The use of EORTC measures in daily clinical practice-A synopsis of a newly developed manual.

PubMed

Wintner, Lisa M; Sztankay, Monika; Aaronson, Neil; Bottomley, Andrew; Giesinger, Johannes M; Groenvold, Mogens; Petersen, Morten Aa; van de Poll-Franse, Lonneke; Velikova, Galina; Verdonck-de Leeuw, Irma; Holzner, Bernhard

2016-11-01

Cancer has increasingly become a chronic condition and the routine collection of patient-reported outcomes (PROs) like quality of life is widely recommended for clinical practice. Nonetheless, the successful implementation of PROs is still a major challenge, although common barriers to and facilitators of their beneficial use are well known. To support health care professionals and other stakeholders in the implementation of the EORTC PRO measures, the EORTC Quality of Life Group provides guidance on issues considered important for their use in daily clinical practice. Herein, we present an outline of the newly developed "'Manual for the use of EORTC measures in daily clinical practice", covering the following issues: * a rationale for using EORTC measures in routine care *selection of EORTC measures, timing of assessments, scoring and presentation of results * aspects of a strategic implementation * electronic data assessment and telemonitoring, and * further use of EORTC measures and ethical considerations. Next to an extensive overview of currently available literature, the manual specifically focuses on knowledge about EORTC measures to give evidence-based recommendations whenever possible and to encourage readers and end-users of EORTC measures to contribute to further needed high-quality research. The manual will be accessible on the EORTC Quality of Life Group website's homepage and will be periodically updated to take into account any new knowledge due to medical, technical, regulatory and scientific advances. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

An analysis of the psychometric properties of the translated versions of the European Organisation for the Research and Treatment of Cancer QLQ CX24 questionnaire in the two South African indigenous languages of Xhosa and Afrikaans.

PubMed

du Toit, G C; Kidd, M

2016-09-01

This study evaluates the psychometric properties of the Xhosa and Afrikaans version, the European Organization for Research and Treatment of Cancer (EORTC) of the Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24). Translated Xhosa and Afrikaans versions, EORTC QLQ-CX24 and the core questionnaire (the EORTC QLQ-C30) were completed by 66 Xhosa and 142 Afrikaans speaking women newly diagnosed with cervical cancer. Construct reliability and validity of the EORTC QLQ-CX24 questionnaire were assessed via factor analysis, multi-trait scaling analyses and known group comparisons. The mean age was similar in the groups with a mean age of the Xhosa group (52 year) and Afrikaans group (49.2 year) (P = 0.25). The study groups had a high unemployment rate of, respectively, 52% (Xhosa) and 51% (Afrikaans) (P = 0.35). The Xhosa group had a statistically significant higher incidence of advanced stage (III and IV) disease (P = 0.006). Scale reliability was confirmed by Cronbach's α coefficients for internal consistency, which ranged from 0.73 to 0.81 (Xhosa) and 0.73 to 0.76 (Afrikaans). Clinical validity of both language versions was demonstrated by the ability to discriminate among different stages of cervical cancer. The translated Xhosa and Afrikaans versions of the EORTC QLQ-CX24 were found to be reliable and valid measure of quality of life of women with cervical cancer. © 2015 John Wiley & Sons Ltd.

An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients.

PubMed

Koller, M; Hjermstad, M J; Tomaszewski, K A; Tomaszewska, I M; Hornslien, K; Harle, A; Arraras, J I; Morag, O; Pompili, C; Ioannidis, G; Georgiou, M; Navarra, C; Chie, W-C; Johnson, C D; Himpel, A; Schulz, C; Bohrer, T; Janssens, A; Kulis, D; Bottomley, A

2017-11-01

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 was the first module to be used in conjunction with the core questionnaire, the QLQ-C30. Since the publication of the LC13 in 1994, major advances have occurred in the treatment of lung cancer. Given this, an update of the EORTC QLQ-LC13 was undertaken. The study followed phases I to III of the EORTC Module Development Guidelines. Phase I generated relevant quality-of-life issues using a mix of sources including the involvement of 108 lung cancer patients. Phase II transformed issues into questionnaire items. In an international multicenter study (phase III), patients completed both the EORTC QLQ-C30 and the 48-item provisional lung cancer module generated in phases I and II. Patients rated each of the items regarding relevance, comprehensibility, and acceptance. Patient ratings were assessed against a set of prespecified statistical criteria. Descriptive statistics and basic psychometric analyses were carried out. The phase III study enrolled 200 patients with histologically confirmed lung cancer from 12 centers in nine countries (Cyprus, Germany, Italy, Israel, Spain, Norway, Poland, Taiwan, and the UK). Mean age was 64 years (39 - 91), 59% of the patients were male, 82% had non-small-cell lung cancer, and 56% were treated with palliative intent. Twenty-nine of the 48 questions met the criteria for inclusion. The resulting module with 29 questions, thus currently named EORTC QLQ-LC29, retained 12 of the 13 original items, supplemented with 17 items that primarily assess treatment side-effects of traditional and newer therapies. © The Author 2017. 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.

[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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Introduction of Questionnaires for Quality of Life of Patients with Malignant Tumors of the Central Nervous System into Neurosurgical Practice in the Republic of Kazakhstan.

PubMed

Akshulakov, Serik; Aldiyarova, Nurgul; Ryskeldiyev, Nurzhan; Akhmetzhanova, Zauresh; Gaitova, Kamila; Auezova, Raushan; Doskaliyev, Aidos; Kerimbayev, Talgat

2016-01-01

Studies of quality of life (QoL) of oncological patients is carried out using questionnaires approved in many international clinical studies. The European Organization for Research and Treatment of Cancer EORTC QLQ-C30 (Quality of Life Questionnary-Core 30) and its special brain cancer module EORTC QLQ-BN20 are widely used in the world neurooncologic practice. They are available in more than 80 official versions of 30 languages of the world. Previously we used the official versions in Russian, which often causes difficulty in understanding for native Kazakh language speakers, who comprise more than 60% of our respondents. This was the reason for creating a version of Kazakh language. Therefore, in 2014 for the first time the process of adaptation of questionnaires to the Kazakh language was initiated. The translation process of questionnaires to Kazakh language was held in accordance with the requirements of the European Organization for Research and Treatment of Cancer EORTC on QoL and consisted of the following stages: preparation - translation - pilot testing - approval. The official permission of authors and "Guideline on translation" was obtained which was developed by the working group of the EORTC on QoL. The pilot testing of EORTC QLQ-C30 and QLQ-BN20 questionnaires was conducted on the basis of the Department of Central Nervous System Pathology of the "National Centre for Neurosurgery" in patients with malignant tumors of the central nervous system. The official versions of the EORTC QLQ-C30 and QLQ-BN20 questionnaires in Kazakh language were introduced and adapted in practical neurosurgical operations in Kazakhstan. The approved versions of the questionnaires in Kazakh language are now available for mainstream use on the official website EORTC.com. The versions of these questionnaires can be used in domestic cohort studies and clinical practice in the Republic of Kazakhstan. The use of these tools for assessing QoL will help professionals in the planning of individual treatment strategies and selection of the necessary therapy.

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.

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 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.

[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.

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.

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.

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

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.

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 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.

Further evaluation of the EORTC QLQ-C30 psychometric properties in a large Brazilian cancer patient cohort as a function of their educational status.

PubMed

Paiva, Carlos Eduardo; Carneseca, Estela Cristina; Barroso, Eliane Marçon; de Camargos, Mayara Goulart; Alfano, Ana Camila Callado; Rugno, Fernanda Capella; Paiva, Bianca Sakamoto Ribeiro

2014-08-01

The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is considered a valid instrument for use in Brazil. However, the previous Brazilian validation study included only 30 lung cancer patients and only measured test-retest reliability. The aim of this study was to evaluate the psychometric properties of the EORTC QLQ-C30 in a sample of cancer patients at different educational levels who completed the instrument administered by an interviewer. Data from six prospective studies conducted by the same group of researchers were combined in this study (N = 986). Reliability was assessed using Cronbach's alpha coefficient, all values of which were >0.7, with the exception of cognitive functioning, social functioning, and nausea and vomiting (α = 0.57, α = 0.69, and α = 0.68, respectively). In multi-trait scaling analysis, convergent and divergent validity were considered adequate (validity indices were 91.6 and 97.4%). In general, moderate to strong correlations were found between the subscales of the EORTC QLQ-C30 and its respective dimensions from the WHOQOL-bref, the hospital anxiety and depression scale, and the Edmonton Symptom Assessment System (ESAS) instruments. In addition, the EORTC QLQ-C30 was able to differentiate groups of patients with distinct performance statuses and types of treatment (known-group validation). Statistical analyses were also performed on educational status, yielding similar results. Detailed psychometric property data using the EORTC QLQ-C30 in Brazil are added by this study. In addition, we demonstrated that this instrument is in general reliable and valid regardless of the patient educational level.

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.

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 EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

PubMed

Petersen, Morten Aa; Aaronson, Neil K; Arraras, Juan I; Chie, Wei-Chu; Conroy, Thierry; Costantini, Anna; Dirven, Linda; Fayers, Peter; Gamper, Eva-Maria; Giesinger, Johannes M; Habets, Esther J J; Hammerlid, Eva; Helbostad, Jorunn; Hjermstad, Marianne J; Holzner, Bernhard; Johnson, Colin; Kemmler, Georg; King, Madeleine T; Kaasa, Stein; Loge, Jon H; Reijneveld, Jaap C; Singer, Susanne; Taphoorn, Martin J B; Thamsborg, Lise H; Tomaszewski, Krzysztof A; Velikova, Galina; Verdonck-de Leeuw, Irma M; Young, Teresa; Groenvold, Mogens

2018-06-21

To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains. The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed. Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power. The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

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.

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.

Validation study of the EORTC information questionnaire (EORTC QLQ-INFO25) in Iranian cancer patients.

PubMed

Asadi-Lari, Mohsen; Ahmadi Pishkuhi, Mahin; Almasi-Hashiani, Amir; Safiri, Saeid; Sepidarkish, Mahdi

2015-07-01

Developing a tool for measuring patient's needs is a vital step in the process of cancer treatment and research. In recent years, the European Organization for Research and Treatment of Cancer (EORTC) made a questionnaire to measure cancer patients' received information. Since validity and reliability of any instrument should be evaluated in the new environment and culture, the aim of this study was to assess the validity and reliability of the EORTC QLQ-INFO25 in Iranian cancer patients. One hundred seventy-three patients with different stages of cancer filled questionnaire EORTC QLQ-INFO25, EORTC QLQ-C30, and EORTC IN-PATSAT32. Twenty-five patients answered the questionnaire twice at an interval of 2 weeks. Reliability and validity of the questionnaire was measured by Cronbach's alpha, interclass correlation, test retest, inter-rater agreement (IRA), and exploratory factorial analyses. Using a conservative approach, the IRA for the overall relevancy and clarity of the tool was 87/86% and 83.33%, respectively. Overall appropriateness and clarity were 94.13 and 91.87%, respectively. Overall integrity of the instrument was determined to be 85%. Cronbach's alpha coefficients for all domains and total inventory were top 70 and 90%, respectively. Interclass correlation index ranges between 0.708 and 0.965. Exploratory factorial analyses demonstrate six fields suitable for instrument. Correlation between areas of the questionnaires EORTC QLQ-INFO25 and EORTC in-Patsat32 represents the convergent validity of the questionnaire. Also, results show a standard divergent validity in all domains of the questionnaire (Rho <0.3). Low correlation between the areas of the questionnaires EORTC QLQ-INFO25 and EORTC QLQ-C30 (<0.3) demonstrates the divergence validity of the questionnaire. The results showed that Persian version of the questionnaire EORTC QLQ-INFO25 is a reliable and valid instrument for measuring the perception of information in cancer patients.

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

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.

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-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 ).

Home-based multidimensional survivorship programmes for breast cancer survivors.

PubMed

Cheng, Karis Kin Fong; Lim, Yee Ting Ethel; Koh, Zhi Min; Tam, Wilson Wai San

2017-08-24

The prognosis and survival rate of women with breast cancer have significantly improved worldwide. Effective home-based multidimensional programmes for breast cancer survivors have gained an ever greater emphasis in survivorship care to maximise women's quality of life for their successful transition to rehabilitation and normal life. It is important to summarise the best available evidence to evaluate the effects of home-based multidimensional survivorship programmes on quality of life in women within 10 years of the completion of surgery or adjuvant cancer therapy for breast cancer, or both. To assess the effects of home-based, multidimensional survivorship (HBMS) programmes on maintaining or improving the quality of life in breast cancer survivors. In April 2016 we searched the Cochrane Breast Cancer Specialised Register, CENTRAL, PubMed, Embase, CINAHL Plus, PsycINFO, Web of Science, and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. We also screened reference lists of all identified studies and contacted study authors. Randomised controlled trials (RCTs) and quasi-RCTs assessing the effects of HBMS programmes in maintaining or improving quality of life in women with stages 0 to 3 breast cancer who completed primary cancer treatment (surgery or adjuvant cancer therapy, or both) up to 10 years earlier. We considered studies where the interventions included more than one of the following listed components: educational (such as information provision and self-management advice), physical (such as exercise training and resistance training) and psychological (such as counselling and cognitive therapies), to constitute a multidimensional programme. Interventions had to be allowed to be carried out at home. Two authors independently assessed eligible studies for inclusion, and performed quality assessment and extracted relevant data of the included studies. Quality of life was the primary outcome of the review. We included 22 RCTs and four quasi-RCTs on 2272 participants. We categorised the intervention components into four groups: educational and psychological; educational and physical; physical and psychological; and educational, physical and psychological. Most of the studies used usual care (routine medical follow-up services) as the comparator. A few studies used a lower level or different type of intervention (e.g. stress management or exercise) or attention control as the comparator.We used the Functional Assessment of Cancer Therapy-Breast (FACT B), European Organisation for Research and Treatment of Cancer Quality of Life C30 (EORTC C30), Quality of Life (QoL) Breast Cancer, and SF36 questionnaires to assess quality of life. HBMS programmes may increase breast cancer-specific quality of life and global quality of life immediately after the intervention, as measured by FACT-B and EORTC C30 (FACT-B: mean difference (MD) 4.55, 95% confidence interval (CI) 2.33 to 6.78, 7 studies, 764 participants; EORTC: MD 4.38, 95% CI 0.11 to 8.64, 6 studies; 299 participants; moderate-quality evidence). There was no evidence of a difference in quality of life as measured by QoL-Breast Cancer or SF-36 (QoL-Breast Cancer: MD 0.42, 95% CI -0.02 to 0.85, 2 studies, 111 participants, very low-quality evidence; physical composite score SF36: MD 0.55, 95% CI -3.52 to 4.63, 2 studies, 308 participants, low-quality evidence).We observed a similar pattern at one to three months after the intervention: FACT-B (MD 6.10, 95% CI 2.48 to 9.72, 2 studies, 426 participants), EORTC-C30 (MD 6.32, 95% CI 0.61 to 12.04, 2 studies; 172 participants) and QoL-Breast Cancer (MD 0.45, 95% CI -0.19 to 1.09, 1 study, 61 participants). At four to six months and 12 months, there was no evidence of a difference in quality of life between groups (four to six months: EORTC - MD 0.08, 95% CI -7.28 to 7.44, 2 studies; 117 participants; SF-36 - MD -1.05, 95% CI -5.60 to 3.51, 2 studies, 308 participants; 12 months: EORTC - MD 2.04, 95% CI -9.91 to 13.99, 1 study; 57 participants).Functional status was incorporated into the quality of life subscale findings. HBMS programmes may decrease anxiety (MD of Hospital Anxiety and Depression Scale (HADS) -1.01, 95% CI -1.94 to -0.08, 5 studies, 253 participants, low-quality evidence) compared to control immediately after the intervention but the effect did not persist at four to six months. There was no evidence of improvements in depression immediately after HBMS (MD of HADS -1.36, 95% CI -2.94 to 0.22, 4 studies, 213 participants, low-quality evidence) or at follow-up. HBMS programmes may also decrease fatigue (MD -1.11, 95% CI -1.78 to -0.45, 3 studies, 127 participants; low-quality evidence) and insomnia (MD -1.81, 95% CI -3.34 to -0.27, 3 studies, 185 participants, low-quality evidence).None of the included studies reported service needs and utilisation and cost of care, and therefore the effect of HBMS programmes on healthcare utilisation and cost is unknown. Due to the variations in assessment methods of adherence among the eight studies, we could not combine the results for meta-analysis. We synthesised the results narratively, with the reported adherence rates of 58% to 100%. The results of this systematic review and meta-analysis revealed that HBMS programmes in breast cancer survivors appear to have a short-term beneficial effect of improving breast cancer-specific quality of life and global quality of life as measured by FACT-B and EORTC-C30, respectively. In addition, HBMS programmes are associated with a reduction in anxiety, fatigue and insomnia immediately after the intervention. We assessed the quality of evidence across studies as moderate for some outcomes, meaning that we are fairly confident about the results, while we assessed other outcomes as being low-quality, meaning that we are uncertain about the result.

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.

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.

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.

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.

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.

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.

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.

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.

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.

[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.

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.

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

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.

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

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.

An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group.

PubMed

Bottomley, Andrew; Tridello, Gloria; Coens, Corneel; Rolland, Frederic; Tesselaar, Margot E T; Leemans, C Rene; Hupperets, Pierre; Licitra, Lisa; Vermorken, Jan B; Van Den Weyngaert, Danielle; Truc, Gilles; Barillot, Isabelle; Lefebvre, Jean-Louis

2014-02-01

The European Organization for Research and Treatment of Cancer (EORTC) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx: sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy. The current study reports detailed effects of both treatment arms on health-related quality of life (HRQOL) and symptoms. A total of 450 patients aged 35 years to 76 years (World Health Organization performance status (WHO PS) ≤ 2) with untreated, resectable advanced squamous cell carcinoma of the larynx (tumor classification of T3-T4) or hypopharynx (tumor classification of T2-T3-T4) with regional lymph nodes in the neck classified as N0 to N2 with no metastases were randomized in this prospective phase 3 trial into either the sequential arm (control) or the alternating arm (experimental). QOL assessment was performed at randomization; at baseline; at 42 days; and at 6, 12, 24, 36, and 48 months. There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea. Significant differences were found in the secondary endpoints of Swallowing and Speech problems at 42 days after randomization in favor of patients in the sequential arm. Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm, but the majority of differences in HRQOL did not exist at the end of treatment, and returned to baseline levels. In the current study, a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance. The HRQOL scores of the majority of patients returned to baseline after therapy. © 2013 American Cancer Society.

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 assurance in head and neck surgical oncology: EORTC 24954 trial on larynx preservation.

PubMed

Leemans, C R; Tijink, B M; Langendijk, J A; Andry, G; Hamoir, M; Lefebvre, J L

2013-09-01

The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment with sequential or alternating chemoradiation. The need for a quality assurance program is the evaluation and prevention of differences in treatments between centres in this multidisciplinary study. The surgical subcommittee of the HNCG prepared a questionnaire, and clinical records of all patients were verified during audits of independent teams. Data relating institutional practices were collected during a face to face interview with members of the local team. 271 clinical records from the nine main contributing centres were reviewed. The main difference between centres was the time interval between first consultation and treatment initiation, with a mean of 45 days. On the pathology report the nodal involvement was described by level in 36% of the cases according to the American Academy of Otolaryngology-Head and Neck Surgery classification. Extranodal spread was not always described in neck dissection specimens. The EORTC 24954 trial on larynx preservation was the first prospective trial with a quality assurance program in head and neck surgical oncology. The analysis shows similarities in practices, but also points out some important differences between centres. Operation reports were fairly complete, but uniformity in pathology reports should be improved. Copyright © 2013 Elsevier Ltd. All rights reserved.

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.

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.

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).

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.

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 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.

The EORTC information questionnaire, EORTC QLQ-INFO25. Validation study for Spanish patients.

PubMed

Arraras, Juan Ignacio; Manterola, Ana; Hernández, Berta; Arias de la Vega, Fernando; Martínez, Maite; Vila, Meritxell; Eito, Clara; Vera, Ruth; Domínguez, Miguel Ángel

2011-06-01

The EORTC QLQ-INFO25 evaluates the information received by cancer patients. This study assesses the psychometric properties of the QLQ-INFO25 when applied to a sample of Spanish patients. A total of 169 patients with different cancers and stages of disease completed the EORTC QLQINFO25, the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients' treatment and follow- up period. Psychometric evaluation of the structure, reliability, validity and responsiveness to changes was conducted. Patient acceptability was assessed with a debriefing questionnaire. Multi-trait scaling confirmed the 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. All items met the standards for convergent validity and all except one met the standards of item discriminant validity. Internal consistency for all scales (α>0.70) and the whole questionnaire (α>0.90) was adequate in the three measurements, except information about the disease (0.67) and other services (0.68) in the first measurement, as was test-retest reliability (intraclass correlations >0.70). Correlations with related areas of IN-PATSAT32 (r>0.40) supported convergent validity. Divergent validity was confirmed through low correlations with EORTC QLQ-C30 scales (r<0.30). The EORTC QLQ-INFO-25 discriminated among groups based on gender, age, education, levels of anxiety and depression, treatment line, wish for information and satisfaction. One scale and an item showed changes over time. The EORTC QLQ-INFO 25 is a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study.

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.

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.

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.

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

Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial.

PubMed

Verleye, Leen; Ottevanger, Petronella B; Kristensen, Gunnar B; Ehlen, Tom; Johnson, Nick; van der Burg, Maria E L; Reed, Nick S; Verheijen, René H M; Gaarenstroom, Katja N; Mosgaard, Berit; Seoane, Jose M; van der Velden, Jacobus; Lotocki, Robert; van der Graaf, Winette; Penninckx, Björn; Coens, Corneel; Stuart, Gavin; Vergote, Ignace

2011-01-01

To assess the quality of surgical pathology reports of advanced stage ovarian, fallopian tube and primary peritoneal cancer. This quality assurance project was performed within the EORTC-GCG 55971/NCIC-CTG OV13 study comparing primary debulking surgery followed by chemotherapy with neoadjuvant chemotherapy and interval debulking surgery. Four hundred and seventy nine pathology reports from 40 institutions in 11 different countries were checked for the following quality indicators: macroscopic description of all specimens, measuring and weighing of major specimens, description of tumour origin and differentiation. All specimens were macroscopically described in 92.3% of the reports. All major samples were measured and weighed in 59.9% of the reports. A description of the origin of the tumour was missing in 20.5% of reports of the primary debulking group and in 23.4% of the interval debulking group. Assessment of tumour differentiation was missing in 10% of the reports after primary debulking and in 20.8% of the reports after interval debulking. Completeness of reports is positively correlated with accrual volume and adversely with hospital volume or type of hospital (academic versus non-academic). Quality of reports differs significantly by country. This audit of ovarian cancer pathology reports reveals that in a substantial number of reports basic pathologic data are missing, with possible adverse consequences for the quality of cancer care. Specialisation by pathologists and the use of standardised synoptic reports can lead to improved quality of reporting. Further research is needed to better define pre- and post-operative diagnostic criteria for ovarian cancer treated with neoadjuvant chemotherapy. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

Assessing health-related quality of life in patients with breast cancer: a systematic and standardized comparison of available instruments using the EMPRO tool.

