type on TTD was observed. For global health, cognitive and social functioning dimensions, patients expecting a deterioration in their QoL at baseline had a significantly shorter TTD. Conclusions Our results showed that RS and baseline QoL expectations were associated with time to deterioration in breast cancer patients. PMID:24828426

A comparative study of art therapy in cancer patients receiving chemotherapy and improvement in quality of life by watercolor painting.

PubMed

Bozcuk, H; Ozcan, K; Erdogan, C; Mutlu, H; Demir, M; Coskun, S

2017-02-01

There is limited data on the role of art therapy used in cancer patients. We wanted to test the effect of painting art therapy provided by a dedicated professional painting artist on quality of life and anxiety and depression levels in patients having chemotherapy. Cancer patients having chemotherapy in the day unit of a medical oncology department of a university hospital were offered to take part in a painting art therapy program (PATP). This program consisted of a professional painting artist facilitating and helping patients to perform painting during their chemotherapy sessions while they were in the day unit, as well as supplying them painting material for home practice. The changes in quality of life domains of EORTC-QLQ-C30 questionnaire and in Hospital Anxiety and Depression Scores (HADS) were assessed before and after the PATP. These results were contrasted with a reference group of cancer patients on chemotherapy but not taking part in the PATP. In order to adjust for multiple comparisons of quality of life parameters between patient groups, we utilized the Bonferroni correction. A total of 48 patients, of which 26 patients did and 22 did not have prior exposure to PATP, were enrolled in the PATP. A control group of 24 patients who did not have any PATP activity during the study period also took part in the study. With PATP, there was significant improvement in global quality of life (F=7.87, P=0.001), and depression scores (F=7.80, P=0.001). To our knowledge, this is the largest comparative PATP experience in cancer patients on chemotherapy and show that PATP is feasible in the clinics. Our results confirm that art therapy in the form of painting improves quality of life and depression in cancer patients having chemotherapy. This effect was more pronounced in patients without any previous experience of PATP. Copyright © 2016 Elsevier Ltd. All rights reserved.

Return to work of cancer patients after a multidisciplinary intervention including occupational counselling and physical exercise in cancer patients: a prospective study in the Netherlands.

PubMed

Leensen, Monique C J; Groeneveld, Iris F; Heide, Iris van der; Rejda, Tomas; van Veldhoven, Peter L J; Berkel, Sietske van; Snoek, Aernout; Harten, Wim van; Frings-Dresen, Monique H W; de Boer, Angela G E M

2017-06-15

To support return to work (RTW) among cancer patients, a multidisciplinary rehabilitation programme was developed which combined occupational counselling with a supervised physical exercise programme during chemotherapy. The aim was to investigate RTW rates of cancer patients and to evaluate changes in work-related quality of life and physical outcomes. Longitudinal prospective intervention study using a one-group design. Two hospitals in the Netherlands. Of the eligible patients, 56% participated; 93 patients with a primary diagnosis of cancer receiving chemotherapy and on sick leave were included. Patients completed questionnaires on RTW, the importance of work, work ability (WAI), RTW self-efficacy, fatigue (MFI), and quality of life (EORTC QLQ C-30) at baseline and 6, 12 and 18 months follow-up. Before and after the exercise programme 1-repetition maximum (1RM) muscle strength and cardiorespiratory fitness (VO 2 peak) were assessed. Six months after the start of a multidisciplinary rehabilitation programme that combined occupational counselling with a supervised physical exercise programme, 59% of the cancer patients returned to work, 86% at 12 months and 83% at 18 months. In addition, significant improvements (p<0.05) in the importance of work, work ability, RTW self-efficacy, and quality of life were observed, whereas fatigue levels were significantly reduced. After completing the exercise programme, 1RM muscle strength was significantly increased but there was no improvement in VO 2 peak level. RTW rates of cancer patients were high after completion of the multidisciplinary rehabilitation programme. A multidisciplinary rehabilitation programme which combines occupational counselling with a supervised physical exercise programme is likely to result in RTW, reduced fatigue and increased importance of work, work ability, and quality of life. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Using quality of life measures in a Phase I clinical trial of noni in patients with advanced cancer to select a Phase II dose.

PubMed

Issell, Brian F; Gotay, Carolyn C; Pagano, Ian; Franke, Adrian A

2009-01-01

ABSTRACT. The purpose of this study was to determine a maximum tolerated dose of noni in cancer patients and whether an optimal quality of life-sustaining dose could be identified as an alternative way to select a dose for subsequent Phase II efficacy trials. Dose levels started at two capsules twice daily (2 g), the suggested dose for the marketed product, and were escalated by 2 g daily in cohorts of at least five patients until a maximum tolerated dose was found. Patients completed subscales of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 quality of life (physical functioning, pain, and fatigue) the brief fatigue inventory (BFI), questionnaires at baseline and at approximately 4-week intervals. Blood and urine were collected at baseline and at approximately 4-week intervals for measurement of scopoletin. Fifty-one patients were enrolled at seven dose levels. The maximum tolerated dose was six capsules four times daily (12 g). Although no dose-limiting toxicity was found, seven of eight patients at the next level (14 g), withdrew due to the challenges of ingesting so many capsules. There were dose-related differences in self-reported physical functioning and pain and fatigue control. Overall, patients taking three or four capsules four times daily experienced better outcomes than patients taking lower or higher doses. Blood and urinary scopoletin concentrations related to noni dose. We concluded that it is feasible to use quality of life measures to select a Phase II dose. Three or four capsules four times daily (6-8 g) is recommended when controlling fatigue, pain, and maintaining physical function are the efficacies of interest. Scopoletin, a bioactive component of noni fruit extract, is measurable in blood and urine following noni ingestion and can be used to study the pharmacokinetics of noni in cancer patients.

Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).

PubMed

Volders, J H; Haloua, M H; Krekel, N M A; Negenborn, V L; Kolk, R H E; Lopes Cardozo, A M F; Bosch, A M; de Widt-Levert, L M; van der Veen, H; Rijna, H; Taets van Amerongen, A H M; Jóźwiak, K; Meijer, S; van den Tol, M P

2017-04-01

The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy. Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Treatment efficacy with electrochemotherapy: A multi-institutional prospective observational study on 376 patients with superficial tumors.

PubMed

Campana, L G; Testori, A; Curatolo, P; Quaglino, P; Mocellin, S; Framarini, M; Borgognoni, L; Ascierto, P A; Mozzillo, N; Guida, M; Bucher, S; Rotunno, R; Marenco, F; De Salvo, G L; De Paoli, A; Rossi, C R; Bonadies, A

2016-12-01

Cutaneous metastases represent a therapeutic challenge. An increasing body of experience suggests that electrochemotherapy (ECT) provides effective tumor control, although its evidence basis should be strengthened. This prospective, multicenter, observational study enrolled patients with superficial metastases, who underwent ECT at 10 centers between 2008 and 2013. Outcomes included adherence to European Standard Operating Procedures of ECT (ESOPE), tumor response, local progression-free survival (LPFS), toxicity and patient-reported outcomes (PROs, EORTC QLQ-C30 plus an 8-item questionnaire). We enrolled 376 eligible patients. Tumor histotype distribution was as follows: melanoma, 56%; squamous cell carcinoma, 11%; Kaposi sarcoma, 11%; breast carcinoma, 8%; basal cell carcinoma, 6%; soft tissue sarcomas, 3%; others, 5%. We registered 1304 target tumors (median size 1 cm). Treatment adhered to ESOPE in 88% of patients as to the route of drug administration, and in 70% as to electrode application. The procedure was mainly performed under sedation (64.6%) and by using intravenous chemotherapy (93.4%). Tumor response rate at 60 days was 88% (complete, 50%). Small tumor size predicted complete response achievement (OR 2.24, p = 0.003), higher LPFS (HR 0.68, p = 0.004) and improved PROs (Global Health Status, p < 0.001; wound bleeding, p < 0.001; healing, p = 0.002; and aesthetics, p < 0.001). Skin toxicity (grade ≥3, 7.8%) was lower in patients with tumors <2 cm (p≤0.001). One-year LPFS was 73.7% (95%CI 68.4-78.3). ECT represents a valuable skin-directed therapy across a range of malignancies. The most frequently applied treatment modality is intravenous chemotherapy under sedation. Small tumor size predicts durable tumor control, fewer side-effects and better PROs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study.

PubMed

Rosati, Gerardo; Pinto, Carmine; Di Fabio, Francesca; Chiara, Silvana; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrara, Raimondo; Antonuzzo, Lorenzo; Adua, Daniela; Racca, Patrizia; Bilancia, Domenico; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

2018-05-01

The influence of age (<70 years and ≥70 years) was retrospectively studied on the quality of life (QoL), incidence of side effects (including skin reactions) and efficacy of chemotherapy plus cetuximab in patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC). 225 patients of the Observed study (PS 0-1) were retrieved based on age (< 70 and ≥70 years) and evaluated through EORTC QLQ-C30 and DLQI questionnaires. The two patient groups (141 < 70 and 84 ≥ 70 years, respectively) were balanced with no differences in any of the clinical and pathological characteristics considered. Both groups underwent similar type of first-line chemotherapy plus cetuximab, treatment duration and compliance. Cetuximab therapy caused similar incidence of side effects and impact on QoL in older and younger patients. No difference was observed in progression free survival (PFS) and in disease control rates between the two patient populations. Median overall survival (OS) was higher in patients <70 (27 months, 95% CI: 22.7-31.27) than in patients ≥70 (19 months, 95% CI: 14.65-23.35) (p = 0.002), which is likely due to higher proportions of metastatic resection (27.0% vs 8.3%; p = 0.001) and utilization of second-line therapy in younger group (58.9% vs 42.9%; p = 0.028). The current data suggest that fit older patients with mCRC can be safely treated with a cetuximab-based therapy, as QoL and safety profile do not seem to be affected by age. In addition, age did not impact the choice of chemotherapy to be associated to cetuximab and treatment compliance. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Late Side Effects and Quality of Life After Radiotherapy for Rectal Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bruheim, Kjersti, E-mail: Kjersti.Bruheim@medisin.uio.n; Guren, Marianne G.; Skovlund, Eva

2010-03-15

Purpose: There is little knowledge on long-term morbidity after radiotherapy (50 Gy) and total mesorectal excision for rectal cancer. Therefore, late effects on bowel, anorectal, and urinary function, and health-related quality of life (QoL), were studied in a national cohort (n = 535). Methods and Materials: All Norwegian patients who received pre- or postoperative (chemo-)radiotherapy for rectal cancer from 1993 to 2003 were identified. Patients treated with surgery alone served as controls. Patients were without recurrence or metastases. Bowel and urinary function was scored with the LENT SOMA scale and the St. Marks Score for fecal incontinence and QoL withmore » the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). Results: Median time since surgery was 4.8 years. Radiation-treated (RT+) patients (n = 199) had increased bowel frequency compared with non-radiation-treated (RT-) patients (n = 336); 19% vs. 6% had more than eight daily bowel movements (p < 0.001). In patients without stoma, a higher proportion of RT+ (n = 69) compared with RT- patients (n = 240), were incontinent for liquid stools (49% vs. 15%, p < 0.001), needed a sanitary pad (52% vs. 13%, p < 0.001), and lacked the ability to defer defecation (44% vs. 16%, p < 0.001). Daily urinary incontinence occurred more frequently after radiotherapy (9% vs. 2%, p = 0.001). Radiation-treated patients had worse social function than RT- patients, and patients with fecal or urinary incontinence had impaired scores for global quality of life and social function (p < 0.001). Conclusions: Radiotherapy for rectal cancer is associated with considerable long-term effects on anorectal function, especially in terms of bowel frequency and fecal incontinence. RT+ patients have worse social function, and fecal incontinence has a negative impact on QoL.« less

A clinical study to assess the efficacy of belly dancing as a tool for rehabilitation in female patients with malignancies.

