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

PubMed

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

2016-10-01

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

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

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.

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.

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.

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

PubMed

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

2016-12-01

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

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.

Development of the European Organisation for Research and Treatment of Cancer quality of life questionnaire module for older people with cancer: The EORTC QLQ-ELD15.

PubMed

Johnson, Colin; Fitzsimmons, Deborah; Gilbert, Jacqueline; Arrarras, Juan-Ignacio; Hammerlid, Eva; Bredart, Anne; Ozmen, Mahir; Dilektasli, Evren; Coolbrandt, Anne; Kenis, Cindy; Young, Teresa; Chow, Edward; Venkitaraman, Ramachandran; Howse, Frances; George, Steve; O'Connor, Steve; Yadegarfar, Ghasem

2010-08-01

There is a lack of instruments that focus on the specific health-related quality of life (HRQOL) issues that affect older people with cancer. The aim of this study was to develop a HRQOL questionnaire module to supplement the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire, the EORTC QLQ-C30 for older (>70years) patients with cancer. Phases 1-3 were conducted in seven countries following modified EORTC Quality of Life Group guidelines for module development. Phase 1: potentially relevant issues were identified by a systematic literature review, a questionnaire survey of 17 multi-disciplinary health professionals and two rounds of qualitative interviews. The first round included 9 patients aged >70. The second round was a comparative series of interviews with 49 patients >70years with a range of cancer diagnoses and 40 patients aged 50-69years matched for gender and disease site. In Phase 2 the issues were formulated into a long provisional item list. This was administered in Phase 3 together with the QLQ-C30 to two further groups of cancer patients aged >70 (n=97) or 50-69years (n=85) to determine the importance, relevance and acceptability of each item. Redundant and duplicate items were removed; issues specific to the older group were selected for the final questionnaire. In Phase 1, 75 issues were identified. These were reduced in Phase 2 to create a 45 item provisional list. Phase 3 testing of the provisional list led to the selection of 15 items with good range of response, high scores of importance and relevance in the older patients. This resulted in the EORTC QLQ-ELD15, containing five conceptually coherent scales (functional independence, relationships with family and friends, worries about the future, autonomy and burden of illness). The EORTC QLQ-ELD15 in combination with the EORTC QLQ-C30 is ready for large-scale validation studies, and will assess HRQOL issues of most relevance and concern for older people with cancer across a wide range of cancer sites and treatment stages. Copyright 2010 Elsevier Ltd. All rights reserved.

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.

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.

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.

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.

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 ).

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.

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.

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

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.

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.

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

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

Cengiz, Mustafa; Ozyar, Enis; Esassolak, Mustafa

2005-12-01

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

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.

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.

[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.

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

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.

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.

Validation of EORTC IN-PATSAT32 for Chinese patients with gastrointestinal cancer

PubMed Central

Zhang, Jishui; Xie, Shumin; Liu, Jiahao; Sun, Weilin; Guo, Hui; Hu, Yingbin; Gao, Xin

2014-01-01

Purpose To test the psychometric properties and applicability of the European Organization for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire 32 (EORTC IN-PATSAT32) for Chinese patients with gastrointestinal cancer. Patients and methods A total of 106 inpatients with gastrointestinal cancer at Cangzhou Center Hospital were enrolled in this study. All were treated at Cangzhou Center Hospital from July 2013–March 2014. All participants self-administered the EORTC IN-PATSAT32 and EORTC Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30). Results The Cronbach’s α coefficients were >0.70 for all scales of the EORTC IN-PATSAT32. Multitrait scaling analysis showed that all-item scale correlation coefficients met the standard of convergent validity, while only 50.0% met the standard of discriminant validity. A weak correlation was found between the scales and single items of the EORTC IN-PATSAT32 and EORTC QLQ-C30. Conclusion The EORTC IN-PATSAT32 appears to be a reliable, valid, and acceptable instrument for measuring patient satisfaction among Chinese patients with gastrointestinal cancer. PMID:25258522

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.

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.

[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.

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.

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

PubMed

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

2000-05-01

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

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

PubMed

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

2016-10-12

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

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.

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.

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.

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.

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.

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.

Development of an EORTC quality of life phase III module measuring cancer-related fatigue (EORTC QLQ-FA13).

PubMed

Weis, Joachim; Arraras, Juan Ignacio; Conroy, Thierry; Efficace, Fabio; Fleissner, Claudia; Görög, Attila; Hammerlid, Eva; Holzner, Bernhard; Jones, Louise; Lanceley, Anne; Singer, Susanne; Wirtz, Markus; Flechtner, Henning; Bottomley, Andrew

2013-05-01

European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer-related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ-C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients. The methodology followed the EORTC guidelines for developing phase III modules. Patients were assessed by questionnaires (EORTC QLQ-C30 with the EORTC Fatigue Module FA15) followed by an interview, asking for their opinions on the difficulty in understanding, on annoyance and on intrusiveness. The phase II FA15 was revised on the basis of qualitative analyses (comments of the patients), quantitative results (descriptive statistics) as well as the multi-item response theory analyses. The three dimensions (physical, emotional and cognitive) of the scale could be confirmed. As a result, EORTC QLQ-FA13 is now available as a valid phase III module measuring cancer-related fatigue in clinical trials and will be psychometrically improved in the upcoming phase IV. Copyright © 2012 John Wiley & Sons, Ltd.

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.

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

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

Validation of EORTC IN-PATSAT32 for Chinese cancer patients.

PubMed

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

2015-09-01

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

Cross-cultural application of the Korean version of the EORTC QLQ-ELD14 questionnaire for elderly patients with cancer.

PubMed

Goo, Ae Jin; Shin, Dong Wook; Yang, Hyung Kook; Park, Jong-Hyock; Kim, So-Young; Shin, Joo Yeon; Kim, Young Ae; Kim, Changhoon; Hong, Nam-Soo; Min, Young Joo; Park, Keeho

2017-07-01

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-ELD14 is a validated tool that measures Health-related Quality-of-life (HRQOL) for elderly patients with cancer. This study was conducted to evaluate the psychometric properties of the Korean version of the EORTC QLQ-ELD14 to determine if this tool can be used to evaluate HRQOL for older Korean patients with cancer. We recruited 439 elderly patients with cancer aged ≥60years from 11 cancer centers and completed the EORTC QLQ-ELD14 questionnaires. The reliability and validity of the EORTC QLQ-ELD14 questionnaire were assessed via Cronbach alpha, multitrait scaling analyses, correlation analyses with the EORTC QLQ-C30, and known-group comparisons. Known-group comparisons were conducted by dividing the patients into groups based on the cancer stage, depression level, and loss of mobility. The scale structure of the Korean version of the EORTC QLQ-ELD14 was consistent with the originally hypothesized scale structure. Cronbach alpha coefficients ranged 0.65-0.88. Multitrait scaling analysis showed good item convergent and discriminant validity. Low scaling errors (3.1%) were observed. Divergent validity was demonstrated by no strong correlation with the EORTC QLQ C30. The clinical validity of the Korean version of the EORTC QLQ-ELD14 was demonstrated by its ability to discriminate among patient subgroups categorized by AJCC stage, depression level, and loss of mobility. Our findings indicate that the Korean version of the EORTC QLQ-ELD14 questionnaire is reliable and valid for measuring QOL of older Korean patients with cancer. Copyright © 2017 Elsevier Inc. 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 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.

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

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.

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.

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.

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.

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.

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

Measuring quality of life in patients with head and neck cancer: Update of the EORTC QLQ-H&N Module, Phase III.

PubMed

Singer, Susanne; Araújo, Cláudia; Arraras, Juan Ignacio; Baumann, Ingo; Boehm, Andreas; Brokstad Herlofson, Bente; Castro Silva, Joaquim; Chie, Wei-Chu; Fisher, Sheila; Guntinas-Lichius, Orlando; Hammerlid, Eva; Irarrázaval, María Elisa; Jensen Hjermstad, Marianne; Jensen, Kenneth; Kiyota, Naomi; Licitra, Lisa; Nicolatou-Galitis, Ourania; Pinto, Monica; Santos, Marcos; Schmalz, Claudia; Sherman, Allen C; Tomaszewska, Iwona M; Verdonck de Leeuw, Irma; Yarom, Noam; Zotti, Paola; Hofmeister, Dirk

2015-09-01

The objective of this study was to pilot test an updated version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N60). Patients with head and neck cancer were asked to complete a list of 60 head and neck cancer-specific items comprising the updated EORTC head and neck module and the core questionnaire EORTC QLQ-C30. Debriefing interviews were conducted to identify any irrelevant items and confusing or upsetting wording. Interviews were performed with 330 patients from 17 countries, representing different head and neck cancer sites and treatments. Forty-one of the 60 items were retained according to the predefined EORTC criteria for module development, for another 2 items the wording was refined, and 17 items were removed. The preliminary EORTC QLQ-H&N43 can now be used in academic research. Psychometrics will be tested in a larger field study. © 2014 Wiley Periodicals, Inc.

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

MGMT-STP27 methylation status as predictive marker for response to PCV in anaplastic Oligodendrogliomas and Oligoastrocytomas. A report from EORTC study 26951.

PubMed

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

2013-10-01

The long-term follow-up results from the EORTC-26951 trial showed that the addition of procarbazine, CCNU, and vincristine (PCV) after radiotherapy increases survival in anaplastic oligodendrogliomas/oligoastrocytomas (AOD/AOA). However, some patients appeared to benefit more from PCV treatment than others. We conducted genome-wide methylation profiling of 115 samples included in the EORTC-26951 trial and extracted the CpG island hypermethylated phenotype (CIMP) and MGMT promoter methylation (MGMT-STP27) status. We first show that methylation profiling can be conducted on archival tissues with a performance that is similar to snap-frozen tissue samples. We then conducted methylation profiling on EORTC-26951 clinical trial samples. Univariate analysis indicated that CIMP+ or MGMT-STP27 methylated tumors had an improved survival compared with CIMP- and/or MGMT-STP27 unmethylated tumors [median overall survival (OS), 1.05 vs. 6.46 years and 1.06 vs. 3.8 years, both P < 0.0001 for CIMP and MGMT-STP27 status, respectively]. Multivariable analysis indicates that CIMP and MGMT-STP27 are significant prognostic factors for survival in presence of age, sex, performance score, and review diagnosis in the model. CIMP+ and MGMT-STP27 methylated tumors showed a clear benefit from adjuvant PCV chemotherapy: the median OS of CIMP+ samples in the RT and RT-PCV arms was 3.27 and 9.51 years, respectively (P = 0.0033); for MGMT-STP27 methylated samples, it was 1.98 and 8.65 years. There was no such benefit for CIMP- or for MGMT-STP27 unmethylated tumors. MGMT-STP27 status remained significant in an interaction test (P = 0.003). Statistical analysis of microarray (SAM) identified 259 novel CpGs associated with treatment response. MGMT-STP27 may be used to guide treatment decisions in this tumor type. ©2013 AACR.

[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.

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

PubMed

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

2018-06-06

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

Quality of life in 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.

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

PubMed

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

2017-05-01

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

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.

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.

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.

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.

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.

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.

Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer quality of life questionnaire cervical cancer module.

PubMed

Shin, Dong Wook; Ahn, Eunmi; Kim, Yong-Man; Kang, Sokbom; Kim, Byoung-Gie; Seong, Seok Ju; Cha, Soon Do; Park, Chan-Yong; Yun, Young Ho

2009-01-01

This study was conducted to evaluate the psychometric properties of the Korean version of the Quality of Life questionnaire cervical cancer module (QLQ-CX24), developed by the European Organization for Research and Treatment of Cancer (EORTC). The EORTC QLQ-CX24 and the core questionnaire (the EORTC QLQ-C30) were administered to 860 Korean disease-free survivors of cervical cancer and 494 female control subjects from the general Korean population. The construct reliability and validity of the EORTC QLQ-CX24 questionnaire were assessed via factor analysis, multitrait scaling analyses and known group comparisons. Factor structure of the Korean version of the EORTC QLQ-CX24 questionnaire agreed with the originally hypothesized scale structure. Scale reliability was confirmed by Cronbach's alpha coefficients for internal consistency, which ranged from 0.78 to 0.87. Convergent and discriminant validity was confirmed by multitrait scaling analysis, which revealed scaling errors of 0.9. The clinical validity of the Korean version of the EORTC QLQ-CX24 was demonstrated by the ability to discriminate among controls and patient subgroups of different stages, treatments and overall health status. The Korean version of the EORTC QLQ-CX24 was found to be a reliable and a valid measure of quality of life among survivors of cervical cancer when administered in a large survey setting. Copyright 2009 S. Karger AG, Basel.

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.

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.

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.

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.

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

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

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.

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.

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

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.

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.

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.

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.

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

Validation of the Chinese version of EORTC QLQ-BN20 for patients with brain cancer.

PubMed

Zhang, K; Tian, J; He, Z; Sun, W; Pekbay, B; Lin, Y; Wu, D; Zhang, J; Chen, P; Guo, H; Wan, Y; Wang, M; Yang, S; Zheng, J; Zhang, L

2018-03-01

This is a single centre study in mainland China aiming to evaluate the reliability, validity and responsiveness of the Chinese version of EORTC QLQ-BN20, designed by The European Organization for Research and Treatment of Cancer Quality of Life Group to evaluate the life quality of patients with brain tumour, cancer or metastases. One hundred and eighty-eight patients with primary or secondary brain cancer from Hunan Provincial Tumor Hospital during September 2013 to June 2014 completed the Chinese EORTC QLQ-C30/BN20 questionnaires developed by translation, back translation and cultural adaptation. Results were statistically analysed using SPSS17.0. The internal consistency (Cronbach's α coefficient) was between .753 and .869, the correlation coefficients among items and its own dimension were bigger than .4, and all items had a better correlation with its own dimension. The Spearman was used to analyse the correlation of each dimension between EORTC QLQ-BN20 and EORTC QLQ-C30, and the result showed that individual dimensions were moderately correlated, other dimensions were weakly correlated. In conclusion, the Chinese version of EORTC QLQ BN20 questionnaire had great relevance, reliability, convergent validity and discriminant validity. It provides a valuable tool for the assessment of health-related quality of life in clinical studies of Chinese patients with primary or secondary brain cancer. © 2018 John Wiley & Sons Ltd.

[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.

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.

[Health-related quality of life in the oncology departments of the hospital of Navarra. The EORTC Quality of Life Group].

PubMed

Arrarás, J I; Arias de la Vega, F; Illarramendi, J J; Manterola, A; Salgado, E; Dominguez, M A; Vera, R

2011-01-01

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer - EORTC - Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients' satisfaction with care. This research line has a direct benefit on the attention that patients receive.

Quality assurance in radiotherapy.

PubMed

Kouloulias, V E

2003-03-01

In 1999, the European Organisation for Research and Treatment of Cancer (EORTC), being a European pioneer in the field of cancer research as well as in quality assurance (QA), launched an Emmanuel van der Schueren fellowship for QA in radiotherapy. In this paper, the work that has been done during the first E. van der Schueren fellowship is reported, focusing on four phase III EORTC clinical trials: 22921 for rectal cancer, 22961 and 22991 for prostate cancer and 22922 for breast cancer. A historical review of the QA programme of the EORTC Radiotherapy group during the past 20 years is included.

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.

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.

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

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.

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.

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

PubMed

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

2016-01-01

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

Quality of life 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.

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.

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.

Whole brain radiotherapy after stereotactic radiosurgery or surgical resection among patients with one to three brain metastases and favorable prognoses: a secondary analysis of EORTC 22952-26001.

PubMed

Churilla, T M; Handorf, E; Collette, S; Collette, L; Dong, Y; Aizer, A A; Kocher, M; Soffietti, R; Alexander, B M; Weiss, S E

2017-10-01

The absence of a survival benefit for whole brain radiotherapy (WBRT) among randomized trials has been attributed to a competing risk of death from extracranial disease. We re-analyzed EORTC 22952 to assess the impact of WBRT on survival for patients with controlled extracranial disease or favorable prognoses. We utilized Cox regression, landmark analysis, and the Kaplan-Meier method to evaluate the impact of WBRT on survival accounting for (i) extracranial progression as a time-dependent covariate in all patients and (ii) diagnosis-specific graded prognostic assessment (GPA) score in patients with primary non-small-cell lung cancer (NSCLC). A total of 329 patients treated per-protocol were included for analysis with a median follow up of 26 months. One hundred and fifteen (35%) patients had no extracranial progression; 70 (21%) patients had progression <90 days, 65 (20%) between 90 and 180 days, and 79 (24%) patients >180 days from randomization. There was no difference in the model-based risk of death in the WBRT group before [hazard ratio (HR) (95% CI)=0.70 (0.45-1.11), P = 0.133), or after [HR (95% CI)=1.20 (0.89-1.61), P = 0.214] extracranial progression. Among 177 patients with NSCLC, 175 had data available for GPA calculation. There was no significant survival benefit to WBRT among NSCLC patients with favorable GPA scores [HR (95% CI)=1.10 (0.68-1.79)] or unfavorable GPA scores [HR (95% CI)=1.11 (0.71-1.76)]. Among patients with limited extracranial disease and one to three brain metastases at enrollment, we found no significant survival benefit to WBRT among NSCLC patients with favorable GPA scores or patients with any histology and controlled extracranial disease status. This exploratory analysis of phase III data supports the practice of omitting WBRT for patients with limited brain metastases undergoing SRS and close surveillance. NCT00002899. © 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.

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.

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

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 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.

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.

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.

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.

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

PubMed

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

2011-01-01

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

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

PubMed Central

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

2011-01-01

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

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

PubMed

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

2017-02-01

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

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.

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

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

PubMed

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

2017-11-01

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

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.

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.

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.

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.

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.

Phase III study of the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and specific complementary outpatient module (EORTC OUT-PATSAT7).

PubMed

Brédart, A; Anota, A; Young, T; Tomaszewski, K A; Arraras, J I; Moura De Albuquerque Melo, H; Schmidt, H; Friend, E; Bergenmar, M; Costantini, A; Vassiliou, V; Hureaux, J; Marchal, F; Tomaszewska, I M; Chie, W-C; Ramage, J; Beaudeau, A; Conroy, T; Bleiker, E; Kulis, D; Bonnetain, F; Aaronson, N K

2018-01-01

Advances in cancer care delivery require revision and further development of questionnaires assessing patients' perceived quality of care. This study pre-tested the revised EORTC satisfaction with cancer care core questionnaire applicable in both the cancer inpatient and outpatient settings, and its new, outpatient-specific complementary module. The process of revision, development of the extended application, and pre-testing of these questionnaires was based on phases I to III of the "EORTC Quality of Life Group Module Development Guidelines." In phase III, patients in 11 countries in four European regions, South America and Asia completed provisional versions of the questionnaires. Fifty-seven relevant issues selected from literature reviews and input from experts were operationalized into provisional items, and subsequently translated into ten languages. Assessment of understanding, acceptability, redundancy and relevance by patients (n = 151) from oncology inpatient wards, and outpatient chemotherapy, radiotherapy and consultation settings, led to retention of, deletion of and merging of 40, 14 and 6 items respectively. Cronbach's alpha coefficients for hypothesized questionnaire scales were above 0.80. Our results provide preliminary support for the 33-item EORTC Satisfaction with cancer care core questionnaire and the 7-item complementary module specific for the outpatient care setting. A large scale phase IV cross-cultural psychometric study is now underway. © 2017 John Wiley & Sons Ltd.

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

PubMed

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

2017-04-01

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

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.

'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.

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.

Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care.

PubMed

Shin, Dong Wook; Choi, Ji Eun; Miyashita, Mitsunori; Choi, Jin Young; Kang, Jina; Baik, Young Ji; Mo, Ha Na; Park, Jeanno; Kim, Hea-Ja; Park, Eun Cheol

2011-02-01

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) is a shortened version of the EORTC QLQ-C30, developed for use in advanced cancer patients. We evaluated the psychometric properties of the Korean version of the EORTC QLQ-C15-PAL to determine if this tool can be used to evaluate Korean patients with cancer who receive palliative care. A multicenter, cross-sectional survey was performed in palliative care units and hospices in Korea from September to October 2009. A total of 102 patients with cancer completed the questionnaires that included the EORTC QLQ-C15-PAL. The compliance rate was high, with the missing rate for each item ranging from 0% to 7.8% (mean 3.1%). A multitrait scaling analysis revealed good convergent and discriminant validity, with only three scaling errors. The Cronbach's alpha coefficients ranged from 0.65 to 0.89. The questionnaire discriminated among patient subgroups with different clinical profiles (e.g., performance status and degree of oral intake), thereby demonstrating the clinical validity of this tool. Our findings indicate that the Korean version of the EORTC QLQ-C15-PAL is a reliable and valid instrument with regard to its psychometric properties. This tool is suitable for measuring quality of life, particularly with regard to physical aspects, in Korean cancer patients who receive palliative care. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 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.

Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

PubMed

Greimel, Elfriede; Nordin, Andy; Lanceley, Anne; Creutzberg, Carien L; van de Poll-Franse, Lonneke V; Radisic, Vesna Bjelic; Galalae, Razvan; Schmalz, Claudia; Barlow, Ellen; Jensen, Pernille T; Waldenström, Ann-Charlotte; Bergmark, Karin; Chie, Wei-Chu; Kuljanic, Karin; Costantini, Anna; Singer, Susanne; Koensgen, Dominique; Menon, Usha; Daghofer, Fedor

2011-01-01

A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbach's alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

[Cross-cultural adaptation of the community-acquired pneumonia score questionnaire in patients with mild-to-moderate pneumonia in Colombia].

PubMed

Bernal-Vargas, Mónica Alejandra; Cortés, Jorge Alberto; Sánchez, Ricardo

2017-01-24

One of the strategies for the rational use of antibiotics is the use of the score for community-acquired pneumonia (CAP Score). This instrument clinically evaluates patients with community-acquired pneumonia, thereby facilitating decision making regarding the early and safe withdrawal of antibiotics. To generate a translation and cross-cultural adaptation of the Community-Acquired Pneumonia (CAP) Score questionnaire in Spanish. Authorization for cross-cultural adaptation of the Community-Acquired Pneumonia (CAP) Score questionnaire was obtained; the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the European Organisation for Research and Treatment of Cancer (EORTC) were carried out through the following stages: forward translation, reconciliation, backward translation, harmonization, obtaining a provisional questionnaire, and applying the questionnaire in a pilot test. The pilot test was conducted at a second-level public hospital in Bogotá after the study was approved by the ethics and research institutional boards. The changes suggested by the forward translators were applied. There were no discrepancies between the backward and forward translations, consequently, no revisions were necessary. Five items had modifications based on suggestions made by eleven patients hospitalized with a diagnosis of community-acquired pneumonia during the pilot test. A Spanish version of the Community-Acquired Pneumonia (CAP) Score was crossculturally adapted and is now available.

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.

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.

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

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

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

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.

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.

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.

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 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.

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.

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.

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.

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.

Comparison of three longitudinal analysis models for the health-related quality of life in oncology: a simulation study.

PubMed

Anota, Amélie; Barbieri, Antoine; Savina, Marion; Pam, Alhousseiny; Gourgou-Bourgade, Sophie; Bonnetain, Franck; Bascoul-Mollevi, Caroline

2014-12-31

Health-Related Quality of Life (HRQoL) is an important endpoint in oncology clinical trials aiming to investigate the clinical benefit of new therapeutic strategies for the patient. However, the longitudinal analysis of HRQoL remains complex and unstandardized. There is clearly a need to propose accessible statistical methods and meaningful results for clinicians. The objective of this study was to compare three strategies for longitudinal analyses of HRQoL data in oncology clinical trials through a simulation study. The methods proposed were: the score and mixed model (SM); a survival analysis approach based on the time to HRQoL score deterioration (TTD); and the longitudinal partial credit model (LPCM). Simulations compared the methods in terms of type I error and statistical power of the test of an interaction effect between treatment arm and time. Several simulation scenarios were explored based on the EORTC HRQoL questionnaires and varying the number of patients (100, 200 or 300), items (1, 2 or 4) and response categories per item (4 or 7). Five or 10 measurement times were considered, with correlations ranging from low to high between each measure. The impact of informative missing data on these methods was also studied to reflect the reality of most clinical trials. With complete data, the type I error rate was close to the expected value (5%) for all methods, while the SM method was the most powerful method, followed by LPCM. The power of TTD is low for single-item dimensions, because only four possible values exist for the score. When the number of items increases, the power of the SM approach remained stable, those of the TTD method increases while the power of LPCM remained stable. With 10 measurement times, the LPCM was less efficient. With informative missing data, the statistical power of SM and TTD tended to decrease, while that of LPCM tended to increase. To conclude, the SM model was the most powerful model, irrespective of the scenario considered, and the presence or not of missing data. The TTD method should be avoided for single-item dimensions of the EORTC questionnaire. While the LPCM model was more adapted to this kind of data, it was less efficient than the SM model. These results warrant validation through comparisons on real data.

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

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

PubMed

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

2014-06-14

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

Quality 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.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).

PubMed

Ruers, T; Punt, C; Van Coevorden, F; Pierie, J P E N; Borel-Rinkes, I; Ledermann, J A; Poston, G; Bechstein, W; Lentz, M A; Mauer, M; Van Cutsem, E; Lutz, M P; Nordlinger, B

2012-10-01

This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively. This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.

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 (

Evidence-Based Diagnostic Algorithm for Glioma: Analysis of the Results of Pathology Panel Review and Molecular Parameters of EORTC 26951 and 26882 Trials.