PubMed

Maratia, Stefano; Cedillo, Sergio; Rejas, Javier

2016-10-01

The objective was to obtain a standardized evaluation of available specific and generic breast cancer health-related quality-of-life instruments. We carried out systematic literature reviews in the PubMed and EMBASE databases to identify manuscripts which contained information regarding either the development process or metric properties of health-related quality-of-life instruments used among breast cancer patients. Each instrument was evaluated independently by two researchers, and occasionally a third one, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall score and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): concept and measurement model, reliability, validity, responsiveness, interpretability, burden, and alternative forms. FACT-B was the instrument with the best global performance, obtaining an overall EMPRO score of 79.27. It was also the most accurate instrument on the Concept and Measurement Model, Reliability, and Interpretability attributes. Four more instruments scored over 50 points on the overall score, which summarizes the five attribute-specific scores: EORTC BR-23, IBCSG, WHO-QOL BREF, and SF-36. An overall score of at least 50 points implies that the use of these instruments could be recommended for assessing health-related quality of life in breast cancer patients. The FACT-B scored the highest on overall on our EMPRO evaluation of instruments measuring health-related quality of life among breast cancer patients. However, depending on the purpose of the study, several instruments (EORTC BR-23, IBCSG, SF-36, and WHO-QOL BREF) have shown good performance in some of the specific individual dimensions included in the EMPRO.

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.

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.

Quality of Life and Symptoms in Long-term Survivors of Colorectal Cancer: Results from NSABP Protocol LTS-01

PubMed Central

Kunitake, Hiroko; Russell, Marcia M.; Zheng, Ping; Yothers, Greg; Land, Stephanie R.; Petersen, Laura; Fehrenbacher, Louis; Giguere, Jeffery K.; Wickerham, D. Lawrence; Ko, Clifford Y.; Ganz, Patricia A.

2016-01-01

Purpose Little is known about health-related quality of life (HRQL) in long-term survivors (LTS) of colorectal cancer (CRC). Methods Long-term CRC survivors (≥ 5 years) treated in previous National Surgical Adjuvant Breast and Bowel Project trials were recruited from 60 sites. After obtaining consent, a telephone survey was administered, which included HRQL instruments to measure physical health (Instrumental Activities of Daily Living [IADL], SF-12 Physical Component Scale [PCS], SF-36 Vitality Scale), mental health (SF-12 Mental Component Scale [MCS], Life Orientation Test, and Impact of Cancer), and clinical symptoms (Fatigue Symptom Inventory [FSI], European Organisation for Research and Treatment of Cancer Colorectal Module [EORTC-CR38], and Brief Pain Inventory). A multivariable model identified predictors of overall quality of life (global health rating). Results Participants (N=708) had significantly higher HRQL compared with age group-matched non-cancer controls with higher mean scores on SF-12 PCS (49.5 vs. 43.7, p=< 0.05), MCS (55.6 vs. 52.1, p=<0.05) and SF-36 Vitality scale (67.1 vs. 59.9, p=< 0.05). Multivariable modeling has demonstrated that better overall physical and mental health (PCS and MCS), positive body image (EORTC-CR38 scale), and less fatigue (FSI), were strongly associated with overall quality of life as measured by the global health rating. Interestingly, ability to perform IADLs, experience of cancer, gastrointestinal complaints, and pain were not important predictors. Conclusions In long-term CRC survivors, overall physical and mental health were excellent compared with general population. Other disease-related symptoms did not detract from good overall health. PMID:27562475

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

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.

The effect of complementary and alternative medicine on quality of life, depression, anxiety, and fatigue levels among cancer patients during active oncology treatment: phase II study.

PubMed

Bar-Sela, Gil; Danos, Sara; Visel, Bella; Mashiach, Tanya; Mitnik, Inbal

2015-07-01

During the past decade, there has been growing interest in complementary and alternative medicine (CAM) among cancer patients and it is being integrated more frequently within conventional cancer centers. The long-term effect of mind-body therapies on quality of life (QoL), depression, anxiety, and fatigue was tested prospectively in this study. Cancer patients who received six weekly sessions of CAM during their oncological treatments participated in the study. The Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and QoL-EORTC-C30 were completed during the intervention and follow-up period. Over a two-year period, 163 patients entered the study, 135 of whom completed all six CAM sessions. An improvement was demonstrated in the median of BFI from 4.8 to 3.9 (p < 0.001), HADS-Anxiety from 8 to 7 (p < 0.001) and HADS-Depression from 7 to 6 (p < 0.001) after 12 weeks. In addition, the median of global QoL improved from 50 to 67 (p < 0.001), and a significant improvement was noticed in several parameters on the functioning and symptoms scales of the QoL-EORTC-C30. Cancer patients who completed six weekly sessions of CAM improved significantly on measured outcomes, regardless of their demographic characteristics.

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.

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.

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.

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.

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

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.

Pressure pain sensitivity as a marker for stress and pressure pain sensitivity-guided stress management in women with primary breast cancer.

PubMed

Axelsson, Christen K; Ballegaard, Søren; Karpatschof, Benny; Schousen, Peer

2014-08-01

To validate (1) Pressure Pain Sensitivity (PPS) as a marker for stress and (2) a PPS-guided intervention in women with primary Breast Cancer (BC). (1) A total of 58 women with BC were examined before and after 6 months of intervention. A control group of 165 women office employees was divided in a High Stress Group (HSG, n = 37) and a Low Stress Group (LSG, n = 128) to evaluate the association between PPS, questionnaire-related Quality of Life (QOL) and self-evaluated stress. (2) A PPS-guided stress management program (n = 40) was compared to a Psychosocial Group Intervention (PGI, n = 91) and no treatment (n = 86) with respect to a European Organization for Research and Treatment of Cancer (EORTC) questionnaire measured QOL. (1) Resting PPS and changes in PPS during the intervention period correlated significantly to EORTC and Short Form 36 (SF 36) main scores: (all p < 0.05). Between BC, HSG and LSG there was a significant and positive correlation with respect to PPS, SF 36 main scores, depression, and clinical stress scores (all p < 0.05). However, the BC group scored significantly lower than both HSG and LSG (both p < 0.05) with respect to self-evaluated stress. (2) The PPS-guided intervention group improved EORTC main score, pain and nausea, when compared to the control groups (all p < 0.05). PPS was positively associated with QOL, which was in contrast to self-evaluated stress. PPS-guided intervention improved QOL in women with breast cancer.

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.

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.

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.

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

Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year-A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy.

PubMed

Cooke, Andrew L; Diaz-Abele, Julian; Hayakawa, Tom; Buchel, Ed; Dalke, Kimberly; Lambert, Pascal

2017-09-01

To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1 year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1 year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1 year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, P<.0001) versus 61 who did not receive RT in univariate and multivariate models. EORTC arm symptoms (20-point difference on 100-point ordinal scale, P=.0200) differed on univariate analysis but not on multivariate analysis. All other outcomes-including Numerical Pain Rating Scale, BREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1 year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo-breast symptoms are more common in patients receiving RT by the EORTC Breast Cancer-Specific Quality of Life Questionnaire but not by the BREAST-Q. Patient-reported results at 1 year after surgery suggest RT following immediate autologous free flap breast reconstruction is well tolerated. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

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.

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.

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.

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.

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

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 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.

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 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.

AACR-NCI-EORTC - 27th International Symposium - Molecular Targets and Cancer Therapeutics (November 5-9, 2015 - Boston, Massachusetts, USA).

PubMed

Carceller, V

2015-11-01

The 27th joint meeting of the European Organization for Research and Treatment of Cancer, National Cancer Institute and the American Association of Cancer Research (EORTC-NCI-AACR) International Conference on Molecular Targets and Cancer Therapeutics was held this year in Boston. Approximately 3,000 international academics, scientists and pharmaceutical industry representatives discussed new discoveries in the field of molecular biology of cancer and presented the latest information on drug discovery, preclinical research, clinical research and target selection in oncology. This report summarizes data on advances in cancer drug discovery. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

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.

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.

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.

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

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.

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.

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

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.

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").

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.

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.

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.

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.

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.

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.

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.

Assessment of quality of life in patients with laryngeal cancer: A review of articles.

PubMed

Kolator, Mateusz; Kolator, Patrycja; Zatoński, Tomasz

2018-04-19

This article presents a review of the medical literature published between 1994 and 2014 with the use of the PubMed database concerning quality-of-life instruments for head and neck cancer patients used to assess general well-being of patients with laryngeal cancer. The PubMed database was searched for articles containing the keywords "quality of life", "laryngeal neoplasm" and "questionnaires". The resulting articles were reviewed and analyzed. After the identification of questionnaires, an additional search was performed. The articles and questionnaires were described and analyzed. In 43 articles, the authors used questionnaires specific to the head and neck regions in order to assess the quality of life in patients with laryngeal cancer. Four different questionnaires were identified. The European Organization for Research and Treatment of Cancer (EORTC) questionnaire is most commonly used to assess the quality of life in patients with laryngeal cancer. Questionnaires are generally used in order to select from a range of different treatment methods. There are a few head and neck cancer-related quality-of-life instruments which are widely used to assess the quality of life in patients with laryngeal cancer, but they are not dedicated to that region of the body. Today, there is much more attention paid to the quality of life; therefore, there is a real need to develop specific scales for different types of cancer.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

PubMed

Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

2016-11-01

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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

Interval debulking surgery in advanced epithelial ovarian cancer.

PubMed

Pecorelli, Sergio; Odicino, Franco; Favalli, Giuseppe

2002-08-01

Cytoreductive surgery and chemotherapy are the mainstay for the treatment of advanced epithelial ovarian cancer. In order to minimize the tumour burden before chemotherapy, cytoreductive surgery is usually performed first. The importance of the amount of residual disease as the main prognostic factor for patients suffering from advanced disease has been almost universally accepted even in the absence of prospective randomized trials addressing the benefit of cytoreductive surgery. In the last decade, the value of debulking surgery after induction chemotherapy - interval debulking surgery, IDS - has been widely debated, especially after the completion of a prospective randomized study from the EORTC addressing the introduction of a surgical procedure with debulking intent preceded and followed by cytoreductive chemotherapy. The rationale of such a strategy in the context of the primary treatment of advanced ovarian cancer lies in a higher cytoreductibility to the 'optimal' status forwarded, and possibly facilitated, by chemotherapy. The results demonstrated a prolongation of both progression-free survival and median survival in favour of patients randomized to IDS (5 and 6 months, respectively). Multivariate analysis revealed IDS to be an independent prognostic factor which reduced the risk of death by 33% at 3 years and by 48% in subsequent re-evaluation after more than 6 years of observation. Despite the above, results have been questioned by many, leading the GOG to perform a similar study which has been concluded very recently. Nevertheless, the main concern regarding the application of IDS in all instances relates to the morbidity of two major surgical procedures integrated within a short period during which cytotoxic chemotherapy is also administered. Neoadjuvant chemotherapy has been recently proposed to avoid a non-useful surgical procedure in patients considered 'optimally unresectable' after diagnosis of advanced ovarian cancer. Whether or not this newer approach will translate into a longer survival with a better quality of life is going to be addressed by a novel EORTC study. Finally, the concept of a 'chemical' cytoreduction preceding and facilitating a subsequent 'surgical' effort has been recently introduced also in the treatment of recurrent disease. The EORTC has recently initiated a prospective randomized study (LOROCSON - Late Onset Recurrent Ovarian Cancer: Surgery or Not) to validate the importance of such an approach to be balanced with medical treatment alone not only in terms of survival but also as far as quality of life is concerned.

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.

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.

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

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.

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.

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.

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.

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 and associated factors in Jordanian cancer patients: A cross-sectional study.

PubMed

Mosleh, Sultan M

2018-06-04

Understanding the factors associated with patients' health-related quality of life along with their social networks can help identify who may benefit from supportive programmes. This study sought to evaluate the impact of a cancer diagnosis on Jordanian cancer patients' health-related quality of life and its relationship with social support and emotional status. A descriptive design was utilized, and 226 clients were participated. Participants completed European Organization for Research and Treatment of cancer quality of life questionnaire (EORTC-version 3), the Hospice Comfort Questionnaire, and the Hospital Anxiety and Depression scale. The results revealed that participants demonstrated unsatisfactory quality of life and many complained of fatigue. A multiple linear regression analysis revealed that social support, hospitalization readmission and being a nonsmoker were significant predictors for poor global quality of life score. In addition, a high educational level, less rehospitalization and high anxiety and depression scores were significant predictors for comfort level. In conclusion, patients with cancer are at an elevated risk of impaired physical functioning and report unsatisfactory quality of life, particularly if they are anxious, depressed and lack social support. The associated factors with decreased quality of life or low comfort level could be amenable to change with appropriate interventions. © 2018 John Wiley & Sons Ltd.

[Associations between vegetables and fruit intake and quality of life in breast cancer patients].

PubMed

Gong, Xiaohuan; Wang, Jiwei; Chen, Xuefen; Shi, Changhong; Sun, Li; Zhang, Qingyun; Yuan, Zhengping; Yu, Jinming

2014-11-01

To investigate the associations between vegetables and fruit intake and quality of life in breast cancer patients. A total of 3 344 community breast cancer patients were selected through cluster sampling method between April and July 2013, in Shanghai, China. Data were collected using a questionnaire, which included socio-demographic situation, cancer survival and health behaviors(i.e. vegetables or fruit intake, exercise), European Organization for Research and Treatment (EORTC) QLQ-C30 Simplified Chinese version(3rd edition) and Functional Assessment of Cancer Therapy scale (FACT-G) Simplified Chinese version(4th edition) were used to evaluate the quality of life. Crude quality of life scores were compared between groups. Multiple linear models were used to calculate and compare adjusted means of quality of life between groups, controlling relevant factors. After adjusting relevant factors, breast cancer patients who ate more than 250 g vegetables reported higher EORTC physical functioning scores, cognitive functioning scores, emotional functioning scores, global health scores than patients who ate equal or less than 250 g vegetables(respectively (80.79 ± 0.85) vs (79.34 ± 0.82), (80.07 ± 1.03) vs (77.84 ± 0.99), (84.17 ± 0.95) vs (82.76 ± 0.92), (65.75 ± 1.50) vs (62.92 ± 1.45)), t values respectively were 2.76, 3.54, 2.40, 3.17, all P values were <0.05; and breast cancer patients who ate more than 250 g vegetables reported higher FACT-G social well-being scores, function well-being scores, FACT-G total scores than patients who ate equal or less than 250 g vegetables (respectively (17.92 ± 0.40) vs (17.31 ± 0.39), (14.86 ± 0.42) vs (14.34 ± 0.40), (74.78 ± 1.01) vs (73.05 ± 0.97)), t values respectively were 2.49, 2.05, 2.90, all P values were <0.05. After adjusting relevant factors, breast cancer patients who ate fruit everyday reported higher EORTC physical functioning scores, role functioning scores, cognitive functioning scores, emotional functioning scores, social functioning scores, global health scores than patients who didn't eat fruit everyday (respectively (80.40 ± 0.82) vs (79.22 ± 0.87), (89.81 ± 1.00) vs (88.06 ± 1.05), (79.78 ± 0.99) vs (77.11 ± 1.04), (84.43 ± 0.92) vs (81.56 ± 0.97), (77.95 ± 1.25) vs (75.56 ± 1.31), (65.48 ± 1.44) vs (61.74 ± 1.51)), t values respectively were 2.15, 2.64, 4.07, 4.71, 2.89, 4.02, all P values were <0.05; and breast cancer patients who ate fruit everyday reported higher FACT-G physical well-being scores, social well-being scores, emotional well-being scores, functional well-being scores, FACT-G total scores than patients who didn't eat fruit everyday(respectively (23.35 ± 0.26) vs (22.85 ± 0.28), (17.91 ± 0.39) vs (16.98 ± 0.41), (18.59 ± 0.22) vs (18.18 ± 0.23), (14.79 ± 0.40) vs (14.17 ± 0.42), (74.71 ± 0.97) vs (72.17 ± 1.02)), t values respectively were 2.92, 3.65, 2.91, 2.35, 4.05 , all P values were <0.05. There are active associations between vegetables / fruit intake and quality of life in breast cancer patients. Proper diet may help improve quality of life in breast cancer patients.

Mode of treatment affects quality of life in head and neck cancer survivors: Implications for holistic care.

PubMed

Bower, Wendy Fiona; Vlantis, Alexander Christopher; Chung, Tiffany M L; Van Hasselt, C Andrew

2010-10-01

As adverse effects of live-saving treatment are unavoidable surgeons have a duty to address physical changes and quality of life issues that matter to head and neck (H&N) cancer patients. We propose a tailored holistic care package. This study compared the quality of life of H&N cancer survivors managed with different approaches in the follow-up phase after initial treatment and identified factors adversely impacting quality of life parameters. H&N cancer patients studied: 1) surgery only, 2) radiotherapy only, 3) surgery and radiotherapy, and 4) any combination of surgery, chemotherapy or radiotherapy. Patients unable to communicate in Cantonese, with thyroid cancer or end-of-life disease were excluded. EORTC QLQ-H&N35 Cantonese version was administered at least 1 year after initial H&N cancer treatment. Quality of life impairment was worse in all of the domains for combination therapy versus monotherapy patients. Scores between surgery or radiotherapy-only patients were not significantly different. Radiotherapy preceding surgery impacted significantly more on speech than surgery before the radiotherapy. Patients with advanced disease had more impairment of quality of life in each domain than patients with early disease. Coughing, eating problems, sticky saliva, and difficulties with social contact were all significant predictors of problems associated with a dry mouth.

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

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.

Summary scores captured changes in subjects' QoL as measured by the multiple scales of the EORTC QLQ-C30.

PubMed

Phillips, Rachel; Gandhi, Mihir; Cheung, Yin Bun; Findlay, Michael P; Win, Khin Maung; Hai, Hoang Hoa; Yang, Jin Mo; Lobo, Rolley Rey; Soo, Khee Chee; Chow, Pierce K H

2015-08-01

To examine the performance of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QoL) scale and two summary scores to detect changes in the QoL profile over time, according to changes in the individual scales. Data came from 167 clinical trial patients with unresectable (advanced) hepatocellular carcinoma. The global health status/QoL scale of the questionnaire contained two items: overall health and overall QoL. Nordin and Hinz proposed summary scores for the questionnaire. A mixed-effect model was fitted to estimate trends in scores over time. Predominantly the individual scale scores declined over time; however, the global health status/QoL score was stable [rate of change = -0.3 per month; 95% confidence interval (CI): -1.2, 0.6]. Nordin's summary score, which gave equal weight to the 15 questionnaire scales, and Hinz's summary score, which gave equal weight to the 30 questionnaire items, showed a statistically significant decline over time, 3.4 (95% CI: -4.5, -2.4) and 4.2 (95% CI: -5.3, -3.0) points per month, respectively. In contrast to the global health status/QoL scale, the summary scores proposed by Nordin and Hinz detected changes in subjects' QoL profile described by the EORTC QLQ-C30 individual scales. Copyright © 2015 Elsevier Inc. All rights reserved.

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

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.

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.

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.

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.

Cosmesis and Breast-Related Quality of Life Outcomes After Intraoperative Radiation Therapy for Early Breast Cancer: A Substudy of the TARGIT-A Trial

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

Corica, Tammy, E-mail: Tammy.Corica@health.wa.gov.au; School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia; Nowak, Anna K.

Purpose: To report the first comprehensive investigation of patient-reported cosmesis and breast-related quality of life (QOL) outcomes comparing patients randomized to risk-adapted single-dose intraoperative radiation therapy (TARGIT-IORT) versus external beam radiation therapy (EBRT) on the TARGIT-A trial. Methods and Materials: Longitudinal cosmesis and QOL data were collected from a subset of TARGIT-A participants who received TARGIT-IORT as a separate procedure (postpathology). Patients completed a cosmetic assessment before radiation therapy and annually thereafter for at least 5 years. Patients also completed the combined European Organization for Research and Treatment of Cancer (EORTC) core questionnaire and Breast-Specific Module in addition to the Body Imagemore » after Breast Cancer Questionnaire at baseline and annually thereafter. The combined EORTC questionnaires were also collected 3, 6, and 9 months after wide local excision. Results: An Excellent–Good cosmetic result was scored more often than a Fair–Poor result for both treatment groups across all time points. The TARGIT-IORT patients reported better breast-related QOL than EBRT patients. Statistically and clinically significant differences were seen at month 6 and year 1, with EBRT patients having moderately worse breast symptoms (a statistically significant difference of more than 10 in a 100-point scale) than TARGIT-IORT patients at these time points. Conclusion: Patients treated with TARGIT-IORT on the TARGIT-A trial have similar self-reported cosmetic outcome but better breast-related QOL outcomes than patients treated with EBRT. This important evidence can facilitate the treatment decision-making process for patients who have early breast cancer suitable for breast-conserving surgery and inform their clinicians.« less

Perceived stigmatization and its impact on quality of life - results from a large register-based study including breast, colon, prostate and lung cancer patients.

PubMed

Ernst, J; Mehnert, A; Dietz, A; Hornemann, B; Esser, P

2017-11-09

To date, research on stigmatization among cancer patients and related psychosocial consequences has been scarce and mostly based on small and highly selected samples. We investigated stigmatization and its impact on quality of life among a large sample including four major tumor entities. We assessed 858 patients with breast, colon, lung or prostate cancer from two cancer registries. Stigmatization and quality of life (QoL) was assessed with the Social Impact Scale (SIS-D) and the EORTC Quality of Life Questionnaire (European Organization for Research and Treatment of Cancer), respectively. Group effects were analyzed via analyses of variance, relationships were investigated via Pearson's r and stepwise regression analyses. The mean age was 60.7 years, 54% were male. Across cancer sites, the dimensions of stigmatization (isolation, social rejection, financial insecurity and internalized shame) were in the lower and middle range, with the highest values found for isolation. Stigmatization was lowest among prostate cancer patients. Stigmatization predicted all five areas of QoL among breast cancer patients (p < .05), but only affected emotional functioning (p < .01) among lung cancer patients. We found an inverse relationship between perceived cancer-related stigmatization and various dimensions of QoL, with variation between cancer sites. Breast cancer patients should be focused in individual therapies regarding the negative consequences accompanied by perceived stigmatization.

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.

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.

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

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 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.

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.

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

Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases.

PubMed

Klaff, Rami; Berglund, Anders; Varenhorst, Eberhard; Hedlund, Per Olov; Jǿnler, Morten; Sandblom, Gabriel

2016-06-01

To describe characteristics and quality-of-life (QoL), and to define factors associated with long-term survival in a subgroup of patients with prostate cancer with M1b disease. The study was based on 915 patients from a prospective randomised multicentre trial (No. 5) by the Scandinavian Prostate Cancer Group, comparing parenteral oestrogen with total androgen blockade. Long-term survival was defined as patients having an overall survival of ≥10 years, and logistic regression models were constructed to identity clinical predictors of survival. QoL during follow-up was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - C30 version 1 (EORTC-C30) ratings. In all, 40 (4.4%) of the 915 men survived for >10 years. Factors significantly associated with increased likelihood of surviving for >10 years in the univariate analyses were: absence of cancer-related pain; Eastern Cooperative Oncology Group (ECOG) performance status of <2; negligible analgesic consumption; T-category of 1-2; prostate-specific antigen (PSA) level of <231 μg/L; and a Soloway score of 1. In the multivariate analyses, ECOG performance status of <2, PSA level of <231 μg/L, and Soloway score of 1, were all independent predictors of long-term survival. All subscales of the EORTC-C30 were higher in this group than for patients with short survival, but slowly declined over the decade. A subgroup of patients with prostate cancer with M1b disease and certain characteristics showed a positive long-term response to androgen-deprivation therapy with an acceptable QoL over a decade or more. Independent predictors of long-term survival were identified as ECOG performance status of <2, limited extent of bone metastases (Soloway score of 1), and a PSA level of <231 μg/L at the time of enrolment. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Feasibility of an expressive-disclosure group intervention for post-treatment colorectal cancer patients: results of the Healthy Expressions study.