PubMed

Szalai, Márta; Lévay, Bernadett; Szirmai, Anna; Papp, István; Prémusz, Viktória; Bódis, József

2015-02-01

This prospective, non-randomised follow-up study was designed to compare the health-related quality of life (HRQoL), perceived social support (PSS) and overall life satisfaction (OLS) in female patients receiving standard medical care for malignant diseases with or without additional belly dancing. The patients were recruited in the Outpatient Department of the National Institute of Oncology, Budapest, Hungary during the period of 2008-2009. 55 patients joined the one-year-long rehabilitation program (research group, RG) while 59 age-matched patients who received only standard medical care volunteered for clinical assessment (control group, CG). HRQoL, PSS and OLS were assessed using validated questionnaires: EORTC QLQ-C30, F-SozU-K14, and Campbell's OLS, respectively. The scores obtained in RG and CG were controlled for baseline socio-demographic characteristics and evaluated by ANCOVA analysis. It was found that patients of the RG scored better at both the baseline and follow-up than the CG, and the differences between the two groups' measured parameters increased further during the course of the study. The respective baseline values in RG and CG were 56.6 ± 10.3 vs 63.5 ± 12 for HRQoL, 65.2 ± 5.5 vs 57.4 ± 8.8 for PSS and 57.4 ± 8.1 vs 48.4 ± 10.7 for OLS. The corresponding follow-up scores were 51.9 ± 4.4 vs 59.9 ± 11.2 (F = 10.637, p = 0.001) for HRQoL, 67.5 ± 2.7 vs 53.9 ± 10.5 (F = 2.646, p = 0.000) for PSS and 59.5 ± 9.6 vs 45.0 ± 11.5 (F = 2.402, p = 0.001) for OLS. Belly dance intervention can be applied as a complementary rehabilitation method to improve HRQoL, PSS and OLS in female patients treated for malignant diseases. Copyright © 2014 Elsevier Ltd. All rights reserved.

Return to work of cancer patients after a multidisciplinary intervention including occupational counselling and physical exercise in cancer patients: a prospective study in the Netherlands

PubMed Central

Leensen, Monique C J; Groeneveld, Iris F; van der Heide, Iris; Rejda, Tomas; van Veldhoven, Peter L J; van Berkel, Sietske; Snoek, Aernout; van Harten, Wim; Frings-Dresen, Monique H W; de Boer, Angela G E M

2017-01-01

Objectives To support return to work (RTW) among cancer patients, a multidisciplinary rehabilitation programme was developed which combined occupational counselling with a supervised physical exercise programme during chemotherapy. The aim was to investigate RTW rates of cancer patients and to evaluate changes in work-related quality of life and physical outcomes. Design Longitudinal prospective intervention study using a one-group design. Setting Two hospitals in the Netherlands. Participants Of the eligible patients, 56% participated; 93 patients with a primary diagnosis of cancer receiving chemotherapy and on sick leave were included. Patients completed questionnaires on RTW, the importance of work, work ability (WAI), RTW self-efficacy, fatigue (MFI), and quality of life (EORTC QLQ C-30) at baseline and 6, 12 and 18 months follow-up. Before and after the exercise programme 1-repetition maximum (1RM) muscle strength and cardiorespiratory fitness (VO2 peak) were assessed. Results Six months after the start of a multidisciplinary rehabilitation programme that combined occupational counselling with a supervised physical exercise programme, 59% of the cancer patients returned to work, 86% at 12 months and 83% at 18 months. In addition, significant improvements (p<0.05) in the importance of work, work ability, RTW self-efficacy, and quality of life were observed, whereas fatigue levels were significantly reduced. After completing the exercise programme, 1RM muscle strength was significantly increased but there was no improvement in VO2 peak level. Conclusions RTW rates of cancer patients were high after completion of the multidisciplinary rehabilitation programme. A multidisciplinary rehabilitation programme which combines occupational counselling with a supervised physical exercise programme is likely to result in RTW, reduced fatigue and increased importance of work, work ability, and quality of life. PMID:28619770

Quality of Life Perception, Cognitive Function, and Psychological Status in a Real-world Population of Glioblastoma Patients Treated With Radiotherapy and Temozolomide: A Single-center Prospective Study.

PubMed

Lombardi, Giuseppe; Bergo, Eleonora; Del Bianco, Paola; Bellu, Luisa; Pambuku, Ardi; Caccese, Mario; Trentin, Leonardo; Zagonel, Vittorina

2018-05-10

Health-related quality of life (HRQoL), cognitive function, and psychological status represent an important focus during the treatment of glioblastoma patients. Nevertheless, few randomized, prospective clinical trials have analyzed these factors, and very little is known in the real-clinical world. We evaluated these characteristics in glioblastoma patients treated with standard first-line therapy outside clinical trials. In total, 111 newly, histologically diagnosed glioblastoma patients treated at our oncology center with radiotherapy and temozolomide were prospectively enrolled. No patient was enrolled in an experimental clinical trial. We assessed HRQoL, cognitive function, and psychological status before starting treatment, at the end of radiotherapy, and every 3 months until 9 months after the end of radiotherapy using EORTC QLQ-C30, BN20, MMSE, and HADS questionnaires. Global health status, physical, cognitive, and social functioning remained unchanged throughout the study period. A statistically significant change was found in emotional functioning as well as a clinically meaningful amelioration in role functioning between the baseline assessment and 9 months after radiotherapy. Patients older than 65 years reported greater impairment on the bladder control scale than younger patients. When considering tumor location, global health status, communication deficit, and drowsiness, scores were significantly different between the right and left hemispheres. Female patients had a clinically relevant lower score for physical functioning at baseline and 3 months after radiation therapy. Female patients also had a clinically relevant lower depression score at 9 months after radiation therapy. In routine neurooncology practice, HRQoL, cognitive function, and psychological status did not worsen during first-line treatment in glioblastoma patients receiving standard radiotherapy and temozolomide treatment. However, some patient subgroups, such as elderly and female patients, may have different experiences with treatment, and further investigation is required.

Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation.

PubMed

Hung, Yun-Chi; Bauer, Judith; Horsley, Pamela; Waterhouse, Mary; Bashford, John; Isenring, Elisabeth

2013-06-01

This pilot exploratory study aimed to describe the changes in nutritional status, body composition, quality of life (QoL), and physical activity levels (PAL) of cancer patients undergoing high-dose conditioning and autologous peripheral blood stem cell transplantation (PBSCT) at pre-admission, hospital discharge, and at 100 days post-transplantation, and to examine if changes in these parameters are interrelated. Twenty-four patients (56.2 ± 12.9 years; 7 females, 17 males) were recruited from an Australian transplant center. Assessment was prospectively conducted at pre-admission, hospital discharge, and 100 days post-transplantation using the scored patient-generated subjective global assessment, air displacement plethysmography, EORTC QLQ-C30 (version 3), and the international physical activity questionnaire. At discharge, nutritional status deteriorated (patient-generated subjective global assessment (PG-SGA) median, +8.0; interquartile range, 6.0-13.0; p < 0.001) and the number of malnourished patients increased (n = 8/23; p = 0.023). Patients experienced significant loss of lean body mass (LBM; -2.2 kg, CI 95% -3.0, -1.4; p < 0.001), and decrease in QoL (-10.6, CI 95% -24.1, 2.9; p = 0.117); the proportion of patients with high PAL decreased (p = 0.012). By 100 days post-transplantation, all patients were well-nourished; however, LBM remained lower -1.0 kg (CI 95% -1.9, -0.1; p = 0.028). Change in nutritional status (PG-SGA score) was associated with weight (r = -0.46; p = 0.039) and fat mass (r = -0.57; p = 0.013). Change in QoL was associated with nutritional reservoir (i.e., fat; r = 0.54; p = 0.024); QoL was consistently higher for patients with high PAL. High-dose conditioning and autologous PBSCT is associated with deterioration in nutritional status, QoL and PAL, with LBM remaining below baseline levels at 100 days post-transplantation. A nutrition and exercise intervention program post-hospital discharge may be beneficial for these patients.

Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) as an alternative therapy for ovarian cancer in an octogenarian patient.

PubMed

Giger-Pabst, Urs; Solass, Wiebke; Buerkle, Bernd; Reymond, Marc-André; Tempfer, Clemens B

2015-04-01

Octogenarians with ovarian cancer limited to the abdomen may not be willing or able to undergo systemic chemotherapy. Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin is a form of intra-abdominal chemotherapy which can be applied repeatedly and potentially prevents from the systemic side-effects of chemotherapy. We present the case of an 84-year-old woman with laparoscopically and histologically confirmed ovarian cancer who refused to undergo systemic chemotherapy. She was treated with eight courses q 28-104 days of low-dose PIPAC with cisplatin at 7.5 mg/m(2) and doxorubicin at 1.5 mg/m(2) at 12 mmHg and 37 °C for 30 min. Objective tumor response was noted, defined as tumor regression on histology, and stable disease noted by peritoneal carcinomatosis index on repeated video-laparoscopy and abdominal computed tomographic scan. The treatment was well-tolerated with no Common Terminology Criteria for Adverse Events (CTCAE) CTCAE >2. With a follow-up of 15 months, the patient is alive and clinically stable. The quality of life measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 demonstrated improvement over 5-6 months (global physical score, global health score, global quality of live) without cumulative increase of gastrointestinal toxicity. Low-dose PIPAC is a new form of intraperitoneal chemotherapy which may be applied repeatedly in octogenarian patients. PIPAC may be an alternative and well-tolerated treatment for selected octogenarian patients with ovarian cancer limited to the abdomen who cannot be treated with systemic chemotherapy. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

The Content Validity of a Chemotherapy-Induced Peripheral Neuropathy Patient-Reported Outcome Measure

PubMed Central

Lavoie Smith, Ellen M.; Haupt, Rylie; Kelly, James P.; Lee, Deborah; Kanzawa-Lee, Grace; Knoerl, Robert; Bridges, Celia; Alberti, Paola; Prasertsri, Nusara; Donohoe, Clare

2018-01-01

Purpose/Objectives To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). Research Approach Cross-sectional, prospective, qualitative design. Setting Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. Participants 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. Methodologic Approach Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument. Findings Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. Interpretation Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. Implications for Nursing Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure. PMID:28820525

[Magnetic resonance guided focused ultrasound surgery for pain palliation of bone metastases: early experience of clinical application in China].