PubMed

Kros, Johan M; Huizer, Karin; Hernández-Laín, Aurelio; Marucci, Gianluca; Michotte, Alex; Pollo, Bianca; Rushing, Elisabeth J; Ribalta, Teresa; French, Pim; Jaminé, David; Bekka, Nawal; Lacombe, Denis; van den Bent, Martin J; Gorlia, Thierry

2015-06-10

With the rapid discovery of prognostic and predictive molecular parameters for glioma, the status of histopathology in the diagnostic process should be scrutinized. Our project aimed to construct a diagnostic algorithm for gliomas based on molecular and histologic parameters with independent prognostic values. The pathology slides of 636 patients with gliomas who had been included in EORTC 26951 and 26882 trials were reviewed using virtual microscopy by a panel of six neuropathologists who independently scored 18 histologic features and provided an overall diagnosis. The molecular data for IDH1, 1p/19q loss, EGFR amplification, loss of chromosome 10 and chromosome arm 10q, gain of chromosome 7, and hypermethylation of the promoter of MGMT were available for some of the cases. The slides were divided in discovery (n = 426) and validation sets (n = 210). The diagnostic algorithm resulting from analysis of the discovery set was validated in the latter. In 66% of cases, consensus of overall diagnosis was present. A diagnostic algorithm consisting of two molecular markers and one consensus histologic feature was created by conditional inference tree analysis. The order of prognostic significance was: 1p/19q loss, EGFR amplification, and astrocytic morphology, which resulted in the identification of four diagnostic nodes. Validation of the nodes in the validation set confirmed the prognostic value (P < .001). We succeeded in the creation of a timely diagnostic algorithm for anaplastic glioma based on multivariable analysis of consensus histopathology and molecular parameters. © 2015 by American Society of Clinical Oncology.

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.

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

PubMed

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

2016-01-01

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

Quality of Life 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.

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.

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

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.

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.

Validity of the histopathological criteria used for diagnosing dysplastic naevi. An interobserver study by the pathology subgroup of the EORTC Malignant Melanoma Cooperative Group.

PubMed

de Wit, P E; van't Hof-Grootenboer, B; Ruiter, D J; Bondi, R; Bröcker, E B; Cesarini, J P; Hastrup, N; Hou-Jensen, K; MacKie, R M; Scheffer, E

1993-01-01

Ten (dermato)pathologists studied 50 cutaneous melanocytic lesions including common naevocellular naevi, dysplastic naevi (DN), melanomas in situ and invasive primary melanomas, with emphasis on the histological criteria of DN. Using a standardised form, 20 defined histopathological features were scored (semi)quantitatively. Concordance of diagnosis, efficacy and reproducibility of features were investigated. DN were distinguished well from the other entities (mean Po 0.87). Agreement on the degree of atypia of DN was low. The reproducibility of the scoring was best for the following features: irregular nests, lymphohistiocytic infiltrate, marked junctional proliferation and large nuclei. The overall values of these features to discriminate between DN and non-DN were better than for the other features studied. Using the presence of at least three of the four features as a condition for the diagnosis of DN, values for sensitivity, specificity and positive and negative predictive values were 0.86, 0.91, 0.96 and 0.73, respectively. On the basis of the results these features seem best suited as histological criteria for the diagnosis of DN.

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.

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.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004)

PubMed Central

Ruers, T.; Punt, C.; Van Coevorden, F.; Pierie, J. P. E. N.; Borel-Rinkes, I.; Ledermann, J. A.; Poston, G.; Bechstein, W.; Lentz, M. A.; Mauer, M.; Van Cutsem, E.; Lutz, M. P.; Nordlinger, B.

2012-01-01

Background This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. Methods This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. Results The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2–73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1–70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42–0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7–22.1) and 9.9 months (95% CI 9.3–13.7), respectively. Conclusions This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain. PMID:22431703

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

PubMed

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

2012-01-01

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

Quality of Life in Patients 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.

[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.

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.

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.

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.

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").

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.

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

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

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

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

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.

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.

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.

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

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.

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

PubMed

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

2016-08-01

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

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.

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

PubMed Central

2013-01-01

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

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.

[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.

The assessment of fatigue: Psychometric qualities and norms for the Checklist individual strength.

PubMed

Worm-Smeitink, M; Gielissen, M; Bloot, L; van Laarhoven, H W M; van Engelen, B G M; van Riel, P; Bleijenberg, G; Nikolaus, S; Knoop, H

2017-07-01

The Checklist Individual Strength (CIS) measures four dimensions of fatigue: Fatigue severity, concentration problems, reduced motivation and activity. On the fatigue severity subscale, a cut-off score of 35 is used. This study 1) investigated the psychometric qualities of the CIS; 2) validated the cut-off score for severe fatigue and 3) provided norms. Representatives of the Dutch general population (n=2288) completed the CIS. The factor structure was investigated using an exploratory factor analysis. Internal consistency and test-retest reliability were determined. Concurrent validity was assessed in two additional samples by correlating the CIS with other fatigue scales (Chalder Fatigue Questionnaire, MOS Short form-36 Vitality subscale, EORTC QLQ-C30 fatigue subscale). To validate the fatigue severity cut-off score, a Receiver Operating Characteristics analysis was performed with patients referred to a chronic fatigue treatment centre (n=5243) and a healthy group (n=1906). Norm scores for CIS subscales were calculated for the general population, patients with chronic fatigue syndrome (CFS; n=1407) and eight groups with other medical conditions (n=1411). The original four-factor structure of the CIS was replicated. Internal consistency (α=0.84-0.95) and test-retest reliability (r=0.74-0.86) of the subscales were high. Correlations with other fatigue scales were moderate to high. The 35 points cut-off score for severe fatigue is appropriate, but, given the 17% false positive rate, should be adjusted to 40 for research in CFS. The CIS is a valid and reliable tool for the assessment of fatigue, with a validated cut-off score for severe fatigue that can be used in clinical practice. Copyright © 2017. Published by Elsevier Inc.

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.

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.

Prognostic significance of the initial cerebro-spinal fluid (CSF) involvement of children with acute lymphoblastic leukaemia (ALL) treated without cranial irradiation: results of European Organization for Research and Treatment of Cancer (EORTC) Children Leukemia Group study 58881.

PubMed

Sirvent, Nicolas; Suciu, Stefan; Rialland, Xavier; Millot, Frédéric; Benoit, Yves; Plantaz, Dominique; Ferster, Alice; Robert, Alain; Lutz, Patrick; Nelken, Brigitte; Plouvier, Emmanuel; Norton, Lucilia; Bertrand, Yves; Otten, Jacques

2011-01-01

To evaluate the prognostic significance of the initial cerebro-spinal fluid (CSF) involvement of children with ALL enrolled from 1989 to 1996 in the EORTC 58881 trial. Patients (2025) were categorised according to initial central nervous system (CNS) status: CNS-1 (CNS negative, n=1866), CNS-2 (<5 leucocytes/mm(3), CSF with blasts, n=50), CNS-3 (CNS positive, n=49), TLP+ (TLP with blasts, n=60). CNS-directed therapy consisted in intravenous (i.v.) methotrexate (5 g/sqm) in 4-10 courses, and intrathecal methotrexate injections (10-20), according to CNS status. Cranial irradiation was omitted in all patients. In the CNS1, TLP+, CNS2 and CNS3 group the 8-year EFS rate (SE%) was 69.7% (1.1%), 68.8% (6.2%), 71.3% (6.5%) and 68.3% (6.2%), respectively. The 8-year incidence of isolated CNS relapse (SE%) was 3.4% (0.4%), 1.7% (1.7%), 6.1% (3.5%) and 9.4% (4.5%), respectively, whereas the 8-year isolated or combined CNS relapse incidence was 7.6% (0.6%), 3.5% (2.4%), 10.2% (4.4%) and 11.7% (5.0%), respectively. Patients with CSF blasts had a higher rate of initial bad risk features. Multivariate analysis indicated that presence of blasts in the CSF had no prognostic value: (i) for EFS and OS; (ii) for isolated and isolated or combined CNS relapse; WBC count<25 × 10(9)/L and Medac E-coli asparaginase treatment were each related to a lower CNS relapse risk. The presence of initial CNS involvement has no prognostic significance in EORTC 58881. Intensification of CNS-directed chemotherapy, without CNS radiation, is an effective treatment of initial meningeal leukaemic involvement. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

PubMed

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

2016-04-27

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

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.

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.

Cross-cultural adaptation and validation of the Korean Toronto Extremity Salvage Score for extremity sarcoma.

PubMed

Kim, Han-Soo; Yun, JiYeon; Kang, Seungcheol; Han, Ilkyu

2015-07-01

A Korean version of Toronto Extremity Salvage Score (TESS), a widely used disease-specific patient-reported questionnaire for assessing physical function of sarcoma patients, has not been developed. 1) to translate and cross-culturally adapt the TESS into Korean, and 2) to examine its comprehensibility, reliability and validity. TESS was translated into Korean, then translated back into English, and reviewed by a committee to develop the consensus version of the Korean TESS. The Korean TESS was administered to 126 patients to examine its comprehensibility, reliability, and validity. Comprehensibility was high, as the patients rated questions as "easy" or "very easy" in 96% for the TESS lower extremity (LE) and in 97% for the TESS upper extremity (UE). Test-retest reliability with intraclass coefficient (0.874 for LE and 0.979 for UE) and internal consistency with Cronbach's alpha (0.978 for LE and 0.989 for UE) were excellent. Korean TESS correlated with the MSTS score (r = 0.772 for LE and r = 0.635 for UE), and physical functioning domain of EORTC-CLQ C30 (r = 0.840 for LE and r = 0.630 for UE). Our study suggests that Korean version of the TESS is a comprehensible, reliable, and valid instrument to measure patient-reported functional outcome in patients with extremity sarcoma. © 2015 Wiley Periodicals, Inc.

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.

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.

Development and evaluation of oral Cancer quality-of-life questionnaire (QOL-OC).

PubMed

Nie, Min; Liu, Chang; Pan, Yi-Chen; Jiang, Chen-Xi; Li, Bao-Ru; Yu, Xi-Jie; Wu, Xin-Yu; Zheng, Shu-Ning

2018-05-03

In this study scales and items for the Oral Cancer Quality-of-life Questionnaire (QOL-OC) were designed and the instrument was evaluated. The QOL-OC was developed and modified using the international definition of quality of life (QOL) promulgated by the European Organization for Research and Treatment of Cancer (EORTC) and analysis of the precedent measuring instruments. The contents of each item were determined in the context of the specific characteristics of oral cancer. Two hundred thirteen oral cancer patients were asked to complete both the EORTC core quality of life questionnaire (EORTC QLC-C30) and the QOL-OC. Data collected was used to conduct factor analysis, test-retest reliability, internal consistency, and construct validity. Questionnaire compliance was relatively high. Fourteen of the 213 subjects accepted the same tests after 24 to 48 h demonstrating a high test-retest reliability for all five scales. Overall internal consistency surpasses 0.8. The outcome of the factor analysis coincides substantially with our theoretical conception. Each item shows a higher correlation coefficient within its own scale than the others which indicates high construct validity. QOL-OC demonstrates fairly good statistical reliability, validity, and feasibility. However, further tests and modification are needed to ensure its applicability to the quality-of-life assessment of Chinese oral cancer patients.

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.

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.

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.

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/

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

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.

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

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.

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

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 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.

Evaluation of long-term results and quality of life in patients who underwent rib fixation with titanium devices after trauma.

PubMed

Billè, Andrea; Okiror, Lawrence; Campbell, Aideen; Simons, Jason; Routledge, Tom

2013-06-01

To describe the long-term results, quality of life and chronic pain after chest wall fixation for traumatic rib fracture using a quality of life (QOL) score and a numeric pain score. Retrospective analysis of 10 consecutive patients who underwent surgery for rib fractures after trauma and reconstruction between October 2010 and March 2012. Chest rib fractures were fixed with titanium clips and bars or titanium plates and screws through a posterolateral thoracotomy. Pain was assessed with a numeric pain scale 0-10 and quality of life (QOL) with the EORTC questionnaire QLQ-C30. There were 5 males and 5 females. The median age was 58 years (range 21-80). There were no postoperative deaths. The only postoperative complication observed was a contralateral pleural effusion requiring drainage. Median length of stay of the drain and median length of hospital stay were 2 days (range 0-8) and 4 days (range 1-42 days), respectively. The average follow-up period of operatively managed patients was 14 months (range 8-23.5 months). Seven patients scored the pain as 0, one as 1 (mild), one as 4 (moderate) and one as 8 (severe). Only two patients are taking occasionally pain killers. Only one patient presents severe limitation in his life scoring his QOL as poor. Titanium devices (clips and bars; screws and plates) are effective and safe for repair of rib fractures and showed good long-term results in terms of pain and quality of life after the operation.

[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.

Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients.

PubMed

Lui, Michelle; Gallo-Hershberg, Daniela; DeAngelis, Carlo

2017-12-22

Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT). The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients. Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal incontinence and abdominal symptoms. Cronbach's alpha was 0.78; kappa ranged from 0.934-0.952, except for abdominal spasms (κ = 0.0455). The positive predictive value was 96.4%, with the minimum score of 1.35 predicting a positive STID occurrence. Patients with moderate or severe diarrhea experience significant decreases in QoL compared to those with no diarrhea. This is the first patient-reported questionnaire that accurately predicts the occurrence and severity of diarrhea in oncology patients via assessing several bowel habit dimensions.

Neurocognitive functioning and health-related quality of life in patients treated with stereotactic radiotherapy for brain metastases: a prospective study

PubMed Central

Habets, Esther J.J.; Dirven, Linda; Wiggenraad, Ruud G.; Verbeek-de Kanter, Antoinette; Lycklama à Nijeholt, Geert J.; Zwinkels, Hanneke; Klein, Martin; Taphoorn, Martin J.B.

2016-01-01

Background Stereotactic radiotherapy (SRT) is expected to have a less detrimental effect on neurocognitive functioning and health-related quality of life (HRQoL) than whole-brain radiotherapy. To evaluate the impact of brain metastases and SRT on neurocognitive functioning and HRQoL, we performed a prospective study. Methods Neurocognitive functioning and HRQoL of 97 patients with brain metastases were measured before SRT and 1, 3, and 6 months after SRT. Seven cognitive domains were assessed. HRQoL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and BN20 questionnaires. Neurocognitive functioning and HRQoL over time were analyzed with linear mixed models and stratified for baseline Karnofsky performance status (KPS), total metastatic volume, and systemic disease. Results Median overall survival of patients was 7.7 months. Before SRT, neurocognitive domain and HRQoL scores were lower in patients than in healthy controls. At group level, patients worsened in physical functioning and fatigue at 6 months, while other outcome parameters of HRQoL and cognition remained stable. KPS < 90 and tumor volume >12.6 cm3 were both associated with worse information processing speed and lower HRQoL scores over 6 months time. Intracranial tumor progression was associated with worsening of executive functioning and motor function. Conclusions Prior to SRT, neurocognitive functioning and HRQoL are moderately impaired in patients with brain metastases. Lower baseline KPS and larger tumor volume are associated with worse functioning. Over time, SRT does not have an additional detrimental effect on neurocognitive functioning and HRQoL, suggesting that SRT may be preferred over whole-brain radiotherapy. PMID:26385615

AIO LQ-0110: a randomized phase II trial comparing oral doxycycline versus local administration of erythromycin as preemptive treatment strategies of panitumumab-mediated skin toxicity in patients with metastatic colorectal cancer.

PubMed

Kripp, Melanie; Prasnikar, Nicole; Vehling-Kaiser, Ursula; Quidde, Julia; Al-Batran, Salah-Eddin; Stein, Alexander; Neben, Kai; Hannig, Carla Verena; Tessen, Hans Werner; Trarbach, Tanja; Hinke, Axel; Hofheinz, Ralf-Dieter

2017-12-01

Dermatologic toxicities, especially akne-like skin rash, are the most common side-effects associated with anti-epidermal growth factor receptor (EGFR) therapy. Preemptive treatment with oral tetracyclines is recommended as a standard. Topical prophylactic options have thus far not been compared to tetracyclines. In the current study, we sought to establish an alternative topical treatment. In this multicentre, randomized, open-label phase II study patients with (K)Ras-wildtype colorectal cancer receiving panitumumab were randomized (1:1) to receive either doxycycline 100 mg b.i.d. (standard arm) or erythromycin ointment 2% followed by doxycycline in case of insufficient activity. The primary endpoint was the percentage of patients developing no skin toxicity ≥ grade 2 at any time during the first 8 weeks of panitumumab treatment. Skin toxicity was assessed using the NCI CTCAE v 4.0. Secondary endpoints comprised the assessment of skin toxicity using a more thorough grading system (WoMo score), evaluation of skin-related (DLQI) and global quality of life (EORTC QLQ C30). In total, 88 patients were included in this trial. 69% of the patients in the erythromycin arm suffered from skin toxicity of grade ≥ 2 versus 63% in the standard arm ( P = n.s .). However, as per WoMo score significantly more patients in the erythromycin arm developed moderate or severe skin toxicity at earlier time points. Skin related and overall quality of life was comparable between both arms. Based on this data erythromycin cannot be regarded as an alternative to doxycycline as prevention of EGFR-related skin toxicity.

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

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.

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

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.

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.

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

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.

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.

Lungtech, a phase II EORTC trial of SBRT for centrally located lung tumours - a clinical physics perspective.

PubMed

Lambrecht, Marie; Melidis, Christos; Sonke, Jan-Jakob; Adebahr, Sonja; Boellaard, Ronald; Verheij, Marcel; Guckenberger, Matthias; Nestle, Ursula; Hurkmans, Coen

2016-01-20

The EORTC has launched a phase II trial to assess safety and efficacy of SBRT for centrally located NSCLC: The EORTC 22113-08113-Lungtech trial. Due to neighbouring critical structures, these tumours remain challenging to treat. To guarantee accordance to protocol and treatment safety, an RTQA procedure has been implemented within the frame of the EORTC RTQA levels. These levels are here expanded to include innovative tools beyond protocol compliance verification: the actual dose delivered to each patient will be estimated and linked to trial outcomes to enable better understanding of dose related response and toxicity. For trial participation, institutions must provide a completed facility questionnaire and beam output audit results. To insure ability to comply with protocol specifications a benchmark case is sent to all centres. After approval, institutions are allowed to recruit patients. Nonetheless, each treatment plan will be prospectively reviewed insuring trial compliance consistency over time. As new features, patient's CBCT images and applied positioning corrections will be saved for dose recalculation on patient's daily geometry. To assess RTQA along the treatment chain, institutions will be visited once during the time of the trial. Over the course of this visit, end-to-end tests will be performed using the 008ACIRS-breathing platform with two separate bodies. The first body carries EBT3 films and an ionization chamber. The other body newly developed for PET- CT evaluation is fillable with a solution of high activity. 3D or 4D PET-CT and 4D-CT scanning techniques will be evaluated to assess the impact of motion artefacts on target volume accuracy. Finally, a dosimetric evaluation in static and dynamic conditions will be performed. Previous data on mediastinal toxicity are scarce and source of cautiousness for setting-up SBRT treatments for centrally located NSCLC. Thanks to the combination of documented patient related outcomes and CBCT based dose recalculation we expect to provide improved models for dose response and dose related toxicity. We have developed a comprehensive RTQA model for trials involving modern radiotherapy. These procedures could also serve as examples of extended RTQA for future radiotherapy trials involving quantitative use of PET and tumour motion.

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

Chromosomal Radiosensitivity in Lymphocytes of Cervix Cancer Patients—Correlation with Side Effect after Radiotherapy

NASA Astrophysics Data System (ADS)

Wegierek-Ciuk, Aneta; Lankoff, Anna; Lisowska, Halina; Banasik-Nowak, Anna; Arabski, Michał; Kedzierawski, Piotr; Florek, Agnieszka; Wojcik, Andrzej

2010-01-01

It is well known that cancer patients receiving similar radiotherapy treatments differ widely in normal tissue reactions ranging from undetectable to unacceptably severe levels. Therefore, an important goal of radiobiological research is to establish a test which would allow identifying individual radiosensitivity of patients prior to radiotherapy. The aim of the presented study is to assess the relationship between lymphocyte intrinsic radiosensitivity in vitro and early reaction of normal tissue in cervix cancer patients treated by radiotherapy. The following endpoints are analyzed in vitro: frequency of micronuclei, the kinetics of DNA repair and apoptosis. Acute normal tissue reaction to radiotherapy in the skin, bladder and rectum are scored according to the EORTC/RTOG scale. Our results show a wide inter-individual variability in chromosomal radiosensitivity in vitro. The majority of patients show a Grade 0, 1 or 2 reaction for all organs studied. No statistically significant correlation has been observed between the in vitro results in lymphocytes and the degree of early normal tissue and organ reaction.

Feasibility and radiation induced toxicity regarding the first application of transperineal implementation of biocompatible balloon for high dose radiotherapy in patients with prostate carcinoma

PubMed Central

2013-01-01

Objective To evaluate the feasibility of the transperineal implementation of biocompatible balloon (Prospace) and the acute toxicity of high dose 3DCRT in patients with localized low risk prostate cancer. Materials and methods Between December 2011 and April 2012, fifteen patients were treated with external 3DCRT consisted of 76–78 Gy in 38–39 daily fractions (2.0 Gy/ fraction). Before 3DCRT, we placed the Prospace though the perineum by a minimally invasive procedure in the intermediate space between the rectum and the prostate. The primary study endpoint was the evaluation of acute toxicity according to the EORTC/RTOG radiation toxicity scale. Erectile function was evaluated with the IIEF-5 questionnaire. Rectosigmoidoscopy was performed at baseline, at the end of 3DCRT and 3 months thereafter in order to assess also the rectal toxicity according to Subjective-RectoSigmoid (S-RS) scale. The evaluation of pain related to Prospace implementation was done with the visual analogue score (VAS). Results The acute toxicities were as follows: grade I GI toxicity in two patients and for GU toxicity, three patients with grade I of nocturia, four patients with grade I of frequency, two patients with grade I and two patients with grade II of dysouria. The mean score of rectal toxicity according to S-RS score was 1.8(±0.6). The mean VAS score related to Prospace was 1.4(±0.5). Erectile function was unchanged. The Prospace device was found stable in sequential CTs during irradiation. Conclusions The implementation of PROSPACE was feasible, while the acute radiation toxicity was low and comparable with IMRT techniques. PMID:23566526

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.

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

PubMed

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

2016-03-01

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

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 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.

[Magnetic resonance guided focused ultrasound surgery for pain palliation of bone metastases: early experience of clinical application in China].

PubMed

Gu, Jianjun; Wang, Han; Tang, Na; Hua, Yingqi; Yang, Haiyan; Qiu, Yimin; Ge, Renbin; Zhou, Ying; Wang, Wenwen; Zhang, Guixiang

2015-11-03

To evaluate the safety and efficacy of magnetic resonance guided focused ultrasound surgery (MRgFUS) in treatment for pain palliation of bone metastases. Eighty-one patients of painful bone metastases were volunteered to screen for this study in Shanghai General Hospital from June 2014 to February 2015. Twenty-three patients among them were treated by MRgFUS, who was more than 18-years old, having the ability to fully understand the informed consent of the research, suffering with pain of numeric rating scale (NRS) ≥ 4, non-received radiotherapy or chemotherapy for pain palliation of bone metastases in the past two weeks. The NRS, the standard question of Brief Pain Inventory (BPI-QoL), and the standard question of Europe Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Bone Metastases 22 (EORTC QLQ-BM22) were respectively recorded before and 1-week, 1-month, 3-month after the treatment. The related adverse events of MRgFUS were observed and recorded in 3 months after the treatment as well. (1)Twenty-three metastatic bone tumor lesions of 23 patients were treated by MRgFUS, the treatment data was as follows: the mean treatment time was (88 ± 33) minutes, the mean sonication number was 13 ± 8. (2) Adverse events included: pain in therapy area 3/23, which spontaneous relieving within one week; numbness in lower limb (1/23), which relieved after physiotherapy. (3) The NRS of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 6.0 ± 1.5, 3.7 ± 1.7,3.1 ± 2.0, and 2.2 ± 1.0,which significantly decreased after the treatment (P<0.01). (4) The BPI-QoL score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 39 ± 16, 27 ± 18, 26 ± 18, and 21 ± 18, which significantly decreased after the treatment (P<0.01). (5) The EORTC QLQ-BM22 score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 52 ± 13, 44 ± 12, 42 ± 12, and 39 ± 12, which also significantly decreased after the treatment (P<0.01). MRgFUS can be used as a non-invasive, safe, and effective method for treating painful bone metastases. Its clinical benefits of pain palliation and patient's quality of life improving are sustained after the treatment at least to 3 months.

The role of interim 18F-FDG PET/CT in prediction of response to ipilimumab treatment in metastatic melanoma.

PubMed

Sachpekidis, Christos; Anwar, Hoda; Winkler, Julia; Kopp-Schneider, Annette; Larribere, Lionel; Haberkorn, Uwe; Hassel, Jessica C; Dimitrakopoulou-Strauss, Antonia

2018-07-01

The aim of the present study was to assess the value of interim 18 F-FDG PET/CT performed after the first two cycles of ipilimumab treatment in the prediction of the final clinical response to this type of immunotherapy. The study group comprised 41 patients with unresectable metastatic melanoma scheduled for ipilimumab therapy. Whole-body 18 F-FDG PET/CT was performed before the start of ipilimumab treatment (baseline PET/CT) and after the initial two cycles of ipilimumab treatment (interim PET/CT). Evaluation of patient response to treatment was based on the European Organization for Research and Treatment of Cancer (EORTC) 1999 criteria for PET as well as the recently proposed PET Response Evaluation Criteria for Immunotherapy (PERCIMT). The patients' best clinical response, assessed at a median of 21.4 months (range 6.3-41.9 months) was used as reference. According to their best clinical response, the patients were divided into two groups: those showing clinical benefit (CB) including stable disease, partial response and complete response (31 patients), and those showing no clinical benefit (no-CB including progressive disease (10 patients). According to the EORTC criteria, interim PET/CT demonstrated progressive metabolic disease (PMD) in 20 patients, stable metabolic disease (SMD) in 11 patients, partial metabolic response (PMR) in 8 patients, and complete metabolic response (CMR) in 2 patients. According to the PERCIMT, interim PET/CT demonstrated PMD in 9 patients, SMD in 24 patients, PMR in 6 patients and CMR in 2 patients. On the basis of the interim PET, the patients were divided in a similar manner to the division according to clinical response into those showing metabolic benefit (MB) including SMD, PMR and CMR, and those showing no metabolic benefit (no-MB) including PMD. According to this dichotomization, the EORTC criteria showed a sensitivity (correctly predicting CB) of 64.5%, a specificity (correctly predicting no-CB) of 90.0%, a positive predictive value (PPV) of 95.2%, a negative predictive value (NPV) of 45.0% and an accuracy of 70.7% in predicting best clinical response. The PERCIMT showed a sensitivity of 93.6%, a specificity of 70.0%, a PPV of 90.6%, a NPV of 77.8% and an accuracy of 87.8%. The McNemar test showed that the PERCIMT had a significantly higher sensitivity than EORTC criteria (p = 0.004), while there was no significant difference in specificity (p = 0.5). The agreement between the two sets of criteria was poor (McNemar test p = 0.001, and accordingly kappa = 0.46). The application of the recently proposed PERCIMT to interim 18 F-FDG PET/CT provides a more sensitive predictor of final clinical response to immunotherapy than the application of the EORTC criteria in patients with metastatic melanoma.

Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial

PubMed Central

Anota, Amélie; Mouillet, Guillaume; Trouilloud, Isabelle; Dupont-Gossart, Anne-Claire; Artru, Pascal; Lecomte, Thierry; Zaanan, Aziz; Gauthier, Mélanie; Fein, Francine; Dubreuil, Olivier; Paget-Bailly, Sophie; Taieb, Julien; Bonnetain, Franck

2015-01-01

Background A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study. Methods HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS. Results 98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21–0.59]) and pain (0.50 [0.31 – 0.81]) than those of Arm 1. Conclusion Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients’ characteristics. Trial registration information Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM). PMID:26010884

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.

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.

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.

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.

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.

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.

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.

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.

Normal tissue complication probability (NTCP) parameters for breast fibrosis: pooled results from two randomised trials.

PubMed

Mukesh, Mukesh B; Harris, Emma; Collette, Sandra; Coles, Charlotte E; Bartelink, Harry; Wilkinson, Jenny; Evans, Philip M; Graham, Peter; Haviland, Jo; Poortmans, Philip; Yarnold, John; Jena, Raj

2013-08-01

The dose-volume effect of radiation therapy on breast tissue is poorly understood. We estimate NTCP parameters for breast fibrosis after external beam radiotherapy. We pooled individual patient data of 5856 patients from 2 trials including whole breast irradiation followed with or without a boost. A two-compartment dose volume histogram model was used with boost volume as the first compartment and the remaining breast volume as second compartment. Results from START-pilot trial (n=1410) were used to test the predicted models. 26.8% patients in the Cambridge trial (5 years) and 20.7% patients in the EORTC trial (10 years) developed moderate-severe breast fibrosis. The best fit NTCP parameters were BEUD3(50)=136.4 Gy, γ50=0.9 and n=0.011 for the Niemierko model and BEUD3(50)=132 Gy, m=0.35 and n=0.012 for the Lyman Kutcher Burman model. The observed rates of fibrosis in the START-pilot trial agreed well with the predicted rates. This large multi-centre pooled study suggests that the effect of volume parameter is small and the maximum RT dose is the most important parameter to influence breast fibrosis. A small value of volume parameter 'n' does not fit with the hypothesis that breast tissue is a parallel organ. However, this may reflect limitations in our current scoring system of fibrosis. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Assessment of Depression, Anxiety, Quality of Life, and Coping in Long-Standing Multiple Endocrine Neoplasia Type 2 Patients.

PubMed

Rodrigues, Karine C; Toledo, Rodrigo A; Coutinho, Flavia L; Nunes, Adriana B; Maciel, Rui M B; Hoff, Ana O; Tavares, Marcos C; Toledo, Sergio P A; Lourenço, Delmar M

2017-05-01

Data on psychological harm in multiple endocrine neoplasia type 2 (MEN2) are scarce. The aim of this study was to assess anxiety, depression, quality of life, and coping in long-standing MEN2 patients. Patients were 43 adults (age ≥18 years) with clinical and genetic diagnosis of MEN2 and long-term follow-up (10.6 ± 8.2 years; range 1-33 years). This was a cross-sectional study with qualitative and quantitative psychological assessment using semi-directed interviews and HADS, EORTC QLQ C30, and MINI-MAC scales. Adopting clinical criteria from 2015 ATA Guidelines on MEN2, biochemical cure (39%; 16/41), persistence/recurrence (61%; 25/41), and stable chronic disease (22/41) of medullary thyroid carcinoma (MTC) were scored. Pheochromocytoma affected 19 (44%) patients, with previous adrenalectomy in 17 of them. Overall, anxiety (42%; mean score 11 ± 2.9; range 8-18; anxiety is defined as a score ≥8) and depression (26%; mean score 11 ± 3.8; range 8-20; depression is defined as a score ≥8) symptoms were frequent. Patients who transmitted RET mutations to a child had higher scores for weakness-discouragement/anxious preoccupation and lower scores for cognitive, emotional, and physical functioning (p < 0.05). Feelings of guilt were present in 35% of patients with mutation-positive children. Lower mean score values for depression and anxiety and higher scores for role, cognitive, and emotional functioning were noticed in 33 patients who were well-informed about their disease (p < 0.05). Fighting spirit was more frequently found in patients with multiple surgical procedures (p = 0.019) and controlled chronic adrenal insufficiency (p = 0.024). Patients with MEN2-related stress-inducing factors had lower scores for fighting spirit and cognitive functioning and higher scores for insomnia and dyspnea (p < 0.05). Eleven patients required sustained psychotherapeutic treatment. Mean global health status was relatively good in MEN2 cases (68.1 ± 22.3), and the cured group had higher physical functioning (p = 0.021). Psychological distress is likely chronic in MEN2 patients. This study identified diverse MEN2-related factors (degree of information on disease, mutation-positive children, number of surgeries, comorbidities, stress-inducing factors, and cure) interfering positively or negatively with the results of the psychometrics scales. The active investigation of these factors and the applied psychological assessment protocol are useful to identify MEN2 patients requiring psychological assistance.

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

PubMed

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

2018-02-01

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

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.

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.

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

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.

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

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.

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.

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

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 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.

Long-term Quality of Life After Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy for Pseudomyxoma Peritonei: A Prospective Longitudinal Study.

PubMed

Stearns, Adam T; Malcomson, Lee; Punnett, Grant; Abudeeb, Haytham; Aziz, Omer; Selvasekar, Chelliah R; Fulford, Paul E; Wilson, Malcolm S; Renehan, Andrew G; O'Dwyer, Sarah T

2018-04-01

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are an established treatment for pseudomyxoma peritonei (PMP), but it is a major surgical procedure and may be associated with long-term morbidity. To date, health-related quality-of-life (HRQL) data among survivors are lacking. A two-period qualitative study investigated patients undergoing CRS-HIPEC for PMP at a national peritoneal tumor center between 2003 and 2011. First, the European Organization for Research and Treatment (EORTC)-QLQ C30 HRQL questionnaire was used longitudinally preoperatively and at postoperative months 3, 6, 9, 12, 18, and 24, then yearly thereafter. Second, it was updated in 2016 as a cross-sectional study. Both studies were compared with age- and sex-matched reference populations (one-way t tests). A total of 553 longitudinal HRQL questionnaires were completed for 137 patients, truncated at 60 months. In the 2016 update, 85 responses were received from 103 survivors (mean follow-up period, 8.11 years). Patients' physical, role, and social function scores were impaired until 12 months postoperatively, after which the scores did not differ significantly from those of with reference populations. Similarly, fatigue, appetite loss, insomnia, and financial difficulties worsened significantly compared with reference populations in the first 12-months and then normalized. In contrast, impaired cognitive function (82.3 vs 88.5; P = 0.017), constipation (13.7 vs 7.3; P = 0.032), and diarrheal symptoms (15.1 vs 4.9; P = 0.0006) persisted through both periods. Global health scores did not differ significantly from those of the reference population. Beyond 12 months postoperatively, CRS-HIPEC for PMP is associated with a good quality of life except for some cognitive functional impairment and bowel disturbances.

Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.

PubMed

Kataoka, Tomoko; Kiyota, Naomi; Shimada, Takanobu; Funakoshi, Yohei; Chayahara, Naoko; Toyoda, Masanori; Fujiwara, Yutaka; Nibu, Ken-Ichi; Komori, Takahide; Sasaki, Ryohei; Mukohara, Toru; Minami, Hironobu

2016-12-01

Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC+G). Gabapentin was maintained at 900mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC+G (n=11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). Adverse events related to gabapentin were manageable. This pilot study is the first prospective randomized trial of gabapentin for RIM-related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM-related pain is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer.

PubMed

Lua, Pei Lin; Salihah, Noor; Mazlan, Nik

2015-06-01

To assess the efficacy of inhaled ginger aromatherapy on nausea, vomiting and health-related quality of life (HRQoL) in chemotherapy breast cancer patients. Single-blind, controlled, randomized cross-over study. Patients received 5-day aromatherapy treatment using either ginger essential oil or fragrance-matched artificial placebo (ginger fragrance oil) which was instilled in a necklace in an order dictated by the treatment group sequence. Two oncology clinics in the East Coast of Peninsular Malaysia. VAS nausea score, frequency of vomiting and HRQoL profile (EORTC QLQ-C30 scores). Sixty female patients completed the study (age=47.3±9.26 years; Malay=98.3%; on highly emetogenic chemotherapy=86.7%). The VAS nausea score was significantly lower after ginger essential oil inhalation compared to placebo during acute phase (P=0.040) but not sustained for overall treatment effect (treatment effect: F=1.82, P=0.183; time effect: F=43.98, P<0.001; treatment×time effect: F=2.04; P=0.102). Similarly, there was no significant effect of aromatherapy on vomiting [F(1, 58)=0.29, P=0.594]. However, a statistically significant change from baseline for global health status (P<0.001) was detected after ginger essential oil inhalation. A clinically relevant 10 points improvement on role functioning (P=0.002) and appetite loss (P<0.001) were also documented while patients were on ginger essential oil. At present time, the evidence derived from this study is not sufficiently convincing that inhaled ginger aromatherapy is an effective complementary therapy for CINV. The findings for HRQoL were however encouraging with significant improvement in several domains. Copyright © 2015 Elsevier Ltd. All rights reserved.

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 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.

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.

Management of acute skin toxicity with Hypericum perforatum and neem oil during platinum-based concurrent chemo-radiation in head and neck cancer patients.

PubMed

Franco, Pierfrancesco; Rampino, Monica; Ostellino, Oliviero; Schena, Marina; Pecorari, Giancarlo; Garzino Demo, Paolo; Fasolis, Massimo; Arcadipane, Francesca; Martini, Stefania; Cavallin, Chiara; Airoldi, Mario; Ricardi, Umberto

2017-02-01

Acute skin toxicity is a frequent finding during combined radiotherapy and chemotherapy in head and neck cancer patients. Its timely and appropriate management is crucial for both oncological results and patient's global quality of life. We herein report clinical data on the use of Hypericum perforatum and neem oil in the treatment of acute skin toxicity during concurrent chemo-radiation for head and neck cancer. A consecutive series of 50 head and neck cancer patients undergoing concomitant radio-chemotherapy with weekly cisplatin was analyzed. Treatment with Hypericum perforatum and neem oil was started in case of G2 acute skin toxicity according to the RTOG/EORTC scoring scale and continued during the whole treatment course and thereafter until complete recovery. The maximum detected acute skin toxicity included Grade 2 events in 62% of cases and G3 in 32% during treatment and G2 and G3 scores in 52 and 8%, respectively, at the end of chemo-radiation. Grade 2 toxicity was mainly observed during weeks 4-5, while G3 during weeks 5-6. Median times spent with G2 or G3 toxicity were 23.5 and 14 days. Patients with G3 toxicity were reconverted to a G2 profile in 80% of cases, while those with a G2 score had a decrease to G1 in 58% of cases. Time between maximum acute skin toxicity and complete skin recovery was 30 days. Mean worst pain score evaluated with the Numerical Rating Scale-11 was 6.9 during treatment and 4.5 at the end of chemo-radiotherapy. Hypericum perforatum and neem oil proved to be a safe and effective option in the management of acute skin toxicity in head and neck cancer patients submitted to chemo-radiation with weekly cisplatin. Further studies with a control group and patient-reported outcomes are needed to confirm this hypothesis.

The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

PubMed

Perrone, F; Jommi, C; Di Maio, M; Gimigliano, A; Gridelli, C; Pignata, S; Ciardiello, F; Nuzzo, F; de Matteis, A; Del Mastro, L; Bryce, J; Daniele, G; Morabito, A; Piccirillo, M C; Rocco, G; Guizzaro, L; Gallo, C

2016-12-01

Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system. Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI). At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings. Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and survival. Any registered clinical trial number should be indicated after the abstract. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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.

NOTCH1 and FBXW7 mutations have a favorable impact on early response to treatment, but not on outcome, in children with T-cell acute lymphoblastic leukemia (T-ALL) treated on EORTC trials 58881 and 58951.

PubMed

Clappier, E; Collette, S; Grardel, N; Girard, S; Suarez, L; Brunie, G; Kaltenbach, S; Yakouben, K; Mazingue, F; Robert, A; Boutard, P; Plantaz, D; Rohrlich, P; van Vlierberghe, P; Preudhomme, C; Otten, J; Speleman, F; Dastugue, N; Suciu, S; Benoit, Y; Bertrand, Y; Cavé, H

2010-12-01

Risk-adjusted treatment stratification in T-cell acute lymphoblastic leukemias (T-ALLs) is currently based only on early response to chemotherapy. We investigated the prognostic implication of hyperactivation of NOTCH pathway resulting from mutations of NOTCH1 or FBXW7 in children with T-ALL enrolled in EORTC-CLG trials. Overall, 80 out of 134 (60%) patients were NOTCH+ (NOTCH1 and/or FBXW7 mutated). Although clinical presentations were not significantly associated with NOTCH status, NOTCH+ patients showed a better early response to chemotherapy as compared with NOTCH- patients, according to the rate of poor pre-phase 'responders' (25% versus 44%; P=0.02) and the incidence of high minimal residual disease (MRD) levels (11% (7/62) versus 32% (10/31); P=0.01) at completion of induction. However, the outcome of NOTCH+ patients was similar to that of NOTCH- patients, with a 5-year event-free survival (EFS) of 73% and 70% (P=0.82), and 5-year overall survival of 82% and 79% (P=0.62), respectively. In patients with high MRD levels, the 5-year EFS rate was 0% (NOTCH+) versus 42% (NOTCH-), whereas in those with low MRD levels, the outcome was similar: 76% (NOTCH+) versus 78% (NOTCH-). The incidence of isolated central nervous system (CNS) relapses was relatively high in NOTCH1+ patients (8.3%), which could be related to a higher propensity of NOTCH+ leukemic blasts to target the CNS.

The ability of cancer-specific and generic preference-based instruments to discriminate across clinical and self-reported measures of cancer severities

PubMed Central

2011-01-01

Objective To evaluate the validity of cancer-specific and generic preference-based instruments to discriminate across different measures of cancer severities. Methods Patients with breast (n = 66), colorectal (n = 57), and lung (n = 61) cancer completed the EORTC QLQ-C30 and the FACT-G, as well as three generic instruments: the EQ-5D, the SF-6D, and the HUI2/3. Disease severity was quantified using cancer stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score, and self-reported health status. Comparative analyses confirmed the multi-dimensional conceptualization of the instruments in terms of construct and convergent validity. Results In general, the instruments were able to discriminate across severity measures. The instruments demonstrated moderate to strong correlation with each other (r = 0.37-0.73). Not all of the measures could discriminate between different groups of disease severity: the EQ-5D and SF-6D were less discriminative than the HUI2/3 and the cancer-specific instruments. Conclusion The cancer-specific and generic preference-based instruments demonstrated to be valid in discriminating across levels of ECOG-PS scores and self-reported health states. However, the usefulness of the generic instruments may be limited if they are not able to detect small changes in health status within cancer patients. This raises concerns regarding the appropriateness of these instruments when comparing different cancer treatments within an economic evaluation framework. PMID:22123196

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.

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.

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.

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

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.

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.

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 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

The antitumour activity of alkylating agents is not correlated with the levels of glutathione, glutathione transferase and O6-alkylguanine-DNA-alkyltransferase of human tumour xenografts. EORTC SPG and PAMM Groups.

PubMed

D'Incalci, M; Bonfanti, M; Pifferi, A; Mascellani, E; Tagliabue, G; Berger, D; Fiebig, H H

1998-10-01

Twenty-three human xenografts, including five colon, five gastric, nine lung (three small cell lung cancer) and four breast carcinomas, were investigated for their sensitivity to nitrosoureas, dacarbazine (DTIC), cyclophosphamide (CTX) and cisplatin (DDP). In 12 cases, at least one of the drugs produced complete or partial remission, in 2, a minor regression was observed and in the other 9, treatment was ineffective. The level of sensitivity to each drug, using a score from 1 to 5, was correlated to three biochemical parameters reported to be involved in resistance to alkylating agents: glutathione (GSH), glutathione transferase (GST) and O6-alkylguanine-DNA-alkyltransferase (AGT). A wide variability was found in these parameters in the xenografts investigated. No correlation was found between any of the three parameters and sensitivity to the drugs used or between sensitivity to one drug and to any of the other drugs tested. These results illustrate the complexity of the question of resistance to alkylating agents and indicate that, at least in xenografts, the biochemical parameters examined are not predictive of response to alkylating agents.

Survival outcomes and prognostic factors in mycosis fungoides/Sézary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal.

PubMed

Agar, Nita Sally; Wedgeworth, Emma; Crichton, Siobhan; Mitchell, Tracey J; Cox, Michael; Ferreira, Silvia; Robson, Alistair; Calonje, Eduardo; Stefanato, Catherine M; Wain, Elizabeth Mary; Wilkins, Bridget; Fields, Paul A; Dean, Alan; Webb, Katherine; Scarisbrick, Julia; Morris, Stephen; Whittaker, Sean J

2010-11-01

We have analyzed the outcome of mycosis fungoides (MF) and Sézary syndrome (SS) patients using the recent International Society for Cutaneous Lymphomas (ISCL)/European Organisation for Research and Treatment of Cancer (EORTC) revised staging proposal. Overall survival (OS), disease-specific survival (DSS), and risk of disease progression (RDP) were calculated for a cohort of 1,502 patients using univariate and multivariate models. The mean age at diagnosis was 54 years, and 71% of patients presented with early-stage disease. Disease progression occurred in 34%, and 26% of patients died due to MF/SS. A significant difference in survival and progression was noted for patients with early-stage disease having patches alone (T1a/T2a) compared with those having patches and plaques (T1b/T2b). Univariate analysis established that (1) advanced skin and overall clinical stage, increased age, male sex, increased lactate dehydrogenase (LDH), and large-cell transformation were associated with reduced survival and increased RDP; (2) hypopigmented MF, MF with lymphomatoid papulosis, and poikilodermatous MF were associated with improved survival and reduced RDP; and (3) folliculotropic MF was associated with an increased RDP. Multivariate analysis established that (1) advanced skin (T) stage, the presence in peripheral blood of the tumor clone without Sézary cells (B0b), increased LDH, and folliculotropic MF were independent predictors of poor survival and increased RDP; (2) large-cell transformation and tumor distribution were independent predictors of increased RDP only; and (3) N, M, and B stages; age; male sex; and poikilodermatous MF were only significant for survival. This study has validated the recently proposed ISCL/EORTC staging system and identified new prognostic factors.

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

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.

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.

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.

Associations between education and physical functioning and pain in adult Danish cancer survivors.

PubMed

Winther, Dorte; Nygaard, Tina K; Horsbøl, Trine A; Kjær, Trille; Vedsted, Peter; Johansen, Christoffer; Hovaldt, Hanna B; Sandager, Mette; Dalton, Susanne O

2017-02-01

Late effects after cancer diagnosis and treatment are common, but only few studies have examined the role of social factors in developing these late effects. The aim of this study was to examine the association between educational level and physical function and pain among cancer survivors two years after diagnosis. The study population consisted of adult Danish patients with a first-time cancer diagnosis who were sent a questionnaire in 2010 and followed up in 2012. In total, 4346 returned the first questionnaire shortly after diagnosis and 2568 returned the follow-up questionnaire. After exclusion of 177 due to missing information, we included 2391 cancer survivors in the analyses. Physical function and pain were measured using the EORTC QLQ-C30. Linear regression analyses were conducted separately for men and women, and adjusted for demographic and clinical characteristics. Additionally, analyses were stratified on comorbidity. Differences in mean scores according to educational level were small. Physical function was better in women with medium (2.8; 95% CI 0.1;5.4) and higher education (3.4; 95% CI 0.9;5.9) compared to women with short education. In contrast, men with medium education reported lower physical function (-2.9; 95% CI -5.7;-0.1) than men with short education. Compared to women with short education, we found lower pain scores among women with medium (-5.0; 95% CI -8.7;-1.4) and higher education (-3.4; 95% CI -6.7;0.0). Similarly, men with higher education experienced lower pain score (-3.4; 95% CI -6.9;0.1) than men with short education. The role of educational level differed between those with and without comorbidity. Educational level is slightly associated with physical function and pain among cancer survivors. However, mean differences in this study were small and below what is considered clinically relevant.

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.

Factors associated with reduced functional outcome and quality of life in patients having limb-sparing surgery for soft tissue sarcomas - a national multicenter study of 128 patients.

PubMed

Saebye, Casper; Fugloe, Hanna M; Nymark, Tine; Safwat, Akmal; Petersen, Michael M; Baad-Hansen, Thomas; Krarup-Hansen, Anders; Keller, Johnny

2017-02-01

Limb-sparing surgery for sarcomas has become possible in most cases. However, the impact of the procedure on the functional outcome has only been investigated in a few studies. The aim of this study has been to identify tumor- and patient-related factors associated with reduced functional outcome and quality of life after limb-sparing surgery in soft tissue sarcoma patients. In total, 128 patients (mean age = 58, female/male = 54/74) who were treated with limb-sparing surgery without bone resection for soft tissue sarcomas in Denmark during the period 1 January 2009 to 31 December 2011 were included. Patients were asked to participate at least one year after surgery, and patients who had experienced local recurrence or metastatic disease were excluded. The Toronto Extremity Salvage Score (TESS) measured functional disability, while the Musculoskeletal Tumor Society Score (MSTS) measured functional impairment. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 measured quality of life. Tumor- and patient-related factors (age, gender, tumor depth, tumor size, malignancy, comorbidity, location, and radiotherapy) were extracted from the Danish National Sarcoma Database. Wilcoxon rank-sum test and Kruskal-Wallis were used for univariable analysis. Adjusted odds ratios were estimated by using multiple logistic regression models. In the multiple regression analysis, it was found that female gender (p = 0.03), lower extremity tumors (p < 0.01) and radiotherapy (p = 0.02) resulted in an increased risk of a lower TESS score. Initial reduced postoperative function was found to be associated with a lower functional outcome. Patients with reduced functional outcome have increased risk for reduced quality of life (p < 0.01). The results of this study show that patient- and tumor-related factors have an important role in the functional outcome.

Quality of life in Malaysian colorectal cancer patients: a preliminary result.

PubMed

Natrah, M S; Ezat, Sharifa W P; Syed, M A; Rizal, A M Mohd; Saperi, S

2012-01-01

Rapidly increasing colorectal cancer (CRC) incidence in Malaysia and the introduction of cutting edge new treatments, which prolong survival, mean that treatment outcome measures meed to be evaluated, including consideration of patient's quality of life (QoL) assessment. There are limited data on QoL in CRC patients, especially in Malaysia. Therefore, this study was performed focusing on cancer stages and age groups. The cross sectional study was conducted from June to September 2011 at three public tertiary hospitals with the EORTC QLQ C-30 questionnaire in addition to face to face interview and review of medical records of 100 respondents. The mean age was 57.3 (SD 11.9) years with 56.0% are males and 44.0% females, 62% of Malay ethnicity, 30% Chinese, 7% Indian and 1% Sikh. Majority were educated up to secondary level (42%) and 90% respondents had CRC stages III and IV. Mean global health status (GHS) score was 79.1 (SD 21.4). Mean scores for functional status (physical, emotional, role, cognitive, social) rangeds between 79.5 (SD 26.6) to 92.2 (SD 13.7). Mean symptom scores (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnoea, loss of appetite) ranged between 4.00 (SD 8.58) to 20.7 (SD 30.6). Respondents role function significantly deteriorates with increasing stage of the disease (p=0.044). Females had worse symptoms of pain (p=0.022), fatigue (p=0.031) and dyspnoea (p=0.031). Mean insomnia (p=0.006) and diarrhea (p=0.024) demonstrated significant differences between age groups. QOL in CRC patients in this study was comparable to that in other studies done in developed countries. Pain, fatigue and dyspnoea are worse among female CRC patients. Given that functions deteriorates with advanced stage of the disease at diagnosis, a systematic screening programme to detect cases as early as possible is essential nationwide.

Late Side Effects and Quality of Life After Radiotherapy for Rectal Cancer

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

Bruheim, Kjersti, E-mail: Kjersti.Bruheim@medisin.uio.n; Guren, Marianne G.; Skovlund, Eva

2010-03-15

Purpose: There is little knowledge on long-term morbidity after radiotherapy (50 Gy) and total mesorectal excision for rectal cancer. Therefore, late effects on bowel, anorectal, and urinary function, and health-related quality of life (QoL), were studied in a national cohort (n = 535). Methods and Materials: All Norwegian patients who received pre- or postoperative (chemo-)radiotherapy for rectal cancer from 1993 to 2003 were identified. Patients treated with surgery alone served as controls. Patients were without recurrence or metastases. Bowel and urinary function was scored with the LENT SOMA scale and the St. Marks Score for fecal incontinence and QoL withmore » the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). Results: Median time since surgery was 4.8 years. Radiation-treated (RT+) patients (n = 199) had increased bowel frequency compared with non-radiation-treated (RT-) patients (n = 336); 19% vs. 6% had more than eight daily bowel movements (p < 0.001). In patients without stoma, a higher proportion of RT+ (n = 69) compared with RT- patients (n = 240), were incontinent for liquid stools (49% vs. 15%, p < 0.001), needed a sanitary pad (52% vs. 13%, p < 0.001), and lacked the ability to defer defecation (44% vs. 16%, p < 0.001). Daily urinary incontinence occurred more frequently after radiotherapy (9% vs. 2%, p = 0.001). Radiation-treated patients had worse social function than RT- patients, and patients with fecal or urinary incontinence had impaired scores for global quality of life and social function (p < 0.001). Conclusions: Radiotherapy for rectal cancer is associated with considerable long-term effects on anorectal function, especially in terms of bowel frequency and fecal incontinence. RT+ patients have worse social function, and fecal incontinence has a negative impact on QoL.« less

A clinical study to assess the efficacy of belly dancing as a tool for rehabilitation in female patients with malignancies.