PubMed

Carmack, Cindy L; Basen-Engquist, Karen; Yuan, Ying; Greisinger, Anthony; Rodriguez-Bigas, Miguel; Wolff, Robert A; Barker, Trina; Baum, George; Pennebaker, James W

2011-11-01

Adjusting to cancer requires effective cognitive and emotional processing. Written and verbal disclosure facilitate processing and have been studied independently in cancer survivors. Combined written and verbal expression may be more effective than either alone, particularly for patients with difficult to discuss or embarrassing side effects. Thus, the authors developed and tested the efficacy of a 12-session combined written and verbal expression group program for psychologically distressed colorectal cancer (CRC) patients. Forty post-treatment patients with CRC (stages I-III) identified as psychologically distressed using the Brief Symptom Inventory (BSI) were randomized to an intervention group (Healthy Expressions; n = 25) or standard care (control group; n = 15). Assessments were completed at baseline, Month 2, and Month 4 (postintervention). Primary outcomes were psychological functioning and quality of life (QOL). Most participants were women (63%), white (63%), and non-Hispanic (75%). The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063). The BSI GSI and Positive Symptom Total, CES-D, and EORTC emotional functioning subscale scores were all significant at Month 4 (P < .05 for each). The Healthy Expressions program improved psychological functioning in CRC patients who reported experiencing distress. Findings demonstrate the program's feasibility and provide strong support for conducting a larger randomized trial. Copyright © 2011 American Cancer Society.

Early versus delayed hormonal treatment in locally advanced or asymptomatic metastatic prostatic cancer patient dilemma.

PubMed

Prezioso, Domenico; Iacono, Fabrizio; Romeo, Giuseppe; Ruffo, Antonio; Russo, Nicola; Illiano, Ester

2014-06-01

The objective of this work is to compare the effectiveness of hormonal treatment (luteinizing hormone-releasing hormone agonists and/or antiandrogens) as an early or as a deferred intervention for patients with locally advanced prostate cancer (LAPC) and/or asymptomatic metastasis. Systematic review of trials published in 1950-2007. Sources included MEDLINE and bibliographies of retrieved articles. Eligible trials included adults with a history of LAPC who are not suitable for curative local treatment of prostate cancer. We retrieved 22 articles for detailed review, of which 8 met inclusion criteria. The Veterans Administration Cooperative Urological Research Group suggested that delaying hormonal therapy did not compromise overall survival and that many of the patients died of causes other than prostate cancer. In European Organisation for Research and Treatment of Cancer (EORTC) 30846 trial, the median survival for delayed endocrine treatment was 6.1 year, and for immediate treatment 7.6 year, the HR for survival on delayed versus immediate treatment was 1.23 (95 % CI 0.88-1.71), indicating a 23 % nonsignificant trend in favour of early treatment. In EORTC 30891, the immediate androgen deprivation resulted in a modest but statistically significant increase in overall survival. The protocol SAKK 08/88 showed the lack of any major advantage of immediate compared with deferred hormonal treatment regarding quality of life or overall survival. The early intervention with hormonal treatment for patients with LAPC provides important reductions in all-cause mortality, prostate cancer-specific mortality, overall progression, and distant progression compared with deferring their use until standard care has failed to halt the disease.

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 (

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.

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

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

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.

Comfort and quality of life in patients with breast cancer undergoing radiation therapy.

PubMed

Pehlivan, Seda; Kuzhan, Abdurrahman; Yildirim, Yasemin; Fadiloglu, Cicek

2016-01-01

Radiation therapy is generally applied after surgery for the treatment of breast cancer, which is among the most frequently observed types of cancer in females. Radiation therapy may have some negative effects on the quality of life due to various side effects such as changes in the skin, mucositis and fatigue. Our study was planned as a descriptive study, in order to examine the relationship between comfort and quality of life in breast cancer patients undergoing radiation therapy. This study involved 61 patients with breast cancer undergoing radiation therapy. Data were collected using "Patient Information Form", "Radiation Therapy Comfort Questionnaire" and "EORTC QLQ-BR23". The scales were applied twice, before the start and at the end of treatment. Data were evaluated via Wilcoxon test and Spearman correlation analyses. No statistically significant difference was determined between comfort and quality of life average score before and after radiotherapy (p>0.05). A positive relationship was determined between the pain and symptom quality of life (p<0.05). Although a positive relationship was determined between comfort score and the functional and general quality of life areas, a negative relationship was detected with the symptom quality of life (p<0.01). Radiation therapy applied to breast cancer patients did not affect comfort and quality of life, On the contrary, the quality of life of patients increased along with their comfort levels and that comfort levels decreased as the experienced symptoms increased.

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.

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.

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 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.

Evaluation of quality of life of adult cancer patients attending Tikur Anbessa specialized referral hospital, Addis Ababa Ethiopia.

PubMed

Tadele, Niguse

2015-01-01

Little is known about the quality of life of cancer patients in the Ethiopian context. This study evaluated quality of life of cancer patients in Ethiopia. A cross-sectional study was conducted in Addis Ababa University Tikur Anbessa Specialized Referral Hospital Addis Ababa, Ethiopia (TASRH) from March to May 2013. A total of 388 cancer patients were included. Translated in to Amharic, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL C-30) was used to measure Quality of life (QoL). The data was analyzed with SPSS Version 17.0. Among the participants, 251(64.7%) were men and 138(35.6%) were below the age of 40 years. Large proportion of patients were diagnosed with breast cancer, 114(29.4%), and cervical cancer, 102(26.3%), and the clinical stages during the beginning of therapy were at stage II a 133(34.3%). The mean of global health status/QoL was 57.28 (SD= 25.28). Quality of life was found to be associated with some functional scales as role functioning, P≤0.001, social function, P=0.00, and symptom scales as pain, P=0.00, loss of appetite, P=0.004, and financial impact, P=0.02, but no associations were noted in relation to socio demographic characteristics. Quality of life assessments should be included in patient treatment protocols to improve their quality of life since being a cancer patient may be associated with a high level of impairment in different aspects of life.

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.

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.

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.

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.

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.

Quality of life in rectal cancer patients with permanent colostomy in Xi'an.

PubMed

Yang, Xiuxiu; Li, Qin; Zhao, Haihong; Li, Junhua; Duan, Jiaobo; Wang, Dandan; Fang, Ningning; Zhu, Ping; Fu, Jufang

2014-03-01

To observe the quality of life (QOL) in rectal cancer patients with permanent colostomy in different periods after operation. A 1-,3-,6-month prospective study of QOL in 51 rectal cancer patients with permanent colostomy and 50 without permanent colostomy was assessed using European Organization for Research and Treatment of Cancer (EORTC) QOL-30 and CR38 questionnaires. The variation of QOL in different periods was "v" type. In the 1st postoperative month, these patients had the lowest quality of life scores, accompanied significantly varied functions and severe symptoms. Almost of all indexes of these patients had improved consistently in the postoperative period. The scores of global QOL even better than pre-operative level at 6th months post-operation, but the social function, body image, chemotherapy side effects and financial difficulties had not restored to the baseline level. Patients without permanent colostomy had a better score in most of categories of QOL-30 and CR38. The 1st postoperative month was crucial for patients' recovery, in which we should pay great attention to these problems which relate to the recovery of rectal cancer patients with permanent colostomy.

'Mind the gap' between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research.

PubMed

Kempf, Emmanuelle; Bogaerts, Jan; Lacombe, Denis; Liu, Lifang

2017-11-01

In Europe, most of the cancer clinical research dedicated to therapeutic innovations aims primarily at regulatory approval. Once an anticancer drug enters the common market, each member state determines its real-world use based on its own criteria: pricing, reimbursement and clinical indications. Such an innovation-centred clinical research landscape might neglect patient-relevant issues in real-world setting, such as comparative effectiveness of distinct treatment options or long-term safety monitoring. The European Organisation for Research and Treatment of Cancer (EORTC) advocates reforming the current 'innovation-centred' system to a truly 'patient-centred' paradigm with systematically coordinated applied clinical research in conjunction with drug development, featuring the following strategy. Copyright © 2017 Elsevier Ltd. All rights reserved.

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).

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

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.

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

Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

PubMed

Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

2012-02-01

Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 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.

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

PubMed

Neijenhuijs, Koen I; Jansen, Femke; Aaronson, Neil K; Brédart, Anne; Groenvold, Mogens; Holzner, Bernhard; Terwee, Caroline B; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

2018-05-07

The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies. Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate. In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

Health Related Quality of Life Following Reconstruction for Common Head and Neck Surgical Defects

PubMed Central

Cohen, Wess; Albornoz, Claudia R.; Cordeiro, Peter G.; Cracchiolo, Jennifer; Encarnacion, Elizabeth; Lee, Meghan; Cavalli, Michele; Patel, Snehal; Pusic, Andrea L.; Matros, Evan

2017-01-01

Background Improved understanding and management of health-related quality of life (HR-QOL) represents one of the greatest unmet needs for patients with head and neck (H&N) malignancies. The purpose of the current study is to prospectively measure HR-QOL associated with different anatomical (H&N) surgical resections. Methods A prospective analysis of HR-QOL was performed in patients undergoing surgical resection with flap reconstruction for stage II or III H&N malignancies. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire 30 and EORTC H&N Cancer Module 35 preoperatively, and at set postoperative time points. Scores were compared with a paired t-test. Results 75 patients were analyzed. The proportion of the cohort not alive at 2 years was 53%. Physical, role, and social functioning scores at 3 months were significantly lower than preoperative values (p<.05). At 12 months postoperatively, none of the function or global QOL scores differed from preoperative levels, whereas 5 of the symptom scales remained below baseline. At one year postoperatively maxillectomy, partial glossectomy, and oral lining defects had better function and less symptoms than mandibulectomy, laryngectomy, and total glossectomy. From 6 to 12 months postoperatively, partial glossectomy and oral lining defects had greater global QOL than laryngectomies (p<.05). Conclusion Postoperative HR-QOL is associated with the anatomic location of the H&N surgical resection. Preoperative teaching should be targeted for common ablative defects with postoperative expectations adjusted appropriately. Because surgery negatively impacts HR-QOL in the immediate post-operative period, the limited survivorship should be reviewed with patients. PMID:27879602

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.

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.

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.

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 Long-term Survivors of Muscle-Invasive Bladder Cancer

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

Mak, Kimberley S.; Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; Smith, Angela B.

Purpose: Health-related quality of life (QOL) has not been well-studied in survivors of muscle-invasive bladder cancer (MIBC). The present study compared long-term QOL in MIBC patients treated with radical cystectomy (RC) versus bladder-sparing trimodality therapy (TMT). Methods and Materials: This cross-sectional bi-institutional study identified 226 patients with nonmetastatic cT2-cT4 MIBC, diagnosed in 1990 to 2011, who were eligible for RC and were disease free for ≥2 years. Six validated QOL instruments were administered: EuroQOL EQ-5D, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire and EORTC MIBC module, Expanded Prostate Cancer Index Composite bowel scale, Cancermore » Treatment and Perception Scale, and Impact of Cancer, version 2. Multivariable analyses of the mean QOL scores were conducted using propensity score matching. Results: The response rate was 77% (n=173). The median follow-up period was 5.6 years. Of the 173 patients, 64 received TMT and 109, RC. The median interval from diagnosis to questionnaire completion was 9 years after TMT and 7 years after RC (P=.009). No significant differences were found in age, gender, comorbidities, tobacco history, performance status, or tumor stage. On multivariable analysis, patients who received TMT had better general QOL by 9.7 points of 100 compared with those who had received RC (P=.001) and higher physical, role, social, emotional, and cognitive functioning by 6.6 to 9.9 points (P≤.04). TMT was associated with better bowel function by 4.5 points (P=.02) and fewer bowel symptoms by 2.7 to 7.1 points (P≤.05). The urinary symptom scores were similar. TMT was associated with better sexual function by 8.7 to 32.1 points (P≤.02) and body image by 14.8 points (P<.001). The patients who underwent TMT reported greater informed decision-making scores by 13.6 points (P=.01) and less concern about the negative effect of cancer by 6.8 points (P=.006). The study limitations included missing baseline QOL data and different follow-up times. Conclusions: Both TMT and RC result in good long-term QOL outcomes in MIBC survivors, supporting TMT as a good alternative to RC for selected patients. Whether TMT leads to superior QOL requires prospective validation.« less

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

Pharmacologically directed strategies in academic anticancer drug discovery based on the European NCI compounds initiative.

PubMed

Hendriks, Hans R; Govaerts, Anne-Sophie; Fichtner, Iduna; Burtles, Sally; Westwell, Andrew D; Peters, Godefridus J

2017-07-11

The European NCI compounds programme, a joint initiative of the EORTC Research Branch, Cancer Research Campaign and the US National Cancer Institute, was initiated in 1993. The objective was to help the NCI in reducing the backlog of in vivo testing of potential anticancer compounds, synthesised in Europe that emerged from the NCI in vitro 60-cell screen. Over a period of more than twenty years the EORTC-Cancer Research Campaign panel reviewed ∼2000 compounds of which 95 were selected for further evaluation. Selected compounds were stepwise developed with clear go/no go decision points using a pharmacologically directed programme. This approach eliminated quickly compounds with unsuitable pharmacological properties. A few compounds went into Phase I clinical evaluation. The lessons learned and many of the principles outlined in the paper can easily be applied to current and future drug discovery and development programmes. Changes in the review panel, restrictions regarding numbers and types of compounds tested in the NCI in vitro screen and the appearance of targeted agents led to the discontinuation of the European NCI programme in 2017 and its transformation into an academic platform of excellence for anticancer drug discovery and development within the EORTC-PAMM group. This group remains open for advice and collaboration with interested parties in the field of cancer pharmacology.

Impact of the revised (2008) EORTC/MSG definitions for invasive fungal disease on the rates of diagnosis of invasive aspergillosis.

PubMed

Tsitsikas, Dimitris A; Morin, Amelie; Araf, Shamzah; Murtagh, Bernadine; Johnson, Gemma; Vinnicombe, Sarah; Ellis, Stephen; Suaris, Tamara; Wilks, Mark; Doffman, Sarah; Agrawal, Samir G

2012-07-01

Diagnosis of invasive aspergillosis (IA) remains a challenge as the clinical manifestations are not specific, and a histological diagnosis is often unfeasible. The 2002 European Organization for Research and Treatment of Cancer (EORTC) and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (MSG) criteria for classification of cases into possible, probable or proven were revised in 2008. Our objective was to analyze the impact of these revisions on the diagnosis of IA. A retrospective analysis of 589 high risk patient-episodes revealed that 125 of 155 'possible' (81%) and 12 of 16 'probable' (75%) cases of IA should be changed to 'non-classifiable' when the new criteria were applied. We concluded, as expected, that the 2008 EORTC/MSG revised definitions reduced the number of cases classified as 'possible' IA, but additionally, there has been a dramatic reduction in 'probable' cases. These changes have significant implications on the interpretation of clinical trial data based on EORTC/MSG classifications.

Clinically Meaningful Differences in Patient-Reported Outcomes With Amifostine in Combination With Chemoradiation for Locally Advanced Non-Small-Cell Lung Cancer: An Analysis of RTOG 9801

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

Sarna, Linda; Swann, Suzanne; Langer, Corey

2008-12-01

Purpose: The purpose of this study is to analyze changes in quality of life (QOL) and symptoms from pretreatment to 6 weeks posttreatment in a Phase III randomized study (Radiation Therapy Oncology Group 9801) of amifostine (AM) vs. no AM in patients with Stages II-III non-small-cell lung cancer receiving paclitaxel and carboplatin as induction and then concurrently with hyperfractionated radiation therapy (RT). Methods and Materials: One hundred thirty-eight patients with baseline and 6-week posttreatment QOL data were analyzed. There were no significant differences in baseline demographics between those who did and did not have QOL data. The QOL and symptomsmore » were assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Global QOL and Pain subscales and the EORTC-Lung Cancer-13 symptom tool. Clinically relevant changes in QOL were characterized by 10-point differences in individual scores pre/post treatment. A daily diary of patient-rated difficulty swallowing and a weekly physician-rated dysphagia log (using National Cancer Institute Common Toxicity Criteria) were completed during treatment. Weight loss was monitored. Differences in outcomes were examined according to smoking status, alcohol use, and sex. Results: Patients receiving AM reported significantly greater pain reduction after chemoradiation (34% vs. no AM, 21%), less difficulty swallowing during chemoradiation, and less weight loss than patients not receiving AM. However, physician-rated assessments of dysphagia were not significantly different by treatment arm. There were no other significant changes in QOL or symptoms according to treatment arm, smoking status, alcohol use, or sex. Conclusions: Patient evaluations of difficulty swallowing and pain suggest benefits from AM use that are distinct from clinician-rated assessments.« less

Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review.

PubMed

Fairchild, Alysa; Weber, Damien C; Bar-Deroma, Raquel; Gulyban, Akos; Fenton, Paul A; Stupp, Roger; Baumert, Brigitta G

2012-06-01

The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC individual case review (ICR) performed to evaluate protocol radiotherapy (RT) compliance. Fifty-eight institutions were asked to submit 1-2 randomly selected cases. Digital ICR datasets were uploaded to the EORTC server and accessed by three central reviewers. Twenty-seven parameters were analysed including volume delineation, treatment planning, organ at risk (OAR) dosimetry and verification. Consensus reviews were collated and summary statistics calculated. Fifty-seven of seventy-two requested datasets from forty-eight institutions were technically usable. 31/57 received a major deviation for at least one section. Relocation accuracy was according to protocol in 45. Just over 30% had acceptable target volumes. OAR contours were missing in an average of 25% of cases. Up to one-third of those present were incorrectly drawn while dosimetry was largely protocol compliant. Beam energy was acceptable in 97% and 48 patients had per protocol beam arrangements. Digital RT plan submission and review within the EORTC 22033-26033 ICR provide a solid foundation for future quality assurance procedures. Strict evaluation resulted in overall grades of minor and major deviation for 37% and 32%, respectively. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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.

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.

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.

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.

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.

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.

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.

Telephone intervention and quality of life in patients with breast cancer.

PubMed

Salonen, Päivi; Tarkka, Marja-Terttu; Kellokumpu-Lehtinen, Pirkko-Liisa; Astedt-Kurki, Päivi; Luukkaala, Tiina; Kaunonen, Marja

2009-01-01

The aim of this quasi-experimental study was to examine the effectiveness of a telephone support intervention 1 week after surgery on the quality of life (QOL) of patients with breast cancer. The sample consisted of 228 patients with breast cancer allocated to an intervention group (n = 120) and control group (n = 108). The data were collected using Ferrans and Powers Quality of Life Index-Cancer Version (QLI-CV) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23). The self-reported QOL of patients with breast cancer was considered moderately high. Statistically significant associations were found between QOL and the demographic characteristics of age, education, and employment status and of having underage children. Statistically significant associations were found between QOL and clinical characteristics such as type of surgery and axilla treatment. The strongest predictors of poor QOL were age, control group, and type of surgery. Age was the strongest predictor of poor QOL in global QLI and in the health and functioning, socioeconomic, and family subscales. The patients' experiences show that the telephone intervention was helpful and the timing was appropriate. The QOL in patients with breast cancer was better in subscales of body image, future perspective, and postoperative side effects. The intervention group showed significantly better body image; they worried less about the future and had less postoperative side effects than the control group did. These results may help in discussing QOL issues and should be considered when planning and implementing interventions for patients with breast cancer.

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.

Images of God and attitudes towards death in relation to spiritual wellbeing: an exploratory side study of the EORTC QLQ-SWB32 validation study in palliative cancer patients.

PubMed

Kruizinga, Renske; Scherer-Rath, Michael; Schilderman, Johannes B A M; Weterman, Mariëtte; Young, Teresa; van Laarhoven, Hanneke W M

2017-12-08

When patients are facing the ends of their lives, spiritual concerns often become more important. It is argued that effective, integrated palliative care should include addressing patients' spiritual wellbeing. In 2002 the EORTC Quality of Life Group began an international study to develop an spiritual wellbeing measure for palliative patients (SWB). Spiritual wellbeing is a complex construct, which comprises multiple contributory components. While conducting the EORTC SWB validation study with Dutch palliative cancer patients we also conducted an exploratory side study to examine the relationship between their spiritual wellbeing, images of God, and attitudes towards death. Patients with incurable cancer who were able to understand Dutch and were well enough to participate, completed the provisional SWB measure and two scales assessing "Images of God" and "attitudes towards death and afterlife". Linear stepwise regression analysis was conducted to assess the relation between SWB and other factors. Fifty two Dutch patients, 28 females and 24 males, participated. The whole SWB measure validation identified four scoring scales: Existential (EX), Relationship with Self (RS), Relationships with Others (RO), Relationship with Something Greater (RSG) and Relationship with God (RG, for believers only). Adherence to an image of an Unknowable God and a worse WHO performance status were negatively associated with the EX scale. The image of an Unknowable God was also found to be negatively associated with the RS scale. Higher education correlated positively with the RO scale. Adherence to a Personal or Non-Personal Image of God was not found to be positively influencing any of the domains of SWB. For our participants, an Unknowable Image of God had a negative relationship with their SWB. Furthermore, specific images of God (Personal or Non Personal) are not associated with domains of SWB. Together, these findings suggest that spiritual wellbeing surpasses traditional religious views. The development of a new language which more naturally expresses different images of a higher being amongst patients in western late-modern societies may further aid our understanding and subsequently lead to an improvement in patients' spiritual wellbeing.

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.

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.

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

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.

Update on PEG-interferon α-2b as adjuvant therapy in melanoma.

PubMed

Di Trolio, Rossella; Simeone, Ester; Di Lorenzo, Giuseppe; Grimaldi, Antonio Maria; Romano, Anna; Ayala, Fabrizio; Caracò, Corrado; Mozzillo, Nicola; Ascierto, Paolo A

2012-09-01

Based on the results of European Organization for Research and Treatment of Cancer (EORTC) 18991 trial, the US Food and Drug Administration (FDA) approved PEG-interferon α-2b (PEG-IFN) (Sylatron) as adjuvant therapy for high-risk melanoma. The EORTC 18991 trial was an open-label study of resectable stage III melanoma with 1,256 patients who were randomized to observation-alone or to treatment with PEG-IFN for up to 5 years. The median recurrence-free survival of the treatment groups was significantly longer, while overall survival, a secondary endpoint, was not significantly different between the two groups. This review, after a short summary of interferon α-2b trials, critically analyzes the EORTC18991 trial, as well as the subgroup results and future perspectives for this stage of disease.

[Role of surgery in multimodal treatment of oral and oropharyngeal cancer].

PubMed

Scheithauer, M O; Riechelmann, H

2009-02-01

The value of surgery in multimodal treatment concepts of oral and oropharyngeal cancer, respecting quality of life and survival rates, should be evaluated. Patients with oral or oropharyngeal cancer were grouped, if tumor-targeted surgery was part of a multimodal treatment concept or if the patients received radiotherapy with or without chemotherapy only. Surgical versus non-surgical therapy, age, disease extent, tumor site and comorbidity as measured by the American Society of Anesthesiologists (ASA) physical status score were included in a Cox proportional hazard analysis. Quality of life was assessed 3 years following treatment employing the EORTC-C30 and H&N35 questionnaires. Patients treated with radiotherapy with or without chemotherapy only (63/140) had a worse survival (hazard ratio 1.7037, 95 % CI 0.9981 to 2.9080, p = 0.0508) than patients treated with surgery (77/140) as a part of a multimodal treatment concept. Disease extent (p < 0.01) and ASA score (p < 0.01) had a significant impact on survival. Quality of life scores were remarkably similar in surgically and non-surgically treated patients. The results of this study indicate that surgery remains a core modality of oral and oropharyngeal cancer treatment. External beam radiotherapy only, also if applied in current fractionation techniques, may not be sufficient to achieve adequate results.