PubMed

Gu, Jianjun; Wang, Han; Tang, Na; Hua, Yingqi; Yang, Haiyan; Qiu, Yimin; Ge, Renbin; Zhou, Ying; Wang, Wenwen; Zhang, Guixiang

2015-11-03

To evaluate the safety and efficacy of magnetic resonance guided focused ultrasound surgery (MRgFUS) in treatment for pain palliation of bone metastases. Eighty-one patients of painful bone metastases were volunteered to screen for this study in Shanghai General Hospital from June 2014 to February 2015. Twenty-three patients among them were treated by MRgFUS, who was more than 18-years old, having the ability to fully understand the informed consent of the research, suffering with pain of numeric rating scale (NRS) ≥ 4, non-received radiotherapy or chemotherapy for pain palliation of bone metastases in the past two weeks. The NRS, the standard question of Brief Pain Inventory (BPI-QoL), and the standard question of Europe Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Bone Metastases 22 (EORTC QLQ-BM22) were respectively recorded before and 1-week, 1-month, 3-month after the treatment. The related adverse events of MRgFUS were observed and recorded in 3 months after the treatment as well. (1)Twenty-three metastatic bone tumor lesions of 23 patients were treated by MRgFUS, the treatment data was as follows: the mean treatment time was (88 ± 33) minutes, the mean sonication number was 13 ± 8. (2) Adverse events included: pain in therapy area 3/23, which spontaneous relieving within one week; numbness in lower limb (1/23), which relieved after physiotherapy. (3) The NRS of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 6.0 ± 1.5, 3.7 ± 1.7,3.1 ± 2.0, and 2.2 ± 1.0,which significantly decreased after the treatment (P<0.01). (4) The BPI-QoL score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 39 ± 16, 27 ± 18, 26 ± 18, and 21 ± 18, which significantly decreased after the treatment (P<0.01). (5) The EORTC QLQ-BM22 score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 52 ± 13, 44 ± 12, 42 ± 12, and 39 ± 12, which also significantly decreased after the treatment (P<0.01). MRgFUS can be used as a non-invasive, safe, and effective method for treating painful bone metastases. Its clinical benefits of pain palliation and patient's quality of life improving are sustained after the treatment at least to 3 months.

Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.

PubMed

Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C

2017-10-01

To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work is also needed to determine whether they can be used at the individual level. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

Standardization of definitions in focal therapy of prostate cancer: report from a Delphi consensus project.

PubMed

Postema, A W; De Reijke, T M; Ukimura, O; Van den Bos, W; Azzouzi, A R; Barret, E; Baumunk, D; Blana, A; Bossi, A; Brausi, M; Coleman, J A; Crouzet, S; Dominguez-Escrig, J; Eggener, S; Ganzer, R; Ghai, S; Gill, I S; Gupta, R T; Henkel, T O; Hohenfellner, M; Jones, J S; Kahmann, F; Kastner, C; Köhrmann, K U; Kovacs, G; Miano, R; van Moorselaar, R J; Mottet, N; Osorio, L; Pieters, B R; Polascik, T J; Rastinehad, A R; Salomon, G; Sanchez-Salas, R; Schostak, M; Sentker, L; Tay, K J; Varkarakis, I M; Villers, A; Walz, J; De la Rosette, J J

2016-10-01

To reach standardized terminology in focal therapy (FT) for prostate cancer (PCa). A four-stage modified Delphi consensus project was undertaken among a panel of international experts in the field of FT for PCa. Data on terminology in FT was collected from the panel by three rounds of online questionnaires. During a face-to-face meeting on June 21, 2015, attended by 38 experts, all data from the online rounds were reviewed and recommendations for definitions were formulated. Consensus was attained on 23 of 27 topics; Targeted FT was defined as a lesion-based treatment strategy, treating all identified significant cancer foci; FT was generically defined as an anatomy-based (zonal) treatment strategy. Treatment failure due to the ablative energy inadequately destroying treated tissue is defined as ablation failure. In targeting failure the energy is not adequately applied to the tumor spatially and selection failure occurs when a patient was wrongfully selected for FT. No definition of biochemical recurrence can be recommended based on the current data. Important definitions for outcome measures are potency (minimum IIEF-5 score of 21), incontinence (new need for pads or leakage) and deterioration in urinary function (increase in IPSS >5 points). No agreement on the best quality of life tool was established, but UCLA-EPIC and EORTC-QLQ-30 were most commonly supported by the experts. A complete overview of statements is presented in the text. Focal therapy is an emerging field of PCa therapeutics. Standardization of definitions helps to create comparable research results and facilitate clear communication in clinical practice.

Effects of a self-care education program on quality of life of patients with gastric cancer after gastrectomy.

PubMed

Davoodi, Arefeh; Gholizadeh, Leila; Rezazadeh, Hassan; Sheikalipour, Zahra; Lakdizaji, Sima; Mirinajad, Kazem; Rahmani, Azad

2015-09-01

Gastrectomy affects different aspects of functionality and impacts on the quality of life (QoL) of patients with gastric cancer. The importance of appropriate assessment of QoL in cancer patients is well established, yet strategies that help improve this important patient outcome are relatively scarce. To examine the effectiveness of a brief self-care education program to improve QoL of gastric cancer patients after gastrectomy. Using a randomized controlled trial, 59 patients with gastric cancer and candidate for gastrectomy were randomly assigned either to an intervention group (n = 31) to participate in a brief self-care education program or to a usual-care group (n = 28). Data were collected on patient demographics, and QoL was measured by the QLQ-C30 and the QLQ-STO22 at baseline and 1 month after gastrectomy. There were no statistically significant between-group differences in any subscales of the QLQ-C30 and the QLQ-STO22. However, participants in the brief self-care education program showed significant improvements from baseline in the global health status-QoL scale (t = 2.243, < .05), experience of pain (t = 2.508, < .05), constipation (t = 2.773, < .05), and the experience of dysphagia at the follow-up assessment. This study is likely to be underpowered to show differences between the groups. A brief self-care education program was not sufficient to significantly improve the quality of life patients with gastric cancer after gastrectomy. ©2015 Frontline Medical Communications.

Patient-centered outcomes to decide treatment strategy for patients with low rectal cancer.

PubMed

Honda, Michitaka; Akiyoshi, Takashi; Noma, Hisashi; Ogura, Atsushi; Nagasaki, Toshiya; Konishi, Tsuyoshi; Fujimoto, Yoshiya; Nagayama, Satoshi; Fukunaga, Yosuke; Ueno, Masashi

2016-10-01

For patients with low-lying rectal cancer, the feasibility of anus-preserving surgery in combination with neoadjuvant chemoradiotherapy (NACRT) has been not well established from the perspective of patient-centered outcomes. We investigated 278 patients with low-lying rectal adenocarcinoma from 2005 to 2012. We compared their symptoms and QOL scores of patients who underwent anus-preserving surgery with (n = 88) and without (n = 143) NACRT according to the Wexner scale, EORTC QLQ C-30, CR29, and the modified fecal incontinence quality life scale (mFIQL). Furthermore, to assess the rationale for intersphincteric resection (ISR) with NACRT, we also compared QOL of patients who underwent ISR with NACRT (n = 31) and abdominoperineal resection (APR, n = 47). The adjusted mean differences of the Wexner score estimates of the patients who underwent ISR and very low anterior resection (VLAR) with or without NACRT were 5.29 (P = 0.004) and 2.67 (P = 0.009), respectively. No significant difference was observed in the QOL scores of two treatment groups. Furthermore, there were no significant differences in the QOL or function scores of patients who underwent ISR with NACRT and APR. The incontinence was significantly worse in patients who receive NACRT. However, there were no significant differences in their QOL or function scores. J. Surg. Oncol. 2016;114:630-636. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Appetite disorders in cancer patients: Impact on nutritional status and quality of life.

PubMed

Barajas Galindo, David E; Vidal-Casariego, Alfonso; Calleja-Fernández, Alicia; Hernández-Moreno, Ana; Pintor de la Maza, Begoña; Pedraza-Lorenzo, Manuela; Rodríguez-García, María Asunción; Ávila-Turcios, Dalia María; Alejo-Ramos, Miran; Villar-Taibo, Rocío; Urioste-Fondo, Ana; Cano-Rodríguez, Isidoro; Ballesteros-Pomar, María D

2017-07-01

Cancer patients are at high risk of malnutrition due to several symptoms such as lack of appetite. The aim of this study was to determine the prevalence of different appetite disorders in cancer patients and their influence on dietary intake, nutritional status, and quality of life. We conducted a cross-sectional study of cancer patients at risk of malnutrition. Nutritional status was studied using Subjective Global Assessment, anthropometry, and grip strength. Dietary intake was evaluated with a 24-h recall, and patients were questioned about the presence of changes in appetite (none, anorexia, early satiety, or both). Quality of life was measured using EORTC-QLQ-C30. Multivariate analysis was performed using linear regression. 128 patients were evaluated. 61.7% experienced changes in appetite: 31% anorexia, 13.3% early satiety, and 17.2% both. Appetite disorders were more common in women and with the presence of cachexia. The combination of anorexia and satiety resulted in a lower weight and BMI. However, there were no significant effects on energy or macronutrient intake among different appetite alterations. Patients with a combination of anorexia and early satiety had worse overall health perception, role function, and fatigue. Appetite disorders are highly prevalent among cancer patients at risk of malnutrition. They have a significant impact on nutritional status and quality of life, especially when anorexia and early satiety are combined. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quality of life in survivors of hematological malignancies stratified by cancer type, time since diagnosis and stem cell transplantation.