PubMed

Szalai, Márta; Lévay, Bernadett; Szirmai, Anna; Papp, István; Prémusz, Viktória; Bódis, József

2015-02-01

This prospective, non-randomised follow-up study was designed to compare the health-related quality of life (HRQoL), perceived social support (PSS) and overall life satisfaction (OLS) in female patients receiving standard medical care for malignant diseases with or without additional belly dancing. The patients were recruited in the Outpatient Department of the National Institute of Oncology, Budapest, Hungary during the period of 2008-2009. 55 patients joined the one-year-long rehabilitation program (research group, RG) while 59 age-matched patients who received only standard medical care volunteered for clinical assessment (control group, CG). HRQoL, PSS and OLS were assessed using validated questionnaires: EORTC QLQ-C30, F-SozU-K14, and Campbell's OLS, respectively. The scores obtained in RG and CG were controlled for baseline socio-demographic characteristics and evaluated by ANCOVA analysis. It was found that patients of the RG scored better at both the baseline and follow-up than the CG, and the differences between the two groups' measured parameters increased further during the course of the study. The respective baseline values in RG and CG were 56.6 ± 10.3 vs 63.5 ± 12 for HRQoL, 65.2 ± 5.5 vs 57.4 ± 8.8 for PSS and 57.4 ± 8.1 vs 48.4 ± 10.7 for OLS. The corresponding follow-up scores were 51.9 ± 4.4 vs 59.9 ± 11.2 (F = 10.637, p = 0.001) for HRQoL, 67.5 ± 2.7 vs 53.9 ± 10.5 (F = 2.646, p = 0.000) for PSS and 59.5 ± 9.6 vs 45.0 ± 11.5 (F = 2.402, p = 0.001) for OLS. Belly dance intervention can be applied as a complementary rehabilitation method to improve HRQoL, PSS and OLS in female patients treated for malignant diseases. Copyright © 2014 Elsevier Ltd. All rights reserved.

Quality of Life Perception, Cognitive Function, and Psychological Status in a Real-world Population of Glioblastoma Patients Treated With Radiotherapy and Temozolomide: A Single-center Prospective Study.

PubMed

Lombardi, Giuseppe; Bergo, Eleonora; Del Bianco, Paola; Bellu, Luisa; Pambuku, Ardi; Caccese, Mario; Trentin, Leonardo; Zagonel, Vittorina

2018-05-10

Health-related quality of life (HRQoL), cognitive function, and psychological status represent an important focus during the treatment of glioblastoma patients. Nevertheless, few randomized, prospective clinical trials have analyzed these factors, and very little is known in the real-clinical world. We evaluated these characteristics in glioblastoma patients treated with standard first-line therapy outside clinical trials. In total, 111 newly, histologically diagnosed glioblastoma patients treated at our oncology center with radiotherapy and temozolomide were prospectively enrolled. No patient was enrolled in an experimental clinical trial. We assessed HRQoL, cognitive function, and psychological status before starting treatment, at the end of radiotherapy, and every 3 months until 9 months after the end of radiotherapy using EORTC QLQ-C30, BN20, MMSE, and HADS questionnaires. Global health status, physical, cognitive, and social functioning remained unchanged throughout the study period. A statistically significant change was found in emotional functioning as well as a clinically meaningful amelioration in role functioning between the baseline assessment and 9 months after radiotherapy. Patients older than 65 years reported greater impairment on the bladder control scale than younger patients. When considering tumor location, global health status, communication deficit, and drowsiness, scores were significantly different between the right and left hemispheres. Female patients had a clinically relevant lower score for physical functioning at baseline and 3 months after radiation therapy. Female patients also had a clinically relevant lower depression score at 9 months after radiation therapy. In routine neurooncology practice, HRQoL, cognitive function, and psychological status did not worsen during first-line treatment in glioblastoma patients receiving standard radiotherapy and temozolomide treatment. However, some patient subgroups, such as elderly and female patients, may have different experiences with treatment, and further investigation is required.

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…

CSF drug levels for children with acute lymphoblastic leukemia treated by 5 g/m2 methotrexate. A study from the EORTC Children's Leukemia Cooperative Group.

PubMed

Milano, G; Thyss, A; Serre Debeauvais, F; Laureys, G; Benoit, Y; Deville, A; Dutour, C; Robert, A; Otten, J; Behar, C

1990-04-01

A multicenter EORTC study was conducted in children with acute lymphocytic leukemia to determine whether 5 g/m2 of methotrexate (MTX) (24 h i.v. infusion, four cycles) is an appropriate dosage for obtaining CSF drug concentrations approaching the critical cytotoxic level of 10(-6) M. A total of 193 cycles were analyzed for 58 patients. At the end of the 24 h infusion, the mean MTX serum level was 65.27 +/- 33.11 microM; the mean CSF MTX level was 1.47 +/- 1.1 microM; no significant difference in CSF MTX levels was observed between patients with (n = 20) and those without i.v. Ara-C (n = 38). The mean CSF MTX/serum MTX ratio was 0.029 +/- 0.027. CSF drug concentrations greater than or equal to 10(-6) M were achieved in 81% of the courses. The highest level was 8.4 X 10(-6) M. Only 5% of patients failed to achieve this drug concentration in at least one cycle. No significant correlation was observed between blood and CSF MTX levels. Mean CSF MTX levels were comparable from one cycle to another.

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

Evaluation of Patient Satisfaction Using the EORTC IN-PATSAT32 Questionnaire and Surgical Outcome in Single-Port Surgery for Benign Adnexal Disease: Observational Comparison with Traditional Laparoscopy

PubMed Central

Buda, Alessandro; Passoni, Paolo; Bargossi, Lorena; Baldo, Romina; Milani, Rodolfo

2013-01-01

Laparoscopic surgery has been demonstrated as a valid approach in almost all gynaecologic procedures including malignant diseases. Benefits of the minimally invasive approach over traditional open surgery have been well demonstrated in terms of minimal perioperative morbidity and reduced postoperative pain and hospital stay duration, with consequent quick postoperative recovery (Medeiros et al. (2009)). Single-port surgery resurfaced in gynaecology surgery in recent years and renewed interest among other surgeons and within the industry to develop this field (Podolsky et al. (2009)). Patient satisfaction is emerging as an increasingly important measure of quality which represents a complex entity that is dependent on patient demographics, comorbidities, disease, and, to a large extent, patient expectations (Tomlinson and Ko (2006)). It can be broadly thought to refer to all relevant experiences and processes associated with health care delivery (Jackson et al. (2001)). In this study we aim to compare single-port surgery (SPS) with conventional laparoscopy in terms of patient satisfaction using the EORTC IN-PATSAT32 questionnaire. We also evaluate the main surgical outcomes of both minimally invasive approaches. PMID:24371418

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

Long-Term Outcome and Morbidity After Treatment With Accelerated Radiotherapy and Weekly Cisplatin for Locally Advanced Head-and-Neck Cancer: Results of a Multidisciplinary Late Morbidity Clinic

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

Ruetten, Heidi, E-mail: h.rutten@rther.umcn.nl; Pop, Lucas A.M.; Janssens, Geert O.R.J.

2011-11-15

Purpose: To evaluate the long-term outcome and morbidity after intensified treatment for locally advanced head-and-neck cancer. Methods and Materials: Between May 2003 and December 2007, 77 patients with Stage III to IV head-and-neck cancer were treated with curative intent. Treatment consisted of accelerated radiotherapy to a dose of 68 Gy and concurrent cisplatin. Long-term survivors were invited to a multidisciplinary outpatient clinic for a comprehensive assessment of late morbidity with special emphasis on dysphagia, including radiological evaluation of swallowing function in all patients. Results: Compliance with the treatment protocol was high, with 87% of the patients receiving at least fivemore » cycles of cisplatin and all but 1 patient completing the radiotherapy as planned. The 5-year actuarial disease-free survival and overall survival rates were 40% and 47%, respectively. Locoregional recurrence-free survival at 5 years was 61%. The 5-year actuarial rates of overall late Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Grade 3 and Grade 4 toxicity were 52% and 25% respectively. Radiologic evaluation after a median follow-up of 44 months demonstrated impaired swallowing in 57% of the patients, including 23% with silent aspiration. Subjective assessment using a systematic scoring system indicated normalcy of diet in only 15.6% of the patients. Conclusion: This regimen of accelerated radiotherapy with weekly cisplatin produced favorable tumor control rates and survival rates while compliance was high. However, comprehensive assessment by a multidisciplinary team of medical and paramedical specialists revealed significant long-term morbidity in the majority of the patients, with dysphagia being a major concern.« less

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).

Does social support from family and friends work as a buffer against reactions to stressful life events such as terminal cancer?

PubMed

Ringdal, Gerd Inger; Ringdal, Kristen; Jordhøy, Marit S; Kaasa, Stein

2007-03-01

To examine the relationship between social support and emotional functioning and stress reactions. Our hypothesis is that patients who reported a high degree of social support will experience better emotional functioning and less serious stress reactions than patients with a low degree of social support. The sample was comprised of 434 patients at the Palliative Medicine Unit (PMU), University Hospital of Trondheim in Norway. The patients completed a questionnaire monthly including questions about social support from the MacAdam's Scale, subjective stress measured by the Impact of Event Scale (IES), and emotional functioning measured by the subscale in the EORTC QLQ-30. Although our hypothesis was not supported at the baseline assessment, it was supported at the second assessment, 2 months later. Patients with high social support reported better emotional functioning and less serious stress reactions, in terms of lower scores on the IES avoidance subscale, than patients with a low degree of social support. SIGNIFICANCE OF THE RESULTS: The mixed findings may indicate that social support has only small effects on emotional functioning and stress reactions. Our results on the second assessment indicate, however, that social support might work as a buffer against reactions toward external stressful events such as terminal cancer.

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.

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.

Transformation of Physical DVHs to Radiobiologically Equivalent Ones in Hypofractionated Radiotherapy Analyzing Dosimetric and Clinical Parameters: A Practical Approach for Routine Clinical Practice in Radiation Oncology

PubMed Central

Thrapsanioti, Zoi; Karanasiou, Irene; Platoni, Kalliopi; Efstathopoulos, Efstathios P.; Matsopoulos, George; Dilvoi, Maria; Patatoukas, George; Chaldeopoulos, Demetrios; Kelekis, Nikolaos; Kouloulias, Vassilis

2013-01-01

Purpose. The purpose of this study was to transform DVHs from physical to radiobiological ones as well as to evaluate their reliability by correlations of dosimetric and clinical parameters for 50 patients with prostate cancer and 50 patients with breast cancer, who were submitted to Hypofractionated Radiotherapy. Methods and Materials. To achieve this transformation, we used both the linear-quadratic model (LQ model) and the Niemierko model. The outcome of radiobiological DVHs was correlated with acute toxicity score according to EORTC/RTOG criteria. Results. Concerning the prostate radiotherapy, there was a significant correlation between RTOG acute rectal toxicity and D 50 (P < 0.001) and V 60 (P = 0.001) dosimetric parameters, calculated for α/β = 10 Gy. Moreover, concerning the breast radiotherapy there was a significant correlation between RTOG skin toxicity and V ≥60 dosimetric parameter, calculated for both α/β = 2.3 Gy (P < 0.001) and α/β = 10 Gy (P < 0.001). The new tool seems reliable and user-friendly. Conclusions. Our proposed model seems user-friendly. Its reliability in terms of agreement with the presented acute radiation induced toxicity was satisfactory. However, more patients are needed to extract safe conclusions. PMID:24348743

Effectiveness of an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study

PubMed Central

Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

2017-01-01

Background Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). Material/Methods This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. Results There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: −39.31 vs. self-efficacy: −27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. Conclusions This intervention promoting self-efficacy could increase patients’ own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC. PMID:28832557

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.

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.

Health-related quality of life, cognitive screening, and functional status in a randomized phase III trial (EF-14) of tumor treating fields with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma.

PubMed

Zhu, Jay-Jiguang; Demireva, Petya; Kanner, Andrew A; Pannullo, Susan; Mehdorn, Maximilian; Avgeropoulos, Nicholas; Salmaggi, Andrea; Silvani, Antonio; Goldlust, Samuel; David, Carlos; Benouaich-Amiel, Alexandra

2017-12-01

We characterized health-related quality of life (HRQoL), cognitive, and functional status in newly diagnosed glioblastoma (GBM) patients receiving Tumor treating fields (TTFields) with temozolomide (TMZ) versus TMZ alone in a planned interim analysis of a randomized phase III trial [NCT00916409], which showed significant improvement in progression-free and overall survival with TTFields/TMZ. After radiotherapy with concomitant TMZ, newly diagnosed GBM patients were randomized (2:1) to TTFields/TMZ (n = 210) or TMZ (n = 105). Interim analysis was performed in 315 patients with ≥18 months of follow-up. HRQoL, a secondary endpoint, was evaluated in per-protocol patient population and expressed as change from baseline (CFB) at 3, 6, and 9 months for each subscale in the EORTC QLQ-C30/BN20. Karnofsky performance scores (KPS) and Mini-Mental State Examination scores (MMSE) were assessed. CFB in HRQoL was balanced in treatment groups at the 12-month time point. Initially, HRQoL improved in patients treated with TTFields/TMZ (CFB3: 24% and CFB6: 13%) versus TMZ (CFB3: -7% and CFB6: -17%), though this difference was no longer evident at the 9-month point. General scales, including physical and social functioning, showed no difference at 9 and 12 months. TTFields/TMZ group reported higher concerns of "itchy skin". KPS over 12 months was just below 90 in both groups. Cognitive status (MMSE) was stable over time. HRQoL, KPS, and MMSE were balanced in both groups over time. There was no preliminary evidence that HRQoL, cognitive, and functional status is adversely affected by the continuous use of TTFields.

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.

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

Quality of life of older rectal cancer patients is not impaired by a permanent stoma.

PubMed

Orsini, R G; Thong, M S Y; van de Poll-Franse, L V; Slooter, G D; Nieuwenhuijzen, G A P; Rutten, H J T; de Hingh, I H J T

2013-02-01

The current study was undertaken to investigate the impact of a stoma on the HRQL with a special focus on age. Using the Eindhoven Cancer Registry, rectal cancer patients diagnosed between 1998 and 2007 in 4 hospitals were identified. All patients underwent TME surgery. Survivors were approached to complete the SF-36 and EORTC QLQ-C38 questionnaires. HRQL scores of the four groups, stratified by stoma status (stoma/no stoma) and age at operation (<70 and ≥ 70), were compared. The SF-36 and the QLQ-CR38 sexuality subscale scores of the survivors were compared with an age- and sex-matched Dutch norm population. Median follow-up of 143 patients was 3.4 years. Elderly had significantly worse physical function (p = 0.0003) compared to younger patients. Elderly (p = 0.005) and patients without a stoma (p = 0.009) had worse sexual functioning compared to younger patients and patients with a stoma. Older males showed more sexual dysfunction (p = 0.01) when compared to younger males. In comparison with the normative population, elderly with a stoma had worse physical function (p < 0.01), but slightly better mental health (p < 0.05). Elderly without a stoma had better emotional role function (p < 0.01), and younger patients had worse sexual functioning and enjoyment (both p < 0.0001). Older patients with a stoma have comparable HRQL to older patients without a stoma or the normative population, indicating the feasibility of a permanent stoma for elderly patients with a low situated rectal carcinoma. The negative impact of treatment on sexual functioning as found in the current study calls for further attention to alleviate this problem in sexually active patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

Ostomy-related problems and their impact on quality of life of colorectal cancer ostomates: a systematic review.

PubMed

Vonk-Klaassen, Sylvia M; de Vocht, Hilde M; den Ouden, Marjolein E M; Eddes, Eric Hans; Schuurmans, Marieke J

2016-01-01

Many long-term ostomates are 'out-of-sight' of healthcare, and it is unknown how ostomates deal with ostomy-related problems and how these problems affect their quality of life (QOL). The aim is to examine patient-related studies describing ostomy-related problems and their impact on the perceived QOL of long-term colostomates. The electronic databases PubMed (MEDLINE), CINAHL, Cochrane Library and PsycINFO were systematically searched. All studies were included in which ostomy-specific QOL was measured using validated multidimensional instruments. Of the 6447 citations identified, 14 prevailingly descriptive cross-sectional studies were included. Three different validated multidimensional instruments for measuring QOL in ostomates were used (EORTC C30/CR38, MCOHQOLQO, Stoma QOL Questionnaire). All studies demonstrated that living with a colostomy influences the overall QOL negatively. The ostomy-related problems described included sexual problems, depressive feelings, gas, constipation, dissatisfaction with appearance, change in clothing, travel difficulties, feeling tired and worry about noises. In conclusion, all 14 studies gave an indication of the impact of ostomy-related problems on the perceived QOL and demonstrated that a colostomy influences the QOL negatively. There is a wide range of ostomy-specific QOL scores, and there seem to be higher QOL scores in the studies where the MCOHQOLQO instrument was used. The MCOHQOLQO and the Stoma QOL Questionnaire gave the most detailed information about which ostomy-related problems were experienced. This review adds knowledge about the impact of stoma-related problems on QOL of long-term ostomates, but more research has to be conducted, to detect ostomy-related problems and especially possible care needs.

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.

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.

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.

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.

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.

Prospective Evaluation of Acute Toxicity and Quality of Life After IMRT and Concurrent Chemotherapy for Anal Canal and Perianal Cancer

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

Han, Kathy; Cummings, Bernard J.; Lindsay, Patricia

Purpose: A prospective cohort study was conducted to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer. Methods and Materials: From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicitymore » was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Results: Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus—positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were significantly better at 12 months than at baseline. Multiple dose-volume parameters correlated moderately with diarrhea, skin, and hematologic toxicity scores. Conclusion: IMRT reduces acute grade 3 + hematologic and gastrointestinal toxicities compared with reports from non-IMRT series, without compromising locoregional control. The reported QOL scores most relevant to acute toxicities returned to baseline by 3 months after treatment.« less

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.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

PubMed

Nguyen, Thanh Vân France; Anota, Amélie; Brédart, Anne; Monnier, Alain; Bosset, Jean-François; Mercier, Mariette

2014-01-25

In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients' perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received.

[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.

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

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

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

2012-11-01

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

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

PubMed Central

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

2007-01-01

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

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.

Evaluation of the impact of tumor HPV status on outcome in patients with locally advanced unresectable head and neck squamous cell carcinoma (HNSCC) receiving cisplatin, 5-fluorouracil with or without docetaxel: a subset analysis of EORTC 24971 study.

PubMed

Psyrri, A; Fortpied, C; Koutsodontis, G; Avgeris, M; Kroupis, C; Goutas, N; Menis, J; Herman, L; Giurgea, L; Remenár, É; Degardin, M; Pateras, I S; Langendijk, J A; van Herpen, C M L; Awada, A; Germà-Lluch, J R; Kienzer, H R; Licitra, L; Vermorken, J B

2017-09-01

EORTC 24971 was a phase III trial demonstrating superiority of induction regimen TPF (docetaxel, cisplatin, 5-fluorouracil) over PF (cisplatin/5-fluorouracil), in terms of progression-free (PFS) and overall survival (OS) in locoregionally advanced unresectable head and neck squamous cell carcinomas. We conducted a retrospective analysis of prospectively collected data aiming to evaluate whether only HPV(-) patients (pts) benefit from adding docetaxel to PF, in which case deintensifying induction treatment in HPV(+) pts could be considered. Pretherapy tumor biopsies (blocks or slides) were assessed for high-risk HPV by p16 immunohistochemistry, PCR and quantitative PCR. HPV-DNA+ and/or p16+ tumors were subjected to in situ hybridization (ISH) and HPV E6 oncogene expression qRT-PCR analysis. Primary and secondary objectives were to evaluate the value of HPV/p16 status as predictive factor of treatment benefit in terms of PFS and OS. The predictive effect was analyzed based on the model used in the primary analysis of the study with the addition of a treatment by marker interaction term and tested at two-sided 5% significance level. Of 358, 119 pts had available tumor samples and 58 of them had oropharyngeal cancer. Median follow-up was 8.7 years. Sixteen of 119 (14%) evaluable samples were p16+ and 20 of 79 (25%) evaluable tumors were HPV-DNA+. 13 of 40 pts (33%) assessed with HPV-DNA ISH and 12 of 28 pts (43%) assessed for HPV E6 mRNA were positive. The preplanned analysis showed no statistical evidence of predictive value of HPV/p16 status for PFS (P = 0.287) or OS (P = 0.118). The incidence of HPV positivity was low in the subset of EORTC 24971 pts analyzed. In this analysis only powered to detect a large treatment by marker interaction, there was no statistical evidence that treatment effect found overall was different in magnitude in HPV(+) or HPV(-) pts. These results do not justify selection of TPF versus PF according to HPV status. © 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.

External audit on the clinical practice and medical decision-making at the departments of radiotherapy in Budapest and Vienna.

PubMed

Esik, O; Seitz, W; Lövey, J; Knocke, T H; Gaudi, I; Németh, G; Pötter, R

1999-04-01

To present an example of how to study and analyze the clinical practice and the quality of medical decision-making under daily routine working conditions in a radiotherapy department, with the aims of detecting deficiencies and improving the quality of patient care. Two departments, each with a divisional organization structure and an established internal audit system, the University Clinic of Radiotherapy and Radiobiology in Vienna (Austria), and the Department of Radiotherapy at the National Institute of Oncology in Budapest (Hungary), conducted common external audits. The descriptive parameters of the external audit provided information on the auditing (auditor and serial number of the audit), the cohorts (diagnosis, referring institution, serial number and intention of radiotherapy) and the staff responsible for the treatment (division and physician). During the ongoing external audits, the qualifying parameters were (1) the sound foundation of the indication of radiotherapy, (2) conformity to the institution protocol (3), the adequacy of the choice of radiation equipment, (4) the appropriateness of the treatment plan, and the correspondence of the latter with (5) the simulation and (6) verification films. Various degrees of deviation from the treatment principles were defined and scored on the basis of the concept of Horiot et al. (Horiot JC, Schueren van der E. Johansson KA, Bernier J, Bartelink H. The program of quality assurance of the EORTC radiotherapy group. A historical overview. Radiother. Oncol. 1993,29:81-84), with some modifications. The action was regarded as adequate (score 1) in the event of no deviation or only a small deviation with presumably no alteration of the desired end-result of the treatment. A deviation adversely influencing the result of the therapy was considered a major deviation (score 3). Cases involving a minor deviation (score 2) were those only slightly affecting the therapeutic end-results, with effects between those of cases with scores 1 and 3. Non-performance of the necessary radiotherapeutic procedures was penalized by the highest score of 4. Statistical evaluation was performed with the BMDP software package, using variance analysis. Bimonthly audits (six with a duration of 4-6 h in each institution) were carried out by three auditors from the evaluating departments; they reviewed a total of 452 cases in Department A, and 265 cases in Department B. Despite the comparable staffing and instrumental conditions, a markedly higher number (1.5 times) of new cases were treated in Department A, but with a lower quality of radiotherapy, as adequate values of qualifying parameters (1-6) were more frequent for the cases treated in Department B (85.3%, 94%, 83.4%, 28.3%, 41.9% and 81.1%) than for those in Department A (67%, 83.4%, 87.8%, 26.1%, 33.2% and 17.7%). The responsible division (including staff and instrumentation), the responsible physician and the type of the disease each exerted a highly significant effect on the quality level of the treatment. Statistical analysis revealed a positive influence of the curative (relative to the palliative/symptomatic) intention of the treatment on the level of quality, but the effect of the first radiotherapy (relative to the second or further one) was statistically significant in only one department. At the same time, the quality parameters did not vary with the referring institution, the auditing person or the serial number of the audit. The external audit relating to the provision of radiotherapeutic care proved feasible with the basic conformity and compliance of the staff and resulted in valuable information to take correction measures.

Is It Time to Include CT "Reverse Halo Sign" and qPCR Targeting Mucorales in Serum to EORTC-MSG Criteria for the Diagnosis of Pulmonary Mucormycosis in Leukemia Patients?

PubMed

Caillot, Denis; Valot, Stéphane; Lafon, Ingrid; Basmaciyan, Louise; Chretien, Marie Lorraine; Sautour, Marc; Million, Laurence; Legouge, Caroline; Payssot, Alexandre; Dalle, Frédéric

2016-10-01

In 23 leukemia patients with proven (n = 17) or possible (n = 6) pulmonary mucormycosis (PM), the presence of reversed halo sign on computed tomography was strongly associated with the positivity of quantitative polymerase chain reaction assays targeting Mucorales in the serum, confirming the value of these two tools for the diagnosis of PM in this setting.

[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.

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.

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.

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.

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.

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.

Impact of age, comorbidity and symptoms on physical function in long-term breast cancer survivors (CALGB 70803)

PubMed Central

Cohen, Harvey Jay; Lan, Lan; Archer, Laura; Kornblith, Alice B.

2012-01-01

Purpose The purpose of this study was to assess the impact of aging, comorbidities and symptoms on physical function in patients surviving 20 years since adjuvant treatment for breast cancer. Patients & Methods Patients were originally treated on CALGB 7581 (from 1975–1980), a randomized trial of three adjuvant therapies and reassessed (153 of 193 eligible survivors) 20 years from the onset of therapy for physical function and symptoms by the EORTC QLQ-C30 and comorbidities by the OARS questionnaire. Results The average age at reassessment was 64.5 years. 66% of patients had at least two comorbidities and 22% had four or more, but relatively little interference with activities. Older patients had greater multimorbidity. Physical function was generally high and comparable to matched population norms. Older patients had greater difficulty with strenuous activities. For every increase in number of comorbidities, physical function score decreased by 5.1 (p<.001). Symptoms were also frequent (80%) and correlated strongly with decreases in function (0–100u scale) (p <.001), to an even greater degree than comorbidities. Conclusion Very long-term cancer survivors have changes in physical function and symptoms largely consistent with their aging suggesting that the impact of cancer and its treatment is attenuated over time and largely replaced by the impact of age-related comorbidities and functional decline. PMID:22707996

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.