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.

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.

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

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.

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.

[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 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.

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.

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

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

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.

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.

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.

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.

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, 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.

Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

PubMed

de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David

2017-02-01

Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; P<.001), psychosocial distress (r = -0.26; P<.001), and HRQOL, as measured by the FACT-G (r = 0.42; P<.001) and by the EORTC QOL instruments (r = 0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P = .04), employment status (P<.001), income (P = .003), number of inpatient admissions (P = .01), and psychological distress (P = .003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

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.

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

[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.

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

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.

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.

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.

A cross-sectional assessment of quality of life of breast cancer patients in Saudi Arabia.

PubMed

Almutairi, K M; Mansour, E A; Vinluan, J M

2016-07-01

This aim of this study was to assess the quality of life of Saudi female breast cancer patients and determine the effects of the sociodemographic and clinical characteristics on the quality of life of those patients. This study was designed as a cross-sectional study. The data were collected from 145 female cancer patients who were recruited from outpatient units in different clinical settings in Riyadh, Saudi Arabia, from September 2014 to February 2015. Questionnaires were distributed to the patients during their visits to the outpatient clinics after obtaining informed consent. Quality of life was assessed using a validated Arabic version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life. Among functional scales, emotional functioning scored the highest (83.25 [95% CI 79.53-86.98]). The most distressing symptom on the symptom scale was insomnia (mean 84.14 [95% CI 79.95-88.32]), followed by appetite loss (mean 80.92 [95% CI 76.51-85.33]) and dyspnoea (mean 80.00 [95% CI 75.51-84.49]). Poor functioning was found in sexual enjoyment (mean 22.52 [95% CI 17.97-27.08]) while future perspective scored the highest (mean 76.32 [95% CI 70.52-82.12]). This study shows breast cancer survivors in Saudi had a low overall global quality of life. Saudi women showed average scores on all the functional scales but the emotional ones scored the highest. Insomnia, appetite loss, and dyspnoea were the distressing symptoms on symptom scales while future perspective domain scored the highest in item of QLQ-BR23. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Evaluation of patient-reported outcome in subjects treated medically for acute pancreatitis: a follow-up study.

PubMed

Pezzilli, R; Morselli-Labate, A M; Campana, D; Casadei, R; Brocchi, E; Corinaldesi, R

2009-01-01

To explore the quality of life in patients treated medically during the acute phase of pancreatitis as well as at 2 and 12 months after discharge from the hospital. 40 patients were studied. The etiology of the pancreatitis was biliary causes in 31 patients and non-biliary causes in 9; mild disease was present in 29 patients and severe disease in 11. 30 patients completed the two surveys at 2 and 12 months after hospital discharge. The SF-12 and EORTC QLQ-C30 questionnaires were used for the purpose of the study. The two physical and mental component summaries of SF-12, all the domains of EORTC QLQ-C30 (except for physical functioning and cognitive functioning) and some symptom scales of EORTC QLQ-C30 (fatigue, nausea/vomiting, pain, and constipation) were significantly impaired during the acute phase of pancreatitis. There was a significant improvement in the SF-12 physical component summary, and global health, role functioning, social functioning, nausea/vomiting, pain, dyspnea, and financial difficulties (EORTC QLQ-C30) at 2 months after discharge as compared to the basal evaluation. Similar results were found after 12 months except for the mental component score at 12-month evaluation, which was significantly impaired in acute pancreatitis patients in comparison to the norms. The physical functioning of the EORTC QLQ-C30 at basal evaluation was significantly impaired in patients with severe pancreatitis in comparison to patients with mild pancreatitis. Two different patterns can be recognized in the quality of life of patients with acute pancreatitis: physical impairment is immediately present followed by mental impairment which appears progressively in the follow-up period. Copyright 2009 S. Karger AG, Basel.

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.

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.

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.

Earlier response assessment in invasive aspergillosis based on the kinetics of serum Aspergillus galactomannan: proposal for a new definition.

PubMed

Nouér, Simone A; Nucci, Marcio; Kumar, Naveen Sanath; Grazziutti, Monica; Barlogie, Bart; Anaissie, Elias

2011-10-01

Current criteria for assessing treatment response of invasive aspergillosis (IA) rely on nonspecific subjective parameters. We hypothesized that an Aspergillus-specific response definition based on the kinetics of serum Aspergillus galactomannan index (GMI) would provide earlier and more objective response assessment. We compared the 6-week European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) response criteria with GMI-based response among 115 cancer patients with IA. Success according to GMI required survival with repeatedly negative GMI for ≥2 weeks. Time to response and agreement between the 2 definitions were the study endpoints. Success according to EORTC/MSG and GMI criteria was observed in 73 patients (63%) and 83 patients (72%), respectively. The GMI-based response was determined at a median of 21 days after treatment initiation (range, 15-41 days), 3 weeks before the EORTC/MSG time point, in 72 (87%) of 83 responders. Agreement between definitions was shown in all 32 nonresponders and in 73 of the 83 responders (91% overall), with an excellent κ correlation coefficient of 0.819. Among 10 patients with discordant response (EORTC/MSG failure, GMI success), 1 is alive without IA 3 years after diagnosis; for the other, aspergillosis could not be detected at autopsy. The presence of other life-threatening complications in the remaining 8 patients indicates that IA had resolved. The Aspergillus-specific GMI-based criteria compare favorably to current response definitions for IA and significantly shorten time to response assessment. These criteria rely on a simple, reproducible, objective, and Aspergillus-specific test and should serve as the primary endpoint in trials of IA.

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.

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

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.

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.

Validity and reliability of the Greek version of the xerostomia questionnaire in head and neck cancer patients.

PubMed

Memtsa, Pinelopi Theopisti; Tolia, Maria; Tzitzikas, Ioannis; Bizakis, Ioannis; Pistevou-Gombaki, Kyriaki; Charalambidou, Martha; Iliopoulou, Chrysoula; Kyrgias, George

2017-03-01

Xerostomia after radiation therapy for head and neck (H&N) cancer has serious effects on patients' quality of life. The purpose of this study was to validate the Greek version of the self-reported eight-item xerostomia questionnaire (XQ) in patients treated with radiotherapy for H&N cancer. The XQ was translated into Greek and administered to 100 XQ patients. An exploratory factor analysis was performed. Reliability measures were calculated. Several types of validity were evaluated. The observer-rated scoring system was also used. The mean XQ value was 41.92 (SD 22.71). Factor analysis revealed the unidimensional nature of the questionnaire. High reliability measures (ICC, Cronbach's α, Pearson coefficients) were obtained. Patients differed statistically significantly in terms of XQ score, depending on the RTOG/EORTC classification. The Greek version of XQ is valid and reliable. Its score is well related to observer's findings and it can be used to evaluate the impact of radiation therapy on the subjective feeling of xerostomia.

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.

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.

Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study.

PubMed

Elshof, Lotte E; Tryfonidis, Konstantinos; Slaets, Leen; van Leeuwen-Stok, A Elise; Skinner, Victoria P; Dif, Nicolas; Pijnappel, Ruud M; Bijker, Nina; Rutgers, Emiel J Th; Wesseling, Jelle

2015-08-01

The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ (DCIS) urges the need for prospective studies to address this issue. A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns non- to slow-growing low-grade DCIS. The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS. This is a randomised, international multicentre, open-label, phase III non-inferiority trial, led by the Dutch Breast Cancer Research Group (BOOG 2014-04) and the European Organization for Research and Treatment of Cancer (EORTC-BCG 1401). Standard treatment will be compared to active surveillance in 1240 women aged ⩾ 45 years with asymptomatic, screen-detected, pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only. Both study arms will be monitored with annual digital mammography for a period of 10 years. The primary end-point is 10-year ipsilateral invasive breast cancer free percentage. Secondary end-points include patient reported outcomes, diagnostic biopsy rate during follow-up, ipsilateral mastectomy rate and translational research. To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres. A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study. The proposed study design is endorsed by nearly all centres. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Localized volume effects for late rectal and anal toxicity after radiotherapy for prostate cancer

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

Peeters, Stephanie T.H.; Lebesque, Joos V.; Heemsbergen, Wilma D.

2006-03-15

Purpose: To identify dosimetric parameters derived from anorectal, rectal, and anal wall dose distributions that correlate with different late gastrointestinal (GI) complications after three-dimensional conformal radiotherapy for prostate cancer. Methods and Materials: In this analysis, 641 patients from a randomized trial (68 Gy vs. 78 Gy) were included. Toxicity was scored with adapted Radiation Therapy Oncology Group/European Organization for the Research and Treatment of Cancer (RTOG/EORTC) criteria and five specific complications. The variables derived from dose-volume histogram of anorectal, rectal, and anal wall were as follows: % receiving {>=}5-70 Gy (V5-V70), maximum dose (D{sub max}), and mean dose (D{sub mean}).more » The anus was defined as the most caudal 3 cm of the anorectum. Statistics were done with multivariate Cox regression models. Median follow-up was 44 months. Results: Anal dosimetric variables were associated with RTOG/EORTC Grade {>=}2 (V5-V40, D{sub mean}) and incontinence (V5-V70, D{sub mean}). Bleeding correlated most strongly with anorectal V55-V65, and stool frequency with anorectal V40 and D{sub mean}. Use of steroids was weakly related to anal variables. No volume effect was seen for RTOG/EORTC Grade {>=}3 and pain/cramps/tenesmus. Conclusion: Different volume effects were found for various late GI complications. Therefore, to evaluate the risk of late GI toxicity, not only intermediate and high doses to the anorectal wall volume should be taken into account, but also the dose to the anal wall.« less

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.

Perspectives on death and an afterlife in relation to quality of life, depression, and hopelessness in cancer patients without evidence of disease and advanced cancer patients.

PubMed

van Laarhoven, Hanneke W M; Schilderman, Johannes; Verhagen, Constans A H H V M; Vissers, Kris C; Prins, Judith

2011-06-01

It is unknown whether cancer patients with different life expectancies have different attitudes and emotions toward death and an afterlife. Also, it is unclear whether these attitudes and emotions toward death and afterlife influence patients' distress. To assess the relationship of attitudes and emotions towards death and an afterlife with quality of life, depression and hopelessness in cancer patients without evidence of disease and advanced cancer patients facing death. Ninety-one cancer patients without evidence of disease and 57 advanced cancer patients completed the Dutch Attitudes Toward Death and Afterlife Scale. Emotions toward death were measured using the Self-Confrontation Method. Quality of life was measured with the Satisfaction with Life Scale and the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire. Depression and hopelessness were measured with the Beck Depression Inventory for Primary Care and the Beck Hopelessness Scale. Average scores on attitudes and emotions toward death and an afterlife were not significantly different between the two groups. However, in the no evidence of disease group, a negative association between negative emotions and social functioning was observed, which was not present in the advanced cancer group. In the advanced cancer group, associations were observed that were not present in the no evidence of disease group: positive associations between an explicitly religious attitude and global health status and between reincarnation belief and role and cognitive functioning, and a negative association between other-directed emotions and social functioning. Patients without evidence of disease and advanced cancer patients do not differ in attitudes or emotions toward death, but the relationship between these attitudes and emotions and aspects of quality of life varies. When there is no evidence of disease, negative emotions play the most important role, whereas in the advanced cancer situation, attitudes toward death and an afterlife, which may provide meaning and value, become more prominent. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

CRC/EORTC/NCI Joint Formulation Working Party: experiences in the formulation of investigational cytotoxic drugs.

PubMed Central

Beijnen, J. H.; Flora, K. P.; Halbert, G. W.; Henrar, R. E.; Slack, J. A.

1995-01-01

The pharmaceutical formulation of a new anti-tumour agent has often been perceived as the bottleneck in anti-cancer drug development. In order to increase the speed of this essential development step, the Cancer Research Campaign (CRC), the European Organization for Research and Treatment of Cancer (EORTC) and the National Cancer Institute (NCI) agreed in 1987 to form the Joint Formulation Working Party (JFWP). The main goal of the JFWP is to facilitate the rapid progress of a new drug through pharmaceutical developmental to preclinical toxicology and subsequently to phase I clinical trial. Under the auspices of the JFWP around 50 new agents have been developed or are currently in development. In this report we present our formulation experiences since the establishment of the JFWP with a selected number of agents: aphidicolin glycinate, bryostatin 1, carmethizole, carzelesin, combretastatin A4, dabis maleate, disulphonated aluminium phthalocyanine, E.O.9, 4-hydroxyanisole, pancratistatin, rhizoxin, Springer pro-drug, SRI 62-834, temozolomide, trimelamol and V489. The approaches used and problems presented may be of general interest to scientists in related fields and those considering submitting agents for development. PMID:7599054

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.

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.

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.

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.

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.

Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen Testing

PubMed Central

White, P. Lewis; Wingard, John R.; Bretagne, Stéphane; Löffler, Jürgen; Patterson, Thomas F.; Slavin, Monica A.; Barnes, Rosemary A.; Pappas, Peter G.; Donnelly, J. Peter

2015-01-01

Background. Aspergillus polymerase chain reaction (PCR) was excluded from the European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions of invasive fungal disease because of limited standardization and validation. The definitions are being revised. Methods. A systematic literature review was performed to identify analytical and clinical information available on inclusion of galactomannan enzyme immunoassay (GM-EIA) (2002) and β-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared. Results. When incorporated, GM-EIA and β-d-glucan sensitivities and specificities for diagnosing invasive aspergillosis were 81.6% and 91.6%, and 76.9% and 89.4%, respectively. Aspergillus PCR has similar sensitivity and specificity (76.8%–88.0% and 75.0%–94.5%, respectively) and comparable utility. Methodological recommendations and commercial PCR assays assist standardization. Although all tests have limitations, currently, PCR is the only test with independent quality control. Conclusions. We propose that there is sufficient evidence that is at least equivalent to that used to include GM-EIA and β-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions. PMID:26113653

Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen Testing.

PubMed

White, P Lewis; Wingard, John R; Bretagne, Stéphane; Löffler, Jürgen; Patterson, Thomas F; Slavin, Monica A; Barnes, Rosemary A; Pappas, Peter G; Donnelly, J Peter

2015-10-15

Aspergillus polymerase chain reaction (PCR) was excluded from the European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions of invasive fungal disease because of limited standardization and validation. The definitions are being revised. A systematic literature review was performed to identify analytical and clinical information available on inclusion of galactomannan enzyme immunoassay (GM-EIA) (2002) and β-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared. When incorporated, GM-EIA and β-d-glucan sensitivities and specificities for diagnosing invasive aspergillosis were 81.6% and 91.6%, and 76.9% and 89.4%, respectively. Aspergillus PCR has similar sensitivity and specificity (76.8%-88.0% and 75.0%-94.5%, respectively) and comparable utility. Methodological recommendations and commercial PCR assays assist standardization. Although all tests have limitations, currently, PCR is the only test with independent quality control. We propose that there is sufficient evidence that is at least equivalent to that used to include GM-EIA and β-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

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

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

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

Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: Initial report on a randomized controlled clinical trial

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

Pow, Edmond; Kwong, Dora; McMillan, Anne S.

2006-11-15

Purpose: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). Methods and Materials: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H and N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. Results:more » Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. Conclusions: IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease. The findings support the case for assessment of health-related QoL in relation to head-and-neck cancer using a site-specific approach.« less

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

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

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.

The clinical picture of cachexia: a mosaic of different parameters (experience of 503 patients).

PubMed

Schwarz, S; Prokopchuk, O; Esefeld, K; Gröschel, S; Bachmann, J; Lorenzen, S; Friess, H; Halle, M; Martignoni, M E

2017-02-14

Despite our growing knowledge about the pathomechanisms of cancer cachexia, a whole clinical picture of the cachectic patient is still missing. Our objective was to evaluate the clinical characteristics in cancer patients with and without cachexia to get the whole picture of a cachectic patient. Cancer patients of the University Clinic "Klinikum rechts der Isar" with gastrointestinal, gynecological, hematopoietic, lung and some other tumors were offered the possibility to take part in the treatment concept including a nutrition intervention and an individual training program according to their capability. We now report on the first 503 patients at the time of inclusion in the program between March 2011 and October 2015. We described clinical characteristics such as physical activity, quality of life, clinical dates and food intake. Of 503 patients with cancer, 131 patients (26.0%) were identified as cachectic, 369 (73.4%) as non-cachectic. The change in cachexia were 23% reduced capacity performance (108 Watt for non-cachectic-patients and 83 Watt for cachectic patients) and 12% reduced relative performance (1.53 Watt/kg for non-cachectic and 1.34 Watt/kg for cachectic patients) in ergometry test. 75.6% of non-cachectic and 54.3% of cachectic patients still received curative treatment. Cancer cachectic patients have multiple symptoms such as anemia, impaired kidney function and impaired liver function with elements of mild cholestasis, lower performance and a poorer quality of life in the EORTC questionnaire. Our study reveals biochemical and clinical specific features of cancer cachectic patients.

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.

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.

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.

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

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.

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.

Potential curability and perception of received information in esophageal cancer patients.

PubMed

Pinto, Eleonora; Cavallin, Francesco; Saadeh, Luca Maria; Bellissimo, Maria Cristina; Alfieri, Rita; Mantoan, Silvia; Cagol, Matteo; Castoro, Carlo; Scarpa, Marco

2018-06-01

This study aimed to evaluate patients' perceived receipt of information according to the possibility of cure in esophageal cancer. One hundred and twelve consecutive patients presenting at the multidisciplinary visit at the Veneto Institute of Oncology for esophageal cancer between 2014 and 2016 were included in the study. The Italian version of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires C30 (core questionnaire), OG25 (esophago-gastric cancer module), and INFO25 (information module) were used. Candidates for palliative treatment were less informed about the disease (adjusted mean difference - 11.5, 95% CI - 23.0 to - 0.02) and less satisfied with information provided (adjusted mean difference - 18.3, 95% CI - 31.9 to - 4.7) than candidates for curative treatment. In addition, candidates for palliative treatment wanted to receive more information than candidates for curative treatment (adjusted mean difference 26.1, 95% CI 0.5 to 51.6). Better quality of life was associated with satisfaction of received information (β = 0.77, p < 0.0001) and of receiving information about things that the patient can do to help himself (β = 0.26, p = 0.04). More anxiety was associated to receiving more information about disease (β = 0.46, p = 0.02) but less information about things that the patient can do to help himself (β = - 0.38, p = 0.02). Candidates for palliative treatment were less satisfied with information about the disease and wanted to receive more information. Additionally, some aspects of quality of life were found to be associated with perceived receipt of information. Appropriate training in communication of prognostic information may improve clinical management of incurable cancer patients.

The impact of vocal rehabilitation on quality of life and voice handicap in patients with total laryngectomy.

PubMed

Ţiple, Cristina; Drugan, Tudor; Dinescu, Florina Veronica; Mureşan, Rodica; Chirilă, Magdalena; Cosgarea, Marcel

2016-01-01

Health-related quality of life (HRQL) and voice handicap index (VHI) of laryngectomies seem to be relevant regarding voice rehabilitation. The aim of this study is to assess the impact on HRQL and VHI of laryngectomies, following voice rehabilitation. A retrospective study done at the Ear, Nose, and Throat Department of the Emergency County Hospital. Sixty-five laryngectomees were included in this study, of which 62 of them underwent voice rehabilitation. Voice handicap and QOL were assessed using the QOL questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC); variables used were functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, and nausea and vomiting), global QOL scale (pain, swallowing, senses, speech, social eating, social contact, and sexuality), and the functional, physical, and emotional aspects of the voice handicap (one-way ANOVA test). The mean age of the patients was 59.22 (standard deviation = 9.00) years. A total of 26 (40%) patients had moderate VHI (between 31 and 60) and 39 (60%) patients had severe VHI (higher than 61). Results of the HRQL questionnaires showed that patients who underwent speech therapy obtained better scores in most scales ( P = 0.000). Patients with esophageal voice had a high score for functional scales compared with or without other voice rehabilitation methods ( P = 0.07), and the VHI score for transesophageal prosthesis was improved after an adjustment period. The global health status and VHI scores showed a statistically significant correlation between speaker groups. The EORTC and the VHI questionnaires offer more information regarding life after laryngectomy.

Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust.

PubMed

Giesinger, Johannes M; Kieffer, Jacobien M; Fayers, Peter M; Groenvold, Mogens; Petersen, Morten Aa; Scott, Neil W; Sprangers, Mirjam A G; Velikova, Galina; Aaronson, Neil K

2016-01-01

To further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score. Using pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables. Although all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores. Our results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Validation of EORTC Prognostic Factors for Adults With Low-Grade Glioma: A Report Using Intergroup 86-72-51

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

Daniels, Thomas B.; Brown, Paul D., E-mail: Brown.paul@mayo.edu; Felten, Sara J.

2011-09-01

Purpose: A prognostic index for survival was constructed and validated from patient data from two European Organisation for Research and Treatment of Cancer (EORTC) radiation trials for low-grade glioma (LGG). We sought to independently validate this prognostic index with a separate prospectively collected data set (Intergroup 86-72-51). Methods and Materials: Two hundred three patients were treated in a North Central Cancer Treatment Group-led trial that randomized patients with supratentorial LGG to 50.4 or 64.8 Gy. Risk factors from the EORTC prognostic index were analyzed for prognostic value: histology, tumor size, neurologic deficit, age, and tumor crossing the midline. The high-riskmore » group was defined as patients with more than two risk factors. In addition, the Mini Mental Status Examination (MMSE) score, extent of surgical resection, and 1p19q status were also analyzed for prognostic value. Results: On univariate analysis, the following were statistically significant (p < 0.05) detrimental factors for both progression-free survival (PFS) and overall survival (OS): astrocytoma histology, tumor size, and less than total resection. A Mini Mental Status Examination score of more than 26 was a favorable prognostic factor. Multivariate analysis showed that tumor size and MMSE score were significant predictors of OS whereas tumor size, astrocytoma histology, and MMSE score were significant predictors of PFS. Analyzing by the EORTC risk groups, we found that the low-risk group had significantly better median OS (10.8 years vs. 3.9 years, p < 0.0001) and PFS (6.2 years vs. 1.9 years, p < 0.0001) than the high-risk group. The 1p19q status was available in 66 patients. Co-deletion of 1p19q was a favorable prognostic factor for OS vs. one or no deletion (median OS, 12.6 years vs. 7.2 years; p = 0.03). Conclusions: Although the low-risk group as defined by EORTC criteria had a superior PFS and OS to the high-risk group, this is primarily because of the influence of histology and tumor size. Co-deletion of 1p19q is a prognostic factor. Future studies are needed to develop a more refined prognostic system that combines clinical prognostic features with more robust molecular and genetic data.« less

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.

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.

Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.

PubMed

Escobar, Antonio; Trujillo-Martín, Maria del Mar; Rueda, Antonio; Pérez-Ruiz, Elisabeth; Avis, Nancy E; Bilbao, Amaia

2015-11-16

The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.

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

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.

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.

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.

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008–2014

PubMed Central

Jeffery, Diana D.; Barbera, Lisa; Andersen, Barbara L.; Siston, Amy K.; Jhingran, Anuja; Baron, Shirley R.; Reese, Jennifer Barsky; Coady, Deborah J.; Carter, Jeanne; Flynn, Kathryn E.