PubMed

Esser, Peter; Kuba, Katharina; Mehnert, Anja; Johansen, Christoffer; Hinz, Andreas; Lordick, Florian; Götze, Heide

2018-06-01

Quality of life (QoL) has become an important tool to guide decision making in oncology. Given the heterogeneity among hematological cancer survivors, however, clinicians need comparative data across different subsets. This study recruited survivors of hematological malignancies (≥ 2.5 years after diagnosis) from two German cancer registries. QoL was assessed with the EORTC QLQ-C30. The sample was stratified by cancer type, time since diagnosis, treatment with stem cell transplantation (SCT) and type of SCT. First, levels of QoL were compared across subsamples when controlling for several covariates. Second, we contrasted subsamples with gender- and age-matched population controls obtained from the general population. Of 2001 survivors contacted by mail, 922 (46%) participated in the study. QoL did not significantly differ between the subsamples. All subsamples scored significantly lower in functioning and significantly higher in symptom burden compared to population controls (all p < .001). Almost all of these group effects reached clinically meaningful sizes (Cohen's d ≥ .5). Group differences in global health/QoL were mostly non-significant. Hematological cancer survivors are associated with practically relevant impairments irrespective of differences in central medical characteristics. Nevertheless, survivors seem to evaluate their overall situation as relatively well. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Adherence and health literacy as related to outcome of patients treated for rheumatoid arthritis : Analyses of a large-scale observational study.

PubMed

Kuipers, J G; Koller, M; Zeman, F; Müller, K; Rüffer, J U

2018-04-24

Disabilities in daily living and quality of life are key endpoints for evaluating the treatment outcome for rheumatoid arthritis (RA). Factors possibly contributing to good outcome are adherence and health literacy. The survey included a representative nationwide sample of German rheumatologists and their patients with RA. The physician questionnaire included the disease activity score (DAS28) and medical prescriptions. The patient questionnaire included fatigue (EORTC QLQ-FA13), health assessment questionnaire (HAQ), quality of life (SF-12), health literacy (HELP), and patients' listings of their medications. Adherence was operationalized as follows: patient-reported (CQR5), behavioral (concordance between physicians' and patients' listings of medications), physician-assessed, and a combined measure of physician rating (1 = very adherent, 0 = less adherent) and the match between physicians' prescriptions and patients' accounts of their medications (1 = perfect match, 0 = no perfect match) that yielded three categories of adherence: high, medium, and low. Simple and multiple linear regressions (controlling for age, sex, smoking, drinking alcohol, and sport) were calculated using adherence and health literacy as predictor variables, and disease activity and patient-reported outcomes as dependent variables. 708 pairs of patient and physician questionnaires were analyzed. The mean patient age (73% women) was 60 years (SD = 12). Multiple regression analyses showed that high adherence was significantly associated with 5/7 outcome variables and health literacy with 7/7 outcome variables. Adherence and health literacy had weak but consistent effects on most outcomes. Thus, enhancing adherence and understanding of medical information could improve outcome, which should be investigated in future interventional studies.

Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications.

PubMed

Heerkens, Hanne D; van Berkel, Lisanne; Tseng, Dorine S J; Monninkhof, Evelyn M; van Santvoort, Hjalmar C; Hagendoorn, Jeroen; Borel Rinkes, Inne H M; Lips, Irene M; Intven, Martijn; Molenaar, I Quintus

2018-02-01

Surgery for pancreatic cancer yields significant morbidity and mortality risks and survival is limited. Therefore, the influence of complications on quality of life (QoL) after pancreatic surgery is important. This study compares QoL in patients with and without severe complications after surgery for pancreatic (pre-)malignancy. This prospective cohort study scored complications after pancreatic surgery according to the Clavien-Dindo system and the definitions of the International Study Group of Pancreatic Surgery. QoL was measured by the RAND36 questionnaire, the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and the pancreas specific QLQ-PAN26. QoL in patients with severe complications was compared with QoL in patients with no or mild complications over a period of 12 months. Analysis was performed with linear mixed models for repeated measurements. Between March 2012 and July 2016, 137 patients were included. Sixty-eight patients (50%) had at least 1 severe complication. There were no statistically significant and clinically relevant differences between both groups in QoL up to 12 months after surgery. In this study, no differences in QoL between patients with and without severe postoperative complications were encountered during the first 12 months after surgery for pancreatic (pre-)malignancy. http://www.clinicaltrials.gov Identifier: NCT02175992. Copyright © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

[Health-related quality of life in the oncology departments of the hospital of Navarra. The EORTC Quality of Life Group].

PubMed

Arrarás, J I; Arias de la Vega, F; Illarramendi, J J; Manterola, A; Salgado, E; Dominguez, M A; Vera, R

2011-01-01

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer - EORTC - Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients' satisfaction with care. This research line has a direct benefit on the attention that patients receive.

The impact on health-related quality of life in the first 12 months: A randomised comparison of preoperative short-course radiation versus long-course chemoradiation for T3 rectal cancer (Trans-Tasman Radiation Oncology Group Trial 01.04).

PubMed

McLachlan, Sue-Anne; Fisher, Richard J; Zalcberg, John; Solomon, Michael; Burmeister, Bryan; Goldstein, David; Leong, Trevor; Ackland, Stephen P; McKendrick, Joseph; McClure, Bev; Mackay, John; Ngan, Samuel Y

2016-03-01

To assess health-related quality of life (HRQOL) in patients participating in a randomised trial of neoadjuvant short course radiation (SC) or long course chemoradiation (LC) for operable rectal cancer. Eligible patients with T3N0-2M0 rectal cancer completed the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ-C30) and the colorectal cancer specific module (QLQ C38) at randomisation and 1, 2, 3, 6, 9 and 12 months later. Of 326 patients randomised, 297 (SC 143, LC 154) were eligible for completion of HRQOL questionnaires. Baseline scores were comparable across the SC and LC groups. Patients reported low scores on sexual functioning and sexual enjoyment. Defaecation problems were the worst of the symptoms at baseline. Surgery had the most profoundly negative effect on HRQOL, seen in both the SC and LC treatment groups to the same extent. The most severely affected domains were physical function and role function and the most severely affected symptoms were fatigue, pain, appetite, weight loss and male sexual problems. Most domains and symptoms returned to baseline levels by 12 months apart from body image, sexual enjoyment and male sexual problems. Future perspective was better than prior to treatment. There is no overall difference in HRQOL between SC and LC neoadjuvant treatment strategies, in the first 12 months, after surgery. In the immediate postoperative period HRQOL was adversely affected in both groups but for the most part was temporary. Some residual sexual functioning concerns persisted at 12 months. Copyright © 2015 Elsevier Ltd. All rights reserved.

Is the Whipple procedure harmful for long-term outcome in treatment of chronic pancreatitis? 15-years follow-up comparing the outcome after pylorus-preserving pancreatoduodenectomy and Frey procedure in chronic pancreatitis.

PubMed

Bachmann, Kai; Tomkoetter, Lena; Kutup, Asad; Erbes, Johannes; Vashist, Yogesh; Mann, Oliver; Bockhorn, Maximilian; Izbicki, Jakob R

2013-11-01

The aim of this study was to report on 15-year long-term results of a randomized controlled trial comparing extended drainage procedure (Frey) and classical resectional procedure [pylorus-preserving pancreatoduodenectomy (PD)] in patients with chronic pancreatitis. Chronic pancreatitis is a common inflammatory disease with a prevalence of 10 to 30 cases per 100,000 inhabitants. It is characterized by the progressive conversion of pancreatic parenchyma to fibrous tissue. Different surgical procedures are used in treatment of persistent pain. Sixty-four patients suffering from chronic pancreatitis with inflammatory mass in the pancreatic head were randomly assigned in 2 treatment groups (PD, n = 32) and (Frey, n = 32). The perioperative course of the randomized controlled trial and the 7 years follow-up have been previously published. All participating patients were contacted with a standardized, validated questionnaire (EORTC QLQ C30) to evaluate the long-term survival, quality-of-life pain, and exocrine and endocrine function. In the 15-year long-term follow-up, the pain control was good and comparable between both groups, but the quality of life was better after Frey procedure in regard of the physical status [PD: 100 (0-100) vs PD: 60 (0-100) (P = 0.011)]. No significant differences in terms of the Pain Score were detected between both groups [PD: 7 (0-100) vs Frey 4 (0-100) P = 0.258]. Seven patients after Frey OP and 6 patients after PD were free of pain. Analyzing the postoperative overall survival, a higher long-term mortality was found after PD (53%) than that found after Frey procedure (30%) resulting in a longer mean survival (14.5 ± 0.8 vs 11.3 ± 0.8 years; P = 0.037). No correlation between endocrine or exocrine pancreatic function and pain was found, whereas continuous alcohol consumption was associated with poorer outcome regarding quality of life (P < 0.001) and pain score (P < 0.001). PD and Frey procedure provide good and permanent pain relief and improvement of the quality of life in long-term follow-up. In addition, a longer survival was found after the organ sparing resection. Together with better short-term results, the organ-sparing procedure seems to be favorable in treatment of chronic pancreatitis.

A case-control, mono-center, open-label, pilot study to evaluate the feasibility of therapeutic touch in preventing radiation dermatitis in women with breast cancer receiving adjuvant radiation therapy.

PubMed

Younus, Jawaid; Lock, Michael; Vujovic, Olga; Yu, Edward; Malec, Jitka; D'Souza, David; Stitt, Larry

2015-08-01

Therapeutic touch (TT) is a non-invasive commonly used complementary therapy. TT is based on the use of hand movements and detection of energy field congestion to correct imbalances. Improvement in subjective symptoms in a variety of clinical trials has been seen with TT. The effect of TT during radiotherapy for breast cancer is unknown. Women undergoing adjuvant radiation for Stage I/II breast cancer post conservative surgery were recruited for this cohort study. TT treatments were administered three times per week following radiation therapy. Feasibility was defined as an a priori threshold of 15 of 17 patients completing all TT treatments. The preventive effectiveness of TT was evaluated by documenting the 'time to develop' and the 'worst grade of radiation' dermatitis. Toxicity was assessed using NCIC CTC V3 dermatitis scale. Cosmetic rating was performed using the EORTC Breast Cosmetic Rating. The quality of life, mood and energy, and fatigue were assessed by EORTC QLQ C30, POMS, and BFI, respectively. The parameters were assessed at baseline, and serially during treatment. A total of 49 patients entered the study (17 in the TT Cohort and 32 in the Control Cohort). Median age in TT arm was 63 years and in control arm was 59 years. TT was considered feasible as all 17 patients screened completed TT treatment. There were no side effects observed with the TT treatments. In the TT Cohort, the worst grade of radiation dermatitis was grade II in nine patients (53%). Median time to develop the worst grade was 22 days. In the Control Cohort, the worst grade of radiation dermatitis was grade III in 1 patient. However, the most common toxicity grade was II in 15 patients (47%). Three patients did not develop any dermatitis. Median time to develop the worst grade in the control group was 31 days. There was no difference between cohorts for the overall EORTC cosmetic score and there was no significant difference in before and after study levels in quality of life, mood and fatigue. This study is the first evaluation of TT in patients with breast cancer using objective measures. Although TT is feasible for the management of radiation induced dermatitis, we were not able to detect a significant benefit of TT on NCIC toxicity grade or time to develop the worst grade for radiation dermatitis. In addition, TT did not improve quality of life, mood, fatigue and overall cosmetic outcome. Copyright © 2014 Elsevier Ltd. All rights reserved.