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

PubMed

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

2017-01-01

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

Quality of life 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.

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.

Are patients satisfied with the head and neck skin cancer service? An evaluation of outpatient services with a review of published reports.

PubMed

Petrosyan, V; Patel, K; Ameerally, P J

2017-12-01

Scientific publications place much emphasis on postoperative outcomes such as recurrence, but little attention to patients' satisfaction. The purpose of this evaluation was to find out patients' reported outcomes after their initial consultation, treatment, and follow-up appointments for non-melanoma skin cancer of the head and neck. We used an adapted version of the European Organisation for Research and Treatment of Cancer (EORTC) validated questionnaire for patients' satisfaction to collect data prospectively from consenting patients between September and December 2015. A total of 179 questionnaires were completed (initial consultation n=51, treatment n=74, and follow up n=54). Patients were most satisfied with the appointments for treatment (Kruskal-Wallis p<0.001, mean (SD) score 4.86/5 (0.15)), and 87% regarding the service as excellent. Patients were least satisfied with services and organisation of care compared with nurses and doctors (Kruskal-Wallis p<0.001). There seemed to be most satisfaction after the appointment for treatment. A possible explanation could simply be the relief of having finally had their cancer removed. Patients are also likely to show greater satisfaction with the clinical team because of the personal nature of the interaction that they experience during this aspect of their care. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

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.

Capecitabine and Oxaliplatin Before, During, and After Radiotherapy for High-Risk Rectal Cancer.

PubMed

Larsen, Finn Ole; Markussen, Alice; Jensen, Benny V; Fromm, Anne L; Vistisen, Kirsten K; Parner, Vibeke K; Linnemann, Dorte; Hansen, Rasmus H; Johannesen, Helle H; Schou, Jakob V

2017-06-01

To evaluate the effect of capecitabine and oxaliplatin before, during, and after radiotherapy for high-risk rectal cancer. Patients with rectum cancer T4 or T3 involving the mesorectal fascia was included in a prospective phase 2 trial. Liver or lung metastases were accepted if the surgeons found them resectable. The patients received 6 weeks of capecitabine and oxaliplatin before chemoradiotherapy (CRT), continued capecitabine and oxaliplatin during radiotherapy, and received 4 weeks of capecitabine and oxaliplatin after CRT. The patients received radiotherapy as intensity-modulated radiotherapy. Total mesorectal excision was planned 8 weeks after CRT. The patients were evaluated with magnetic resonance imaging (MRI) before start of treatment, after 6 weeks of chemotherapy, and again just before the operation. The European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR29 scoring system was used to evaluate adverse events. Fifty-two patients were enrolled between 2009 and 2012. The treatment was well tolerated, with only one death during treatment. Eighty percent of assessable patients experienced response to chemotherapy alone as evaluated by MRI, which increased to 94% after complete oncologic treatment. Forty-nine patients had a total mesorectal excision performed, all with a R0 resection and with a pathologic complete response of 20% for patients with T3 tumor and 7% for patients with T4 tumor. Five patients had metastases at study entry, while 47 patients had locally advanced rectal cancer without metastases. Of these 47 patients, overall survival and progression-free survival at 5 years was 72% and 62%, respectively, with a median follow-up of 60 months. This aggressive approach with capecitabine and oxaliplatin before, during, and after radiotherapy for high-risk rectal cancer is safe and feasible; it also has an impressive response rate as measured by MRI and a promising 5-year overall survival. Copyright © 2016 Elsevier Inc. 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.

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.

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.

Fatigue, insomnia and hot flashes after definitive radiochemotherapy and image-guided adaptive brachytherapy for locally advanced cervical cancer: An analysis from the EMBRACE study.

PubMed

Smet, Stéphanie; Pötter, Richard; Haie-Meder, Christine; Lindegaard, Jacob C; Schulz-Juergenliemk, Ina; Mahantshetty, Umesh; Segedin, Barbara; Bruheim, Kjersti; Hoskin, Peter; Rai, Bhavana; Huang, Fleur; Cooper, Rachel; van Limbergen, Erik; Tanderup, Kari; Kirchheiner, Kathrin

2018-04-04

To evaluate the pattern of manifestation of fatigue, insomnia and hot flashes within the prospective, observational, multi-center EMBRACE study. Morbidity was prospectively assessed according to CTCAE v.3 and patient-reported outcome with EORTC QLQ-C30/CX24 at baseline and regular follow-up. Analyses of crude incidence, prevalence rates and actuarial estimates were performed. A total of 1176 patients were analyzed with a median follow-up of 27 months. At baseline, CTCAE G1/G2 prevalence rates for fatigue were 29%/6.2%, for insomnia 18%/3.1% and for hot flashes 7.9%/1.6% with respective 3-year prevalence rates of 29%/6.8%, 17%/4.4% and 19%/5.9%. Similar patterns of manifestation were seen in patient-reported EORTC outcomes. The 3-year actuarial estimates for G ≥ 3 CTCAE fatigue, insomnia and hot flashes were 5.5%, 4.7% and 1.9%. Younger age was associated with significantly higher risk for fatigue, insomnia and hot flashes. Fatigue, insomnia and hot flashes occurred mainly in the mild to moderate range. Fatigue and insomnia were already present before treatment and showed minor fluctuations or recovery during follow-up, whereas hot flashes showed a considerable increase after treatment. More research is needed to evaluate contributing risk factors in order to define intervention strategies. Copyright © 2018 Elsevier B.V. All rights reserved.

The accuracy of serum galactomannan assay in diagnosing invasive pulmonary aspergillosis.

PubMed

Sarrafzadeh, Shokooh Azam; Hoseinpoor Rafati, Ali; Ardalan, Maryam; Mansouri, Davood; Tabarsi, Payam; Pourpak, Zahra

2010-09-01

Galactomannan (GM) antigen is an aspergillus specific antigen that is released during the growth phase of invasive aspergillosis. We aimed to find the optimum cutoff and accuracy of serum Galactomannan assay in immunocompromised patients. Immunocompromised patients diagnosed with invasive pulmonary aspergillosis (IPA) based on the European Organization for Research and Treatment of Cancer/Invasive Mycosis Study Group (EORTC/MSG) with three levels of certainty proven, probable and possible, referred for GM antigen measurement at Immunology, Asthma and Allergy Research Institute (IAARI) from 2006 to 2009 and if they met the criteria were enrolled in this study. Totally 49 patients with IPA were enrolled in our study. According to EORTC/MSG, patients categorized into three levels of certainty: They were diagnosed as 'proven' invasive pulmonary aspergillosis 16(32.7%), 'probable' 18(36.7%) and 'possible' 15(30.6%). The most common host risk factor was solid tumors 17(34.7%). The accuracy of Galactomannan assay increased from 0.5 to 2 cutoffs. The optimum sensitivity and specificity obtained at the index cutoff of ≥1.5 for diagnosis of "proven" IPA; which were respectively, 69.2% and 72.2%. Other cutoffs had high variance between sensitivity and specificity for diagnosis of IPA. The calculated cutoff gained by receiver operating characteristic (ROC) analysis for detecting proven IPA was 1.5. Intermediate accuracy of serum GM test in conjunct with clinical findings would help early IPA detection among immunocompromised patients.

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.

Diffuse Large B-Cell Lymphoma: Prospective Multicenter Comparison of Early Interim FLT PET/CT versus FDG PET/CT with IHP, EORTC, Deauville, and PERCIST Criteria for Early Therapeutic Monitoring

PubMed Central

Minamimoto, Ryogo; Fayad, Luis; Advani, Ranjana; Vose, Julie; Macapinlac, Homer; Meza, Jane; Hankins, Jordan; Mottaghy, Felix; Juweid, Malik

2016-01-01

Purpose To compare the performance characteristics of interim fluorine 18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) (after two cycles of chemotherapy) by using the most prominent standardized interpretive criteria (including International Harmonization Project [IHP] criteria, European Organization for Research and Treatment of Cancer [EORTC] criteria, and PET Response Criteria in Solid Tumors (PERCIST) versus those of interim 18F fluorothymidine (FLT) PET/CT and simple visual interpretation. Materials and Methods This HIPAA-compliant prospective study was approved by the institutional review boards, and written informed consent was obtained. Patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) underwent both FLT and FDG PET/CT 18–24 days after two cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone or rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin. For FDG PET/CT interpretation, IHP criteria, EORTC criteria, PERCIST, Deauville criteria, standardized uptake value, total lesion glycolysis, and metabolic tumor volume were used. FLT PET/CT images were interpreted with visual assessment by two reviewers in consensus. The interim (after cycle 2) FDG and FLT PET/CT studies were then compared with the end-of-treatment FDG PET/CT studies to determine which interim examination and/or criteria best predicted the result after six cycles of chemotherapy. Results From November 2011 to May 2014, there were 60 potential patients for inclusion, of whom 46 patients (24 men [mean age, 60.9 years ± 13.7; range, 28–78 years] and 22 women [mean age, 57.2 years ± 13.4; range, 25–76 years]) fulfilled the criteria. Thirty-four patients had complete response, and 12 had residual disease at the end of treatment. FLT PET/CT had a significantly higher positive predictive value (PPV) (91%) in predicting residual disease than did any FDG PET/CT interpretation method (42%–46%). No difference in negative predictive value (NPV) was found between FLT PET/CT (94%) and FDG PET/CT (82%–95%), regardless of the interpretive criteria used. FLT PET/CT showed statistically higher (P < .001–.008) or similar NPVs than did FDG PET/CT. Conclusion Early interim FLT PET/CT had a significantly higher PPV than standardized FDG PET/CT–based interpretation for therapeutic response assessment in DLBCL. © RSNA, 2016 Online supplemental material is available for this article. PMID:26854705

Long-term trajectories of self-reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance).

PubMed

Mandelblatt, Jeanne S; Clapp, Jonathan D; Luta, Gheorghe; Faul, Leigh Anne; Tallarico, Michelle D; McClendon, Trina D; Whitley, Jessica A; Cai, Ling; Ahles, Tim A; Stern, Robert A; Jacobsen, Paul B; Small, Brent J; Pitcher, Brandelyn N; Dura-Fernandis, Estrella; Muss, Hyman B; Hurria, Arti; Cohen, Harvey J; Isaacs, Claudine

2016-07-22

The number of survivors of breast cancer aged ≥65 years ("older") is growing, but to the authors' knowledge, little is known regarding the cognitive outcomes of these individuals. A cohort of cognitively intact older survivors with nonmetastatic, invasive breast cancer was recruited from 78 sites from 2004 through 2011; approximately 83.7% of the survivors (1280 survivors) completed baseline assessments. Follow-up data were collected at 6 months and annually for up to 7 years (median, 4.1 years). Cognitive function was self-reported using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30); scores ranged from 0 to 100, with a higher score indicating better function. Group-based trajectory modeling determined trajectories; women were assigned to a trajectory group based on the highest predicted probability of membership. Multinomial logistic regression evaluated the association between receipt of chemotherapy (with or without hormonal treatment) and trajectory group. Survivors were aged 65 to 91 years; approximately 41% received chemotherapy. There were 3 cognitive trajectories: "maintained high" (42.3% of survivors); "phase shift" (50.1% of survivors), with scores slightly below but parallel to maintained high; and "accelerated decline" (7.6% of survivors), with the lowest baseline scores and greatest decline (from 71.7 [standard deviation, 19.8] to 58.3 [standard deviation, 21.9]). The adjusted odds of being in the accelerated decline group (vs the maintained high group) were 2.1 times higher (95% confidence interval, 1.3-3.5) for survivors who received chemotherapy (with or without hormonal therapy) versus those treated with hormonal therapy alone. Greater comorbidity and frailty also were found to be associated with accelerated decline. Trajectory group analysis demonstrated that the majority of older survivors maintained good long-term self-reported cognitive function, and that only a small subset who were exposed to chemotherapy manifested accelerated cognitive decline. Future research is needed to determine factors that place some older survivors at risk of experiencing cognitive decline. Cancer 2016. 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

EANM-EORTC general recommendations for sentinel node diagnostics in melanoma.

PubMed

Chakera, Annette H; Hesse, Birger; Burak, Zeynep; Ballinger, James R; Britten, Allan; Caracò, Corrado; Cochran, Alistair J; Cook, Martin G; Drzewiecki, Krzysztof T; Essner, Richard; Even-Sapir, Einat; Eggermont, Alexander M M; Stopar, Tanja Gmeiner; Ingvar, Christian; Mihm, Martin C; McCarthy, Stanley W; Mozzillo, Nicola; Nieweg, Omgo E; Scolyer, Richard A; Starz, Hans; Thompson, John F; Trifirò, Giuseppe; Viale, Giuseppe; Vidal-Sicart, Sergi; Uren, Roger; Waddington, Wendy; Chiti, Arturo; Spatz, Alain; Testori, Alessandro

2009-10-01

The accurate diagnosis of a sentinel node in melanoma includes a sequence of procedures from different medical specialities (nuclear medicine, surgery, oncology, and pathology). The items covered are presented in 11 sections and a reference list: (1) definition of a sentinel node, (2) clinical indications, (3) radiopharmaceuticals and activity injected, (4) dosimetry, (5) injection technique, (6) image acquisition and interpretation, (7) report and display, (8) use of dye, (9) gamma probe detection, (10) surgical techniques in sentinel node biopsy, and (11) pathological evaluation of melanoma-draining sentinel lymph nodes. If specific recommendations given cannot be based on evidence from original, scientific studies, referral is given to "general consensus" and similar expressions. The recommendations are designed to assist in the practice of referral to, performance, interpretation and reporting of all steps of the sentinel node procedure in the hope of setting state-of-the-art standards for good-quality evaluation of possible spread to the lymphatic system in intermediate-to-high risk melanoma without clinical signs of dissemination.

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.

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.

The influence of simultaneous integrated boost, hypofractionation and oncoplastic surgery on cosmetic outcome and PROMs after breast conserving therapy.

PubMed

Lansu, J T P; Essers, M; Voogd, A C; Luiten, E J T; Buijs, C; Groenendaal, N; Poortmans, P M H

2015-10-01

We retrospectively investigated the possible influence of a simultaneous integrated boost (SIB), hypofractionation and oncoplastic surgery on cosmetic outcome in 125 patients with stage I-II breast cancer treated with breast conserving therapy (BCT). The boost was given sequentially (55%) or by SIB (45%); fractionation was conventional (83%) or hypofractionated (17%); the surgical technique was a conventional lumpectomy (74%) or an oncoplastic technique (26%). We compared cosmetic results subjectively using a questionnaire independently completed by the patient and by the physician and objectively with the BCCT.core software. Independent-samples T-tests were used to compare outcome in different groups. Patients also completed the EORTC QLQ C30 and BR23. Univariate analyses indicated no significant differences of the cosmetic results (P ≤ 0.05) for the type of boost or fractionation. However, the conventional lumpectomy group scored significantly better than the oncoplastic group in the BCCT.core evaluation, without a significant difference in the subjective cosmetic evaluation. Quality of life outcome was in favour of SIB, hypofractionation and conventional surgery. Our study indicates that the current RT techniques seem to be safe for cosmetic outcome and quality of life. Further investigation is needed to verify the possible negative influence of oncoplastic surgery on the cosmetic outcome and the quality of life as this technique is especially indicated for patients with an unfavourable tumour/breast volume ratio. Copyright © 2015 Elsevier Ltd. All rights reserved.

Quality of life 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.

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.

Quality of life after cancer-How the extent of impairment is influenced by patient characteristics.

PubMed

Peters, Elisabeth; Mendoza Schulz, Laura; Reuss-Borst, Monika

2016-10-10

Although this effect is well known, tailored treatment methods have not yet been broadly adopted. The aim of this study was to identify those patient characteristics that most influence the impairment of quality of life and thus to identify those patients who need and can benefit most from specific intervention treatment. 1879 cancer patients were given the EORTC QLQ C-30 questionnaire at the beginning and end of their inpatient rehabilitation. Patients' scores were compared to those of 2081 healthy adults (Schwarz and Hinz, Eur J Cancer 37:1345-1351, 2001). Furthermore, differences in quality of life corresponding to sex, age, tumor site, TNM stage, interval between diagnosis and rehabilitation, and therapy method were examined. Compared to the healthy population, the study group showed a decreased quality of life in all analyzed domains. This difference diminished with increasing age. Women reported a lower quality of life then men in general. Patients with prostate cancer showed the least impairment in several domains. Patients having undergone chemotherapy as well as radiotherapy were impaired the most. Surprisingly, TNM stage and interval between diagnosis and rehabilitation did not significantly influence quality of life. Global quality of life and all functional domains significantly improved after a 3-week rehabilitation program. Despite an individualized and increasingly better tolerable therapy, the quality of life of cancer patients is still considerably impaired. However, systematic screening of psychosocial aspects of cancer, e.g. quality of life, could enable improved intervention.

Weight loss and quality of life in patients surviving 2 years after gastric cancer resection.

PubMed

Climent, M; Munarriz, M; Blazeby, J M; Dorcaratto, D; Ramón, J M; Carrera, M J; Fontane, L; Grande, L; Pera, M

2017-07-01

Malnutrition is common in patients undergoing gastric cancer resection, leading to weight loss, although little is known about how this impacts on health-related quality of life (HRQL). This study aimed to explore the association between HRQL and weight loss in patients 2 years after curative gastric cancer resection. Consecutive patients undergoing curative gastric cancer resection and surviving at least 2 years without disease recurrence were recruited. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the specific module for gastric cancer (STO22) before and 2 years postoperatively and associations between HRQL scores and patients with and without ≥ 10% body weight loss (BWL) were examined. A total of 76 patients were included, of whom 51 (67%) had BWL ≥10%. At 2 years postoperatively, BWL ≥10% was associated with deterioration of all functional aspects of quality of life, with persistent pain (21.6%), diarrhoea (13.7%) and nausea/vomiting (13.7%). By contrast, none of the patients with BWL <10% experienced severe nausea/vomiting, pain or diarrhoea. Disabling symptoms occurred more frequently in patients with ≥10% BWL than in those with <10% BWL, with a relevant negative impact on HRQL. A cause-effect relationship between weight loss and postoperative outcome remains unsolved. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Construction of quality of life change patterns: example in oncology in a phase III therapeutic trial (FFCD 0307).

PubMed

Nuemi, Gillles; Devilliers, Hervé; Le Malicot, Karine; Guimbaud, Rosine; Lepage, Côme; Quantin, Catherine

2015-09-22

Quality of life data in cancerology are often difficult to summarize due to missing data and difficulty to analyze the pattern of evolution in different groups of patients. The aim of this work was to apply a new methodology to construct Quality of Life (QoL) change patterns within patients included in a clinical trial comparing to regimen of treatment in locally advanced eosogastric cancer. In this trial, QoL was assessed every 2 months by self-reported EORTC QLQ-C30 questionnaire. Physical dimension scores were analyzed. After multiple imputation of missing data, 27 statistical measures aiming to describe the variation of QoL measures among follow-up were computed for each patient. Based on these measures, patient were grouped into homogenous groups in terms of QoL variation pattern using a K-Means classification method. The mean QoL score at each time was graphically represented in each obtained pattern. Finally, clinical characteristic of patients in each pattern of QoL were described and compared. The trial included 416 patients and 1023 questionnaire were collected. 74% of patients were male with a mean ± SD age of 62 ± 11 years. 43% of scores were missing. Patients were grouped into four classes of homogeneous QoL variation patterns. 1) a Pattern of 24 (6%) patients showing improvement in QoL with a mean variation of +10.7 points on the 0-100 scale, 2) a Pattern of 171 (41 %) patients showing a stability 3) two Patterns of 78 (19%) and 143 (34%) patients respectively showing a deterioration of QoL with a mean variation of -67.2 and -67.6, respectively. There were no difference between patterns in terms of gender or age. Patients within "degradation" pattern had significantly lower performance status (p = 0.015), higher severe after-effects rate (p < 10-3) and death rate (p < 10-3). This work opens up perspectives for longitudinal data analysis with a high probability of missing values while providing a relevant graphical summary. Patterns of QoL evolution with clinical relevance may help to interpret longitudinal QoL data in Cancer studies.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire

PubMed Central

2014-01-01

Background In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. Methods Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients’ perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. Results Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. Conclusions Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received. PMID:24460858

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.

A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN).

PubMed

Schloss, Janet M; Colosimo, Maree; Airey, Caroline; Masci, Paul; Linnane, Anthony W; Vitetta, Luis

2017-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect resulting from neurotoxic chemotherapeutic agents. This study aimed to assess the efficacy and safety of an oral B group vitamin compared to placebo, in preventing the incidence of CIPN in cancer patients undergoing neurotoxic chemotherapy. A pilot, randomised, placebo-controlled trial was conducted. Newly diagnosed cancer patients prescribed with taxanes, oxaliplatin or vincristine were invited to participate. A total of 71 participants (female 68 %, male 32 %) were enrolled into the study and randomised to the B group vitamin (n = 38) arm or placebo (n = 33). The data from 47 participants were eligible for analysis (B group vitamins n = 27, placebo n = 22). The primary outcome measure was the total neuropathy score assessed by an independent neurologist. Secondary outcome measures included serum vitamin B levels, quality of life, pain inventory and the patient neurotoxicity questionnaires. Outcome measures were conducted at baseline, 12, 24 and 36 weeks. The total neuropathy score (TNS) demonstrated that a B group vitamin did not significantly reduce the incidence of CIPN compared to placebo (p = 0.73). Statistical significance was achieved for patient perceived sensory peripheral neuropathy (12 weeks p = 0.03; 24 weeks p = 0.005; 36 weeks p = 0.021). The risk estimate for the Patient Neurotoxicity Questionnaire (PNQ) was also statistically significant (OR = 5.78, 95 % CI = 1.63-20.5). The European Organisation of Research and Treatment of Cancer (EORTC) quality of life, total pain score and pain interference showed no significance (p = 0.46, p = 0.9, p = 0.37 respectively). A trend was observed indicating that vitamin B12 may reduce the onset and severity of CIPN. An oral B group vitamin as an adjunct to neurotoxic chemotherapy regimens was not superior to placebo (p > 0.05) for the prevention of CIPN. Patients taking the B group vitamin perceived a reduction in sensory peripheral neuropathy in the PNQ. Moreover, a robust clinical study is warranted given that vitamin B12 may show potential in reducing the onset and severity of CIPN. Trial number: ACTRN12611000078954 Protocol number: UH2010000749.

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.

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.

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

PubMed

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

2004-02-01

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

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.

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

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

PubMed

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

2004-01-01

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

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

PubMed

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

2014-09-01

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

Patterns of practice of regional nodal irradiation in breast cancer: results of the European Organization for Research and Treatment of Cancer (EORTC) NOdal Radiotherapy (NORA) survey.

PubMed

Belkacemi, Y; Kaidar-Person, O; Poortmans, P; Ozsahin, M; Valli, M-C; Russell, N; Kunkler, I; Hermans, J; Kuten, A; van Tienhoven, G; Westenberg, H

2015-03-01

Predicting outcome of breast cancer (BC) patients based on sentinel lymph node (SLN) status without axillary lymph node dissection (ALND) is an area of uncertainty. It influences the decision-making for regional nodal irradiation (RNI). The aim of the NORA (NOdal RAdiotherapy) survey was to examine the patterns of RNI. A web-questionnaire, including several clinical scenarios, was distributed to 88 EORTC-affiliated centers. Responses were received between July 2013 and January 2014. A total of 84 responses were analyzed. While three-dimensional (3D) radiotherapy (RT) planning is carried out in 81 (96%) centers, nodal areas are delineated in only 51 (61%) centers. Only 14 (17%) centers routinely link internal mammary chain (IMC) and supraclavicular node (SCN) RT indications. In patients undergoing total mastectomy (TM) with ALND, SCN-RT is recommend by 5 (6%), 53 (63%) and 51 (61%) centers for patients with pN0(i+), pN(mi) and pN1, respectively. Extra-capsular extension (ECE) is the main factor influencing decision-making RNI after breast conserving surgery (BCS) and TM. After primary systemic therapy (PST), 49 (58%) centers take into account nodal fibrotic changes in ypN0 patients for RNI indications. In ypN0 patients with inner/central tumors, 23 (27%) centers indicate SCN-RT and IMC-RT. In ypN1 patients, SCN-RT is delivered by less than half of the centers in patients with ypN(i+) and ypN(mi). Twenty-one (25%) of the centers recommend ALN-RT in patients with ypN(mi) or 1-2N+ after ALND. Seventy-five (90%) centers state that age is not considered a limiting factor for RNI. The NORA survey is unique in evaluating the impact of SLNB/ALND status on adjuvant RNI decision-making and volumes after BCS/TM with or without PST. ALN-RT is often indicated in pN1 patients, particularly in the case of ECE. Besides the ongoing NSABP-B51/RTOG and ALLIANCE trials, NORA could help to design future specific RNI trials in the SLNB era without ALND in patients receiving or not PST. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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.

Use of complementary and alternative medicine by lymphoma survivors in South Korea.

PubMed

Kim, Kisook; Kim, Soo Hyun; Ok, Oh Nam; Kim, Im-Ryung; Lee, Suyeon; Kim, So Hee; Kim, Won Seog; Ryu, Min-Hee; Lee, Moon Hee

2018-04-01

We aimed to examine the experience of complementary and alternative medicine (CAM) use and its association with health-related quality of life (HRQOL) in lymphoma survivors in South Korea. The participants were 869 lymphoma survivors from three hospitals in South Korea, all diagnosed with lymphoma at least 24 months prior to participation. Self-reported questionnaires were used to assess CAM use. The questionnaire addressed types of CAM used, sources of information about CAM, reason for CAM use, satisfaction with CAM use, discussion of CAM use with doctors, experience of side effects, costs of CAM use, and intentions to continue using CAM. HRQOL was measured with the EORTC QLQ-C30. Of the 869 participants, 42.2% had experience using CAM, and there were statistically significant differences among CAM users and non-users in terms of sex, religion, and time since diagnosis. A special diet (e.g., ginseng, chitosan, mixed cereals) was the most commonly used type of CAM, and most CAM users (82.1%) were satisfied with their CAM use. Most CAM users (77.5%) did not discuss the use of CAM with their doctors, and only 9.2% reported any side effects from CAM. CAM users showed significantly lower HRQOL scores than did non-users. A significant number of lymphoma survivors in Korea have used CAM, and most CAM users are satisfied with their CAM use. Oncology nurses should be aware of the range of CAM use among patients and reflect their responses in their treatment and/or follow-up care. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Standardization of definitions in focal therapy of prostate cancer: report from a Delphi consensus project.