2016-01-01

Background A systematic review was conducted to identify and characterize self-reported sexual function (SF) measures administered to women with a history of cancer. Methods Using 2009 PRISMA guidelines, we searched electronic bibliographic databases for quantitative studies published January 2008–September 2014 that used a self-reported measure of SF, or a quality of life (QOL) measure that contained at least one item pertaining to SF. Results Of 1,487 articles initially identified, 171 were retained. The studies originated in 36 different countries with 23% from U.S.-based authors. Most studies focused on women treated for breast, gynecologic, or colorectal cancer. About 70% of the articles examined SF as the primary focus; the remaining examined QOL, menopausal symptoms, or compared treatment modalities. We identified 37 measures that assessed at least one domain of SF, eight of which were dedicated SF measures developed with cancer patients. Almost one-third of the studies used EORTC QLQ modules to assess SF, and another third used the Female Sexual Function Inventory. There were few commonalities among studies, though nearly all demonstrated worse SF after cancer treatment or compared to healthy controls. Conclusions QOL measures are better suited to screening while dedicated SF questionnaires provide data for more in depth assessment. This systematic review will assist oncology clinicians and researchers in their selection of measures of SF and encourage integration of this quality of life domain in patient care. PMID:25997102

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.

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.

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.

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.

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.

[Evaluation of patient satisfaction with the quality of health care received within the EORTC IN-PATSAT32 trial by patients with breast and colorectal cancer, and non-Hodgkin lymphoma at different stages. Correlation with sociodemographic characteristics, comorbidities and other procedural variables at the Mexican Institute of Social Security].

PubMed

Balderas-Peña, Luz-Ma-Adriana; Sat-Muñoz, Daniel; Contreras-Hernández, Iris; Solano-Murillo, Pedro; Hernández-Chávez, Guillermo-Allan; Mariscal-Ramírez, Ignacio; Lomelí-García, Martha; Díaz-Cortés, Margarita-Arimatea; Mould-Quevedo, Joaquín-Federico; Castro-Cervantes, Juan-Manuel; Garcés-Ruiz, Oscar-Miguel; Morgan-Villela, Gilberto

2011-01-01

In Mexico cancer is a public health burden. Nowadays the health care systems pay special attention to patient's perception and satisfaction of the health care received. Satisfaction with quality of health care has an impact in the adherence to the treatment. To evaluate the satisfaction with the quality of health care received at the IMSS in a group of cancer patients [non Hodgkin lymphoma (NHL), breast and colorectal cancer]. Socio-demographic features, co-morbid diseases, and attendance processes impact on satisfaction are also evaluated. 476 cancer patients were studied: 314 with breast cancer, 92 with NHL and 70 with colorectal cancer. In women with breast cancer the mean score to nurses' interpersonal skills in non-classified disease group and clinical stage III group were: 73.64 ± 32.53, 90.00 ± 18.25 respectively (p=0.005), nurses' availability in non-classified and clinical stage III group were: 69.71 ± 30.25, 89.21 ± 19.00 respectively (p=0.003). In subjects with NHL the mean scores for doctors' technical skills in clinical stage I and III groups, were: 63.69 ± 37.78, 80.30 ± 18.46 respectively (p=0.017), doctors' information provision scores in subject in clinical stage I and IV were: 49.40 ± 40.75, 79.49 ± 24.63 respectively (p=0.043). In the group of colorectal cancer patients the mean of the score to exchange of information between clinical stage II and clinical stage III group were 50.00 ± 41.83, 84.21 ± 22.37 respectively (p=0.036). Were not observed association between attendance processes features and general satisfaction. In Mexico 50% of cancer patients are attended at the IMSS. The continued evaluation of the satisfaction with health care received by the health care service users is important to enhance attention's quality. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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.

Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

PubMed Central

Slotman, Berend J.; Mauer, Murielle E.; Bottomley, Andrew; Faivre-Finn, Corinne; Kramer, Gijs W.P.M.; Rankin, Elaine M.; Snee, Michael; Hatton, Matthew; Postmus, Pieter E.; Collette, Laurence; Senan, Suresh

2009-01-01

Purpose Prophylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here. Patients and Methods Patients (age, 18 to 75 years; WHO ≤ 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter. Results Compliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P = .018) and 3 months (P = .055). Conclusion PCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care. PMID:19047288

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.

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.

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.

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

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.

Phenytoin mouthwash to treat cancer therapy-induced oral mucositis: A pilot studyPrimary neuroendocrine carcinoma of breast: A rare tumor.

PubMed

Baharvand, M; Hamian, M; Moosavizadeh, M A; Mortazavi, A; Ameri, A

2015-01-01

Oral mucositis is one of the most common side effects of cancer therapy with no definite treatment. Phenytoin has positive effects on healing of mucosal and dermal wounds. In this study efficacy of 1% phenytoin mouthwash on severity of mucositis (on the basis of WHO scale), pain relief (based on Visual Analogue Scale), and improvement of patients' quality of life (on the basis of EORTC-QLQ-H and N35 questionnaire) was evaluated. In a pilot -double-blind randomized clinical trial, eight patients in study group were given 1% phenytoin mouthwash while eight patients in control group used normal saline. Data analysis was performed by Mann-Whitney and Repeated Measured ANOVA tests. Reduction of mucositis severity was observed, but the difference was not significant. On the other hand, patients on phenytoin therapy had better pain relief (VAS# 6.75 ± 1.58 at the beginning of the study reached to # 3.75 ± 1.16 after 3 weeks in phenytoin group) and improvement in quality of life (score of QOL was 70.63 ± 5.5 that reached to 63.61 ± 6.39 in phenytoin group) than normal saline group significantly (P < 0.05). One percent phenytoin mouthwash caused pain relief and improvement of life quality significantly in patients with mucositis due to cancer therapy, but it did not reduce the severity of mucositis in a statistically significant scale.

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

In vivo dosimetry with TLD in conservative treatment of breast cancer patients treated with the EORTC protocol 22881.

PubMed

Hamers, H P; Johansson, K A; Venselaar, J L; de Brouwer, P; Hansson, U; Moudi, C

1993-01-01

Two anthropomorphic phantom breasts and six patients with breast carcinoma were irradiated according the prescriptions of the EORTC protocol 22881 on the conservative management of breast carcinoma by tumorectomy and radiotherapy. During the implantation procedure for an iridium-192 boost, three tubes were implanted, enabling the measurement with TLD rods of the dose within the breasts of the phantom and the patients during one fraction of the external x-ray therapy and during the interstitial therapy. Measured doses were compared with calculated values from a 2-D dose planning system. In general a fair agreement was found between the measured and calculated doses in points within the breast for the external beam therapy as well as for the interstitial treatment.

[Granulocyte- colony stimulating factor (G-CSF) use in clinical practice in patients receiving chemotherapy for breast cancer: The Opaline Study].

PubMed

Jacot, William; Antoine, Eric-Charles; Hacini, Maya; Giron, Cathy; Rivière, Alain; Moureau-Zabotto, Laurence; Cassin, Daniel; Yazbek, Gabriel; Orfeuvre, Hubert; Sakek, Nacera; Diab, Rafik; Bastit, Laurent; Mille, Dominique; Azria, David

2015-12-01

To describe the French routine use of G-CSF in patients treated for breast cancer as per the EORTC recommendations. A prospective multicenter observational study conducted between February 2008 and September 2009 in 869 breast cancer patients treated by chemotherapy (CT) and for whom G-CSF treatment will be delivered in primary (PP) or secondary prophylaxis. The mean age was 55 years. A total of 80.3% of CT was in neoadjuvant/adjuvant setting (NAS). PP was delivered in 78.9% of the NAS patients and 67.5% in metastatic situation. Of the 702 evaluable patients, incidences of severe (SN) and febrile neutropenias (FN) in patients who received PP were 9.3% and 4.2%, respectively. In patients who did not received G-CSF at first cycle, SN and FN were 12.4% and 7.3%, respectively. The use of PP was mainly driven by the type of CT for patients treated in the NAS and by patient or disease related risk factors in the locally advanced/metastatic setting. This study has shown that the use of G-CSF was in accordance with the 2010 updates of the EORTC recommendations. However, G-CSF appears more widely used in the routine practice. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

The impact of vocal rehabilitation on quality of life and voice handicap in patients with total laryngectomy

PubMed Central

Ţiple, Cristina; Drugan, Tudor; Dinescu, Florina Veronica; Mureşan, Rodica; Chirilă, Magdalena; Cosgarea, Marcel

2016-01-01

Background: Health-related quality of life (HRQL) and voice handicap index (VHI) of laryngectomies seem to be relevant regarding voice rehabilitation. The aim of this study is to assess the impact on HRQL and VHI of laryngectomies, following voice rehabilitation. Materials and Methods: A retrospective study done at the Ear, Nose, and Throat Department of the Emergency County Hospital. Sixty-five laryngectomees were included in this study, of which 62 of them underwent voice rehabilitation. Voice handicap and QOL were assessed using the QOL questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC); variables used were functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, and nausea and vomiting), global QOL scale (pain, swallowing, senses, speech, social eating, social contact, and sexuality), and the functional, physical, and emotional aspects of the voice handicap (one-way ANOVA test). Results: The mean age of the patients was 59.22 (standard deviation = 9.00) years. A total of 26 (40%) patients had moderate VHI (between 31 and 60) and 39 (60%) patients had severe VHI (higher than 61). Results of the HRQL questionnaires showed that patients who underwent speech therapy obtained better scores in most scales (P = 0.000). Patients with esophageal voice had a high score for functional scales compared with or without other voice rehabilitation methods (P = 0.07), and the VHI score for transesophageal prosthesis was improved after an adjustment period. The global health status and VHI scores showed a statistically significant correlation between speaker groups. Conclusion: The EORTC and the VHI questionnaires offer more information regarding life after laryngectomy. PMID:28331513

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.

Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

PubMed

Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

2018-05-01

Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

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.

Integrating mindfulness in supportive cancer care: a cohort study on a mindfulness-based day care clinic for cancer survivors.

PubMed

Dobos, Gustav; Overhamm, Tatiana; Büssing, Arndt; Ostermann, Thomas; Langhorst, Jost; Kümmel, Sherko; Paul, Anna; Cramer, Holger

2015-10-01

The aim of this study was to investigate the effects of a mindfulness-based day care clinic group program for cancer survivors on health-related quality of life and mental health; and to investigate which psychological variables are associated with changes in health variables. One hundred seventeen cancer survivors (91.0 % female; mean age 53.9 ± 10.7 years; 65.0 % breast cancer; mean time since diagnosis 27.2 ± 46.5 months) participated in an 11-week mindfulness-based day care clinic group program, 6 h per week. The intervention incorporated mindfulness-based meditation, yoga, cognitive-behavioral techniques, and lifestyle modification. Outcome measures including health-related quality of life (EORTC QLQ-C30), depression and anxiety (HADS); and psychological variables including life satisfaction (BMLSS), mindfulness (FMI), adaptive coping styles (AKU), spiritual/religious attitudes in dealing with illness (SpREUK), and interpretation of illness (IIQ) were assessed before, after, and 3 months after the intervention. Using mixed linear models, significant improvements in global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning were found. Cancer-related symptoms, including fatigue, pain, insomnia, constipation, anxiety, and depression, also improved significantly. Mindfulness, life satisfaction, health satisfaction, all coping styles, all spiritual/religious attitudes, and interpretation of illness as something of value increased; interpretation of illness as punishment decreased significantly (all p < 0.05). Improved outcomes were associated with increases in psychological variables, mainly life satisfaction, health satisfaction, and trust in medical help (R (2) = 7.3-43.6 %). Supportive mindfulness-based interventions can be considered as an effective means to improve cancer survivors' physical and mental health. Functional improvements are associated with improved satisfaction and coping styles.

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.

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

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.

Health-related quality of life, anxiety and depression in the diagnostic phase of suspected cancer, and the influence of diagnosis.

PubMed

Moseholm, Ellen; Rydahl-Hansen, Susan; Overgaard, Dorthe; Wengel, Hanne S; Frederiksen, Rikke; Brandt, Malene; Lindhardt, Bjarne Ø

2016-05-20

Undergoing diagnostic evaluation for cancer has been associated with a high prevalence of anxiety and depression and affected health-related quality of life (HRQoL). The aims of this study were to assess HRQoL, anxiety, and depression pre- and post-diagnosis in patients undergoing diagnostic evaluations for cancer due to non-specific symptoms; to examine changes over time in relation to final diagnosis (cancer yes/no); and to assess the predictive value of pre-diagnostic psychological, socio-demographic and clinical factors. A prospective, multicenter survey study of patients suspected to have cancer based on non-specific symptoms was performed. Participants completed the EORTC-QLQ-C30 quality of life scale, HADS, SOC-13 and self-rated health before and after completing diagnostic evaluations. Intra- and inter-group differences between patients diagnosed with cancer versus patients with non-cancer diagnoses were calculated. The impact of baseline psychological, socio-demographic, and medical factors on HRQoL, anxiety and depression at follow-up was explored by bootstrapped multivariate linear regression analyses and logistic regression analyses. A total of 838 patients participated in this study; 679 (81 %) completed the follow-up. Twenty-two percent of the patients received a cancer diagnosis at the end of the follow-up. Patients presented initially with a high burden of symptoms and affected role and emotional functioning and global health/QL, irrespective of diagnosis. The prevalence of clinical anxiety prior to knowledge of the diagnosis was 32 % in patients with cancer and 35 % in patients who received a non-cancer diagnosis. HRQoL and anxiety improved after diagnosis, and a larger improvement was seen in patients who received a non-cancer diagnosis. There were no intra- or inter-group differences in the depression scores. The strongest predictors of global QL, anxiety, and depression after a known diagnosis were baseline scores, co-morbidity and poor self-rated health. Patients undergoing diagnostic evaluations for cancer based on non-specific symptoms experience a high prevalence of anxiety and affected quality of life prior to knowledge of the diagnosis. The predictive value of the baseline scores is important when assessing the psychological impact of undergoing diagnostic evaluations for cancer.

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

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.

Emotional distress and dysfunctional illness perception are associated with low mental and physical quality of life in Chinese breast cancer patients.

PubMed

Tang, Lili; Fritzsche, Kurt; Leonhart, Rainer; Pang, Ying; Li, Jinjiang; Song, Lili; Fischer, Irmela; Koch, Maike; Wuensch, Alexander; Mewes, Ricarda; Schaefert, Rainer

2017-12-01

To evaluate the relationship between quality of life (QOL) and physical as well as psychological variables in Chinese breast cancer patients. This multicenter cross-sectional study enrolled 254 Chinese breast cancer patients in different stages and treatment phases. They answered standard instruments assessing QOL (EORTC), somatic symptom severity (PHQ-15), depression (PHQ-9), anxiety (GAD-7), health-related anxiety (WI-7), illness perception (BIPQ), and sense of coherence (SOC-9). Canonical correlation was applied to identify the strongest correlates between the physical, emotional and social QOL scales and the physical and psychological variables. In our sample, a low global QOL was significantly associated with the following physical and psychological variables: symptom-related disability (Karnofsky Index) (r = .211, p < .01), somatic symptom severity (r = -.391, p < .001), depression (r = -.488, p < .001), anxiety (r = -.439, p < .001), health-related anxiety (r = -.398, p < .001), dysfunctional illness perception (r = -.411, p < .001), and sense of coherence (r = .371, p < .001). In the canonical correlation analysis, high somatic symptom severity, depression, anxiety, dysfunctional illness perception, and low sense of coherence showed the strongest correlations with low physical, emotional and social functioning. The first three significant canonical correlations between these two sets of variables were .78, .56, and .45. QOL in Chinese breast cancer patients is strongly associated with psychological factors. Our results suggest that Chinese physicians and nurses should incorporate these factors into their care for women with breast cancer to improve patients' QOL.

Hypofractionated intensity modulated irradiation for localized prostate cancer, results from a phase I/II feasibility study

PubMed Central

Junius, Sara; Haustermans, Karin; Bussels, Barbara; Oyen, Raymond; Vanstraelen, Bianca; Depuydt, Tom; Verstraete, Jan; Joniau, Steven; Van Poppel, Hendrik

2007-01-01

Background To assess acute (primary endpoint) and late toxicity, quality of life (QOL), biochemical or clinical failure (secondary endpoints) of a hypofractionated IMRT schedule for prostate cancer (PC). Methods 38 men with localized PC received 66 Gy (2.64 Gy) to prostate,2 Gy to seminal vesicles (50 Gy total) using IMRT. Acute toxicity was evaluated weekly during radiotherapy (RT), at 1–3 months afterwards using RTOG acute scoring system. Late side effects were scored at 6, 9, 12, 16, 20, 24 and 36 months after RT using RTOG/EORTC criteria. Quality of life was assessed by EORTC-C30 questionnaire and PR25 prostate module. Biochemical failure was defined using ASTRO consensus and nadir+2 definition, clinical failure as local, regional or distant relapse. Results None experienced grade III-IV toxicity. 10% had no acute genito-urinary (GU) toxicity, 63% grade I; 26% grade II. Maximum acute gastrointestinal (GI) scores 0, I, II were 37%, 47% and 16%. Maximal acute toxicity was reached weeks 4–5 and resolved within 4 weeks after RT in 82%. Grade II rectal bleeding needing coagulation had a peak incidence of 18% at 16 months after RT but is 0% at 24–36 months. One developed a urethral stricture at 2 years (grade II late GU toxicity) successfully dilated until now. QOL urinary symptom scores reached a peak incidence 1 month after RT but normalized 6 months later. Bowel symptom scores before, at 1–6 months showed similar values but rose slowly 2–3 years after RT. Nadir of sexual symptom scores was reached 1–6 months after RT but improved 2–3 years later as well as physical, cognitive and role functional scales. Emotional, social functional scales were lowest before RT when diagnosis was given but improved later. Two years after RT global health status normalized. Conclusion This hypofractionated IMRT schedule for PC using 25 fractions of 2.64 Gy did not result in severe acute side effects. Until now late urethral, rectal toxicities seemed acceptable as well as failure rates. Detailed analysis of QOL questionnaires resulted in the same conclusion. PMID:17686162

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

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.

Heath-related quality of life in Spanish breast cancer patients: a systematic review.

PubMed

Delgado-Sanz, María Concepción; García-Mendizábal, María José; Pollán, Marina; Forjaz, Maria João; López-Abente, Gonzalo; Aragonés, Nuria; Pérez-Gómez, Beatriz

2011-01-14

Breast cancer is one of the oncological diseases in which health-related quality of life (HRQL) has been most studied. This is mainly due to its high incidence and survival. This paper seeks to: review published research into HRQL among women with breast cancer in Spain; analyse the characteristics of these studies; and describe the instruments used and main results reported. The databases consulted were MEDLINE, EMBASE, PsycINFO, Dialnet, IBECS, CUIDEN, ISOC and LILACS. The inclusion criteria required studies to: 1) include Spanish patients, and a breakdown of results where other types of tumours and/or women from other countries were also included; and, 2) furnish original data and measure HRQL using a purpose-designed questionnaire. The methodological quality of studies was assessed. Spain ranked midway in the European Union in terms of the number of studies conducted on the HRQL of breast cancer patients. Of the total of 133 papers published from 1993 to 2009, 25 met the inclusion criteria. Among them, only 12 were considered as having good or excellent quality. A total of 2236 women participated in the studies analysed. In descending order of frequency, the questionnaires used were the EORTC, FACT-B, QL-CA-Afex, SF-12, FLIC, RSCL and CCV. Five papers focused on validation or adaptation of questionnaires. Most papers examined HRQL in terms of type of treatment. Few differences were detected by type of chemotherapy, with the single exception of worse results among younger women treated with radiotherapy. In the short term, better results were reported for all HRQL components by women undergoing conservative rather than radical surgery. Presence of lymphedema was associated with worse HRQL. Three studies assessed differences in HRQL by patients' psychological traits. Psychosocial disorder and level of depression and anxiety, regardless of treatment or disease stage, worsened HRQL. In addition, there was a positive effect among patients who reported having a "fighting spirit" and using "denial" as a defence mechanism. One study found that breast cancer patients scored worse than did healthy women on almost all SF-12 scales. Research into health-related quality of life of breast-cancer patients is a little developed field in Spain.

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.

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.

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.

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.

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

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.

Beam Output Audit results within the EORTC Radiation Oncology Group network.

PubMed

Hurkmans, Coen W; Christiaens, Melissa; Collette, Sandra; Weber, Damien Charles

2016-12-15

Beam Output Auditing (BOA) is one key process of the EORTC radiation therapy quality assurance program. Here the results obtained between 2005 and 2014 are presented and compared to previous results.For all BOA reports the following parameters were scored: centre, country, date of audit, beam energies and treatment machines audited, auditing organisation, percentage of agreement between stated and measured dose.Four-hundred and sixty-one BOA reports were analyzed containing the results of 1790 photon and 1366 electron beams, delivered by 755 different treatment machines. The majority of beams (91.1%) were within the optimal limit of ≤ 3%. Only 13 beams (0.4%; n = 9 electrons; n = 4 photons), were out of the range of acceptance of ≤ 5%. Previous reviews reported a much higher percentage of 2.5% or more of the BOAs with >5% deviation.The majority of EORTC centres present beam output variations within the 3% tolerance cutoff value and only 0.4% of audited beams presented with variations of more than 5%. This is an important improvement compared to previous BOA results.

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.

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

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.

Axillary irradiation omitting axillary dissection in breast cancer: is there a role for shoulder-sparing proton therapy?

PubMed

Farace, P; Deidda, M A; Amichetti, M

2015-10-01

The recent EORTC 10981-22023 AMAROS trial showed that axillary radiotherapy and axillary lymph node dissection provide comparable local control and reduced lymphoedema in the irradiated group. However, no significant differences between the two groups in range of motion and quality of life were reported. It has been acknowledged that axillary irradiation could have induced some toxicity, particularly shoulder function impairment. In fact, conventional breast irradiation by tangential beams has to be modified to achieve full-dose coverage of the axillary nodes, including in the treatment field a larger portion of the shoulder structures. In this scenario, alternative irradiation techniques were discussed. Compared with modern photon techniques, axillary irradiation by proton therapy has the potential for sparing the shoulder without detrimental increase of the medium-to-low doses to the other normal tissues.

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.

Perceived control and psychological distress in women with breast cancer: a longitudinal study.

PubMed

Bárez, Milagros; Blasco, Tomas; Fernández-Castro, Jordi; Viladrich, Carme

2009-04-01

The relationship between perceived control and psychological distress in cancer patients has been widely studied, but longitudinal designs are scarce. The aim of this study was to examine whether perceived control could predict changes in the evolution of psychological distress in breast cancer patients at stages I or II. One hundred and one women were assessed on five occasions: one week after surgery, and again 1, 3, 6 and 12 months later, using the Mental Adjustment to Cancer (MAC) Scale, a Self-Efficacy Scale, the Personal Competence Scale, the Hospital Anxiety and Depression Scale (HADS), the Profile of Mood Sates (POMS), and the EORTC questionnaire of quality of life. Latent growth curve (LGC) model analysis was used to test the relationship between perceived control and psychological distress in a longitudinal, 1-year study. The results showed that perceived control increases linearly and that distress also decreases linearly. Moreover, the evolution of distress can be predicted from the initial value and the rate of change of perceived control. This close relationship between perceived control and psychological distress was found to be independent of the evolution of the physical state. These findings suggest that perceived control could be used as an early predictor of psychological adjustment to illness.

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.