Relationship between Spiritual Health and Quality of Life in Patients with Cancer.

PubMed

Mohebbifar, Rafat; Pakpour, Amir H; Nahvijou, Azin; Sadeghi, Atefeh

2015-01-01

As the essence of health in humans, spiritual health is a fundamental concept for discussing chronic diseases such as cancer and a major approach for improving quality of life in patients is through creating meaningfulness and purpose. The present descriptive analytical study was conducted to assess the relationship between spiritual health and quality of life in 210 patients with cancer admitted to the Cancer Institute of Iran, selected through convenience sampling in 2014. Data were collected using Spiritual Health Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). Patients' performance was assessed through the Karnofsky Performance Status Indicator and their cognitive status through the Mini-Mental State Examination (MMSE). Data were analyzed in SPSS-16 using descriptive statistics and stepwise linear regression. The results obtained reported the mean and standard deviation of the patients' spiritual health scoreas 78.4±16.1and the mean and standard deviation of their quality of life score as 58.1±18.7. The stepwise linear regression analysis confirmed a positive and significant relationship between spiritual health and quality of life in patients with cancer (β=0.688 and r=0.00). The results of the study show that spiritual health should be more emphasized and reinforced as a factor involved in improving quality of life in patients with cancer. Designing care therapies and spiritual interventions is a priority in the treatment of these patients.

Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial.

PubMed

Jansen, Femke; Cnossen, Ingrid C; Eerenstein, Simone E J; Coupé, Veerle M H; Witte, Birgit I; van Uden-Kraan, Cornelia F; Doornaert, Patricia; Braunius, Weibel W; De Bree, Remco; Hardillo, José A U; Honings, Jimmie; Halmos, György B; Leemans, C René; Verdonck-de Leeuw, Irma M

2016-08-02

Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy. Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up. This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice. NTR5255 Protocol version 4 date September 2015.

Construction of quality of life change patterns: example in oncology in a phase III therapeutic trial (FFCD 0307).

PubMed

Nuemi, Gillles; Devilliers, Hervé; Le Malicot, Karine; Guimbaud, Rosine; Lepage, Côme; Quantin, Catherine

2015-09-22

Quality of life data in cancerology are often difficult to summarize due to missing data and difficulty to analyze the pattern of evolution in different groups of patients. The aim of this work was to apply a new methodology to construct Quality of Life (QoL) change patterns within patients included in a clinical trial comparing to regimen of treatment in locally advanced eosogastric cancer. In this trial, QoL was assessed every 2 months by self-reported EORTC QLQ-C30 questionnaire. Physical dimension scores were analyzed. After multiple imputation of missing data, 27 statistical measures aiming to describe the variation of QoL measures among follow-up were computed for each patient. Based on these measures, patient were grouped into homogenous groups in terms of QoL variation pattern using a K-Means classification method. The mean QoL score at each time was graphically represented in each obtained pattern. Finally, clinical characteristic of patients in each pattern of QoL were described and compared. The trial included 416 patients and 1023 questionnaire were collected. 74% of patients were male with a mean ± SD age of 62 ± 11 years. 43% of scores were missing. Patients were grouped into four classes of homogeneous QoL variation patterns. 1) a Pattern of 24 (6%) patients showing improvement in QoL with a mean variation of +10.7 points on the 0-100 scale, 2) a Pattern of 171 (41 %) patients showing a stability 3) two Patterns of 78 (19%) and 143 (34%) patients respectively showing a deterioration of QoL with a mean variation of -67.2 and -67.6, respectively. There were no difference between patterns in terms of gender or age. Patients within "degradation" pattern had significantly lower performance status (p = 0.015), higher severe after-effects rate (p < 10-3) and death rate (p < 10-3). This work opens up perspectives for longitudinal data analysis with a high probability of missing values while providing a relevant graphical summary. Patterns of QoL evolution with clinical relevance may help to interpret longitudinal QoL data in Cancer studies.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire

PubMed Central

2014-01-01

Background In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. Methods Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients’ perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. Results Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. Conclusions Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received. PMID:24460858

Short- and Long-Term Quality of Life and Bowel Function in Patients With MRI-Defined, High-Risk, Locally Advanced Rectal Cancer Treated With an Intensified Neoadjuvant Strategy in the Randomized Phase 2 EXPERT-C Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sclafani, Francesco; Peckitt, Clare; Cunningham, David, E-mail: david.cunningham@rmh.nhs.uk

Objective: Intensified preoperative treatments have been increasingly investigated in locally advanced rectal cancer (LARC), but limited data are available for the impact of these regimens on quality of life (QoL) and bowel function (BF). We assessed these outcome measures in EXPERT-C, a randomized phase 2 trial of neoadjuvant capecitabine combined with oxaliplatin (CAPOX), followed by chemoradiation therapy (CRT), total mesorectal excision, and adjuvant CAPOX with or without cetuximab in magnetic resonance imaging-defined, high-risk LARC. Methods and Materials: QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Bowel incontinence was assessed using the modifiedmore » Fecal Incontinence Severity Index questionnaire. Results: Compared to baseline, QoL scores during preoperative treatment were better for symptoms associated with the primary tumor in the rectum (blood and mucus in stool, constipation, diarrhea, stool frequency, buttock pain) but worse for global health status, role functioning, and symptoms related to the specific safety profile of each treatment modality. During follow-up, improved emotional functioning and lessened anxiety and insomnia were observed, but deterioration of body image, increased urinary incontinence, less sexual interest (men), and increased impotence and dyspareunia were observed. Cetuximab was associated with a deterioration of global health status during neoadjuvant chemotherapy but did not have any long-term detrimental effect. An improvement in bowel continence was observed after preoperative treatment and 3 years after sphincter-sparing surgery. Conclusions: Intensifying neoadjuvant treatment by administering induction systemic chemotherapy before chemoradiation therapy improves tumor-related symptoms and does not appear to have a significantly detrimental effect on QoL and BF, in both the short and the long term.« less

The ability of cancer-specific and generic preference-based instruments to discriminate across clinical and self-reported measures of cancer severities

PubMed Central

2011-01-01

Objective To evaluate the validity of cancer-specific and generic preference-based instruments to discriminate across different measures of cancer severities. Methods Patients with breast (n = 66), colorectal (n = 57), and lung (n = 61) cancer completed the EORTC QLQ-C30 and the FACT-G, as well as three generic instruments: the EQ-5D, the SF-6D, and the HUI2/3. Disease severity was quantified using cancer stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score, and self-reported health status. Comparative analyses confirmed the multi-dimensional conceptualization of the instruments in terms of construct and convergent validity. Results In general, the instruments were able to discriminate across severity measures. The instruments demonstrated moderate to strong correlation with each other (r = 0.37-0.73). Not all of the measures could discriminate between different groups of disease severity: the EQ-5D and SF-6D were less discriminative than the HUI2/3 and the cancer-specific instruments. Conclusion The cancer-specific and generic preference-based instruments demonstrated to be valid in discriminating across levels of ECOG-PS scores and self-reported health states. However, the usefulness of the generic instruments may be limited if they are not able to detect small changes in health status within cancer patients. This raises concerns regarding the appropriateness of these instruments when comparing different cancer treatments within an economic evaluation framework. PMID:22123196

Are depression and anxiety determinants or indicators of quality of life in breast cancer patients?

PubMed

Hutter, Nico; Vogel, Barbara; Alexander, Tatjana; Baumeister, Harald; Helmes, Almut; Bengel, Jürgen

2013-01-01

Depression and anxiety are associated with a decline of health-related quality of life (QoL) in breast cancer patients, and the present study aims to investigate the longitudinal relationship of depression and anxiety with QoL in breast cancer patients. Depression and anxiety (HADS) as well as QoL (EORTC QLQ-C30) were assessed at baseline and six-month follow-up in 118 breast cancer patients and analysed using cross-lagged partial correlation analysis (CLPC). There were significant partial correlations between depression and anxiety at baseline and physical functioning, emotional functioning and "global health and QoL" at six-month follow-up (range of pr = -0.197 and -0.392; p < 0.05). "Global health and QoL" at baseline was significantly correlated with depression and anxiety at follow-up (pr = -0.207 and -0.327; p < 0.05). Cognitive functioning at baseline was significantly associated with anxiety at follow-up (pr = -0.248; p < 0.01). CLPC analysis of two models (depression and anxiety determining QoL vs. QoL determining depression and anxiety) did not show significant results. Hence, in breast cancer patients, depression and anxiety are closely related to QoL and the observed correlations suggest a complex interrelation in which depression and anxiety have to be regarded as indicators of QoL rather than determinants.

Clinical factors impacting on late dysphagia following radiotherapy in patients with head and neck cancer.

PubMed

Deschuymer, Sarah; Nevens, Daan; Duprez, Fréderic; Laenen, Annouschka; Dejaeger, Eddy; De Neve, Wilfried; Goeleven, Ann; Nuyts, Sandra

2018-05-23

Patient and treatment characteristics of patients with head and neck cancer (HNSCC) were correlated with dysphagia scored on swallowing-videofluoroscopy (VFS) and with patient- and physician-scored dysphagia. 63 HNSCC patients treated with radiotherapy (RT) were evaluated at baseline, and 6 and 12 months post-RT. VFS was scored with Penetration Aspiration Scale (PAS) and Swallowing Performance Scale (SPS). Physician- and patient-scored dysphagia were prospectively recorded according to Common Terminology Criteria for Adverse Events scoring system, Radiation Therapy Oncology Group/EORTC scoring system and European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ H&N35). Univariable analysis revealed a significant association between tumour-subsite and higher SPS (p = 0.02) and patient-scored dysphagia (p = 0.02) at baseline. At 12 months, tumour-subsite was significantly associated with higher PAS and SPS. Multivariable analysis and pairwise comparison showed that hypopharyngeal cancer and carcinoma of unknown primary  were associated with higher SPS at baseline and at 12 months, respectively (p = 0.03 and p = 0.01). Upfront neck dissection (UFND) was significantly associated with higher SPS and physician-scored dysphagia in univariable analysis at all timepoints. At 12 months, there was also a significant association with higher PAS (p < 0.01) and patient-scored dysphagia (p < 0.01). After multivariable analysis, the association between UFND and higher PAS (p < 0.01) and SPS (p < 0.01) remained significant at 12 months. Hypopharyngeal tumours and carcinoma of unknown primary were related to more dysphagia at baseline and at 12 months, respectively. Furthermore, UFND was associated with more severe dysphagia scored by physicians and patients and on VFS at 12 months. Advances in knowledge: This is the first paper reporting a significant link between UFND and late dysphagia scored with VFS. We advocate abandoning UFND and preserving neck dissection as a salvage option post-RT.