PubMed

Postema, A W; De Reijke, T M; Ukimura, O; Van den Bos, W; Azzouzi, A R; Barret, E; Baumunk, D; Blana, A; Bossi, A; Brausi, M; Coleman, J A; Crouzet, S; Dominguez-Escrig, J; Eggener, S; Ganzer, R; Ghai, S; Gill, I S; Gupta, R T; Henkel, T O; Hohenfellner, M; Jones, J S; Kahmann, F; Kastner, C; Köhrmann, K U; Kovacs, G; Miano, R; van Moorselaar, R J; Mottet, N; Osorio, L; Pieters, B R; Polascik, T J; Rastinehad, A R; Salomon, G; Sanchez-Salas, R; Schostak, M; Sentker, L; Tay, K J; Varkarakis, I M; Villers, A; Walz, J; De la Rosette, J J

2016-10-01

To reach standardized terminology in focal therapy (FT) for prostate cancer (PCa). A four-stage modified Delphi consensus project was undertaken among a panel of international experts in the field of FT for PCa. Data on terminology in FT was collected from the panel by three rounds of online questionnaires. During a face-to-face meeting on June 21, 2015, attended by 38 experts, all data from the online rounds were reviewed and recommendations for definitions were formulated. Consensus was attained on 23 of 27 topics; Targeted FT was defined as a lesion-based treatment strategy, treating all identified significant cancer foci; FT was generically defined as an anatomy-based (zonal) treatment strategy. Treatment failure due to the ablative energy inadequately destroying treated tissue is defined as ablation failure. In targeting failure the energy is not adequately applied to the tumor spatially and selection failure occurs when a patient was wrongfully selected for FT. No definition of biochemical recurrence can be recommended based on the current data. Important definitions for outcome measures are potency (minimum IIEF-5 score of 21), incontinence (new need for pads or leakage) and deterioration in urinary function (increase in IPSS >5 points). No agreement on the best quality of life tool was established, but UCLA-EPIC and EORTC-QLQ-30 were most commonly supported by the experts. A complete overview of statements is presented in the text. Focal therapy is an emerging field of PCa therapeutics. Standardization of definitions helps to create comparable research results and facilitate clear communication in clinical practice.

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.

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.

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.

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.

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.

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.

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.

A Safety Run-in and Randomized Phase II Study of Cilengitide Combined with Chemoradiation for Newly Diagnosed Glioblastoma (NABTT 0306)

PubMed Central

Nabors, L. Burt; Mikkelsen, Tom; Hegi, Monika E.; Ye, Xiaubu; Batchelor, Tracy; Lesser, Glenn; Peereboom, David; Rosenfeld, Myrna R.; Olsen, Jeff; Brem, Steve; Fisher, Joy D.; Grossman, Stuart A.

2012-01-01

Background Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biological activity in patients with recurrent malignant glioma. The primary objectives of this randomized phase II trial were to determine safety and efficacy of cilengitide when combined with radiation and temozolomide for newly diagnosed glioblastoma (GBM) and to select a dose for comparative clinical testing. Methods A total of 112 patients were accrued. Eighteen patients received standard RT+TMZ with cilengitide in a safety run-in phase followed by a randomized phase II with ninety-four patients assigned to either 500 or 2000 mg dose groups. The trial was designed to estimate overall survival benefit when compared with the NABTT internal historical control or the published EORTC 26981 data. Results Cilengitide at all doses studied was well tolerated with radiation and temozolomide. The median survival was 19.7 months for all patients, 17.4 months for those receiving the 500 mg dose, 20.8 months for those receiving the 2000mg dose, 30 months for patients with methylated MGMT promoters and 17.4 months for unmethylated patients. For patients ages 70 and younger, the median survival and survival at 24 months was superior to that observed in the EORTC trial (20.7 months vs 14.6 months and 41% vs 27% (p=0.008) respectively). Conclusions Cilengitide is well tolerated when combined with standard chemoradiation and may improve survival for patients newly diagnosed with GBM regardless of MGMT status. From an efficacy and safety standpoint, future trials of this agent in this population should utilize the 2000 mg dose. PMID:22517399

Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma

PubMed Central

Gorlia, T.; Cairncross, J.G.; van den Bent, M.J.; Mason, W.; Belanger, K.; Brandes, A.A.; Bogdahn, U.; Macdonald, D.R.; Forsyth, P.; Rossetti, A.O.; Lacombe, D.; Mirimanoff, R.-O.; Vecht, C.J.; Stupp, R.

2011-01-01

Objective: This analysis was performed to assess whether antiepileptic drugs (AEDs) modulate the effectiveness of temozolomide radiochemotherapy in patients with newly diagnosed glioblastoma. Methods: The European Organization for Research and Treatment of Cancer (EORTC) 26981–22981/National Cancer Institute of Canada (NCIC) CE.3 clinical trial database of radiotherapy (RT) with or without temozolomide (TMZ) for newly diagnosed glioblastoma was examined to assess the impact of the interaction between AED use and chemoradiotherapy on survival. Data were adjusted for known prognostic factors. Results: When treatment began, 175 patients (30.5%) were AED-free, 277 (48.3%) were taking any enzyme-inducing AED (EIAED) and 135 (23.4%) were taking any non-EIAED. Patients receiving valproic acid (VPA) only had more grade 3/4 thrombopenia and leukopenia than patients without an AED or patients taking an EIAED only. The overall survival (OS) of patients who were receiving an AED at baseline vs not receiving any AED was similar. Patients receiving VPA alone (97 [16.9%]) appeared to derive more survival benefit from TMZ/RT (hazard ratio [HR] 0.39, 95% confidence interval [CI] 0.24–0.63) than patients receiving an EIAED only (252 [44%]) (HR 0.69, 95% CI 0.53–0.90) or patients not receiving any AED (HR 0.67, 95% CI 0.49–0.93). Conclusions: VPA may be preferred over an EIAED in patients with glioblastoma who require an AED during TMZ-based chemoradiotherapy. Future studies are needed to determine whether VPA increases TMZ bioavailability or acts as an inhibitor of histone deacetylases and thereby sensitizes for radiochemotherapy in vivo. PMID:21880994

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.

Clinical significance of HOX11L2 expression linked to t(5;14)(q35;q32), of HOX11 expression, and of SIL-TAL fusion in childhood T-cell malignancies: results of EORTC studies 58881 and 58951.

PubMed

Cavé, Hélène; Suciu, Stefan; Preudhomme, Claude; Poppe, Bruce; Robert, Alain; Uyttebroeck, Anne; Malet, Michèle; Boutard, Patrick; Benoit, Yves; Mauvieux, Laurent; Lutz, Patrick; Méchinaud, Françoise; Grardel, Nathalie; Mazingue, Francoise; Dupont, Madeleine; Margueritte, Geneviève; Pages, Marie-Pierre; Bertrand, Yves; Plouvier, Emmanuel; Brunie, Ghislaine; Bastard, Christian; Plantaz, Dominique; Vande Velde, Isabel; Hagemeijer, Anne; Speleman, Frank; Lessard, Michel; Otten, Jacques; Vilmer, Etienne; Dastugue, Nicole

2004-01-15

In a series of 153 children with T-cell malignancies enrolled in 2 consecutive European Organization for Research and Treatment of Cancer (EORTC) trials, we assessed the HOX11L2 expression and/or the presence of a t(5;14)(q35;q32). Additionally, in 138 of these patients, HOX11 expression and SIL-TAL rearrangement were also assessed. These alterations were mutually exclusive, and their frequency was 23% (n = 35), 7% (n = 10), and 12% (n = 17), respectively. HOX11L2/t(5;14) positivity was more frequent in acute lymphoblastic leukemia (ALL) with cortical T immunophenotype and in children aged between 6 and 9 years. In contrast with previously reported data, patients positive and negative for HOX11L2/t(5;14) were comparable with regard to clinical outcome as well as to the response to a 7-day prephase treatment or to residual disease at completion of induction therapy. The 3-year event-free survival (EFS) rate (+/- SE percentage) for patients positive and negative for HOX11L2/t(5;14) was 75.5% (+/- 8.1%) and 68.3% (+/- 5.0%), respectively; the hazard ratio was 0.84 (95% confidence interval, 0.40-1.80). Patients with HOX11-high expression and those with SIL-TAL fusion had low levels of residual disease at the end of induction and a favorable prognosis: the 3-year EFS rate was 83.3% (+/- 8.5%) and 75.3% (+/- 12.6%), respectively. The results obtained in HOX11L2/t(5;14) patients in this study do not confirm the unfavorable prognosis reported in previous studies.

CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol

PubMed Central

Ghazavi, Farzaneh; Clappier, Emmanuelle; Lammens, Tim; Suciu, Stefan; Caye, Aurélie; Zegrari, Samira; Bakkus, Marleen; Grardel, Nathalie; Benoit, Yves; Bertrand, Yves; Minckes, Odile; Costa, Vitor; Ferster, Alina; Mazingue, Françoise; Plat, Geneviève; Plouvier, Emmanuel; Poirée, Marilyne; Uyttebroeck, Anne; van der Werff-ten Bosch, Jutte; Yakouben, Karima; Helsmoortel, Hetty; Meul, Magali; Van Roy, Nadine; Philippé, Jan; Speleman, Frank; Cavé, Hélène; Van Vlierberghe, Pieter; De Moerloose, Barbara

2015-01-01

DNA copy number analysis has been instrumental for the identification of genetic alterations in B-cell precursor acute lymphoblastic leukemia. Notably, some of these genetic defects have been associated with poor treatment outcome and might be relevant for future risk stratification. In this study, we characterized recurrent deletions of CD200 and BTLA genes, mediated by recombination-activating genes, and used breakpoint-specific polymerase chain reaction assay to screen a cohort of 1154 cases of B-cell precursor acute lymphoblastic leukemia uniformly treated according to the EORTC-CLG 58951 protocol. CD200/BTLA deletions were identified in 56 of the patients (4.8%) and were associated with an inferior 8-year event free survival in this treatment protocol [70.2% ± 1.2% for patients with deletions versus 83.5% ± 6.4% for non-deleted cases (hazard ratio 2.02; 95% confidence interval 1.23–3.32; P=0.005)]. Genetically, CD200/BTLA deletions were strongly associated with ETV6-RUNX1-positive leukemias (P<0.0001), but were also identified in patients who did not have any genetic abnormality that is currently used for risk stratification. Within the latter population of patients, the presence of CD200/BTLA deletions was associated with inferior event-free survival and overall survival. Moreover, the multivariate Cox model indicated that these deletions had independent prognostic impact on event-free survival when adjusting for conventional risk criteria. All together, these findings further underscore the rationale for copy number profiling as an important tool for risk stratification in human B-cell precursor acute lymphoblastic leukemia. This trial was registered at www.ClinicalTrials.gov as #NCT00003728. PMID:26137961

IKZF1 deletion is an independent prognostic marker in childhood B-cell precursor acute lymphoblastic leukemia, and distinguishes patients benefiting from pulses during maintenance therapy: results of the EORTC Children's Leukemia Group study 58951.

PubMed

Clappier, E; Grardel, N; Bakkus, M; Rapion, J; De Moerloose, B; Kastner, P; Caye, A; Vivent, J; Costa, V; Ferster, A; Lutz, P; Mazingue, F; Millot, F; Plantaz, D; Plat, G; Plouvier, E; Poirée, M; Sirvent, N; Uyttebroeck, A; Yakouben, K; Girard, S; Dastugue, N; Suciu, S; Benoit, Y; Bertrand, Y; Cavé, H

2015-11-01

The added value of IKZF1 gene deletion (IKZF1(del)) as a stratifying criterion in B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is still debated. We performed a comprehensive analysis of the impact of IKZF1(del) in a large cohort of children (n=1223) with BCR-ABL1-negative BCP-ALL treated in the EORTC-CLG trial 58951. Patients with IKZF1(del) had a lower 8-year event-free survival (EFS, 67.7% versus 86.5%; hazard ratio (HR)=2.41; 95% confidence interval (CI)=1.75-3.32; P<0.001). Importantly, despite association with high-risk features such as high minimal residual disease, IKZF1(del) remained significantly predictive in multivariate analyses. Analysis by genetic subtype showed that IKZF1(del) increased risk only in the high hyperdiploid ALLs (HR=2.57; 95% CI=1.19-5.55; P=0.013) and in 'B-other' ALLs, that is, lacking classifying genetic lesions (HR=2.22; 95% CI=1.45-3.39; P<0.001), the latter having then a dramatically low 8-year EFS (56.4; 95% CI=44.6-66.7). Among IKZF1(del)-positive patients randomized for vincristine-steroid pulses during maintenance, those receiving pulses had a significantly higher 8-year EFS (93.3; 95% CI=61.3-99.0 versus 42.1; 95% CI=20.4-62.5). Thus, IKZF1(del) retains independent prognostic significance in the context of current risk-adapted protocols, and is associated with a dismal outcome in 'B-other' ALL. Addition of vincristine-steroid pulses during maintenance may specifically benefit to IKZF1(del) patients in preventing relapses.

CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol.

PubMed

Ghazavi, Farzaneh; Clappier, Emmanuelle; Lammens, Tim; Suciu, Stefan; Caye, Aurélie; Zegrari, Samira; Bakkus, Marleen; Grardel, Nathalie; Benoit, Yves; Bertrand, Yves; Minckes, Odile; Costa, Vitor; Ferster, Alina; Mazingue, Françoise; Plat, Geneviève; Plouvier, Emmanuel; Poirée, Marilyne; Uyttebroeck, Anne; van der Werff-Ten Bosch, Jutte; Yakouben, Karima; Helsmoortel, Hetty; Meul, Magali; Van Roy, Nadine; Philippé, Jan; Speleman, Frank; Cavé, Hélène; Van Vlierberghe, Pieter; De Moerloose, Barbara

2015-10-01

DNA copy number analysis has been instrumental for the identification of genetic alterations in B-cell precursor acute lymphoblastic leukemia. Notably, some of these genetic defects have been associated with poor treatment outcome and might be relevant for future risk stratification. In this study, we characterized recurrent deletions of CD200 and BTLA genes, mediated by recombination-activating genes, and used breakpoint-specific polymerase chain reaction assay to screen a cohort of 1154 cases of B-cell precursor acute lymphoblastic leukemia uniformly treated according to the EORTC-CLG 58951 protocol. CD200/BTLA deletions were identified in 56 of the patients (4.8%) and were associated with an inferior 8-year event free survival in this treatment protocol [70.2% ± 1.2% for patients with deletions versus 83.5% ± 6.4% for non-deleted cases (hazard ratio 2.02; 95% confidence interval 1.23-3.32; P=0.005)]. Genetically, CD200/BTLA deletions were strongly associated with ETV6-RUNX1-positive leukemias (P<0.0001), but were also identified in patients who did not have any genetic abnormality that is currently used for risk stratification. Within the latter population of patients, the presence of CD200/BTLA deletions was associated with inferior event-free survival and overall survival. Moreover, the multivariate Cox model indicated that these deletions had independent prognostic impact on event-free survival when adjusting for conventional risk criteria. All together, these findings further underscore the rationale for copy number profiling as an important tool for risk stratification in human B-cell precursor acute lymphoblastic leukemia. This trial was registered at www.ClinicalTrials.gov as #NCT00003728. Copyright© Ferrata Storti Foundation.

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

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.

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.

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/.

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.

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.

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.

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

Results and adverse events of personalized peptide receptor radionuclide therapy with 90Yttrium and 177Lutetium in 1048 patients with neuroendocrine neoplasms.

PubMed

Baum, Richard P; Kulkarni, Harshad R; Singh, Aviral; Kaemmerer, Daniel; Mueller, Dirk; Prasad, Vikas; Hommann, Merten; Robiller, Franz C; Niepsch, Karin; Franz, Holger; Jochems, Arthur; Lambin, Philippe; Hörsch, Dieter

2018-03-30

Peptide receptor radionuclide therapy (PRRT) of patients with somatostatin receptor expressing neuroendocrine neoplasms has shown promising results in clinical trials and a recently published phase III study. In our center, 2294 patients were screened between 2004 and 2014 by 68 Ga somatostatin receptor (SSTR) PET/CT. Intention to treat analysis included 1048 patients, who received at least one cycle of 90 Yttrium or 177 Lutetium-based PRRT. Progression free survival was determined by 68 Ga SSTR-PET/CT and EORTC response criteria. Adverse events were determined by CTCAE criteria. Overall survival (95% confidence interval) of all patients was 51 months (47.0-54.9) and differed significantly according to radionuclide, grading, previous therapies, primary site and functionality. Progression free survival (based on PET/CT) of all patients was 19 months (16.9-21), which was significantly influenced by radionuclide, grading, and origin of neuroendocrine neoplasm. Progression free survival after initial progression and first and second resumption of PRRT after therapy-free intervals of more than 6 months were 11 months (9.4-12.5) and 8 months (6.4-9.5), respectively. Myelodysplastic syndrome or leukemia developed in 22 patients (2.1%) and 5 patients required hemodialysis after treatment, other adverse events were rare. PRRT is effective and overall survival is favorable in patients with neuroendocrine neoplasms depending on the radionuclide used for therapy, grading and origin of the neuroendocrine neoplasm which is not exactly mirrored in progression free survival as determined by highly sensitive 68 Ga somatostatin receptor PET/CT using EORTC criteria for determining response to therapy.

Results and adverse events of personalized peptide receptor radionuclide therapy with 90Yttrium and 177Lutetium in 1048 patients with neuroendocrine neoplasms

PubMed Central

Baum, Richard P.; Kulkarni, Harshad R.; Singh, Aviral; Kaemmerer, Daniel; Mueller, Dirk; Prasad, Vikas; Hommann, Merten; Robiller, Franz C.; Niepsch, Karin; Franz, Holger; Jochems, Arthur; Lambin, Philippe; Hörsch, Dieter

2018-01-01

Introduction Peptide receptor radionuclide therapy (PRRT) of patients with somatostatin receptor expressing neuroendocrine neoplasms has shown promising results in clinical trials and a recently published phase III study. Methods In our center, 2294 patients were screened between 2004 and 2014 by 68Ga somatostatin receptor (SSTR) PET/CT. Intention to treat analysis included 1048 patients, who received at least one cycle of 90Yttrium or 177Lutetium-based PRRT. Progression free survival was determined by 68Ga SSTR-PET/CT and EORTC response criteria. Adverse events were determined by CTCAE criteria. Results Overall survival (95% confidence interval) of all patients was 51 months (47.0-54.9) and differed significantly according to radionuclide, grading, previous therapies, primary site and functionality. Progression free survival (based on PET/CT) of all patients was 19 months (16.9-21), which was significantly influenced by radionuclide, grading, and origin of neuroendocrine neoplasm. Progression free survival after initial progression and first and second resumption of PRRT after therapy-free intervals of more than 6 months were 11 months (9.4-12.5) and 8 months (6.4-9.5), respectively. Myelodysplastic syndrome or leukemia developed in 22 patients (2.1%) and 5 patients required hemodialysis after treatment, other adverse events were rare. Conclusion PRRT is effective and overall survival is favorable in patients with neuroendocrine neoplasms depending on the radionuclide used for therapy, grading and origin of the neuroendocrine neoplasm which is not exactly mirrored in progression free survival as determined by highly sensitive 68Ga somatostatin receptor PET/CT using EORTC criteria for determining response to therapy. PMID:29682195

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

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

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.

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.

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.

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.

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.

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.

Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial.

PubMed

Ignatiadis, Michail; Rack, Brigitte; Rothé, Francoise; Riethdorf, Sabine; Decraene, Charles; Bonnefoi, Hervé; Dittrich, Christian; Messina, Carlo; Beauvois, Melanie; Trapp, Elisabeth; Goulioti, Theodora; Tryfonidis, Konstantinos; Pantel, Klaus; Repollet, Madeline; Janni, Wolfgang; Piccart, Martine; Sotiriou, Christos; Litiere, Saskia; Pierga, Jean-Yves

2016-08-01

There is increasing evidence that breast cancer evolves over time under the selection pressure of systemic treatment. Today, treatment decisions in early breast cancer are based on primary tumour characteristics without considering the disease evolution. Chemoresistant micrometastatic disease is poorly characterised and thus it is not used in current clinical practice as a tool to personalise treatment approaches. The detection of chemoresistant circulating tumour cells (CTCs) has been shown to be associated with worse prognosis in early breast cancer. The ongoing Treat CTC trial is the first international, liquid biopsy-based trial evaluating the concept of targeting chemoresistant minimal residual disease: detection of CTCs following adjuvant chemotherapy (adjuvant cohort) or neoadjuvant chemotherapy in patients who did not achieve pathological complete response (neoadjuvant cohort). This article presents the rational and design of this trial and the results of the pilot phase after 350 patients have been screened and provides insights that might provide information for future trials using the liquid biopsy approach as a tool towards precision medicine (NCT01548677). Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of anxiety, depression and health-related quality of life in oncology patients without initial symptoms according to the Hospital Anxiety and Depression Scale - a comparative study.

PubMed

Thalén-Lindström, Annika; Glimelius, Bengt; Johansson, Birgitta

2017-08-01

Depression and anxiety are associated with decreased health-related quality of life (HRQoL). The knowledge about the development of anxiety, depression and HRQoL in cancer patients without depression or anxiety, that is initially scoring as non-cases (cutoff <8) according to the Hospital Anxiety and Depression Scale (HADS), is sparse. The objectives were: (1) to evaluate changes in anxiety, depression and HRQoL over 6 months in two independent cohorts of oncology patients initially scoring as non-cases by the HADS, (2) to compare stable non-case patients with the general population regarding HRQoL and (3) to explore the outcomes using >4 rather than >7 as cutoff on any of HADS subscales. The study group (SG) included 245 and the validation group (VG), a previous cohort, included 281 non-cases. Patients who were non-cases (HADS <8) at all completed assessments were categorized as stable non-cases (stable-NC); those who were doubtful/clinical cases (HADS >7) in at least one follow-up were categorized as unstable-NC. Questionnaires were completed at baseline, and after 1, 3 and 6 months. Age- and sex-matched EORTC QLQ-C30 data from the general population were used for HRQoL comparisons. One hundred ninety-six (80%) SG and 244 (87%) VG patients were stable-NC and 49 (20%) SG and 37 (13%) VG patients were unstable-NC. SG and VG were similar in all outcomes. Anxiety, depression and HRQoL deteriorated over 6 months for unstable-NC (p < .05). HRQoL for stable-NC was comparable to that in the general population. If >4 had been used as cutoff, most unstable-NC (36/49 and 25/37, respectively) would have been identified at baseline. Most non-cases are stable-NC with a high stable HRQoL, indicating no need for re-assessment. A minority develop anxiety or depression symptoms and impaired HRQoL; for these a cutoff >4 rather than >7 on HADS subscales may be useful for early detection.

Colostomy is a simple and effective procedure for severe chronic radiation proctitis.

PubMed

Yuan, Zi-Xu; Ma, Teng-Hui; Wang, Huai-Ming; Zhong, Qing-Hua; Yu, Xi-Hu; Qin, Qi-Yuan; Wang, Jian-Ping; Wang, Lei

2016-06-28

To assess the efficacy and safety of diverting colostomy in treating severe hemorrhagic chronic radiation proctitis (CRP). Patients with severe hemorrhagic CRP who were admitted from 2008 to 2014 were enrolled into this study. All CRP patients were diagnosed by a combination of pelvic radiation history, clinical rectal bleeding, and endoscopic findings. Inclusion criteria were CRP patients with refractory bleeding with moderate to severe anemia with a hemoglobin level < 90 g/L. The study group included patients who were treated by diverting colostomy, while the control group included patients who received conservative treatment. The remission of bleeding was defined as complete cessation or only occasional bleeding that needed no further treatment. The primary outcome was bleeding remission at 6 mo after treatment. Quality of life before treatment and at follow-up was evaluated according to EORTC QLQ C30. Severe CRP complications were recorded during follow-up. Forty-seven consecutive patients were enrolled, including 22 in the colostomy group and 27 in the conservative treatment group. When compared to conservative treatment, colostomy obtained a higher rate of bleeding remission (94% vs 12%), especially in control of transfusion-dependent bleeding (100% vs 0%), and offered a better control of refractory perianal pain (100% vs 0%), and a lower score of bleeding (P < 0.001) at 6 mo after treatment. At 1 year after treatment, colostomy achieved better remission of both moderate bleeding (100% vs 21.5%, P = 0.002) and severe bleeding (100% vs 0%, P < 0.001), obtained a lower score of bleeding (0.8 vs 2.0, P < 0.001), and achieved obvious elevated hemoglobin levels (P = 0.003), when compared to the conservative treatment group. The quality of life dramatically improved after colostomy, which included global health, function, and symptoms, but it was not improved in the control group. Pathological evaluation after colostomy found diffused chronic inflammation cells, and massive fibrosis collagen depositions under the rectal wall, which revealed potential fibrosis formation. Diverting colostomy is a simple, effective and safe procedure for severe hemorrhagic CRP. Colostomy can improve quality of life and reduce serious complications secondary to radiotherapy.