Cancer in Europe: Death sentence or life sentence?

PubMed

Liu, Lifang; O'Donnell, Peter; Sullivan, Richard; Katalinic, Alexander; Moser, Lotte; de Boer, Angela; Meunier, Francoise

2016-09-01

With so many adults and children receiving successful treatment for their cancer, survivorship is now a 'new' and critical issue. It is increasingly recognised that the growing numbers of survivors face new challenges in their bid to return to 'normal' life. What is not yet so widely recognised is the need for a broad response to help them cope-with stigmatisation, misunderstanding, lifelong issues of confidence and social adaptation, and even access to employment and to financial services. As a further stage in its programme of attention to this aspect of cancer, the European Organisation for Research and Treatment of Cancer (EORTC) brought survivors, researchers, carers, authorities and policymakers together at a meeting in Brussels in March/April 2016, to learn at first hand about the posttreatment experience of cancer survivors. The meeting demonstrated that while research is well advanced in many of the medical consequences of survivorship, understanding is still lacking of many non-clinical, personal and administrative issues. The meeting raised the discussion of survivorship research beyond the individual to a population-based approach, exploring the related socioeconomic issues. Its exploration of initiatives across Europe countries provoked new thinking on the need for effective collaboration, with a new focus on non-clinical issues, including effective dialogue with financial service providers and employers, improvements in collecting, exchanging and accessing data, and above all, ways of translating research outcomes into action. This will require wider recognition that, as Françoise Meunier, Director Special Projects, EORTC, said, 'It is time for a new mind set'. Copyright © 2016 Elsevier Ltd. All rights reserved.

Survival data for 299 patients with primary cutaneous lymphomas: a monocentre study.

PubMed

Hallermann, Christian; Niermann, Christoph; Fischer, Rudolf-Josef; Schulze, Hans-Joachim

2011-09-01

The aim of this study was retrospectively to assess the validity of the 2005 WHO-EORTC classification for primary cutaneous lymphomas (PCL) in a large cohort of patients of a single German skin cancer unit. All patients with PCLs consecutively visiting our hospital between January 1980 and December 2005 were included in a retrospective monocentre study, analysing their histological and clinical data. A total of 312 patients fulfilled the inclusion criteria for PCL. In 299 patients clinical information and paraffin material were sufficient for detailed classification. Of the 299 patients, 63% expressed a T-cell and 37% a B-cell phenotype. Mycosis fungoides was the entity with the highest frequency (30.9%), followed by primary cutaneous follicle centre lymphomas (16.9%) and lymphomatoid papulosis (15.9%). The mean follow-up period was 38.4 months. Five-year disease-specific survival was 80.5% for mycosis fungoides, 92.5% in primary cutaneous anaplastic large cell lymphoma, 100% in lymphomatoid papulosis, 98.1% in primary cutaneous follicle center lymphoma, 100% in primary cutaneous marginal zone lymphoma and 63.2% in diffuse large B-cell lymphoma, leg type. Our data are in line with the data collected by the WHO-EORTC. This is further evidence for the reliability of the WHO-EORTC classification and staging system.

Profile of European proton and carbon ion therapy centers assessed by the EORTC facility questionnaire.

PubMed

Weber, Damien C; Abrunhosa-Branquinho, André; Bolsi, Alessandra; Kacperek, Andrzej; Dendale, Rémi; Geismar, Dirk; Bachtiary, Barbara; Hall, Annika; Heufelder, Jens; Herfarth, Klaus; Debus, Jürgen; Amichetti, Maurizio; Krause, Mechthild; Orecchia, Roberto; Vondracek, Vladimir; Thariat, Juliette; Kajdrowicz, Tomasz; Nilsson, Kristina; Grau, Cai

2017-08-01

We performed a survey using the modified EORTC Facility questionnaire (pFQ) to evaluate the human, technical and organizational resources of particle centers in Europe. The modified pFQ consisted of 235 questions distributed in 11 sections accessible on line on an EORTC server. Fifteen centers from 8 countries completed the pFQ between May 2015 and December 2015. The average number of patients treated per year and per particle center was 221 (range, 40-557). The majority (66.7%) of centers had pencil beam or raster scanning capability. Four (27%) centers were dedicated to eye treatment only. An increase in the patients-health professional FTE ratio was observed for eye tumor only centers when compared to other centers. All centers treated routinely chordomas/chondrosarcomas, brain tumors and sarcomas but rarely breast cancer. The majority of centers treated pediatric cases with particles. Only a minority of the queried institutions treated non-static targets. As the number of particle centers coming online will increase, the experience with this treatment modality will rise in Europe. Children can currently be treated in these facilities in a majority of cases. The majority of these centers provide state of the art particle beam therapy. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

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.

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…

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.

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.

The korean version of the body image scale-reliability and validity in a sample of breast cancer patients.

PubMed

Khang, Dongwoo; Rim, Hyo-Deog; Woo, Jungmin

2013-03-01

The Body Image Scale (BIS) developed in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group is a brief questionnaire for measuring body image concerns in patients with cancer. This study sought to assess the reliability and validity of the Korean version of the Body Image Scale (K-BIS). The participants consisted of 155 postoperative breast cancer patients (56 breast conserving surgery, 56 mastectomy, and 43 oncoplastic surgery). Subjects were evaluated using the K-BIS, the Body-Esteem Scale for Adolescents and Adults (BESAA), the Rosenberg Self-Esteem Scale (RSES), the Hospital Anxiety and Depression Scale (HADS), and the World Health Organization Quality of Life Scale Abbreviated Version (WHOQOL-BREF). Test-retest reliability and internal consistency were examined as a measure of reliability and validity was evaluated by convergent validity, discriminant validity and factor analysis. Cronbach's α value was 0.943. The total score of the K-BIS was negatively correlated with the BESAA (r=0.301, p<0.001) and the body image facet in the WHOQOL-BREF (r=0.315, p<0.001). The total score of K-BIS positively correlated with the HADS (HAD-A: r=0.501, p<0.001, HAD-D: r=0.466, p<0.001). As for determining discriminant validity, scores were compared between the BCS subgroup, mastectomy subgroup, and oncoplastic surgery subgroup. Difference between the mastectomy subgroup and oncoplastic surgery subgroup was statistically significant (p=0.017). Factor analysis resulted in a single factor solution in three out of four anlyses, accounting for >59% variance. The K-BIS showed good reliability and validity for assessment of body image in Korean breast cancer patients.

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.

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.

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.

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.

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.

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.

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.

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

PubMed

Augestad, Knut M; Vonen, Barthold; Aspevik, Ranveig; Nestvold, Torunn; Ringberg, Unni; Johnsen, Roar; Norum, Jan; Lindsetmo, Rolv-Ole

2008-06-25

All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve. This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

Effects of yoga on symptom management in breast cancer patients: A randomized controlled trial.

PubMed

Vadiraja, S Hosakote; Rao, M Raghavendra; Nagendra, R Hongasandra; Nagarathna, Raghuram; Rekha, Mohan; Vanitha, Nanjundiah; Gopinath, S Kodaganuru; Srinath, Bs; Vishweshwara, Ms; Madhavi, Ys; S Ajaikumar, Basavalingaiah; Ramesh, S Bilimagga; Rao, Nalini

2009-07-01

This study compares the effects of an integrated yoga program with brief supportive therapy on distressful symptoms in breast cancer outpatients undergoing adjuvant radiotherapy. Eighty-eight stage II and III breast cancer outpatients were randomly assigned to receive yoga (n = 44) or brief supportive therapy (n = 44) prior to their radiotherapy treatment. Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted supportive therapy once in 10 days during the course of their adjuvant radiotherapy. Assessments included Rotterdam Symptom Check List and European Organization for Research in the Treatment of Cancer-Quality of Life (EORTC QoL C30) symptom scale. Assessments were done at baseline and after 6 weeks of radiotherapy treatment. A GLM repeated-measures ANOVA showed a significant decrease in psychological distress (P = 0.01), fatigue (P = 0.007), insomnia (P = 0.001), and appetite loss (P = 0.002) over time in the yoga group as compared to controls. There was significant improvement in the activity level (P = 0.02) in the yoga group as compared to controls. There was a significant positive correlation between physical and psychological distress and fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, and constipation. There was a significant negative correlation between the activity level and fatigue, nausea and vomiting, pain, dyspnea, insomnia, and appetite loss. The results suggest beneficial effects with yoga intervention in managing cancer-and treatment-related symptoms in breast cancer patients.

Axillary irradiation omitting axillary dissection in breast cancer: is there a role for shoulder-sparing proton therapy?

PubMed Central

Deidda, M A; Amichetti, M

2015-01-01

The recent EORTC 10981-22023 AMAROS trial showed that axillary radiotherapy and axillary lymph node dissection provide comparable local control and reduced lymphoedema in the irradiated group. However, no significant differences between the two groups in range of motion and quality of life were reported. It has been acknowledged that axillary irradiation could have induced some toxicity, particularly shoulder function impairment. In fact, conventional breast irradiation by tangential beams has to be modified to achieve full-dose coverage of the axillary nodes, including in the treatment field a larger portion of the shoulder structures. In this scenario, alternative irradiation techniques were discussed. Compared with modern photon techniques, axillary irradiation by proton therapy has the potential for sparing the shoulder without detrimental increase of the medium-to-low doses to the other normal tissues. PMID:26153903

Development of a Set of Nomograms to Predict Acute Lower Gastrointestinal Toxicity for Prostate Cancer 3D-CRT

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

Valdagni, Riccardo; Rancati, Tiziana; Fiorino, Claudio

2008-07-15

Purpose: To predict acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) and Subjective Objective Signs Management and Analysis/Late Effect of Normal Tissue (SOMA/LENT) toxicities of the lower gastrointestinal (LGI) syndrome in patients with prostate cancer undergoing three-dimensional conformal radiotherapy using a tool (nomogram) that takes into account clinical and dosimetric variables that proved to be significant in the Italian Association for Radiation Oncology (AIRO) Group on Prostate Cancer (AIROPROS) 0102 trial. Methods and Materials: Acute rectal toxicity was scored in 1,132 patients by using both the RTOG/EORTC scoring system and a 10-item self-assessed questionnaire.more » Correlation between clinical variables/dose-volume histogram constraints and rectal toxicity was investigated by means of multivariate logistic analyses. Multivariate logistic analyses results were used to create nomograms predicting the symptoms of acute LGI syndrome. Results: Mean rectal dose was a strong predictor of Grade 2-3 RTOG/EORTC acute LGI toxicity (p 0.0004; odds ratio (OR) = 1.035), together with hemorrhoids (p = 0.02; OR 1.51), use of anticoagulants/antiaggregants (p = 0.02; OR = 0.63), and androgen deprivation (AD) (p = 0.04; OR = 0.65). Diabetes (p = 0.34; OR 1.28) and pelvic node irradiation (p = 0.11; OR = 1.56) were significant variables to adjust toxicity prediction. Bleeding was related to hemorrhoids (p = 0.02; OR = 173), AD (p = 0.17; OR = 0.67), and mean rectal dose (p 0.009; OR = 1.024). Stool frequency was related to seminal vesicle irradiation (p = 0.07; OR = 6.46), AD administered for more than 3 months (p = 0.002; OR = 0.32), and the percent volume of rectum receiving more than 60 Gy (V60Gy) V60 (p = 0.02; OR = 1.02). Severe fecal incontinence depended on seminal vesicle irradiation (p = 0.14; OR = 4.5) and V70 (p = 0.033; OR 1.029). Conclusions: To the best of our knowledge, this work presents the first set of nomograms available in the literature specific to symptoms of LGI syndrome and provides clinicians with a tailored probability of the specific outcome. Validation of the tool is in progress.« less

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.

Prevalence and risk factors associated with pain 21 months following surgery for breast cancer.

PubMed

Moloney, Niamh; Sung, Jennie Man Wai; Kilbreath, Sharon; Dylke, Elizabeth

2016-11-01

This study investigated (1) the prevalence of pain following breast cancer treatment including moderate-to-severe persistent pain and (2) the association of risk factors, present 1 month following surgery, with pain at 21 months following surgery. This information may aid the development of clinical guidelines for early pain assessment and intervention in this population. This study was a retrospective analysis of core and breast modules of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire from 121 participants with early breast cancer. The relationships between potential risk factors (subscales derived from the EORTC), measured within 1 month following surgery, and pain at 21 months following surgery were analysed using univariable and multi-variable logistic regression. At 21 months following surgery, 46.3 % of participants reported pain, with 24 % categorised as having moderate or severe pain. Prevalence of pain was similar between those who underwent axillary lymph node dissection versus biopsy. Univariate logistic regression identified baseline pain (odds ratio (95 % CI): 2.7 (1.1 to 6.4)); baseline arm symptoms (11.2 (1.4 to 89.8)); emotional function (0.4 (0.1 to 0.8)) and insomnia (2.3 (1.1 to 4.7) as significantly associated with pain at 21 months. In multi-variable analysis, two factors were independently associated with pain at 21 months-baseline arm symptoms and emotional subscale scores. Pain is a significant problem following breast cancer treatment in both the early post-operative period and months following surgery. Risk factors for pain at long-term follow-up included arm symptoms and higher emotional subscale scores at baseline.

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.

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 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

[Effects of Feiji decoction for soothing the liver combined with psychotherapy on quality of life in primary lung cancer patients].

PubMed

Yao, Yilin

2012-01-01

Primary lung cancer is one of the most common malignant tumors. It causes great pain and mood disorders to patients, and significantly reduces their quality of life. The aim of the current study is to evaluate the effect of Feiji Decoction for soothing the liver combined with psychotherapy on quality of life (QoL) and physical status of patients with primary lung cancer. A total of 118 patients with primary non-small cell lung cancer were randomly divided into two groups. The 57 patients in the combined therapy group were treated with Feiji Decoction for soothing the liver and psychotherapy combined with chemotherapy, whereas the 61 patients in the control group were treated with chemotherapy only. Both groups were observed for the two treatment courses. The European Organization for Research and Treatment of Cancer QoL Questionnaire LC-43 (EORTC QLQ-LC43) was used to assess the QoL of every patient in both groups before and after treatment scales. At the same time, physical status was assessed using the Karnofsky performance status (KPS) and East Cooperative Oncology Group performance status (ECOG). The scores of physiology function, role function, emotion function, cognize function, society function, and general health in the therapy group were higher than that of the control group. The therapy group also showed better QoL results than the contol group. Significant differences were observed between the two groups (P<0.01). Meanwhile, the scores of fatigue, vomit, pain, polypnea, insomnia, anorexia, constipation, and specific manifestation of lung cancer in the therapy group were obviously lower than that of the control group; more patients were observed to be relieved. Significant differences between the two groups were observed (P<0.01). The KPS and ECOG scores of the patients were observed to have improved and stabilized in the therapy group than that of the control group; the differences were statistically significant (P<0.01). Feiji Decoction for soothing the liver combined with psychotherapy can alleviate the clinical symptoms, elevate the physical status, and improve the QOL of patients with primary lung cancer. Thus, this therapy has a good clinical therapeutic effect.

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.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

PubMed

Bauhofer, A; Lorenz, W; Stinner, B; Rothmund, M; Koller, M; Sitter, H; Celik, I; Farndon, J R; Fingerhut, A; Hay, J M; Lefering, R; Lorijn, R; Nyström, P O; Schäfer, H; Schein, M; Solomkin, J; Troidl, H; Volk, H D; Wittmann, D H; Wyatt, J

2001-04-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Distinct types of primary cutaneous large B-cell lymphoma identified by gene expression profiling.

PubMed

Hoefnagel, Juliette J; Dijkman, Remco; Basso, Katia; Jansen, Patty M; Hallermann, Christian; Willemze, Rein; Tensen, Cornelis P; Vermeer, Maarten H

2005-05-01

In the European Organization for Research and Treatment of Cancer (EORTC) classification 2 types of primary cutaneous large B-cell lymphoma (PCLBCL) are distinguished: primary cutaneous follicle center cell lymphomas (PCFCCL) and PCLBCL of the leg (PCLBCL-leg). Distinction between both groups is considered important because of differences in prognosis (5-year survival > 95% and 52%, respectively) and the first choice of treatment (radiotherapy or systemic chemotherapy, respectively), but is not generally accepted. To establish a molecular basis for this subdivision in the EORTC classification, we investigated the gene expression profiles of 21 PCLBCLs by oligonucleotide microarray analysis. Hierarchical clustering based on a B-cell signature (7450 genes) classified PCLBCL into 2 distinct subgroups consisting of, respectively, 8 PCFCCLs and 13 PCLBCLsleg. PCLBCLs-leg showed increased expression of genes associated with cell proliferation; the proto-oncogenes Pim-1, Pim-2, and c-Myc; and the transcription factors Mum1/IRF4 and Oct-2. In the group of PCFCCL high expression of SPINK2 was observed. Further analysis suggested that PCFCCLs and PCLBCLs-leg have expression profiles similar to that of germinal center B-cell-like and activated B-cell-like diffuse large B-cell lymphoma, respectively. The results of this study suggest that different pathogenetic mechanisms are involved in the development of PCFCCLs and PCLBCLs-leg and provide molecular support for the subdivision used in the EORTC classification.

The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery.

PubMed

Catsman, Coriene J L M; Beek, Martinus A; Voogd, Adri C; Mulder, Paul G H; Luiten, Ernest J T

2018-04-23

Cosmetic result in breast cancer surgery is gaining increased interest. Currently, some 30-40% of the patients treated with breast conserving surgery (BCS) are dissatisfied with their final cosmetic result. In order to prevent disturbing breast deformity oncoplastic surgical techniques have been introduced. The extent of different levels of oncoplastic surgery incorporated in breast conserving surgery and its value with regard to cosmetic outcome, patient satisfaction and quality of life remains to be defined. The aim of this prospective cohort study is to investigate quality of life and satisfaction with cosmetic result in patients with breast cancer, undergoing standard lumpectomy versus level I or II oncoplastic breast conserving surgery. Female breast cancer patients scheduled for BCS, from 18 years of age, referred to our outpatient clinic from July 2015 are asked to participate in this study. General, oncologic and treatment information will be collected. Patient satisfaction will be scored preceding surgery, and at 1 month and 1 year follow up. Photographs of the breast will be used to score cosmetic result both by the patient, an independent expert panel and BCCT.Core software. Quality of life will be measured by using the BREAST-Q BCT, EORTC-QLQ and EQ-5D-5 L questionnaires. The purpose of this prospective study is to determine the clinical value of different levels of oncoplastic techniques in breast conserving surgery, with regard to quality of life and cosmetic result. Analysis will be carried out by objective measurements of the final cosmetic result in comparison with standard breast conserving surgery. The results of this study will be used to development of a clinical decision model to guide the use oncoplastic surgery in future BCS. Central Commission of Human Research (CCMO), The Netherlands: NL54888.015.15. Medical Ethical Commission (METC), Maxima Medical Centre, Veldhoven, The Netherlands: 15.107. Dutch Trial Register: NTR5665 , retrospectively registered, 02-25-2016.

Heath-related quality of life in Spanish breast cancer patients: a systematic review

PubMed Central

2011-01-01

Background Breast cancer is one of the oncological diseases in which health-related quality of life (HRQL) has been most studied. This is mainly due to its high incidence and survival. This paper seeks to: review published research into HRQL among women with breast cancer in Spain; analyse the characteristics of these studies; and describe the instruments used and main results reported. Methods The databases consulted were MEDLINE, EMBASE, PsycINFO, Dialnet, IBECS, CUIDEN, ISOC and LILACS. The inclusion criteria required studies to: 1) include Spanish patients, and a breakdown of results where other types of tumours and/or women from other countries were also included; and, 2) furnish original data and measure HRQL using a purpose-designed questionnaire. The methodological quality of studies was assessed. Results Spain ranked midway in the European Union in terms of the number of studies conducted on the HRQL of breast cancer patients. Of the total of 133 papers published from 1993 to 2009, 25 met the inclusion criteria. Among them, only 12 were considered as having good or excellent quality. A total of 2236 women participated in the studies analysed. In descending order of frequency, the questionnaires used were the EORTC, FACT-B, QL-CA-Afex, SF-12, FLIC, RSCL and CCV. Five papers focused on validation or adaptation of questionnaires. Most papers examined HRQL in terms of type of treatment. Few differences were detected by type of chemotherapy, with the single exception of worse results among younger women treated with radiotherapy. In the short term, better results were reported for all HRQL components by women undergoing conservative rather than radical surgery. Presence of lymphedema was associated with worse HRQL. Three studies assessed differences in HRQL by patients' psychological traits. Psychosocial disorder and level of depression and anxiety, regardless of treatment or disease stage, worsened HRQL. In addition, there was a positive effect among patients who reported having a "fighting spirit" and using "denial" as a defence mechanism. One study found that breast cancer patients scored worse than did healthy women on almost all SF-12 scales. Conclusion Research into health-related quality of life of breast-cancer patients is a little developed field in Spain. PMID:21235770

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.

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

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.

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.

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

Symptom reporting in cancer patients: the role of negative affect and experienced social stigma.

PubMed

Koller, M; Kussman, J; Lorenz, W; Jenkins, M; Voss, M; Arens, E; Richter, E; Rothmund, M

1996-03-01

Recent research suggests that patients' appraisal of somatic symptoms is more closely related to emotional variables (particularly negative affect) than to their actual health as determined by external criteria. Sixty surgical cancer patients who at the time of a routine follow-up examination filled out the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire-C30, which included a positive/negative affect scale and a scale tapping into experienced social stigma. Patients' health status was determined in two ways: the examining physician gave a global judgement on a standardized scale at the end of the examination, and an additional two external physicians later rated the patients based on the findings listed in the medical record. Patients' reports of somatic symptoms were strongly correlated with two measures of negative affect (r = 0.75 and r = 0.65, respectively) and with experienced social stigma (r = 0.51). In contrast, the correlations between reported symptoms and the examining or external physicians' ratings were considerably weaker (r = 0.31 and r = 0.19). According to a multiple linear regression with 6 predictors, negative affect was the best single predictor of symptom reporting (beta = 0.68; P < 0.001) and global quality of life (beta = 0.48; P < 0.001). Factor analysis yielded a dimension of somatopsychosocial distress that accounted for 44.1% of the variance and is comprised of reported symptoms (factor loading = 0.86), negative affect (0.90 and 0.82), experienced social stigma (0.74), and global quality of life (0.70). Physicians' ratings and positive affect constituted two additional separate factors. Cancer patients' reporting of somatic symptoms by means of a standardized quality of life questionnaire is closely related to emotional and social distress and is not equivalent to health status as determined from a clinical perspective. Researchers and practitioners have to be aware of this fact when interpreting quality of life data. Furthermore, negative affect deserves attention as an important signal for intervention in tumor follow-up programs.

Association between socioeconomic status and altered appearance distress, body image, and quality of life among breast cancer patients.