Health-Related Quality of Life up to Six Years After {sup 125}I Brachytherapy for Early-Stage Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Roeloffzen, Ellen M.A., E-mail: E.M.A.Roeloffzen@UMCUtrecht.n; Lips, Irene M.; Gellekom, Marion P.R. van

2010-03-15

Purpose: Health-related quality of life (HRQOL) after prostate brachytherapy has been extensively described in published reports but hardly any long-term data are available. The aim of the present study was to prospectively assess long-term HRQOL 6 years after {sup 125}I prostate brachytherapy. Methods and Materials: A total of 127 patients treated with {sup 125}I brachytherapy for early-stage prostate cancer between December 2000 and June 2003 completed a HRQOL questionnaire at five time-points: before treatment and 1 month, 6 months, 1 year, and 6 years after treatment. The questionnaire included the RAND-36 generic health survey, the cancer-specific European Organization for Researchmore » and Treatment of Cancer core questionnaire (EORTCQLQ-C30), and the tumor-specific EORTC prostate cancer module (EORTC-PR25). A change in a score of >=10 points was considered clinically relevant. Results: Overall, the HRQOL at 6 years after {sup 125}I prostate brachytherapy did not significantly differ from baseline. Although a statistically significant deterioration in HRQOL at 6 years was seen for urinary symptoms, bowel symptoms, pain, physical functioning, and sexual activity (p <.01), most changes were not clinically relevant. A statistically significant improvement at 6 years was seen for mental health, emotional functioning, and insomnia (p <.01). The only clinically relevant changes were seen for emotional functioning and sexual activity. Conclusion: This is the first study presenting prospective HRQOL data up to 6 years after {sup 125}I prostate brachytherapy. HRQOL scores returned to approximately baseline values at 1 year and remained stable up to 6 years after treatment. {sup 125}I prostate brachytherapy did not adversely affect patients' long-term HRQOL.« less

Exploring prostate cancer survivors' self-management behaviours and examining the mechanism effect that links coping and social support to health-related quality of life, anxiety and depression: a prospective longitudinal study.

PubMed

Paterson, Catherine; Robertson, Allison; Nabi, Ghulam

2015-04-01

Little is known about the influence of psycho-social factors on health-related quality of life (HRQoL), anxiety and depression in men affected by prostate cancer. Developing an understanding in this area can help to identify men who are at high risk of inadequate support and suggest directions for appropriately targeted interventions. Moreover, little is known about how men affected by prostate cancer mobilise social support in their self-management behaviours over time. This is the first study to test the effects of coping and social support on HRQoL and emotional outcome, and assessed the self-management behaviours of men affected by prostate cancer overtime. The study population was 74 prostate cancer patients with a mean age of 67.3 (SD 7.9) years and mixed treatment modalities. The EORTC QLQ-C30, PR25 and HADS were used to assess the dependant variables before treatment and at six months follow-up. Statistical analysis was performed in SPSS version 17.0 using parametric tests and non-parametric tests. A significant decline in quality of life was observed at 6 months post diagnosis (p < 0.001). Perceived social support before radical treatment was the most important social support construct that predicted better global quality of life and less depression at six months, explaining approximately 30% of the variance. Despite men's self-management efforts and use of social support overtime, self-management self-efficacy significantly reduced at six months (p < 0.05). These findings provide support towards the development of a psycho-social intervention study to improve quality of life, self-management self-efficacy and improve patients' symptom management. Copyright © 2014 Elsevier Ltd. All rights reserved.

Using Multivariate Regression Model with Least Absolute Shrinkage and Selection Operator (LASSO) to Predict the Incidence of Xerostomia after Intensity-Modulated Radiotherapy for Head and Neck Cancer

PubMed Central

Ting, Hui-Min; Chang, Liyun; Huang, Yu-Jie; Wu, Jia-Ming; Wang, Hung-Yu; Horng, Mong-Fong; Chang, Chun-Ming; Lan, Jen-Hong; Huang, Ya-Yu; Fang, Fu-Min; Leung, Stephen Wan

2014-01-01

Purpose The aim of this study was to develop a multivariate logistic regression model with least absolute shrinkage and selection operator (LASSO) to make valid predictions about the incidence of moderate-to-severe patient-rated xerostomia among head and neck cancer (HNC) patients treated with IMRT. Methods and Materials Quality of life questionnaire datasets from 206 patients with HNC were analyzed. The European Organization for Research and Treatment of Cancer QLQ-H&N35 and QLQ-C30 questionnaires were used as the endpoint evaluation. The primary endpoint (grade 3+ xerostomia) was defined as moderate-to-severe xerostomia at 3 (XER3m) and 12 months (XER12m) after the completion of IMRT. Normal tissue complication probability (NTCP) models were developed. The optimal and suboptimal numbers of prognostic factors for a multivariate logistic regression model were determined using the LASSO with bootstrapping technique. Statistical analysis was performed using the scaled Brier score, Nagelkerke R2, chi-squared test, Omnibus, Hosmer-Lemeshow test, and the AUC. Results Eight prognostic factors were selected by LASSO for the 3-month time point: Dmean-c, Dmean-i, age, financial status, T stage, AJCC stage, smoking, and education. Nine prognostic factors were selected for the 12-month time point: Dmean-i, education, Dmean-c, smoking, T stage, baseline xerostomia, alcohol abuse, family history, and node classification. In the selection of the suboptimal number of prognostic factors by LASSO, three suboptimal prognostic factors were fine-tuned by Hosmer-Lemeshow test and AUC, i.e., Dmean-c, Dmean-i, and age for the 3-month time point. Five suboptimal prognostic factors were also selected for the 12-month time point, i.e., Dmean-i, education, Dmean-c, smoking, and T stage. The overall performance for both time points of the NTCP model in terms of scaled Brier score, Omnibus, and Nagelkerke R2 was satisfactory and corresponded well with the expected values. Conclusions Multivariate NTCP models with LASSO can be used to predict patient-rated xerostomia after IMRT. PMID:24586971

Using multivariate regression model with least absolute shrinkage and selection operator (LASSO) to predict the incidence of Xerostomia after intensity-modulated radiotherapy for head and neck cancer.

PubMed

Lee, Tsair-Fwu; Chao, Pei-Ju; Ting, Hui-Min; Chang, Liyun; Huang, Yu-Jie; Wu, Jia-Ming; Wang, Hung-Yu; Horng, Mong-Fong; Chang, Chun-Ming; Lan, Jen-Hong; Huang, Ya-Yu; Fang, Fu-Min; Leung, Stephen Wan

2014-01-01

The aim of this study was to develop a multivariate logistic regression model with least absolute shrinkage and selection operator (LASSO) to make valid predictions about the incidence of moderate-to-severe patient-rated xerostomia among head and neck cancer (HNC) patients treated with IMRT. Quality of life questionnaire datasets from 206 patients with HNC were analyzed. The European Organization for Research and Treatment of Cancer QLQ-H&N35 and QLQ-C30 questionnaires were used as the endpoint evaluation. The primary endpoint (grade 3(+) xerostomia) was defined as moderate-to-severe xerostomia at 3 (XER3m) and 12 months (XER12m) after the completion of IMRT. Normal tissue complication probability (NTCP) models were developed. The optimal and suboptimal numbers of prognostic factors for a multivariate logistic regression model were determined using the LASSO with bootstrapping technique. Statistical analysis was performed using the scaled Brier score, Nagelkerke R(2), chi-squared test, Omnibus, Hosmer-Lemeshow test, and the AUC. Eight prognostic factors were selected by LASSO for the 3-month time point: Dmean-c, Dmean-i, age, financial status, T stage, AJCC stage, smoking, and education. Nine prognostic factors were selected for the 12-month time point: Dmean-i, education, Dmean-c, smoking, T stage, baseline xerostomia, alcohol abuse, family history, and node classification. In the selection of the suboptimal number of prognostic factors by LASSO, three suboptimal prognostic factors were fine-tuned by Hosmer-Lemeshow test and AUC, i.e., Dmean-c, Dmean-i, and age for the 3-month time point. Five suboptimal prognostic factors were also selected for the 12-month time point, i.e., Dmean-i, education, Dmean-c, smoking, and T stage. The overall performance for both time points of the NTCP model in terms of scaled Brier score, Omnibus, and Nagelkerke R(2) was satisfactory and corresponded well with the expected values. Multivariate NTCP models with LASSO can be used to predict patient-rated xerostomia after IMRT.

Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial.

PubMed

van Vulpen, Jonna K; Siersema, Peter D; van Hillegersberg, Richard; Nieuwenhuijzen, Grard A P; Kouwenhoven, Ewout A; Groenendijk, Richard P R; van der Peet, Donald L; Hazebroek, Eric J; Rosman, Camiel; Schippers, Carlo C G; Steenhagen, Elles; Peeters, Petra H M; May, Anne M

2017-08-18

Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery. The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO 2peak ), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program. This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies. Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

Development of anxiety, depression and health-related quality of life in oncology patients without initial symptoms according to the Hospital Anxiety and Depression Scale - a comparative study.