Colostomy is a simple and effective procedure for severe chronic radiation proctitis

PubMed Central

Yuan, Zi-Xu; Ma, Teng-Hui; Wang, Huai-Ming; Zhong, Qing-Hua; Yu, Xi-Hu; Qin, Qi-Yuan; Wang, Jian-Ping; Wang, Lei

2016-01-01

AIM: To assess the efficacy and safety of diverting colostomy in treating severe hemorrhagic chronic radiation proctitis (CRP). METHODS: Patients with severe hemorrhagic CRP who were admitted from 2008 to 2014 were enrolled into this study. All CRP patients were diagnosed by a combination of pelvic radiation history, clinical rectal bleeding, and endoscopic findings. Inclusion criteria were CRP patients with refractory bleeding with moderate to severe anemia with a hemoglobin level < 90 g/L. The study group included patients who were treated by diverting colostomy, while the control group included patients who received conservative treatment. The remission of bleeding was defined as complete cessation or only occasional bleeding that needed no further treatment. The primary outcome was bleeding remission at 6 mo after treatment. Quality of life before treatment and at follow-up was evaluated according to EORTC QLQ C30. Severe CRP complications were recorded during follow-up. RESULTS: Forty-seven consecutive patients were enrolled, including 22 in the colostomy group and 27 in the conservative treatment group. When compared to conservative treatment, colostomy obtained a higher rate of bleeding remission (94% vs 12%), especially in control of transfusion-dependent bleeding (100% vs 0%), and offered a better control of refractory perianal pain (100% vs 0%), and a lower score of bleeding (P < 0.001) at 6 mo after treatment. At 1 year after treatment, colostomy achieved better remission of both moderate bleeding (100% vs 21.5%, P = 0.002) and severe bleeding (100% vs 0%, P < 0.001), obtained a lower score of bleeding (0.8 vs 2.0, P < 0.001), and achieved obvious elevated hemoglobin levels (P = 0.003), when compared to the conservative treatment group. The quality of life dramatically improved after colostomy, which included global health, function, and symptoms, but it was not improved in the control group. Pathological evaluation after colostomy found diffused chronic inflammation cells, and massive fibrosis collagen depositions under the rectal wall, which revealed potential fibrosis formation. CONCLUSION: Diverting colostomy is a simple, effective and safe procedure for severe hemorrhagic CRP. Colostomy can improve quality of life and reduce serious complications secondary to radiotherapy. PMID:27350738

Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation.

PubMed

Hung, Yun-Chi; Bauer, Judith; Horsley, Pamela; Waterhouse, Mary; Bashford, John; Isenring, Elisabeth

2013-06-01

This pilot exploratory study aimed to describe the changes in nutritional status, body composition, quality of life (QoL), and physical activity levels (PAL) of cancer patients undergoing high-dose conditioning and autologous peripheral blood stem cell transplantation (PBSCT) at pre-admission, hospital discharge, and at 100 days post-transplantation, and to examine if changes in these parameters are interrelated. Twenty-four patients (56.2 ± 12.9 years; 7 females, 17 males) were recruited from an Australian transplant center. Assessment was prospectively conducted at pre-admission, hospital discharge, and 100 days post-transplantation using the scored patient-generated subjective global assessment, air displacement plethysmography, EORTC QLQ-C30 (version 3), and the international physical activity questionnaire. At discharge, nutritional status deteriorated (patient-generated subjective global assessment (PG-SGA) median, +8.0; interquartile range, 6.0-13.0; p < 0.001) and the number of malnourished patients increased (n = 8/23; p = 0.023). Patients experienced significant loss of lean body mass (LBM; -2.2 kg, CI 95% -3.0, -1.4; p < 0.001), and decrease in QoL (-10.6, CI 95% -24.1, 2.9; p = 0.117); the proportion of patients with high PAL decreased (p = 0.012). By 100 days post-transplantation, all patients were well-nourished; however, LBM remained lower -1.0 kg (CI 95% -1.9, -0.1; p = 0.028). Change in nutritional status (PG-SGA score) was associated with weight (r = -0.46; p = 0.039) and fat mass (r = -0.57; p = 0.013). Change in QoL was associated with nutritional reservoir (i.e., fat; r = 0.54; p = 0.024); QoL was consistently higher for patients with high PAL. High-dose conditioning and autologous PBSCT is associated with deterioration in nutritional status, QoL and PAL, with LBM remaining below baseline levels at 100 days post-transplantation. A nutrition and exercise intervention program post-hospital discharge may be beneficial for these patients.

Patient satisfaction with health-care professionals and structure is not affected by longer hospital stay and complications after lung resection: a case-matched analysis.

PubMed

Pompili, Cecilia; Tiberi, Michela; Salati, Michele; Refai, Majed; Xiumé, Francesco; Brunelli, Alessandro

2015-02-01

The objective of this investigation was to assess satisfaction with care of patients with long hospital stay (LHS) or complications after pulmonary resection in comparison with case-matched counterparts with a regular postoperative course. This is a prospective observational analysis on 171 consecutive patients submitted to pulmonary resections (78 wedges, 8 segmentectomies, 83 lobectomies, 3 pneumonectomies) for benign (35), primary (93) or secondary malignant (43) diseases. A hospital stay >7 days was defined as long (LHS). Major cardiopulmonary complications were defined according to the ESTS database. Patient satisfaction was assessed by the administration of the EORTC IN-PATSAT32 module at discharge. The questionnaire is a 32-item self-administered survey including different scales, reflecting the perceived level of satisfaction about the care provided by doctors, nurses and other personnel. To minimize selection bias, propensity score case-matching technique was applied to generate two sets of matched patients: patients with LHS with counterparts without it; patients with complications with counterparts without it. Median length of postoperative stay was 4 days (range 2-43). Forty-one patients (24%) had a hospital stay>7 days and 21 developed cardiopulmonary complications (12%). Propensity score yielded two well-matched groups of 41 patients with and without LHS. There were no significant differences in any patient satisfaction scale between the two groups. The comparison of the results of the patient satisfaction questionnaire between the two matched groups of 21 patients with and without complications did not show significant differences in any scale. Patients experiencing poor outcomes such as long hospital stay or complications have similar perception of quality of care compared with those with regular outcomes. Patient-reported outcome measures are becoming increasingly important in the evaluation of the quality of care and may complement more traditional objective indicators such as morbidity or length of stay. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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.

[Scoring systems in intensive care medicine : principles, models, application and limits].

PubMed

Fleig, V; Brenck, F; Wolff, M; Weigand, M A

2011-10-01

Scoring systems are used in all diagnostic areas of medicine. Several parameters are evaluated and rated with points according to their value in order to simplify a complex clinical situation with a score. The application ranges from the classification of disease severity through determining the number of staff for the intensive care unit (ICU) to the evaluation of new therapies under study conditions. Since the introduction of scoring systems in the 1980's a variety of different score models has been developed. The scoring systems that are employed in intensive care and are discussed in this article can be categorized into prognostic scores, expenses scores and disease-specific scores. Since the introduction of compulsory recording of two scoring systems for accounting in the German diagnosis-related groups (DRG) system, these tools have gained more importance for all intensive care physicians. Problems remain in the valid calculation of scores and interpretation of the results.

Evaluation of modified Alvarado scoring system and RIPASA scoring system as diagnostic tools of acute appendicitis.

PubMed

Shuaib, Abdullah; Shuaib, Ali; Fakhra, Zainab; Marafi, Bader; Alsharaf, Khalid; Behbehani, Abdullah

2017-01-01

Acute appendicitis is the most common surgical condition presented in emergency departments worldwide. Clinical scoring systems, such as the Alvarado and modified Alvarado scoring systems, were developed with the goal of reducing the negative appendectomy rate to 5%-10%. The Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) scoring system was established in 2008 specifically for Asian populations. The aim of this study was to compare the modified Alvarado with the RIPASA scoring system in Kuwait population. This study included 180 patients who underwent appendectomies and were documented as having "acute appendicitis" or "abdominal pain" in the operating theatre logbook (unit B) from November 2014 to March 2016. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy, predicted negative appendectomy and receiver operating characteristic (ROC) curve of the modified Alvarado and RIPASA scoring systems were derived using SPSS statistical software. A total of 136 patients were included in this study according to our criteria. The cut-off threshold point of the modified Alvarado score was set at 7.0, which yielded a sensitivity of 82.8% and a specificity of 56%. The PPV was 89.3% and the NPV was 42.4%. The cut-off threshold point of the RIPASA score was set at 7.5, which yielded a 94.5% sensitivity and an 88% specificity. The PPV was 97.2% and the NPV was 78.5%. The predicted negative appendectomy rates were 10.7% and 2.2% for the modified Alvarado and RIPASA scoring systems, respectively. The negative appendectomy rate decreased significantly, from 18.4% to 10.7% for the modified Alvarado, and to 2.2% for the RIPASA scoring system, which was a significant difference (P<0.001) for both scoring systems. Based on the results of this study, the RIPASA score is a simple scoring system with better sensitivity and specificity than the modified Alvarado scoring system in Asian populations. It consists of 14 clinical parameters that can be obtained from a good patient history, clinical examination and laboratory investigations. The RIPASA scoring system is more accurate and specific than the modified Alvarado scoring system for Kuwait population.

Similar predictions of etravirine sensitivity regardless of genotypic testing method used: comparison of available scoring systems.

PubMed

Vingerhoets, Johan; Nijs, Steven; Tambuyzer, Lotke; Hoogstoel, Annemie; Anderson, David; Picchio, Gaston

2012-01-01

The aims of this study were to compare various genotypic scoring systems commonly used to predict virological outcome to etravirine, and examine their concordance with etravirine phenotypic susceptibility. Six etravirine genotypic scoring systems were assessed: Tibotec 2010 (based on 20 mutations; TBT 20), Monogram, Stanford HIVdb, ANRS, Rega (based on 37, 30, 27 and 49 mutations, respectively) and virco(®)TYPE HIV-1 (predicted fold change based on genotype). Samples from treatment-experienced patients who participated in the DUET trials and with both genotypic and phenotypic data (n=403) were assessed using each scoring system. Results were retrospectively correlated with virological response in DUET. κ coefficients were calculated to estimate the degree of correlation between the different scoring systems. Correlation between the five scoring systems and the TBT 20 system was approximately 90%. Virological response by etravirine susceptibility was comparable regardless of which scoring system was utilized, with 70-74% of DUET patients determined as susceptible to etravirine by the different scoring systems achieving plasma viral load <50 HIV-1 RNA copies/ml. In samples classed as phenotypically susceptible to etravirine (fold change in 50% effective concentration ≤3), correlations with genotypic score were consistently high across scoring systems (≥70%). In general, the etravirine genotypic scoring systems produced similar results, and genotype-phenotype concordance was high. As such, phenotypic interpretations, and in their absence all genotypic scoring systems investigated, may be used to reliably predict the activity of etravirine.

The rat whole embryo culture assay using the Dysmorphology Score system.

PubMed

Zhang, Cindy; Panzica-Kelly, Julie; Augustine-Rauch, Karen

2013-01-01

The rat whole embryo culture (WEC) system has been used extensively for characterizing teratogenic properties of test chemicals. In this chapter, we describe the methodology for culturing rat embryos as well as a new morphological score system, the Dysmorphology Score (DMS) system for assessing morphology of mid gestation (gestational day 11) rat embryos. In contrast to the developmental stage focused scoring associated with the Brown and Fabro score system, this new score system assesses the respective degree of severity of dysmorphology, which delineates normal from abnormal morphology of specific embryonic structures and organ systems. This score system generates an approach that allows rapid identification and quantification of adverse developmental findings, making it conducive for characterization of compounds for teratogenic properties and screening activities.

Scoring systems for outcome prediction in patients with perforated peptic ulcer.

PubMed

Thorsen, Kenneth; Søreide, Jon Arne; Søreide, Kjetil

2013-04-10

Patients with perforated peptic ulcer (PPU) often present with acute, severe illness that carries a high risk for morbidity and mortality. Mortality ranges from 3-40% and several prognostic scoring systems have been suggested. The aim of this study was to review the available scoring systems for PPU patients, and to assert if there is evidence to prefer one to the other. We searched PubMed for the mesh terms "perforated peptic ulcer", "scoring systems", "risk factors", "outcome prediction", "mortality", "morbidity" and the combinations of these terms. In addition to relevant scores introduced in the past (e.g. Boey score), we included recent studies published between January 2000 and December 2012) that reported on scoring systems for prediction of morbidity and mortality in PPU patients. A total of ten different scoring systems used to predict outcome in PPU patients were identified; the Boey score, the Hacettepe score, the Jabalpur score the peptic ulcer perforation (PULP) score, the ASA score, the Charlson comorbidity index, the sepsis score, the Mannheim Peritonitis Index (MPI), the Acute physiology and chronic health evaluation II (APACHE II), the simplified acute physiology score II (SAPS II), the Mortality probability models II (MPM II), the Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity physical sub-score (POSSUM-phys score). Only four of the scores were specifically constructed for PPU patients. In five studies the accuracy of outcome prediction of different scoring systems was evaluated by receiver operating characteristics curve (ROC) analysis, and the corresponding area under the curve (AUC) among studies compared. Considerable variation in performance both between different scores and between different studies was found, with the lowest and highest AUC reported between 0.63 and 0.98, respectively. While the Boey score and the ASA score are most commonly used to predict outcome for PPU patients, considerable variations in accuracy for outcome prediction were shown. Other scoring systems are hampered by a lack of validation or by their complexity that precludes routine clinical use. While the PULP score seems promising it needs external validation before widespread use.

Comparing traditional and novel injury scoring systems in a US level-I trauma center: an opportunity for improved injury surveillance in low- and middle-income countries.

PubMed

Laytin, Adam D; Dicker, Rochelle A; Gerdin, Martin; Roy, Nobhojit; Sarang, Bhakti; Kumar, Vineet; Juillard, Catherine

2017-07-01

In most low- and middle-income countries (LMICs), the resources to accurately quantify injury severity using traditional injury scoring systems are limited. Novel injury scoring systems appear to have adequate discrimination for mortality in LMIC contexts, but they have not been rigorously compared where traditional injury scores can be accurately calculated. To determine whether novel injury scoring systems perform as well as traditional ones in a HIC with complete and comprehensive data collection. Data from an American level-I trauma registry collected 2008-2013 were used to compare three traditional injury scoring systems: Injury Severity Score (ISS); Revised Trauma Score (RTS); and Trauma Injury Severity Score (TRISS); and three novel injury scoring systems: Kampala Trauma Score (KTS); Mechanism, GCS, Age and Pressure (MGAP) score; and GCS, Age and Pressure (GAP) score. Logistic regression was used to assess the association between each scoring system and mortality. Standardized regression coefficients (β 2 ), Akaike information criteria, area under the receiver operating characteristics curve, and the calibration line intercept and slope were used to evaluate the discrimination and calibration of each model. Among 18,746 patients, all six scores were associated with hospital mortality. GAP had the highest effect size, and KTS had the lowest median Akaike information criteria. Although TRISS discriminated best, the discrimination of KTS approached that of TRISS and outperformed GAP, MGAP, RTS, and ISS. MGAP was best calibrated, and KTS was better calibrated than RTS, GAP, ISS, or TRISS. The novel injury scoring systems (KTS, MGAP, and GAP), which are more feasible to calculate in low-resource settings, discriminated hospital mortality as well as traditional injury scoring systems (ISS and RTS) and approached the discrimination of a sophisticated, data-intensive injury scoring system (TRISS) in a high-resource setting. Two novel injury scoring systems (KTS and MGAP) surpassed the calibration of TRISS. These novel injury scoring systems should be considered when clinicians and researchers wish to accurately account for injury severity. Implementation of these resource-appropriate tools in LMICs can improve injury surveillance, guiding quality improvement efforts, and supporting advocacy for resource allocation commensurate with the volume and severity of trauma. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

Bastani, Peivand; Kiadaliri, Aliasghar Ahmad

2012-04-01

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

Patient satisfaction after pulmonary resection for lung cancer: a multicenter comparative analysis.

PubMed

Pompili, Cecilia; Brunelli, Alessandro; Rocco, Gaetano; Salvi, Rosario; Xiumé, Francesco; La Rocca, Antonello; Sabbatini, Armando; Martucci, Nicola

2013-01-01

Patient satisfaction reflects the perception of the customer about the level of quality of care received during the episode of hospitalization. To compare the levels of satisfaction of patients submitted to lung resection in two different thoracic surgical units. Prospective analysis of 280 consecutive patients submitted to pulmonary resection for neoplastic disease in two centers (center A: 139 patients; center B: 141 patients; 2009-2010). Patients' satisfaction was assessed at discharge through the EORTC-InPatSat32 module, a 32-item, multi-scale self-administered anonymous questionnaire. Each scale (ranging from 0 to 100 in score) was compared between the two units. Multivariable regression and bootstrap were used to verify factors associated with the patients' general satisfaction (dependent variable). Patients from unit B reported a higher general satisfaction (91.5 vs. 88.3, p = 0.04), mainly due to a significantly higher satisfaction in the doctor-related scales (doctors' technical skill: p = 0.001; doctors' interpersonal skill: p = 0.008; doctors' availability: p = 0.005, and doctors information provision: p = 0.0006). Multivariable regression analysis and bootstrap confirmed that level of care in unit B (p = 0.006, bootstrap frequency 60%) along with lower level of education of the patient population (p = 0.02, bootstrap frequency 62%) were independent factors associated with a higher general patient satisfaction. We were able to show a different level of patient satisfaction in patients operated on in two different thoracic surgery units. A reduced level of patient satisfaction may trigger changes in the management policy of individual units in order to meet patients' expectations and improve organizational efficiency. Copyright © 2012 S. Karger AG, Basel.

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.

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.

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.

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.

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.

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

PubMed

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

2018-02-01

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

Adherence and health literacy as related to outcome of patients treated for rheumatoid arthritis : Analyses of a large-scale observational study.

PubMed

Kuipers, J G; Koller, M; Zeman, F; Müller, K; Rüffer, J U

2018-04-24

Disabilities in daily living and quality of life are key endpoints for evaluating the treatment outcome for rheumatoid arthritis (RA). Factors possibly contributing to good outcome are adherence and health literacy. The survey included a representative nationwide sample of German rheumatologists and their patients with RA. The physician questionnaire included the disease activity score (DAS28) and medical prescriptions. The patient questionnaire included fatigue (EORTC QLQ-FA13), health assessment questionnaire (HAQ), quality of life (SF-12), health literacy (HELP), and patients' listings of their medications. Adherence was operationalized as follows: patient-reported (CQR5), behavioral (concordance between physicians' and patients' listings of medications), physician-assessed, and a combined measure of physician rating (1 = very adherent, 0 = less adherent) and the match between physicians' prescriptions and patients' accounts of their medications (1 = perfect match, 0 = no perfect match) that yielded three categories of adherence: high, medium, and low. Simple and multiple linear regressions (controlling for age, sex, smoking, drinking alcohol, and sport) were calculated using adherence and health literacy as predictor variables, and disease activity and patient-reported outcomes as dependent variables. 708 pairs of patient and physician questionnaires were analyzed. The mean patient age (73% women) was 60 years (SD = 12). Multiple regression analyses showed that high adherence was significantly associated with 5/7 outcome variables and health literacy with 7/7 outcome variables. Adherence and health literacy had weak but consistent effects on most outcomes. Thus, enhancing adherence and understanding of medical information could improve outcome, which should be investigated in future interventional studies.

Liver metastases from colorectal cancer: propensity score-based comparison of stereotactic body radiation therapy vs. microwave ablation.

PubMed

Franzese, Ciro; Comito, Tiziana; Clerici, Elena; Di Brina, Lucia; Tomatis, Stefano; Navarria, Pierina; Reggiori, Giacomo; Viganò, Luca; Poretti, Dario; Pedicini, Vittorio; Torzilli, Guido; Solbiati, Luigi; Scorsetti, Marta

2018-06-22

The study aim was to compare the disease control in two groups of patients affected by liver metastases from CRC treated with microwave ablation (MWA) or stereotactic body radiation therapy (SBRT). We extracted data of patients treated between 2009 and 2016. Inclusion criteria were: (1) maximum diameter of the liver lesions less than 4 cm; (2) no more than three liver lesions; (3) no evidence of progressive or untreated gross disease outside the liver; (4) adequate liver function; (5) no concurrent chemotherapy; (6) minimum age of 18. Tumour response was classified according to EORTC-RECIST criteria. Aim of the present study was to evaluate freedom from local progression (FFLP). To reduce indication bias, an inverse probability of treatment weighting was used to estimate treatment effect. A total of 135 patients with 214 lesions were included in the analysis. Median follow-up time was 24.5 months (range 2.4-95.8). The 1-year freedom from local progression (FFLP) was 88% (95%CI 80-92). In the SBRT group, FFLP was statistically longer than MWA group (p = 0.0214); the 1-year FFLP was 91% (95% CI 81-95) in SBRT group and 84% (95% CI 0.72-0.91) in MWA group. Patients treated with SBRT showed a reduce risk of local relapse compared to MWA (adjusted HR 0.31; 95%CI 0.13-0.70, p = 0.005). As expected, analogous result obtained in the inverse probability weighting analysis (HR 0.38; 95%CI 0.18-0.80; p = 0.011). In conclusion, there seems to be an advantage of SBRT compared to MWA in treating CRC liver metastases, particularly for lesions bigger than 30 mm.

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.

Systematic review and meta-analysis of non RCT's on health related quality of life after radical cystectomy using validated questionnaires: Better results with orthotopic neobladder versus ileal conduit.

PubMed

Cerruto, M A; D'Elia, C; Siracusano, S; Gedeshi, X; Mariotto, A; Iafrate, M; Niero, M; Lonardi, C; Bassi, P; Belgrano, E; Imbimbo, C; Racioppi, M; Talamini, R; Ciciliato, S; Toffoli, L; Rizzo, M; Visalli, F; Verze, P; Artibani, W

2016-03-01

The current literature on the impact of different urinary diversions on patients' health related quality of life (HR-QoL) showed a marginally better quality of life scores of orthotopic neobladder (ONB) compared to ileal conduit (IC). The aim of this study was to update the review of all relevant published studies on the comparison between ONB and IC. Studies were identified by searching multiple literature databases, including MEDLINE, CINAHL, the Cochrane Library, PubMed Data were synthesized using meta-analytic methods conformed to the PRISMA statement. The current meta-analysis was based on 18 papers that reported a HR-QoL comparison between IC and ONB using at least a validate questionnaire. Pooled effect sizes of combined QoL outcomes for IC versus ONB showed a slight, but not significant, better QoL in patients with ONB (Hedges' g = 0.150; p = 0.066). Patients with ileal ONB showed a significant better QoL than those with IC (Hedges' g = 0.278; p = 0.000); in case series with more than 65% males, ONB group showed a slight significant better QoL than IC (Hedges' g = 0.190; p = 0.024). Pooled effects sizes of all EORTC-QLQ-C30 aspects showed a significant better QoL in patients with ONB (Hedges' g = 0.400; p = 0.0000). This meta-analysis of not-randomized comparative studies on the impact of different types of urinary diversions on HR-QoL showed demonstrated a significant advantage of ileal ONB compared to IC in terms of HR-QoL. Copyright © 2015 Elsevier Ltd. All rights reserved.

Can the prognosis of individual patients with glioblastoma be predicted using an online calculator?

PubMed Central

Parks, Christopher; Heald, James; Hall, Gregory; Kamaly-Asl, Ian

2013-01-01

Background In an exploratory subanalysis of the European Organisation for Research and Treatment of Cancer and National Cancer Institute of Canada (EORTC/NCIC) trial data, Gorlia et al. identified a variety of factors that were predictive of overall survival, including therapy administered, age, extent of surgery, mini-mental score, administration of corticosteroids, World Health Organization (WHO) performance status, and O-methylguanine-DNA methyltransferase (MGMT) promoter methylation status. Gorlia et al. developed 3 nomograms, each intended to predict the survival times of patients with newly diagnosed glioblastoma on the basis of individual-specific combinations of prognostic factors. These are available online as a “GBM Calculator” and are intended for use in patient counseling. This study is an external validation of this calculator. Method One hundred eighty-seven patients from 2 UK neurosurgical units who had histologically confirmed glioblastoma (WHO grade IV) had their information at diagnosis entered into the GBM calculator. A record was made of the actual and predicted median survival time for each patient. Statistical analysis was performed to assess the accuracy, precision, correlation, and discrimination of the calculator. Results The calculator gives both inaccurate and imprecise predictions. Only 23% of predictions were within 25% of the actual survival, and the percentage bias is 140% in our series. The coefficient of variance is 76%, where a smaller percentage would indicate greater precision. There is only a weak positive correlation between the predicted and actual survival among patients (R2 of 0.07). Discrimination is inadequate as measured by a C-index of 0.62. Conclusions The authors would not recommend the use of this tool in patient counseling. If departments were considering its use, we would advise that a similar validating exercise be undertaken. PMID:23543729

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.

The impact of prostate cancer diagnosis and treatment decision-making on health-related quality of life before treatment onset.

PubMed

Cuypers, Maarten; Lamers, Romy E D; Cornel, Erik B; van de Poll-Franse, Lonneke V; de Vries, Marieke; Kil, Paul J M

2018-04-01

The objective of this study is to test if patients' health-related quality of life (HRQoL) declines after prostate biopsy to detect Pca, and after subsequent treatment decision-making in case Pca is confirmed, and to test whether personality state and traits are associated with these potential changes in HRQoL. Patients who were scheduled for prostate biopsy to detect Pca (N = 377) filled out a baseline questionnaire about HRQoL (EORTC QLQ-C30 and PR25), "big five" personality traits (BFI-10), optimism (LOT-r), and self-efficacy (Decision Self-efficacy Scale) (t0). Patients with confirmed Pca (N = 126) filled out a follow-up questionnaire on HRQoL within 2 weeks after treatment was chosen but had not yet started (t1). HRQoL declined between t0 and t1, reflected in impaired role and cognitive functioning, and elevated fatigue, constipation, and prostate-specific symptoms. Sexual activity and functioning improved. Baseline HRQoL scores were unrelated to the selection of a particular treatment, but for patients who chose a curative treatment, post-decision HRQoL showed a greater decline compared to patients who chose active surveillance. Optimism was associated with HRQoL at baseline; decisional self-efficacy was positively associated with HRQoL at follow-up. No associations between HRQoL and the "big five" personality traits were found. Patients who have undergone prostate biopsy and treatment decision-making for Pca experience a decline in HRQoL. Choosing treatment with a curative intent was associated with greater decline in HRQoL. Interventions aimed at optimism and decision self-efficacy could be helpful to reduce HRQoL impairment around the time of prostate biopsy and treatment decision-making.

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.

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.

A stage is a stage is a stage: a direct comparison of two scoring systems.