PubMed

Chang, Oliver; Choi, Eun-Kyung; Kim, Im-Ryung; Nam, Seok-Jin; Lee, Jeong Eon; Lee, Se Kyung; Im, Young-Hyuck; Park, Yeon Hee; Cho, Juhee

2014-01-01

Breast cancer patients experience a variety of altered appearance--such as loss or disfigurement of breasts, discolored skin, and hair loss--which result in psychological distress that affect their quality of life. This study aims to evaluate the impact of socioeconomic status on the altered appearance distress, body image, and quality of life among Korean breast cancer patients. A cross-sectional survey was conducted at advocacy events held at 16 different hospitals in Korea. Subjects were eligible to participate if they were 18 years of age or older, had a histologically confirmed diagnosis of breast cancer, had no evidence of recurrence or metastasis, and had no psychological problems at the time of the survey. Employment status, marital status, education, and income were assessed for patient socioeconomic status. Altered appearance distress was measured using the NCI's cancer treatment side effects scale; body image and quality of life were measured by the EORTC QLC-C30 and BR23. Means and standard deviations of each outcome were compared by socioeconomic status and multivariate linear regression models for evaluating the association between socioeconomic status and altered appearance distress, body image, and quality of life. A total of 126 breast cancer patients participated in the study; the mean age of participants was 47.7 (SD=8.4). Of the total, 83.2% were married, 85.6% received more than high school education, 35.2% were employed, and 41% had more than $3000 in monthly household income. About 46% had mastectomy, and over 30% were receiving either chemotherapy or radiation therapy at the time of the survey. With fully adjusted models, the employed patients had significantly higher altered appearance distress (1.80 vs 1.48; p<0.05) and poorer body image (36.63 vs 51.69; p<0.05) compared to the patients who were unemployed. Higher education (10.58, standard error (SE)=7.63) and family income (12.88, SE=5.08) was positively associated with better body image after adjusting for age, disease stage at diagnosis, current treatment status, and breast surgery type. Similarly, patients who were married and who had higher education had better quality of life were statistically significant in the multivariate models. Socioeconomic status is significantly associated with altered appearance distress, body image, and quality of life in Korean women with breast cancer. Patients who suffer from altered appearance distress or lower body image are much more likely to experience psychosocial, physical, and functional problems than women who do not, therefore health care providers should be aware of the changes and distresses that these breast cancer patients go through and provide specific information and psychosocial support to socioeconomically more vulnerable patients.

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.

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.

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

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.

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

Effects of yoga on symptom management in breast cancer patients: A randomized controlled trial

PubMed Central

Vadiraja, S Hosakote; Rao, M Raghavendra; Nagendra, R Hongasandra; Nagarathna, Raghuram; Rekha, Mohan; Vanitha, Nanjundiah; Gopinath, S Kodaganuru; Srinath, BS; Vishweshwara, MS; Madhavi, YS; S Ajaikumar, Basavalingaiah; Ramesh, S Bilimagga; Rao, Nalini

2009-01-01

Objectives: This study compares the effects of an integrated yoga program with brief supportive therapy on distressful symptoms in breast cancer outpatients undergoing adjuvant radiotherapy. Materials and Methods: Eighty-eight stage II and III breast cancer outpatients were randomly assigned to receive yoga (n = 44) or brief supportive therapy (n = 44) prior to their radiotherapy treatment. Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted supportive therapy once in 10 days during the course of their adjuvant radiotherapy. Assessments included Rotterdam Symptom Check List and European Organization for Research in the Treatment of Cancer—Quality of Life (EORTC QoL C30) symptom scale. Assessments were done at baseline and after 6 weeks of radiotherapy treatment. Results: A GLM repeated-measures ANOVA showed a significant decrease in psychological distress (P = 0.01), fatigue (P = 0.007), insomnia (P = 0.001), and appetite loss (P = 0.002) over time in the yoga group as compared to controls. There was significant improvement in the activity level (P = 0.02) in the yoga group as compared to controls. There was a significant positive correlation between physical and psychological distress and fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, and constipation. There was a significant negative correlation between the activity level and fatigue, nausea and vomiting, pain, dyspnea, insomnia, and appetite loss. Conclusion: The results suggest beneficial effects with yoga intervention in managing cancer-and treatment-related symptoms in breast cancer patients. PMID:20842268

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.

[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.

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.

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.

European Organization for Research and Treatment of Cancer and International Society for Cutaneous Lymphoma consensus recommendations for the management of cutaneous B-cell lymphomas.

PubMed

Senff, Nancy J; Noordijk, Evert M; Kim, Youn H; Bagot, Martine; Berti, Emilio; Cerroni, Lorenzo; Dummer, Reinhard; Duvic, Madeleine; Hoppe, Richard T; Pimpinelli, Nicola; Rosen, Steven T; Vermeer, Maarten H; Whittaker, Sean; Willemze, Rein

2008-09-01

Primary cutaneous B-cell lymphomas (CBCL) represent approximately 20% to 25% of all primary cutaneous lymphomas. With the advent of the World Health Organization-European Organization for Research and Treatment of Cancer (EORTC) Consensus Classification for Cutaneous Lymphomas in 2005, uniform terminology and classification for this rare group of neoplasms were introduced. However, staging procedures and treatment strategies still vary between different cutaneous lymphoma centers, which may be because consensus recommendations for the management of CBCL have never been published. Based on an extensive literature search and discussions within the EORTC Cutaneous Lymphoma Group and the International Society for Cutaneous Lymphomas, the present report aims to provide uniform recommendations for the management of the 3 main groups of CBCL. Because no systematic reviews or (randomized) controlled trials were available, these recommendations are mainly based on retrospective studies and small cohort studies. Despite these limitations, there was consensus among the members of the multidisciplinary expert panel that these recommendations reflect the state-of-the-art management as currently practiced in major cutaneous lymphoma centers. They may therefore contribute to uniform staging and treatment and form the basis for future clinical trials in patients with a CBCL.

Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.

PubMed

Maillet, Denis; Gan, Hui K; Blay, Jean-Yves; You, Benoit; Péron, Julien

2016-01-01

Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership. RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of A-AEs-outcomes. A-AEs were defined as summary outcome combining several related AEs, usually grouped by organ system e.g. cardiac-AEs, dermatologic-AEs. Trial characteristics associated with the use of A-AEs outcomes were investigated. The expectation of EORTC members concerning A-AEs utilisation was queried through a survey. Among 325 RCTs published between 2007 and 2011, 94 (29%) included one or more A-AE outcomes. A clear description of the nature of AEs included in such aggregations was provided in 19 articles (20%). No description of A-AEs was conversely provided in the other 75 articles (80%). The most commonly used A-AEs-outcomes were dermatologic-AEs (45%) and cardiac-AEs (33%). In multivariate analysis, the use of A-AEs outcomes was more frequent when trials were conducted in Europe (p = 0.038) and in trials performed on colon/rectal cancers (p = 0.016). Finally, there is no consensus of EORTC members regarding the utilisation of A-AEs but a majority of them (88%) felt that a clear description of A-AEs should systematically be reported. The use of A-AEs is infrequent in oncology RCT manuscripts although their use is accepted by most clinicians. However, a clear definition of A-AEs is strongly recommended if they are to be used in order to avoid a loss of important details about drug toxicities that is useful to clinicians. Copyright © 2015 Elsevier Ltd. All rights reserved.

Methodology of health-related quality of life analysis in phase III advanced non-small-cell lung cancer clinical trials: a critical review.

PubMed

Fiteni, Frédéric; Anota, Amélie; Westeel, Virginie; Bonnetain, Franck

2016-02-18

Health-related quality of life (HRQoL) is recognized as a component endpoint for cancer therapy approvals. The aim of this review was to evaluate the methodology of HRQoL analysis and reporting in phase III clinical trials of first-line chemotherapy in advanced non-small cell lung cancers (NSCLC). A search in MEDLINE databases identified phase III clinical trials in first-line chemotherapy for advanced NSCLC, published between January 2008 to December 2014. Two authors independently extracted information using predefined data abstraction forms. A total of 55 phase III advanced NSCLC trials were identified. HRQoL was declared as an endpoint in 27 studies (49%). Among these 27 studies, The EORTC questionnaire Quality of Life Questionnaire C30 was used in 13 (48%) of the studies and The Functional Assessment of Cancer Therapy-General was used in 12 (44%) trials. The targeted dimensions of HRQoL, the minimal clinically important difference and the statistical approaches for dealing with missing data were clearly specified in 13 (48.1%), 9 (33.3%) and 5 (18.5%) studies, respectively. The most frequent statistical methods for HRQoL analysis were: the mean change from baseline (33.3%), the linear mixed model for repeated measures (22.2%) and time to HRQoL score deterioration (18.5%). For each targeted dimension, the results for each group, the estimated effect size and its precision were clearly reported in 4 studies (14.8%), not clearly reported in 11 studies (40.7%) and not reported at all in 12 studies (44.4%). This review demonstrated the weakness and the heterogeneity of the measurement, analysis, and reporting of HRQoL in phase III advanced NSCLC trials. Precise and uniform recommendations are needed to compare HRQoL results across publications and to provide understandable messages for patients and clinicians.

Reliability and validity of a new scale on internal coherence (ICS) of cancer patients

PubMed Central

Kröz, Matthias; Büssing, Arndt; von Laue, Hans Broder; Reif, Marcus; Feder, Gene; Schad, Friedemann; Girke, Matthias; Matthes, Harald

2009-01-01

Background Current inventories on quality of life used in oncology mainly focus on functional aspects of patients in the context of disease adaption and treatments (side) effects (EORTC QLQ C30) or generically the status of common functions (Medical Outcome Study SF 36). Beyond circumscribed dimensions of quality of life (i.e., physical, emotional, social, cognitive etc.), there is a lack of inventories which also address other relevant dimensions such as the 'sense of coherence' (SOC) in cancer patients. SOC is important because of its potential prognostic relevance in cancer patients, but the current SOC scale has mainly been validated for psychiatric and psychosomatic patients. Our two-step validation study addresses the internal coherence (ICS) scale, which is based on expert rating, using specific items for oncological patients, with respect to its reliability, validity and sensitivity to chemotherapy. Methods The items were tested on 114 participants (57 cancer patients and a matched control group), alongside questions on autonomic regulation (aR), the Hospital Anxiety and Depression Scale (HADS), self-regulation (SRQ) and Karnofsky the Performance-Index (KPI). A retest of 65 participants was carried out after a median time span of four weeks. In the second part of the study, the ICS was used to assess internal coherence during chemotherapy in 25 patients with colorectal carcinoma (CRC) and 17 breast cancer patients. ICS was recorded before, during and 4 – 8 weeks after treatment. Results The 10-item scale of 'internal coherence' (ICS) shows good to very good reliability: Cronbach-α r = 0.91, retest-reliability r = 0.80. The ICS correlates with r = 0.43 – 0.72 to the convergence criteria (all p < 0.001). We are able to show decreased ICS-values after the third cycle for CRC and breast cancer patients, with a subsequent increase of ICS scores after the end of chemotherapy. Conclusion The ICS has good to very good reliability, validity and sensitivity to chemotherapy. PMID:19552807

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.

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.

The validity of EORTC GBM prognostic calculator on survival of GBM patients in the West of Scotland.

PubMed

Teo, Mario; Clark, Brian; MacKinnon, Mairi; Stewart, Willie; Paul, James; St George, Jerome

2014-06-01

It is now accepted that the addition of temozolomide to radiotherapy in the treatment of patients with newly diagnosed glioblastoma multiforme (GBM) significantly improves survival. In 2008, a subanalysis of the original study data was performed, and an online "GBM Calculator" was made available on the European Organisation for Research and Treatment of Cancer (EORTC) website allowing users to estimate patients' survival outcomes. We tested this calculator against actual local survival data to validate its use in our patients. Prospectively collected clinical data were analysed on 105 consecutive patients receiving concurrent chemoradiotherapy following surgical treatment of GBM between December 2004 and February 2009. Using the EORTC online calculator, survival outcomes were generated for these patients and compared with their actual survival. The median overall survival for the entire cohort was 15.3 months (range 2.8-50.5 months), with 1-year and 2-year overall survival of 65.7% and 19%, respectively. This is in comparison to the median overall predictive survival of 21.3 months, with 1-year and 2-year survival of 95% and 39.5%, respectively. Case by case analysis also showed that the survival was overestimated in nearly 80% of patients. Subgroup analyses showed similar overestimation of patients' survival, except calculator Model 3 which utilised MGMT status. Use of the EORTC GBM prognostic calculator would have overestimated the survival of the majority of our patients with GBM. Uncertainty exists as to the cause of overestimation in the cohort although local socioeconomic factors might play a role. The different calculator models yielded different outcomes and the "best" predictor of survival for the cohort under study utilised the tumour MGMT status. We would strongly encourage similar local studies of validity testing prior to employing the online prognostic calculator for other population groups.

Pathological characterisation of male breast cancer: Results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program.

PubMed

Vermeulen, Marijn A; Slaets, Leen; Cardoso, Fatima; Giordano, Sharon H; Tryfonidis, Konstantinos; van Diest, Paul J; Dijkstra, Nizet H; Schröder, Carolien P; van Asperen, Christi J; Linderholm, Barbro; Benstead, Kim; Foekens, Renee; Martens, John W M; Bartlett, John M S; van Deurzen, Carolien H M

2017-09-01

Several prognostic histological features have been established in female breast cancer (BC), but it is unknown whether these can be extrapolated to male BC patients. The aim of this study was to evaluate the prognostic value of several histological features in a large series of male BC. Central pathology review was performed for 1483 male BCs collected through part 1 of the European Organisation for Research and Treatment of Cancer (EORTC) International Male BC Program. Pathology review included histological subtype, grade, mitotic activity index (MAI), presence of a fibrotic focus and density of tumour-infiltrating lymphocytes (TILs). These features were correlated with clinical outcome. The relationship between these features and surrogate molecular subtypes using immunohistochemistry was also assessed. Median follow-up for overall survival (OS) was 7.1 years. Overall histological grade was not significantly associated with OS (p = 0.129). MAI, the presence of a fibrotic focus and a low TIL density however were correlated with unfavourable OS (p = 0.023, p = 0.004 and p = 0.011, respectively). BC subtype correlated with TIL density (p = 0.015), as we observed a higher density for human epidermal growth factor receptor type 2 (HER2) positive BC compared to luminal HER2-negative subtype. No association was observed between subtype and fibrotic focus. Histologic grade was not significantly correlated with clinical outcome in this series, unlike what is seen in female patients. These results contribute to our understanding of male BC and indicate the importance of further research on the optimisation of risk stratification and treatment decisions for male BC patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Salvage brachytherapy for local recurrences of prostate cancer treated previously with radiotherapy.

PubMed

Gawkowska-Suwinska, Marzena; Fijałkowski, Marek; Białas, Brygida; Szlag, Marta; Kellas-Ślęczka, Sylwia; Nowicka, Elżbieta; Behrendt, Katarzyna; Plewicki, Grzegorz; Smolska-Ciszewska, Beata; Giglok, Monika; Zajusz, Aleksander; Owczarek, Grzegorz

2009-12-01

The aim of the study was to analyze early effects and toxicity of salvage high dose rate brachytherapy for local recurrences of adenocarcinoma of the prostate after external beam radiotherapy (EBRT). In MCS Memorial Institute of Oncology in Gliwice a research programme on salvage HDR brachytherapy for local recurrences of prostate cancer treated previously with EBRT has been ongoing since February 2008. The treatment consisted of 3 fractions of 10 Gy each given every 14 days. Maximal urethral doses were constrained to be ≤ 120% of the prescribed dose. Maximal bladder and rectum doses were constrained to be ≤ 70% of the prescribed dose. Fifteen eligible patients were treated and analyzed from February 2008. All patients completed the treatment without major complications. The most common early complications were: macroscopic haematuria, pain in lower part of the abdomen, and transient dysuria. During the first week after the procedure a transient increase in IPSS score was noticed. The Foley catheter was removed on day 2 to 5. No complications after spinal anaesthesia were observed. Acute toxicity according to EORTC/RTOG was low. For bladder EORTC/RTOG score ranged from 0 to 2. Only in two patients grade 1 toxicity for rectum was observed. The follow-up ranged from 3 to 9 months. In one patient grade 2 rectal toxicity was observed, and one had urethral stricture. Other patients did not have any other significant late toxicity of the treatment. Two patients developed bone metastases. Salvage brachytherapy for localized prostate cancer (3 × 10 Gy every 14 days) seems to be a safe and well tolerated procedure. A significant decline in prostate-specific antigen (PSA) level is seen in patients with hormone-responsive cancer. Long-term efficiency and toxicity of the procedure are yet to be established.

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.

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.

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.

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.

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.

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.

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.

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.

Resistance training as supportive measure in advanced cancer patients undergoing TKI therapy-a controlled feasibility trial.

PubMed

Rosenberger, F; Wiskemann, J; Vallet, S; Haag, G M; Schembri, E; Jäger, D; Grüllich, C

2017-12-01

While there is growing evidence for positive effects of progressive resistance training in curatively treated cancer patients, data on advanced cancer patients are scarce. This pilot study aimed at investigating for the first time feasibility and effects of progressive resistance training in advanced cancer patients undergoing tyrosine kinase inhibitor (TKI) therapy. Patients starting a TKI-based anti-tumor therapy were assigned to a resistance training group (RT, 12 weeks of progressive machine-based resistance training 2×/week) or a control group (CON, treatment as usual) until 10 patients had finished in each group (RT 80% males, 90% renal cell carcinoma, 65 ± 11 years, CON 80% males, 70% renal cell carcinoma, 61 ± 6 years). Primary endpoint was feasibility. Furthermore, fatigue (MFI), quality of life (QoL, EORTC QLQC30), and muscle strength were assessed. Testing occurred at baseline and after 12 weeks. Training was feasible in 9 out of 10 participants and no serious adverse events occurred. It had beneficial effects on muscle strength (maximum voluntary isometric contraction of the quadriceps: RT +11 ± 9 Nm, CON -13 ± 25 Nm, p = 0.005), but not on fatigue (general fatigue score RT +0.3 ± 4.1, CON -1.5 ± 3.0, p = 0.223) or QoL (global QoL score RT -5.6 ± 16.1, CON -2.0 ± 18.2, p = 0.617). Progressive machine-based resistance training appears feasible in the majority of advanced cancer patients undergoing TKI therapy. However, its positive effects on muscle strength do not seem to be associated with positive effects on fatigue or quality of life. Future studies should therefore compare whether home-based training is more beneficial for patient-reported outcomes. NCT01645150.

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.

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.

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) .

The Process of Translation and Linguistic Validation of the Functional Assessment of Cancer Therapy-Brain Quality of Life Instrument from English to Malayalam: The Challenges Faced.

PubMed

Menon, Durgapoorna; Venkateswaran, Chitra

2017-01-01

Both brain tumors and their treatments have a major negative impact on the quality of life (QoL). EORTC BN20 and Functional Assessment of Cancer Therapy-Brain (FACT-BR) are the most commonly used tools to assess QoL. The FACT-BR is a 23-item questionnaire, especially about the psychosocial aspects of QoL. This paper describes the challenges we faced during the process of translation and validation of the FACT-BR into Malayalam. We first screened the patients to ensure their mental status was satisfactory and that they could communicate well in both languages. According to the Functional Assessment of Chronic Illness Therapy methodology, there were two forward translations from English to Malayalam by two independent translators, a reconciliation of the two forward translations, a back-translation into English, a review/finalization by a fifth translator, proofreading, and then testing on a small cohort of patients. The whole process of translation was fraught with small and large hurdles - from small technical issues to the gaps in sociocultural norms. The sub item BR 7, due to the lack of an exact equivalent word, had issues that persisted up to the validation phase. The postquestionnaire debriefing interviews confirmed that the translations were well understood and conceptually equivalent to the original English one. Translation of the FACT-BR into Malayalam nearly completely reproduced the concepts of the original English questionnaire, as proved in the subsequent validation process.

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.

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 in Arab Muslim cancer survivors following hematopoietic stem cell transplantation: comparison with matched healthy group.

PubMed

Alaloul, Fawwaz; Brockopp, Dorothy Y; Andrykowski, Michael A; Hall, Lynne A; Al Nusairat, Taghreed S

2015-07-01

The aims of this study were to determine if quality of life (QOL) among Arab Muslim hematopoietic stem cell transplantation (HSCT) survivors differs from that of a healthy matched comparison group and to examine the relationships of demographic and medical variables and perceived social support with post-HSCT QOL. HSCT survivors (n = 63) were recruited from the King Hussein Cancer Center outpatient clinic. A matched (age, gender, education), healthy comparison group (n = 63) was recruited through public advertisements. Participants completed the EORTC-30 QOL scale and the Medical Outcomes Study Social Support Survey. Differences were found between the Arab Muslim HSCT survivor and healthy comparison groups for physical functioning (p < .0001), role functioning (p < .01), social functioning (p < .0001) QOL domains, and an overall symptom score (p = .003) with the HSCT group reporting poorer status than the healthy comparison group. Effect sizes for the three QOL domains ranged from .50 (role functioning) to 1.20 (social functioning). No significant difference was noted between the Arab Muslim HSCT and comparison groups in emotional and cognitive QOL domains. Higher overall symptom scores were significantly associated with poorer QOL across all QOL domains. Similar to prior research with HSCT survivors, results suggest that HSCT has a significant negative impact on QOL. However, despite this general similarity, results suggest that the needs and experience of Muslim Arab HSCT survivors might differ from those of Western HSCT survivors in the social and emotional QOL domains. Given growing numbers of Arab and Muslim cancer survivors in the USA and other Western countries, future research is warranted.

Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data.

PubMed

Nout, Remi A; Putter, Hein; Jürgenliemk-Schulz, Ina M; Jobsen, Jan J; Lutgens, Ludy C H W; van der Steen-Banasik, Elzbieta M; Mens, Jan Willem M; Slot, Annerie; Stenfert Kroese, Marika C; Nijman, Hans W; van de Poll-Franse, Lonneke V; Creutzberg, Carien L

2012-07-01

The PORTEC-2 trial showed efficacy and reduced side-effects of vaginal brachytherapy (VBT) compared with external beam pelvic radiotherapy (EBRT) for patients with high-intermediate risk endometrial cancer. The current analysis was done to evaluate long-term health related quality of life (HRQL), and compare HRQL of patients to an age-matched norm population. Patients were randomly allocated to EBRT (n=214) or VBT (n=213). HRQL was assessed using EORTC QLQ-C30 and subscales from PR25 and OV28 (bladder, bowel, sexual symptoms); and compared to norm data. Median follow-up was 65 months; 348 (81%) patients were evaluable for HRQL (EBRT n=166, VBT n=182). At baseline, patient functioning was at lowest level, increasing during and after radiotherapy to reach a plateau after 12 months, within range of scores of the norm population. VBT patients reported better social functioning (p=0.005) and lower symptom scores for diarrhoea, faecal leakage, need to stay close to a toilet and limitation in daily activities due to bowel symptoms (p⩽0.001), compared to EBRT. There were no differences in sexual functioning or symptoms between the treatment groups; however, sexual functioning was lower and sexual symptoms more frequent in both treatment groups compared to the norm population. Patients who received EBRT reported clinically relevant higher levels of bowel symptoms and related limitations in daily activities with lower social functioning, 5 years after treatment. VBT provides a better HRQL, which remained similar to that of an age-matched norm population, except for sexual symptoms which were more frequent in both treatment groups. Copyright © 2011 Elsevier Ltd. All rights reserved.

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.

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.

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.

Intrinsic Molecular Subtypes of Glioma Are Prognostic and Predict Benefit From Adjuvant Procarbazine, Lomustine, and Vincristine Chemotherapy in Combination With Other Prognostic Factors in Anaplastic Oligodendroglial Brain Tumors: A Report From EORTC Study 26951

PubMed Central

Erdem-Eraslan, Lale; Gravendeel, Lonneke A.; de Rooi, Johan; Eilers, Paul H.C.; Idbaih, Ahmed; Spliet, Wim G.M.; den Dunnen, Wilfred F.A.; Teepen, Johannes L.; Wesseling, Pieter; Sillevis Smitt, Peter A.E.; Kros, Johan M.; Gorlia, Thierry; van den Bent, Martin J.; French, Pim J.