PubMed

Thalén-Lindström, Annika; Glimelius, Bengt; Johansson, Birgitta

2017-08-01

Depression and anxiety are associated with decreased health-related quality of life (HRQoL). The knowledge about the development of anxiety, depression and HRQoL in cancer patients without depression or anxiety, that is initially scoring as non-cases (cutoff <8) according to the Hospital Anxiety and Depression Scale (HADS), is sparse. The objectives were: (1) to evaluate changes in anxiety, depression and HRQoL over 6 months in two independent cohorts of oncology patients initially scoring as non-cases by the HADS, (2) to compare stable non-case patients with the general population regarding HRQoL and (3) to explore the outcomes using >4 rather than >7 as cutoff on any of HADS subscales. The study group (SG) included 245 and the validation group (VG), a previous cohort, included 281 non-cases. Patients who were non-cases (HADS <8) at all completed assessments were categorized as stable non-cases (stable-NC); those who were doubtful/clinical cases (HADS >7) in at least one follow-up were categorized as unstable-NC. Questionnaires were completed at baseline, and after 1, 3 and 6 months. Age- and sex-matched EORTC QLQ-C30 data from the general population were used for HRQoL comparisons. One hundred ninety-six (80%) SG and 244 (87%) VG patients were stable-NC and 49 (20%) SG and 37 (13%) VG patients were unstable-NC. SG and VG were similar in all outcomes. Anxiety, depression and HRQoL deteriorated over 6 months for unstable-NC (p < .05). HRQoL for stable-NC was comparable to that in the general population. If >4 had been used as cutoff, most unstable-NC (36/49 and 25/37, respectively) would have been identified at baseline. Most non-cases are stable-NC with a high stable HRQoL, indicating no need for re-assessment. A minority develop anxiety or depression symptoms and impaired HRQoL; for these a cutoff >4 rather than >7 on HADS subscales may be useful for early detection.

Factors influencing life satisfaction in acute myeloid leukemia survivors following allogeneic stem cell transplantation: a cross-sectional study.

PubMed

Amler, Susanne; Sauerland, Maria Cristina; Deiters, Christian; Büchner, Thomas; Schumacher, Andrea

2015-02-27

Allogeneic stem cell transplantation (alloSCT) is the preferred option of postremission therapy for high-risk patients suffering from acute myeloid leukemia (AML). Therefore, monitoring life satisfaction (LS) of long-term survivors following alloSCT is becoming increasingly important for oncologists. The aim of the study was to evaluate individual survivor priority of various general and health-related domains of life and their satisfaction with these domains. Furthermore, we investigated the impact of general and health-related LS on resilience, anxiety, depression and quality of life in AML survivors following alloSCT. Forty-one AML survivors (median age at time of assessment = 49.0 years) who had undergone alloSCT (median time since transplantation = 3.1 years) were enrolled in the study. Psychosocial parameters were assessed using the following instruments: FLZ(M) (Questions on Life Satisfaction), EORTC QLQ-C30, HADS (Hospital Anxiety and Depression Scale) and the RS-25 (Resilience Scale-25 items). Correlation analyses were computed to reveal the associations between the different questionnaires. Independence from help or care, well-regulated living conditions and financial security contributed positively to LS, whereas being off work due to health-reasons and dissatisfaction with physical aspects were negatively associated to the subjective feelings of overall satisfaction. Moreover, a high quality of life was strongly positively correlated with LS (Spearman's rho general LS: 0.643 and health-related LS: 0.726, both p < 0.001). A high degree of resilience was also strongly positively correlated with better LS (general LS: 0.700, health-related LS: 0.675, both p < 0.001). Symptoms of anxiety and depression were associated with an impaired general LS (anxiety: -0.674, depression: -0.698, both p < 0.001). Our results indicate that LS should be considered an important key contributor to the survivors' well-being following alloSCT. Thus, identifying protective psychological and physical factors that relieve stressors is of high importance in order to support long-term AML survivors with their special needs.

Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial.

PubMed

Mijwel, Sara; Backman, Malin; Bolam, Kate A; Jervaeus, Anna; Sundberg, Carl Johan; Margolin, Sara; Browall, Maria; Rundqvist, Helene; Wengström, Yvonne

2018-02-01

Exercise training is an effective and safe way to counteract cancer-related fatigue (CRF) and to improve health-related quality of life (HRQoL). High-intensity interval training has proven beneficial for the health of clinical populations. The aim of this randomized controlled trial was to compare the effects of resistance and high-intensity interval training (RT-HIIT), and moderate-intensity aerobic and high-intensity interval training (AT-HIIT) to usual care (UC) in women with breast cancer undergoing chemotherapy. The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms. Two hundred and forty women planned to undergo chemotherapy were randomized to supervised RT-HIIT, AT-HIIT, or UC. Measurements were performed at baseline and at 16 weeks. Questionnaires included Piper Fatigue Scale, EORTC-QLQ-C30, and Memorial Symptom Assessment Scale. The RT-HIIT group was superior to UC for CRF: total CRF (p = 0.02), behavior/daily life (p = 0.01), and sensory/physical (p = 0.03) CRF. Role functioning significantly improved while cognitive functioning was unchanged for RT-HIIT compared to declines shown in the UC group (p = 0.04). AT-HIIT significantly improved emotional functioning versus UC (p = 0.01) and was superior to UC for pain symptoms (p = 0.03). RT-HIIT reported a reduced symptom burden, while AT-HIIT remained stable compared to deteriorations shown by UC (p < 0.01). Only RT-HIIT was superior to UC for total symptoms (p < 0.01). 16 weeks of resistance and HIIT was effective in preventing increases in CRF and in reducing symptom burden for patients during chemotherapy for breast cancer. These findings add to a growing body of evidence supporting the inclusion of structured exercise prescriptions, including HIIT, as a vital component of cancer rehabilitation. Clinicaltrials.gov Registration Number: NCT02522260.

Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™).

PubMed

Hagelstein, V; Ortland, I; Wilmer, A; Mitchell, S A; Jaehde, U

2016-12-01

Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Sexual functioning in women after mastectomy versus breast conserving therapy for early-stage breast cancer: a prospective controlled study.

PubMed

Aerts, L; Christiaens, M R; Enzlin, P; Neven, P; Amant, F

2014-10-01

Breast cancer (BC) and/or its treatments may affect sexual functioning based on physiological and psychosocial mechanisms. The aim of this study was to prospectively investigate sexual adjustment of BC patients during a follow-up period of one year after mastectomy (ME) or breast conserving therapy (BCT). In this prospective controlled study, women with BC and an age-matched control group of healthy women completed the Beck Depression Inventory Scale, World Health Organization 5 Well-being scale, Body Image Scale, EORTC QLQ questionnaire, Dyadic Adjustment Scale, Short Sexual Functioning Scale and Specific Sexual Problems Questionnaire to assess various aspects of sexual and psychosocial functioning before surgery, six months and one year after surgical treatment. In total, 149 women with BC and 149 age-matched healthy controls completed the survey. Compared to the situation before surgery, significantly more BCT women reported problems with sexual arousal six months after surgery and significantly more women of the ME group reported problems with sexual desire, arousal and the ability to achieve an orgasm six months and one year after surgery. While in comparison with healthy controls, no significant differences in sexual functioning were found after BCT surgery, significantly more women who underwent ME reported problems with sexual desire, arousal, the ability to achieve an orgasm and intensity of the orgasm. Although little differences were seen in sexual functioning in the BCT group during prospective analyses and in comparison with healthy controls, analyses revealed that women who underwent a ME were at risk for post-operative sexual dysfunctions. Copyright © 2014. Published by Elsevier Ltd.

Prospective Evaluation of Acute Toxicity and Quality of Life After IMRT and Concurrent Chemotherapy for Anal Canal and Perianal Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Han, Kathy; Cummings, Bernard J.; Lindsay, Patricia

Purpose: A prospective cohort study was conducted to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer. Methods and Materials: From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicitymore » was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Results: Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus—positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were significantly better at 12 months than at baseline. Multiple dose-volume parameters correlated moderately with diarrhea, skin, and hematologic toxicity scores. Conclusion: IMRT reduces acute grade 3 + hematologic and gastrointestinal toxicities compared with reports from non-IMRT series, without compromising locoregional control. The reported QOL scores most relevant to acute toxicities returned to baseline by 3 months after treatment.« less

Toxicity and quality of life after choline-PET/CT directed salvage lymph node dissection and adjuvant radiotherapy in nodal recurrent prostate cancer.

PubMed

Jilg, Cordula A; Leifert, Anja; Schnell, Daniel; Kirste, Simon; Volegova-Neher, Natalia; Schlager, Daniel; Wieser, Gesche; Henne, Karl; Schultze-Seemann, Wolfgang; Grosu, Anca-L; Rischke, Hans Christian

2014-08-12

In a previous study we demonstrated that, based on 11C/18 F-choline positron emission tomography-computerized-tomography as a diagnostic tool, salvage lymph node dissection (LND) plus adjuvant radiotherapy (ART) is feasible for treatment of pelvic/retroperitoneal nodal recurrence of prostate cancer (PCa). However, the toxicity of this combined treatment strategy has not been systematically investigated before. The aim of the current study was to evaluate the acute and late toxicity and quality of life of ART after LND in pelvic/retroperitoneal nodal recurrent PCa. 43 patients with nodal recurrent PCa were treated with 46 LND followed by ART (mean 49.6 Gy total dose) at the sites of nodal recurrence. Toxicity of ART was analysed by physically examination (31/43, 72.1%), by requesting 15 frequent items of adverse events from the Common-Terminology-Criteria for Adverse Events Version 4.0-catalogue and by review of medical records. QLQ-C30 (EORTC quality of life assessment) and PR25 (prostate cancer module) questionnaires were used to investigate quality of life. Toxicity was evaluated before starting of ART, during ART (acute toxicity), after ART (mean 2.3 months) and at end of follow up (mean 3.2 years after end of ART) reflecting late toxicity. 71.7% (33/46) of 46 ART were treatment of pelvic, 10.9% (5/46) of retroperitoneal only and 28.3% (13/46) of pelvic and retroperitoneal regions. Overall 52 symptoms representing toxicities were observed before ART, 107 during ART, 88 after end of ART and 52 at latest follow up. Leading toxicities during ART were diarrhoea (19%, 20/107), urinary incontinence (16%, 17/107) and fatigue (16%, 17/107). The spectrum of late toxicities was almost equal to those before beginning of ART. No grade 3 adverse events or chronic lymphedema at extremities were observed. We observed no clear correlation between localisation of treated regions, technique of ART and frequency or severity of toxicities. Mean quality of life at final evaluation was 74%. ART after extended LND in PCa relapse is justifiable with respect to adverse effects and toxicity. The side effects were circumscribed and well tolerated. The spectrum of adverse events at latest follow up was almost equal to those before start of ART.

Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy.