2013-01-01

Purpose Intrinsic glioma subtypes (IGSs) are molecularly similar tumors that can be identified based on unsupervised gene expression analysis. Here, we have evaluated the clinical relevance of these subtypes within European Organisation for Research and Treatment of Cancer (EORTC) 26951, a randomized phase III clinical trial investigating adjuvant procarbazine, lomustine, and vincristine (PCV) chemotherapy in anaplastic oligodendroglial tumors. Our study includes gene expression profiles of formalin-fixed, paraffin-embedded (FFPE) clinical trial samples. Patients and Methods Gene expression profiling was performed in 140 samples, 47 fresh frozen samples and 93 FFPE samples, on HU133_Plus_2.0 and HuEx_1.0_st arrays, respectively. Results All previously identified six IGSs are present in EORTC 26951. This confirms that different molecular subtypes are present within a well-defined histologic subtype. Intrinsic subtypes are highly prognostic for overall survival (OS) and progression-free survival (PFS). They are prognostic for PFS independent of clinical (age, performance status, and tumor location), molecular (1p/19q loss of heterozygosity [LOH], IDH1 mutation, and MGMT methylation), and histologic parameters. Combining known molecular (1p/19q LOH, IDH1) prognostic parameters with intrinsic subtypes improves outcome prediction (proportion of explained variation, 30% v 23% for each individual group of factors). Specific genetic changes (IDH1, 1p/19q LOH, and EGFR amplification) segregate into different subtypes. We identified one subtype, IGS-9 (characterized by a high percentage of 1p/19q LOH and IDH1 mutations), that especially benefits from PCV chemotherapy. Median OS in this subtype was 5.5 years after radiotherapy (RT) alone versus 12.8 years after RT/PCV (P = .0349; hazard ratio, 2.18; 95% CI, 1.06 to 4.50). Conclusion Intrinsic subtypes are highly prognostic in EORTC 26951 and improve outcome prediction when combined with other prognostic factors. Tumors assigned to IGS-9 benefit from adjuvant PCV. PMID:23269986

[Quinze questions importantes à se poser en oncologie en 2015].

PubMed

Blay, Jean-Yves; Tredan, Olivier; Ray-Coquard, Isabelle; Rivoire, Michel; Mehlen, Patrick; Puisieux, Alain; Bachelot, Thomas

2015-06-01

Cancers can now be classified by multidimensional criteria including tumour site, histology, primary - "driver" - molecular alterations, secondary molecular alterations, characteristics of the immune stroma, and genetic profile of the patient. The development of tools for the characterisation of the cancers, as well as novel molecular and immune therapeutics are evolving at an unprecedented pace. In 2012, a list of future challenges was identified at the occasion of the European Organisation for Research and Treatment of Cancer (EORTC) 50(th) anniversary. Three years after, it is interesting to look back at the questions addressed then and to assess the progress of these questions. We propose here a novel set questions which have emerged from the recent publications in this area. Copyright © 2015 Société Françise du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés. Published by Elsevier Masson SAS. All rights reserved.

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.

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.

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.

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

Trans sectoral care of geriatric cancer patients based on comprehensive geriatric assessment and patient-reported quality of life - Results of a multicenter study to develop and pilot test a patient-centered interdisciplinary care concept for geriatric oncology patients (PIVOG).

PubMed

Schmidt, Heike; Boese, Stephanie; Lampe, Katharina; Jordan, Karin; Fiedler, Eckhard; Müller-Werdan, Ursula; Wienke, Andreas; Vordermark, Dirk

2017-07-01

For older patients with cancer the maintenance of independence, functionality and health-related quality of life (HRQOL) is of great importance. Aiming to maintain HRQOL of older patients with cancer we developed an interdisciplinary care program based on comprehensive geriatric assessment (CGA) and patient-reported HRQOL comprising tailored supportive measures and telephone-based counseling during 6month aftercare. Pilot-testing of the intervention took place in three centers at the University Hospital Halle to examine feasibility, acceptance and potential benefit. Patients≥70years with confirmed diagnosis of cancer, at least one comorbidity and/or one functional impairment, receiving curative or palliative care were eligible. Primary endpoint was global HRQOL (EORTC QLQ C30). Mean age of the participants (n=100) was 76.3years (SD 4.8), 47% were female. On average they had 5 comorbidities (SD 2.8, min. 0, max. 15) and took 8 prescribed medications (SD 3.6, min. 0, max. 15). According to predefined treatment pathways, supportive care was triggered by summarized individual assessments that were presented to the treating physicians. Descriptive analyses showed that global HRQOL measured at the 6-month follow-up (n=57) had declined (≥10 points) for n=16 (28%) and improved or remained unchanged for n=41 (72%) patients, although some functional scales (e.g. mobility, role function) and some symptoms (e.g. fatigue, pain) had worsened. The nurse-led telephone-based aftercare was well accepted. The results show feasibility and potential benefit of the combination of CGA and HRQOL to complement standard assessments. Patient-reported symptoms and functioning indicate the need for intensified supportive therapy during aftercare. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial

PubMed Central

2012-01-01

Background Cancer is one of the major health issues worldwide. An increasing number of cancer patients are offered treatment with surgery, chemotherapy and radiotherapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies offered to cancer patients in Taiwan. We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in patients with cancer. Methods/design In this study, inclusion criteria are postoperative patients with histologically confirmed cancer within 3 years who are undergoing chemotherapy or radiotherapy, more than 18 years old, have given signed informed consent, have the ability to read Chinese, and the ability for oral intake. Exclusion criteria include being pregnant, breast feeding, having completed chemotherapy or radiotherapy, brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four, delusion or hallucinations, acute infection, and have received medications under other clinical trials. The patients were separated into an intervention group (Shen-Mai-San, SMS) and a placebo group for four weeks using a randomized, double-blind procedure. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QOL-C30) was used to evaluate the quality of life. General data, hemoglobin (Hb), hematocrit (Hct), glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), blood urea nitrogen (BUN), creatinine, carcinoembryonic antigen (CEA), TCM diagnosis data and heart rate variability (HRV) were also recorded. These data were collected at baseline, two weeks and four weeks after receiving medication. The patients were prescribed granules which contained therapeutic medicines or placebo. Paired-T test was used for statistical analysis. Discussion Shen-Mai-San is composed of processed Ginseng radis, Liriope spicata, and Schizandrae fructus. It was found to be effective for treating cancer-related fatigue and had anti-fatigue activity. In TCM theory, SMS has a synergistic effect for qi and yin deficiency and has the ability to prevent fatigue. The symptoms of qi and yin deficiency are similar to chemotherapy- or radiotherapy-induced side effects. In order to evaluate the efficacy of SMS on cancer treatment, we designed a randomized, double-blind, placebo-controlled trial. Trial registration This study is registered to Clinical Trails.gov NCT01580358 PMID:23206440

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.

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.

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

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.

[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.

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.

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.

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.

Cardiovascular disease after treatment for Hodgkin's lymphoma: an analysis of nine collaborative EORTC-LYSA trials.

PubMed

Maraldo, Maja V; Giusti, Francesco; Vogelius, Ivan R; Lundemann, Michael; van der Kaaij, Marleen A E; Ramadan, Safaa; Meulemans, Bart; Henry-Amar, Michel; Aleman, Berthe M P; Raemaekers, John; Meijnders, Paul; Moser, Elisabeth C; Kluin-Nelemans, Hanneke C; Feugier, Pierre; Casasnovas, Olivier; Fortpied, Catherine; Specht, Lena

2015-11-01

Cardiovascular disease after treatment is an important concern in cancer survivors. However, knowledge of cardiotoxicity is limited by the retrospective nature of data, which often does not contain details of treatment exposure. To facilitate individual risk counselling of patients, we aimed to quantify the effect of anthracyclines, vinca-alkaloids, and radiotherapy on the risk of cardiovascular disease in patients treated for Hodgkin's lymphoma. In 2009-10, a Life Situation Questionnaire (LSQ) was distributed to patients by mail to assess late-onset effects of Hodgkin's lymphoma treatment in patients who were included in nine successive European Organisation for Research and Treatment of Cancer (EORTC) and the Groupe d'Etude des Lymphomes de l'Adulte (GELA, now renamed LYSA) randomised trials between 1964 and 2004. We reconstructed the mean radiation doses to the heart and carotid arteries and the cumulative doses of anthracyclines and vinca-alkaloids for all patients. Incidence of cardiovascular disease was reported during follow-up and updated through the LSQ. We applied Cox proportional hazards regression analyses to quantify the effect of chemotherapy and radiation on the risk of a first cardiovascular disease event. Information of primary treatment was complete for 6039 patients (median age at diagnosis 30 years [IQR 23-40]; median length of follow-up 9 years [6-14]). 1919 patients responded to the LSQ. 1238 first cardiovascular events were recorded in 703 patients, most were ischaemic heart disease (132 [19%]), congestive heart failure (85 [12%]), arrhythmia (110 [16%]), and valvular disease (77 [11%]). The mean heart radiation dose per 1 Gy increase (HR 1·015 [95% CI 1·006-1·024], p=0·0014) and the dose of anthracyclines per 50 mg/m(2) increase in cumulative dose (1·077 [1·021-1·137], p=0·0064) were significant predictors of cardiovascular disease. Cumulative dose of vinblastine (unadjusted model p=0·77), vincristine (p=0·36), and mean radiation dose to the left (p=0·41) or right (p=0·70) internal carotid artery did not predict for cardiovascular events. Quantification of the increased cardiovascular risk with specific doses of radiation and anthracycline exposure will enable a quantitative assessment of the optimum combination of systemic therapy and radiation, which will help clinicians to balance the risks and benefits of different regimens for individual patients. Rigshospitalet Research Committee, the EORTC Cancer Research Fund, and the Sally Snowman Survivorship Fellowship. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

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.

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

Hyperdiploidy with 58-66 chromosomes in childhood B-acute lymphoblastic leukemia is highly curable: 58951 CLG-EORTC results.

PubMed

Dastugue, Nicole; Suciu, Stefan; Plat, Geneviève; Speleman, Frank; Cavé, Hélène; Girard, Sandrine; Bakkus, Marleen; Pagès, Marie Pierre; Yakouben, Karima; Nelken, Brigitte; Uyttebroeck, Anne; Gervais, Carine; Lutz, Patrick; Teixeira, Manuel R; Heimann, Pierre; Ferster, Alice; Rohrlich, Pierre; Collonge, Marie Agnès; Munzer, Martine; Luquet, Isabelle; Boutard, Patrick; Sirvent, Nicolas; Karrasch, Matthias; Bertrand, Yves; Benoit, Yves

2013-03-28

The aim of our study was to analyze the factors contributing to heterogeneity of prognosis in patients with hyperdiploidy>50 chromosomes (HD>50), a group of B-cell precursor acute lymphoblastic leukemia with favorable outcome. The 541 HD>50 patients registered prospectively in the 58951 European Organisation for Research and Treatment of Cancer (EORTC) Children's Leukemia Group (CLG) trial, identified by karyotype (446 patients) and by DNA index (DI) (490 patients), had a 6-year event-free survival (EFS) of 89.0% (standard error [SE] = 1.5%) and a 6-year overall survival (OS) of 95.9% (SE = 0.9%). The strongest prognostic factor was the modal number of chromosomes (MNC): the 6-year EFS of 51-53, 54-57, and 58-66 MNC groups were 80%, 89%, and 99%, respectively (P < .0001). Ploidy assessed by DI was also a favorable factor: the higher the DI, the better the outcome. The 6-year EFS of the 3 subgroups of DI < 1.16/≥1.16-<1.24/≥1.24 were 83%, 90%, and 95%, respectively (P = .009). All usual combinations of trisomies (chromosomes 4, 10, 17, 18) were significant favorable factors but had lower EFS when MNC was lower than 58. In multivariate analysis, MNC remained the strongest factor. Consequently, the best indicator for excellent outcome was ploidy assessed by karyotype because patients with 58-66 chromosomes stood every chance of being cured (OS of 100% at 6-year follow-up) with less-intensive therapy. This trial was registered at www.clinicaltrials.gov as #NCT00003728. Registered: http://www.eortc.org/, http://clinicaltrials.gov/show/NCT00003728.

Oral and Cutaneous Lymphomas other than Mycosis Fungoides and Sézary Syndrome in a Mexican Cohort: Recategorization and Evaluation of International Geographical Disparities

PubMed Central

Hernández-Salazar, Amparo; García-Vera, Jorge Andrés; Charli-Joseph, Yann; Ortiz-Pedroza, Guadalupe; Méndez-Flores, Silvia; Orozco-Topete, Rocío; Morales-Leyte, Ana Lilia; Domínguez-Cherit, Judith; Lome-Maldonado, Carmen

2017-01-01

Background: Nonmycosis fungoides/Sézary syndrome (non-MF/SS) primary cutaneous lymphomas (PCL) are currently categorized under the 2005-World Health Organization/European Organization for Research and Treatment of Cancer (WHO-EORTC) classification for PCL. These differ in behavior from secondary cutaneous lymphomas (SCL) and to lymphomas limited to the oral cavity (primary oral lymphomas [POL]) both categorized under the 2016-WHO classification for lymphoid neoplasms. Aims: This study aims to report the first series of non-MF/SS PCL, SCL, and POL in a Mexican cohort, examine the applicability of current classification systems and compare our findings with those from foreign cohorts. Materials and Methods: Eighteen non-MF/SS PCL, four SCL, and two POL with available tissue for morphology and immunophenotypic assessment were reclassified according to the 2005-WHO/EORTC and 2016-WHO classifications. Results: Non-MF/SS PCLs were primarily of T-cell origin (61%) where CD30+ lymphoproliferative disorders predominated, followed by Epstein–Barr virus-induced lymphomas, and peripheral T-cell lymphomas, not otherwise specified. Primary cutaneous B-cell lymphomas (BCL) were primarily of follicle center cell origin followed by postgerminal lymphomas of the diffuse large BCL variety. Conclusions: Most non-MF/SS PCL, SCL, and POL can be adequately categorized according to the 2005-WHO/EORTC and 2016-WHO classification systems, even when dealing with clinically atypical cases. The relative frequencies in our cohort hold closer similarities to Asian registries than from those of Europe/USA, supporting the concept of individual and/or racial susceptibility, and the notion of geographical variances in the rate of lymphomas. In particular, such disparity may arise from viral-induced lymphomas which might show partial geographical restriction. PMID:28400635

Clinical practice in secondary prophylaxis and management of febrile neutropenia in Poland: results of the febrile neutropenia awareness project

PubMed Central

Chmielowska, Ewa; Filipczyk-Cisarż, Emilia; Krzemieniecki, Krzysztof; Leśniewski-Kmak, Krzysztof; Litwiniuk, Maria M.; Wieruszewska-Kowalczyk, Karolina; Kosno-Kruszewska, Elżbieta

2014-01-01

Aim of the study This paper presents the second part of the GoPractice project involving oncologists from seven Polish provinces. The aim of this part of the project was to assess the knowledge of oncologists on indications for granulocyte colony-stimulating factor (G-CSF) secondary prophylaxis (SP) of febrile neutropenia (FN) and FN management based on current therapeutic guidelines (Polish Society of Clinical Oncology [PTOK] and European Organisation for Research and Treatment of Cancer [EORTC]). Material and methods The project involved 169 oncologists from 7 regions working in large specialist oncological centers, university hospitals, regional and city hospitals, specialist outpatient clinics and oncological wards in small, local hospitals. The participants completed a questionnaire based on 7 prepared clinical cases of patients with different tumor types and patient characteristics, receiving chemotherapy (CT) with different levels of FN risk. Participants answered questions related to FN risk assessment and G-CSF use as secondary prophylaxis (SP) and for the management of FN. After completing the questionnaire, the participants proceeded to an educational module in which they were provided with an analysis of correct diagnostic and therapeutic procedures according to the PTOK and EORTC guidelines. Results and Conclusions Indications for G-CSF SP were generally well recognized: in nearly 90% of responses, oncologists assessed correctly indications/lack of indications for secondary prophylaxis, in accordance with guideline recommendations and Experts’ opinion. However, the use of daily G-CSFs was often recommended by the study participants for the management of FN. This clinical practice is contradictory to PTOK and EORTC recommendations and may unnecessarily increase treatment costs. Changing this clinical approach may be achieved through regular training to improve guideline adherence. PMID:25784842

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.

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.

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.

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.

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.

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.

[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.

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

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.

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

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.

Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training.

PubMed

Kristanti, Martina Sinta; Setiyarini, Sri; Effendy, Christantie

2017-01-17

Palliative care in Indonesia is problematic because of cultural and socio-economic factors. Family in Indonesia is an integral part of caregiving process in inpatient and outpatient settings. However, most families are not adequately prepared to deliver basic care for their sick family member. This research is a pilot project aiming to evaluate how basic skills training (BST) given to family caregivers could enhance the quality of life (QoL) of palliative care cancer patients in Indonesia. The study is a prospective quantitative with pre and post-test design. Thirty family caregivers of cancer patients were trained in basic skills including showering, washing hair, assisting for fecal and urinary elimination and oral care, as well as feeding at bedside. Patients' QoL were measured at baseline and 4 weeks after training using EORTC QLQ C30. Hypothesis testing was done using related samples Wilcoxon Signed Rank. A paired t-test and one-way ANOVA were used to check in which subgroups was the intervention more significant. The intervention showed a significant change in patients' global health status/QoL, emotional and social functioning, pain, fatigue, dyspnea, insomnia, appetite loss, constipation and financial hardship of the patients. Male patient's had a significant effect on global health status (qol) (p = 0.030); female patients had a significant effect on dyspnea (p = 0.050) and constipation (p = 0.038). Younger patients had a significant effect in global health status/QoL (p = 0.002). Patients between 45 and 54 years old had significant effect on financial issue (p = 0.039). Caregivers between 45 and 54 years old had significant effect on patients' dyspnea (p = 0.031). Basic skills training for family caregivers provided some changes in some aspects of QoL of palliative cancer patients. The intervention showed promises in maintaining the QoL of cancer patients considering socio-economic and cultural challenges in the provision of palliative care in Indonesia.

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.

[Initial experience of proton beam therapy at the new facility of the University of Tsukuba].

PubMed

Kagei, Kenji; Tokuuye, Koichi; Sugahara, Shinji; Hata, Masaharu; Igaki, Hiroshi; Hashimoto, Takayuki; Ohara, Kiyoshi; Akine, Yasuyuki

2004-05-01

To present the initial experience with proton beam therapy at the new Proton Medical Research Center (PMRC) of the University of Tsukuba. The new facility has a synchrotron with maximum energy of 250MeV and two rotational gantries. We treated 105 patients with 120 lesions with proton beams in the first year, beginning in September 2001. The most common lesion treated was primary liver cancer (40 lesions) followed by lung cancer, head and neck cancers, and prostate cancer. Concurrent X-ray radiotherapy was given for 38 of the 120 lesions. The median follow-up period was 11 months (range, 1-19 months). Of the 105 patients, 97% had Grade 0-2 RTOG/EORTC acute morbidities, while the remaining 3% had Grade 3. Tumor response after irradiation was CR for 35% of the lesions, PR for 25%, SD for 22%, PD for 9%, and not evaluated for 9%. The proton beam therapy conducted at the new facility of the University of Tsukuba was safe and effective.

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.

Undesirable financial effects of head and neck cancer radiotherapy during the initial treatment period.

PubMed

Egestad, Helen; Nieder, Carsten

2015-01-01

Healthcare cost and reforms are at the forefront of international debates. One of the current discussion themes in oncology is whether and how patients' life changes due to costs of cancer care. In Norway, the main part of the treatment costs is supported by general taxpayer revenues. The objective of this study was to clarify whether head and neck cancer patients (n=67) in northern Norway experienced financial health-related quality of life (HRQOL) deterioration due to costs associated with treatment. HRQOL was examined by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 in the beginning and in the end of radiation treatment in patients treated at the University Hospital in Northern Norway. Changes in financial HRQOL were calculated and compared by paired sample T-tests. Multiple regression analyses were used to examine correlations among gender, marital status, age and treatment with or without additional chemotherapy and changes in the HRQOL domain of financial difficulties. The majority of score results at both time points were in the lower range (mean 15-25), indicating limited financial difficulties. We observed no statistically significant differences by gender, marital status and age. Increasing financial difficulties during treatment were reported by male patients and those younger than 65, that is, patients who were younger than retirement age. The largest effect was seen in singles. However, differences were not statistically significant. During the initial phase of the disease trajectory, no significant increase in financial difficulties was found. This is in line with the aims of the Norwegian public healthcare model. However, long-term longitudinal studies should be performed, especially with regard to the trends we observed in single, male and younger patients.

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.

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.

PubMed

Pye, Kirstie; Totton, Nicola; Stuart, Nicholas; Whitaker, Rhiannon; Morrison, Val; Edwards, Rhiannon Tudor; Yeo, Seow Tien; Timmis, Laura J; Butterworth, Caryl; Hall, Liz; Rai, Tekendra; Hoare, Zoe; Neal, Richard D; Wilkinson, Clare; Leeson, Simon

2016-01-01

Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment. The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation. The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention. ISRCTN45565436.

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.

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.

[Quality of life and sexual function of cervical cancer patients following radical hysterectomy and vaginal extension].

PubMed

Ye, Shuang; Yang, Jiaxin; Cao, Dongyan; Zhu, Lan; Lang, Jinghe; Shen, Keng

2014-08-01

To investigate the quality of life and sexual function of cervical cancer patients following radical hysterectomy (RH) and vaginal extension. Case-control and questionnaire- based method was employed in this study. Thirty-one patients of early-stage (I b1-I b2) cervical cancer who had undergone vaginal extension following classic RH in Peking Union Medical College Hospital from December 2008 to September 2012 were included in study group, while 28 patients with matching factors and RH only during the same period were allocated to control group. There was no significant difference between two groups in terms of clinical and demographic variables including age at diagnosis, tumor stage and follow-up time (P > 0.05). Patients were assessed retrospectively by validated self-reported questionnaires the European Organization for Research and Treatment of Cancer Cervix Cancer Module Questionnaire (EORTC QLQ-CX24) mainly for quality of life and sexual function for cervical cancer patients; the Sexual Function and Vaginal Changes Questionnaire (SVQ) further investigates sexual function and vaginal changes of patients with gynecologic malignancy at least 6 months after treatment. Vaginal length acquired by pelvic examination by gynecologic oncologists during follow-up visits was (10.0 ± 1.3) cm and (5.9 ± 1.0)cm in study group and control group respectively (P = 0.000). Sixty-eight percent (21/31) of cases in study group and 64% (18/28) of cases in control group had resumed sexual activity at the time of interview, and the time interval between treatment and regular sexual activity was mean 6 months (range 3-20 months) and mean 5 months (range 1-12 months) in study and control group respectively, in which there was not statistical significance (P > 0.05). No difference was observed regarding pelvic floor symptoms (P > 0.05) while difficulty emptying bladder, incomplete emptying and constipation were most commonly reported. Both group presented with hypoactive sexual desire disorder [88% (52/59)], orgasm dysfunction [72% (28/39)] and low enjoyment or relaxation after sex [51% (20/39)], which was not statistically significant (P > 0.05). Reduced vagina size and shorter vagina was more prominent in control group (12/18) than that in study group [19% (4/21)] with statistical significance (P < 0.05), while no difference in sexual desire, vaginal lubrication, dyspareunia and sexual enjoyment (P > 0.05). Patients with peritoneovaginoplasty following RH had much longer vagina and less self-perceived short vagina. Vaginal extension following RH does not worsen the pelvic floor symptoms.