PubMed

Knoerl, Robert; Gray, Evan; Stricker, Carrie; Mitchell, Sandra A; Kippe, Kelsey; Smith, Gloria; Dudley, William N; Lavoie Smith, Ellen M

2017-11-01

The aim of this study is to examine and compare with the validated, paper/pencil European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20), the psychometric properties of three electronically administered patient reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN): (1) the two neuropathy items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), (2) the QLQ-CIPN20, and (3) the 0-10 Neuropathy Screening Question (NSQ). We employed a descriptive, cross-sectional design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy at an academic hospital. Participants completed the paper/pencil QLQ-CIPN20 and electronic versions of the QLQ-CIPN20, PRO-CTCAE, and NSQ. Internal consistency reliability, intraclass correlation, and concurrent and discriminant validity analyses were conducted. The alpha coefficients for the electronic QLQ-CIPN20 sensory and motor subscales were 0.76 and 0.75. Comparison of the electronic and paper/pencil QLQ-CIPN20 subscales supported mode equivalence (intraclass correlation range >0.91). Participants who reported the presence of numbness/tingling via the single-item NSQ reported higher mean QLQ-CIPN20 sensory subscale scores (p < 0.001). PRO-CTCAE neuropathy severity and interference items correlated well with the QLQ-CIPN20 electronic and paper/pencil sensory (r = 0.76; r = 0.70) and motor (r = 0.55; r = 0.62) subscales, and with the NSQ (r = 0.72; r = 0.44). These data support the validity of the electronically administered PRO-CTCAE neuropathy items, NSQ, and QLQ-CIPN20 for neuropathy screening in clinical practice. The electronic and paper/pencil versions of the QLQ-CIPN can be used interchangeably based on evidence of mode equivalence.

Associations of Body Mass Index and Physical Activity With Sexual Dysfunction in Breast Cancer Survivors.

PubMed

Paiva, Carlos Eduardo; Rezende, Fabiana Faria; Paiva, Bianca Sakamoto Ribeiro; Mauad, Edmundo Carvalho; Zucca-Matthes, Gustavo; Carneseca, Estela Cristina; Syrjänen, Kari Juhani; Schover, Leslie R

2016-11-01

Sexual dysfunction is a common and distressing consequence of breast cancer (BC) treatment. In the present study, we investigated the sexual functioning of BC patients and its association with women's personal characteristics and cancer treatments. In this cross-sectional study, sexual function was assessed using the Female Sexual Function Index (FSFI). The health-related quality of life (HRQOL) was measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and its breast module BR-23. Of the 235 participants approached, 216 participants were included in the study. Of these, 63 patients reported no sexual activity in the last month and thus were analyzed only in relation to the sexual desire domain of FSFI. A total of 154 (71.3 %) patients were classified with hypoactive sexual desire disorder (HSDD). From those patients reporting sexual activity in the last month, 63.3 % (97 out of 153) were classified with sexual dysfunction. Using hierarchical logistic regression, the variance explained (change in R 2 ) by the addition of body mass index (BMI) and mild to moderate physical activity in the prediction models of sexual dysfunction and HSDD were 6.8 and 7.2 %, respectively. Age, BMI, and physical activity were independently associated with sexual dysfunction and HSDD. Additionally, BC patients with sexual dysfunction reported lower scores on global HRQOL, role functioning, and fatigue. Based on our findings, BC survivors should be encouraged to practice regular physical activity and to lose weight in order to avoid sexual dysfunction. However, future clinical trials are needed to confirm these findings.

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture

PubMed Central

Rostock, M.; Jaroslawski, K.; Guethlin, C.; Ludtke, R.; Schröder, S.; Bartsch, H. H.

2013-01-01

Purpose. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA) from which preliminary data showed promising results. Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; n = 14) with hydroelectric baths (HB, n = 14), vitamin B1/B6 capsules (300/300 mg daily; VitB, n = 15), and placebo capsules (n = 17). The statistical power in this trial was primarily calculated for proving EA only, so results of HB and VitB are pilot data. Results. CIPN complaints improved by 0.8 ± 1.2 (EA), 1.7 ± 1.7 (HB), 1.6 ± 2.0 (VitB), and 1.3 ± 1.3 points (placebo) on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30) were found. Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. This trial is registered with DRKS00004448. PMID:24066010

Treatment of painful bone metastases in prostate and breast cancer patients with the therapeutic radiopharmaceutical rhenium-188-HEDP. Clinical benefit in a real-world study.

PubMed

Lange, Rogier; Overbeek, Floor; de Klerk, John M H; Pasker-de Jong, Pieternel C M; van den Berk, Alexandra M; Ter Heine, Rob; Rodenburg, Cees J; Kooistra, Anko; Hendrikse, N Harry; Bloemendal, Haiko J

2016-09-26

Rhenium-188-HEDP ((188)Re-HEDP) is an effective radiopharmaceutical for the palliative treatment of osteoblastic bone metastases. However, only limited data on its routine use are available and its effect on quality of life (QoL) has not been studied. Therefore, we evaluated the clinical benefit of (188)Re-HEDP in routine clinical care. Prostate or breast cancer patients with painful bone metastases receiving (188)Re-HEDP as a routine clinical procedure were eligible for evaluation. Clinical benefit was assessed in terms of efficacy and toxicity. Pain palliation and QoL were monitored using the visual analogue scale (VAS), corrected for opioid intake, and the EORTC QLQ-C30 Global health status/QoL-scale. Thrombocyte and leukocyte nadirs were used to assess haematological toxicity. 45 and 47 patients were evaluable for pain palliation and QoL, respectively. After a single injection of (188)Re-HEDP, the overall pain response rate was 69% and mean VAS-scores decreased relevantly and significantly (p < 0.05). Repeated treatment resulted in similar pain response. The overall QoL response rate was 68% and mean Global health status/QoL-scores increased relevantly and significantly. Haematological side effects were mild and transient. The clinically relevant response on pain and quality of life and the limited adverse events prove clinical benefit of treatment with (188)Re-HEDP and support its use in routine clinical care. Its effectiveness appears comparable to that of external beam radiotherapy.

Using a retrospective pretest instead of a conventional pretest is replacing biases: a qualitative study of cognitive processes underlying responses to thentest items.

PubMed

Taminiau-Bloem, Elsbeth F; Schwartz, Carolyn E; van Zuuren, Florence J; Koeneman, Margot A; Visser, Mechteld R M; Tishelman, Carol; Koning, Caro C E; Sprangers, Mirjam A G

2016-06-01

The thentest design aims to detect and control for recalibration response shift. This design assumes (1) more consistency in the content of the cognitive processes underlying patients' quality of life (QoL) between posttest and thentest assessments than between posttest and pretest assessments; and (2) consistency in the time frame and description of functioning referenced at pretest and thentest. Our objective is to utilize cognitive interviewing to qualitatively examine both assumptions. We conducted think-aloud interviews with 24 patients with cancer prior to and after radiotherapy to elicit cognitive processes underlying their assessment of seven EORTC QLQ-C30 items at pretest, posttest and thentest. We used an analytic scheme based on the cognitive process models of Tourangeau et al. and Rapkin and Schwartz that yielded five cognitive processes. We subsequently used this input for quantitative analysis of count data. Contrary to expectation, the number of dissimilar cognitive processes between posttest and thentest was generally larger than between pretest and posttest across patients. Further, patients considered a range of time frames when answering the thentest questions. Moreover, patients' description at the thentest of their pretest functioning was often not similar to that which was noted at pretest. Items referring to trouble taking a short walk, overall health and QoL were most often violating the assumptions. Both assumptions underlying the thentest design appear not to be supported by the patients' cognitive processes. Replacing the conventional pretest-posttest design with the thentest design may simply be replacing one set of biases with another.

Prostate cancer-related anxiety in long-term survivors after radical prostatectomy.

PubMed

Meissner, Valentin H; Herkommer, Kathleen; Marten-Mittag, Birgitt; Gschwend, Jürgen E; Dinkel, Andreas

2017-12-01

Knowledge of the psychological distress of long- and very long-term (>10 years) prostate cancer (PC) survivors is limited. This study intended to examine the parameters influencing anxiety related to prostate-specific antigen (PSA) and PC in long-term survivors after radical prostatectomy. We surveyed 4719 PC survivors from the German multicenter prospective database "Familial Prostate Cancer." We evaluated the association of PC-related anxiety (MAX-PC) with sociodemographic characteristics, family history of PC, global health status/quality of life (EORTC QLQ-C30), depression and anxiety (PHQ-2; GAD-2), latest PSA level, time since radical prostatectomy, and current therapy. The survey participants' mean age was 75.2 years (SD = 6.5). Median follow-up was 11.5 years, and 19.5% of participants had survived more than 15 years since the initial treatment. The final regression analysis found that younger age, lower global health status/quality of life, higher depression and anxiety scores, higher latest PSA level, and shorter time since radical prostatectomy predicted increased PSA-related anxiety and PC anxiety. Familial PC was predictive only of PSA anxiety (all p < 0.05). The final model explained 12% of the variance for PSA anxiety and 24% for PC anxiety. PC-related anxiety remained relevant many years after prostatectomy and was influenced by younger age, psychological status, rising PSA level, and shorter time since initial treatment. Survivors with these characteristics are at increased risk of PC-related anxieties, which should be considered by the treating physician during follow-up.

Activities of daily living and quality of life during treatment with neoadjuvant chemoradiotherapy and after surgery in patients with esophageal cancer.

PubMed

Haj Mohammad, Nadia; De Rooij, Sophia; Hulshof, Maarten; Ruurda, Jelle; Wijnhoven, Bas; Erdkamp, Frans; Sosef, Meindert; Gisbertz, Suzanne; van Berge Henegouwen, Mark; Sprangers, Mirjam; van Laarhoven, Hanneke

2016-11-01

Neoadjuvant chemoradiation (nCRT) followed by esophagectomy is a treatment with curative intent for resectable esophageal cancer. The aim of this study was to measure activities of daily living (ADL) and quality of life (QoL), and to examine correlates of changes in ADL and QoL. A prospective study was performed with three time points (baseline, 1 week after the end of nCRT, 3-months post-surgery) together with a cross-sectional post-treatment study. ADL was measured with the Amsterdam Linear Disability Score (ALDS), and QoL with the EORTC QLQ-C30 and the OES-18. Regression analysis was performed to identify factors associated with changes in ADL and QoL. Seventy-six patients were included in the prospective study, 79 in the cross-sectional study. After nCRT, ALDS decreased from 90 to 88 (P < 0.01) and remained stable after surgery. Global QoL decreased from 75 to 61 (P < 0.01); no significant changes were observed after surgery. Only timing of the measurement of ALDS was negatively associated with non-maximum ALDS (n = 155, based on both studies) and QoL (n = 76) (P < 0.01). Patients who undergo nCRT plus surgery should be prepared to experience a short-term decline in ADL and QoL. The findings of this study can support patients and healthcare workers to guide expectations. J. Surg. Oncol. 2016;114:684-690. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.