PubMed

Dawson, Theo L

2003-09-01

L. Kohlberg (1969) argued that his moral stages captured a developmental sequence specific to the moral domain. To explore that contention, the author compared stage assignments obtained with the Standard Issue Scoring System (A. Colby & L. Kohlberg, 1987a, 1987b) and those obtained with a generalized content-independent stage-scoring system called the Hierarchical Complexity Scoring System (T. L. Dawson, 2002a), on 637 moral judgment interviews (participants' ages ranged from 5 to 86 years). The correlation between stage scores produced with the 2 systems was .88. Although standard issue scoring and hierarchical complexity scoring often awarded different scores up to Kohlberg's Moral Stage 2/3, from his Moral Stage 3 onward, scores awarded with the two systems predominantly agreed. The author explores the implications for developmental research.

Improvement of the Mair scoring system using structural equations modeling for classifying the diagnostic adequacy of cytology material from thyroid lesions.

PubMed

Kulkarni, H R; Kamal, M M; Arjune, D G

1999-12-01

The scoring system developed by Mair et al. (Acta Cytol 1989;33:809-813) is frequently used to grade the quality of cytology smears. Using a one-factor analytic structural equations model, we demonstrate that the errors in measurement of the parameters used in the Mair scoring system are highly and significantly correlated. We recommend the use of either a multiplicative scoring system, using linear scores, or an additive scoring system, using exponential scores, to correct for the correlated errors. We suggest that the 0, 1, and 2 points used in the Mair scoring system be replaced by 1, 2, and 4, respectively. Using data on fine-needle biopsies of 200 thyroid lesions by both fine-needle aspiration (FNA) and fine-needle capillary sampling (FNC), we demonstrate that our modification of the Mair scoring system is more sensitive and more consistent with the structural equations model. Therefore, we recommend that the modified Mair scoring system be used for classifying the diagnostic adequacy of cytology smears. Diagn. Cytopathol. 1999;21:387-393. Copyright 1999 Wiley-Liss, Inc.

Standardization and quantification in FDG-PET/CT imaging for staging and restaging of malignant disease.

PubMed

Gámez-Cenzano, Cristina; Pino-Sorroche, Francisco

2014-04-01

There is a growing interest in using quantification in FDG-PET/CT in oncology, especially for evaluating response to therapy. Complex full quantitative procedures with blood sampling and dynamic scanning have been clinically replaced by the use of standardized uptake value measurements that provide an index of regional tracer uptake normalized to the administered dose of FDG. Some approaches have been proposed for assessing quantitative metabolic response, such as EORTC and PERCIST criteria in solid tumors. When using standardized uptake value in clinical routine and multicenter trials, standardization of protocols and quality control procedures of instrumentation is required. Copyright © 2014 Elsevier Inc. All rights reserved.

Multiparametric and semiquantitative scoring systems for the evaluation of mouse model histopathology - a systematic review

PubMed Central

2013-01-01

Background Histopathology has initially been and is still used to diagnose infectious, degenerative or neoplastic diseases in humans or animals. In addition to qualitative diagnoses semiquantitative scoring of a lesion`s magnitude on an ordinal scale is a commonly demanded task for histopathologists. Multiparametric, semiquantitative scoring systems for mouse models histopathology are a common approach to handle these questions and to include histopathologic information in biomedical research. Results Inclusion criteria for scoring systems were a first description of a multiparametric, semiquantiative scoring systems which comprehensibly describe an approach to evaluate morphologic lesion. A comprehensive literature search using these criteria identified 153 originally designed semiquantitative scoring systems for the analysis of morphologic changes in mouse models covering almost all organs systems and a wide variety of disease models. Of these, colitis, experimental autoimmune encephalitis, lupus nephritis and collagen induced osteoarthritis colitis were the disease models with the largest number of different scoring systems. Closer analysis of the identified scoring systems revealed a lack of a rationale for the selection of the scoring parameters or a correlation between scoring parameter value and the magnitude of the clinical symptoms in most studies. Conclusion Although a decision for a particular scoring system is clearly dependent on the respective scientific question this review gives an overview on currently available systems and may therefore allow for a better choice for the respective project. PMID:23800279

A comparison between modified Alvarado score and RIPASA score in the diagnosis of acute appendicitis.

PubMed

Singla, Anand; Singla, Satpaul; Singh, Mohinder; Singla, Deeksha

2016-12-01

Acute appendicitis is a common but elusive surgical condition and remains a diagnostic dilemma. It has many clinical mimickers and diagnosis is primarily made on clinical grounds, leading to the evolution of clinical scoring systems for pin pointing the right diagnosis. The modified Alvarado and RIPASA scoring systems are two important scoring systems, for diagnosis of acute appendicitis. We prospectively compared the two scoring systems for diagnosing acute appendicitis in 50 patients presenting with right iliac fossa pain. The RIPASA score correctly classified 88 % of patients with histologically confirmed acute appendicitis compared with 48.0 % with modified Alvarado score, indicating that RIPASA score is more superior to Modified Alvarado score in our clinical settings.

2014 KLCSG-NCC Korea Practice Guidelines for the management of hepatocellular carcinoma: HCC diagnostic algorithm.

PubMed

Lee, Jeong Min; Park, Joong-Won; Choi, Byung Ihn

2014-01-01

Hepatocellular carcinoma (HCC) is the fifth most commonly occurring cancer in Korea and typically has a poor prognosis with a 5-year survival rate of only 28.6%. Therefore, it is of paramount importance to achieve the earliest possible diagnosis of HCC and to recommend the most up-to-date optimal treatment strategy in order to increase the survival rate of patients who develop this disease. After the establishment of the Korean Liver Cancer Study Group (KLCSG) and the National Cancer Center (NCC), Korea jointly produced for the first time the Clinical Practice Guidelines for HCC in 2003, revised them in 2009, and published the newest revision of the guidelines in 2014, including changes in the diagnostic criteria of HCC and incorporating the most recent medical advances over the past 5 years. In this review, we will address the noninvasive diagnostic criteria and diagnostic algorithm of HCC included in the newly established KLCSG-NCC guidelines in 2014, and review the differences in the criteria for a diagnosis of HCC between the KLCSG-NCC guidelines and the most recent imaging guidelines endorsed by the European Organisation for Research and Treatment of Cancer (EORTC), the Liver Imaging Reporting and Data System (LI-RADS), the Organ Procurement and Transplantation Network (OPTN) system, the Asian Pacific Association for the Study of the Liver (APASL) and the Japan Society of Hepatology (JSH).

Information contained in miscarriage-related websites and the predictive value of website scoring systems.

PubMed

Hardwick, J Christopher R; MacKenzie, Fiona M

2003-01-10

To identify websites providing information about early pregnancy loss and compare this information with published guidelines from the Royal College of Obstetricians and Gynaecologists (RCOG). The value of 'Silberg' and 'Health on the net (HON)' website scoring systems in predicting the information provided via websites identified was assessed. A cross-sectional survey. Nineteen websites identified via two search engines (http://www.lycos.co.uk and http://www.msn.co.uk). Websites were searched for specific information in a structured manner and then scored by two independent observers against the website scoring systems and against a scoring system derived from guidelines published by the RCOG. Website scores against the scoring systems and against RCOG guidelines. Information concerning miscarriage contained within these websites was poor and scored accordingly against the RCOG guidelines (median score, 4.5/8). The website scoring systems did not predict the RCOG scores for a website (HON score R(S)=0.193 (95% confidence interval from -0.286 to 0.595), Silberg score, R(S)=0.035 (95% confidence interval from -0.426 to 0.482)). Few relevant websites were identified despite searching a large number via two search engines. The websites found did not answer our specific questions and consequently scored poorly against the RCOG guidelines. RCOG scores did not correlate with either scoring system. Web-based information for women attending with early pregnancy complications needs to be easily accessed and comprehensive. Written information given to women when seen with early pregnancy complications should include details of available comprehensive websites. Professional organisations, colleges or Government agencies should provide this type of information.

Scoring systems for outcome prediction in patients with perforated peptic ulcer

PubMed Central

2013-01-01

Background Patients with perforated peptic ulcer (PPU) often present with acute, severe illness that carries a high risk for morbidity and mortality. Mortality ranges from 3-40% and several prognostic scoring systems have been suggested. The aim of this study was to review the available scoring systems for PPU patients, and to assert if there is evidence to prefer one to the other. Material and methods We searched PubMed for the mesh terms “perforated peptic ulcer”, “scoring systems”, “risk factors”, ”outcome prediction”, “mortality”, ”morbidity” and the combinations of these terms. In addition to relevant scores introduced in the past (e.g. Boey score), we included recent studies published between January 2000 and December 2012) that reported on scoring systems for prediction of morbidity and mortality in PPU patients. Results A total of ten different scoring systems used to predict outcome in PPU patients were identified; the Boey score, the Hacettepe score, the Jabalpur score the peptic ulcer perforation (PULP) score, the ASA score, the Charlson comorbidity index, the sepsis score, the Mannheim Peritonitis Index (MPI), the Acute physiology and chronic health evaluation II (APACHE II), the simplified acute physiology score II (SAPS II), the Mortality probability models II (MPM II), the Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity physical sub-score (POSSUM-phys score). Only four of the scores were specifically constructed for PPU patients. In five studies the accuracy of outcome prediction of different scoring systems was evaluated by receiver operating characteristics curve (ROC) analysis, and the corresponding area under the curve (AUC) among studies compared. Considerable variation in performance both between different scores and between different studies was found, with the lowest and highest AUC reported between 0.63 and 0.98, respectively. Conclusion While the Boey score and the ASA score are most commonly used to predict outcome for PPU patients, considerable variations in accuracy for outcome prediction were shown. Other scoring systems are hampered by a lack of validation or by their complexity that precludes routine clinical use. While the PULP score seems promising it needs external validation before widespread use. PMID:23574922

Prostate ultrasound imaging: evaluation of a two-step scoring system in the diagnosis of prostate cancer.

PubMed

Gao, Yong; Liao, Xin-Hong; Ma, Yan; Lu, Lu; Wei, Li-Yan; Yan, Xue

2017-12-01

This study aims to investigate the feasibility and performance of a two-step scoring system of ultrasound imaging in the diagnosis of prostate cancer. 75 patients with 888 consecutive histopathologically verified lesions were included in this study. Step 1, an initial 5-point scoring system was developed based on conventional transrectal ultrasound (TRUS). Step 2, a final scoring system was evaluated according to contrast-enhanced transrectal ultrasound (CE-TRUS). Each lesion was evaluated using the two-step scoring system (step 1 + step 2) and compared with only using conventional TRUS (step 1). 888 lesions were histologically verified: 315 of them were prostate cancer from 46 patients and 573 were benign prostatic hypertrophy (BPH) from 29 patients. According to the two-step scoring system, 284 lesions were upgraded and 130 lesions were downgraded from step 1 to step 2 (this means using step 2 to assess the results by step 1). However, 96 cases were improperly upgraded after step 2 and 48 malignant lesions were still missed after step 2 as score-1. For the two-step scoring system, the sensitivity, specificity, and accuracy were 84.7%, 83.2%, and 83.7%, respectively, versus 22.8%, 96.6%, and 70.4%, respectively, for conventional TRUS. The area under the ROC curve (AUC) for lesion diagnosis was 0.799-0.952 for the two-step scoring system, versus 0.479-0.712 for conventional TRUS. The difference in the diagnostic accuracy of the two-step scoring system and conventional TRUS was statistically significant (P<0.0001). The two-step scoring system was straightforward to use and achieved a considerably accurate diagnostic performance for prostate cancer. The application of the two-step scoring system for prostate cancer is promising.

Qualitative and quantitative assessment of degeneration of cervical intervertebral discs and facet joints.

PubMed

Walraevens, Joris; Liu, Baoge; Meersschaert, Joke; Demaerel, Philippe; Delye, Hans; Depreitere, Bart; Vander Sloten, Jos; Goffin, Jan

2009-03-01

Degeneration of intervertebral discs and facet joints is one of the most frequently encountered spinal disorders. In order to describe and quantify degeneration and evaluate a possible relationship between degeneration and biomechanical parameters, e.g., the intervertebral range of motion and intradiscal pressure, a scoring system for degeneration is mandatory. However, few scoring systems for the assessment of degeneration of the cervical spine exist. Therefore, two separate objective scoring systems to qualitatively and quantitatively assess the degree of cervical intervertebral disc and facet joint degeneration were developed and validated. The scoring system for cervical disc degeneration consists of three variables which are individually scored on neutral lateral radiographs: "height loss" (0-4 points), "anterior osteophytes" (0-3 points) and "endplate sclerosis" (0-2 points). The scoring system for facet joint degeneration consists of four variables which are individually scored on neutral computed tomography scans: "hypertrophy" (0-2 points), "osteophytes" (0-1 point), "irregularity" on the articular surface (0-1 point) and "joint space narrowing" (0-1 point). Each variable contributes with varying importance to the overall degeneration score (max 9 points for the scoring system of cervical disc degeneration and max 5 points for facet joint degeneration). Degeneration of 20 discs and facet joints of 20 patients was blindly assessed by four raters: two neurosurgeons (one senior and one junior) and two radiologists (one senior and one junior), firstly based on first subjective impression and secondly using the scoring systems. Measurement errors and inter- and intra-rater agreement were determined. The measurement error of the scoring system for cervical disc degeneration was 11.1 versus 17.9% of the subjective impression results. This scoring system showed excellent intra-rater agreement (ICC = 0.86, 0.75-0.93) and excellent inter-rater agreement (ICC = 0.78, 0.64-0.88). Surgeons as well as radiologists and seniors as well as juniors obtained excellent inter- and intra-rater agreement. The measurement error of the scoring system for cervical facet joint degeneration was 20.1 versus 24.2% of the subjective impression results. This scoring system showed good intra-rater agreement (ICC = 0.71, 0.42-0.89) and fair inter-rater agreement (ICC = 0.49, 0.26-0.74). Both scoring systems fulfilled the criteria for recommendation proposed by Kettler and Wilke. Our scoring systems can be reliable and objective tools for assessing cervical disc and facet joint degeneration. Moreover, the scoring system of cervical disc degeneration was shown to be experience- and discipline-independent.

Array-based comparative genomic hybridization analysis reveals recurrent chromosomal alterations and prognostic parameters in primary cutaneous large B-cell lymphoma.

PubMed

Dijkman, Remco; Tensen, Cornelis P; Jordanova, Ekaterina S; Knijnenburg, Jeroen; Hoefnagel, Juliette J; Mulder, Aat A; Rosenberg, Carla; Raap, Anton K; Willemze, Rein; Szuhai, Károly; Vermeer, Maarten H

2006-01-10

To evaluate the clinical relevance of genomic aberrations in primary cutaneous large B-cell lymphoma (PCLBCL). Skin biopsy samples of 31 patients with a PCLBCL classified as either primary cutaneous follicle center lymphoma (PCFCL; n = 19) or PCLBCL, leg type (n = 12), according to the WHO-European Organisation for Research and Treatment of Cancer (EORTC) classification, were investigated using array-based comparative genomic hybridization, fluorescence in situ hybridization (FISH), and examination of promoter hypermethylation. The most recurrent alterations in PCFCL were high-level DNA amplifications at 2p16.1 (63%) and deletion of chromosome 14q32.33 (68%). FISH analysis confirmed c-REL amplification in patients with gains at 2p16.1. In PCLBCL, leg type, most prominent aberrations were a high-level DNA amplification of 18q21.31-q21.33 (67%), including the BCL-2 and MALT1 genes as confirmed by FISH, and deletions of a small region within 9p21.3 containing the CDKN2A, CDKN2B, and NSG-x genes. Homozygous deletion of 9p21.3 was detected in five of 12 patients with PCLBCL, leg type, but in zero of 19 patients with PCFCL. Complete methylation of the promoter region of the CDKN2A gene was demonstrated in one PCLBCL, leg type, patient with hemizygous deletion, in one patient without deletion, but in zero of 19 patients with PCFCL. Seven of seven PCLBCL, leg type, patients with deletion of 9p21.3 and/or complete methylation of CDKN2A died as a result of their lymphoma. Our results demonstrate prominent differences in chromosomal alterations between PCFCL and PCLBCL, leg type, that support their classification as separate entities within the WHO-EORTC scheme. Inactivation of CDKN2A by either deletion or methylation of its promoter could be an important prognostic parameter for the group of PCLBCL, leg type.

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

Adjuvant ganglioside GM2-KLH/QS-21 vaccination versus observation after resection of primary tumor > 1.5 mm in patients with stage II melanoma: results of the EORTC 18961 randomized phase III trial.

PubMed

Eggermont, Alexander M M; Suciu, Stefan; Rutkowski, Piotr; Marsden, Jeremy; Santinami, Mario; Corrie, Philippa; Aamdal, Steinar; Ascierto, Paolo A; Patel, Poulam M; Kruit, Wim H; Bastholt, Lars; Borgognoni, Lorenzo; Bernengo, Maria Grazia; Davidson, Neville; Polders, Larissa; Praet, Michel; Spatz, Alan

2013-10-20

The GM2 ganglioside is an antigen expressed in the majority of melanomas. The GM2-KLH/QS-21 vaccine induces high immunoglobulin M (IgM) and IgG antibody responses. The EORTC 18961 trial compared the efficacy of GM2-KLH/QS-21 vaccination versus observation. A total of 1,314 patients with a primary tumor > 1.50 mm in thickness (T3-4N0M0; American Joint Committee on Cancer stage II) were randomly assigned to GM2-KLH/QS-21 vaccination (n = 657) or observation (n = 657). Treatment consisted of subcutaneous injections once per week from week 1 to 4, then every 3 months for the first 2 years and every 6 months during the third year. Primary end point was relapse-free survival (RFS). Secondary end points were distant metastasis-free survival (DMFS) and overall survival (OS). Analyses were by intent to treat. After a median follow-up of 1.8 years, the trial was stopped at the second interim analysis for futility regarding RFS (hazard ratio [HR], 1.00; P = .99) and detrimental outcome regarding OS (HR, 1.66; P = .02). After a median follow-up of 4.2 years, we had recorded 400 relapses, nine deaths without relapse, a total of 236 deaths. At 4 years, the vaccination arm showed a decreased RFS rate of 1.2% (HR, 1.03; 95% CI, 0.84 to 1.25) and OS rate of 2.1% (HR, 1.16; 95% CI, 0.90 to 1.51). Toxicity was acceptable, with 4.6% of patients ending study participation because of toxicity. GM2-KLH/QS-21 vaccination does not improve outcome for patients with stage II melanoma.

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.

Decitabine improves progression-free survival in older high-risk MDS patients with multiple autosomal monosomies: results of a subgroup analysis of the randomized phase III study 06011 of the EORTC Leukemia Cooperative Group and German MDS Study Group.

PubMed

Lübbert, Michael; Suciu, Stefan; Hagemeijer, Anne; Rüter, Björn; Platzbecker, Uwe; Giagounidis, Aristoteles; Selleslag, Dominik; Labar, Boris; Germing, Ulrich; Salih, Helmut R; Muus, Petra; Pflüger, Karl-Heinz; Schaefer, Hans-Eckart; Bogatyreva, Lioudmila; Aul, Carlo; de Witte, Theo; Ganser, Arnold; Becker, Heiko; Huls, Gerwin; van der Helm, Lieke; Vellenga, Edo; Baron, Frédéric; Marie, Jean-Pierre; Wijermans, Pierre W

2016-01-01

In a study of elderly AML patients treated with the hypomethylating agent decitabine (DAC), we noted a surprisingly favorable outcome in the (usually very unfavorable) subgroup with two or more autosomal monosomies (MK2+) within a complex karyotype (Lübbert et al., Haematologica 97:393-401, 2012). We now analyzed 206 myelodysplastic syndrome (MDS) patients (88 % of 233 patients randomized in the EORTC/GMDSSG phase III trial 06011, 61 of them with RAEBt, i.e. AML by WHO) with cytogenetics informative for MK status.. Endpoints are the following: complete/partial (CR/PR) and overall response rate (ORR) and progression-free (PFS) and overall survival (OS). Cytogenetic subgroups are the following: 63 cytogenetically normal (CN) patients, 143 with cytogenetic abnormalities, 73 of them MK-negative (MK-), and 70 MK-positive (MK+). These MK+ patients could be divided into 17 with a single autosomal monosomy (MK1) and 53 with at least two monosomies (MK2+). ORR with DAC in CN patients: 36.1 %, in MK- patients: 16.7 %, in MK+ patients: 43.6 % (MK1: 44.4 %, MK2+ 43.3 %). PFS was prolonged by DAC compared to best supportive care (BSC) in the CN (hazard ratio (HR) 0.55, 99 % confidence interval (CI), 0.26; 1.15, p = 0.03) and MK2+ (HR 0.50; 99 % CI, 0.23; 1.06, p = 0.016) but not in the MK-, MK+, and MK1 subgroups. OS was not improved by DAC in any subgroup. In conclusion, we demonstrate for the first time in a randomized phase III trial that high-risk MDS patients with complex karyotypes harboring two or more autosomal monosomies attain encouraging responses and have improved PFS with DAC treatment compared to BSC.

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.

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.

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

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.

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.

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

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

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

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

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.

Hyperfractionated accelerated radiotherapy with concomitant integrated boost of 70-75 Gy in 5 weeks for advanced head and neck cancer. A phase I dose escalation study.

PubMed

Cvek, J; Kubes, J; Skacelikova, E; Otahal, B; Kominek, P; Halamka, M; Feltl, D

2012-08-01

The present study was performed to evaluate the feasibility of a new, 5-week regimen of 70-75 Gy hyperfractionated accelerated radiotherapy with concomitant integrated boost (HARTCIB) for locally advanced, inoperable head and neck cancer. A total of 39 patients with very advanced, stage IV nonmetastatic head and neck squamous cell carcinoma (median gross tumor volume 72 ml) were included in this phase I dose escalation study. A total of 50 fractions intensity-modulated radiotherapy (IMRT) were administered twice daily over 5 weeks. Prescribed total dose/dose per fraction for planning target volume (PTV(tumor)) were 70 Gy in 1.4 Gy fractions, 72.5 Gy in 1.45 Gy fractions, and 75 Gy in 1.5 Gy fractions for 10, 13, and 16 patients, respectively. Uninvolved lymphatic nodes (PTV(uninvolved)) were irradiated with 55 Gy in 1.1 Gy fractions using the concomitant integrated boost. Acute toxicity was evaluated according to the RTOG/EORTC scale; the incidence of grade 3 mucositis was 51% in the oral cavity/pharynx and 0% in skin and the recovery time was ≤ 9 weeks for all patients. Late toxicity was evaluated in patients in complete remission according to the RTOG/EORTC scale. No grade 3/4 late toxicity was observed. The 1-year locoregional progression-free survival was 50% and overall survival was 55%. HARTCIB (75 Gy in 5 weeks) is feasible for patients deemed unsuitable for chemoradiation. Acute toxicity was lower than predicted from radiobiological models; duration of dysphagia and confluent mucositis were particularly short. Better conformity of radiotherapy allows the use of more intensive altered fractionation schedules compared with older studies. These results suggest that further dose escalation might be possible when highly conformal techniques (e.g., stereotactic radiotherapy) are used.

Clock Drawing Test and the diagnosis of amnestic mild cognitive impairment: can more detailed scoring systems do the work?

PubMed

Rubínová, Eva; Nikolai, Tomáš; Marková, Hana; Siffelová, Kamila; Laczó, Jan; Hort, Jakub; Vyhnálek, Martin

2014-01-01

The Clock Drawing Test is a frequently used cognitive screening test with several scoring systems in elderly populations. We compare simple and complex scoring systems and evaluate the usefulness of the combination of the Clock Drawing Test with the Mini-Mental State Examination to detect patients with mild cognitive impairment. Patients with amnestic mild cognitive impairment (n = 48) and age- and education-matched controls (n = 48) underwent neuropsychological examinations, including the Clock Drawing Test and the Mini-Mental State Examination. Clock drawings were scored by three blinded raters using one simple (6-point scale) and two complex (17- and 18-point scales) systems. The sensitivity and specificity of these scoring systems used alone and in combination with the Mini-Mental State Examination were determined. Complex scoring systems, but not the simple scoring system, were significant predictors of the amnestic mild cognitive impairment diagnosis in logistic regression analysis. At equal levels of sensitivity (87.5%), the Mini-Mental State Examination showed higher specificity (31.3%, compared with 12.5% for the 17-point Clock Drawing Test scoring scale). The combination of Clock Drawing Test and Mini-Mental State Examination scores increased the area under the curve (0.72; p < .001) and increased specificity (43.8%), but did not increase sensitivity, which remained high (85.4%). A simple 6-point scoring system for the Clock Drawing Test did not differentiate between healthy elderly and patients with amnestic mild cognitive impairment in our sample. Complex scoring systems were slightly more efficient, yet still were characterized by high rates of false-positive results. We found psychometric improvement using combined scores from the Mini-Mental State Examination and the Clock Drawing Test when complex scoring systems were used. The results of this study support the benefit of using combined scores from simple methods.

The discriminatory capability of existing scores to predict advanced colorectal neoplasia: a prospective colonoscopy study of 5,899 screening participants.

PubMed

Wong, Martin C S; Ching, Jessica Y L; Ng, Simpson; Lam, Thomas Y T; Luk, Arthur K C; Wong, Sunny H; Ng, Siew C; Ng, Simon S M; Wu, Justin C Y; Chan, Francis K L; Sung, Joseph J Y

2016-02-03

We evaluated the performance of seven existing risk scoring systems in predicting advanced colorectal neoplasia in an asymptomatic Chinese cohort. We prospectively recruited 5,899 Chinese subjects aged 50-70 years in a colonoscopy screening programme(2008-2014). Scoring systems under evaluation included two scoring tools from the US; one each from Spain, Germany, and Poland; the Korean Colorectal Screening(KCS) scores; and the modified Asia Pacific Colorectal Screening(APCS) scores. The c-statistics, sensitivity, specificity, positive predictive values(PPVs), and negative predictive values(NPVs) of these systems were evaluated. The resources required were estimated based on the Number Needed to Screen(NNS) and the Number Needed to Refer for colonoscopy(NNR). Advanced neoplasia was detected in 364 (6.2%) subjects. The German system referred the least proportion of subjects (11.2%) for colonoscopy, whilst the KCS scoring system referred the highest (27.4%). The c-statistics of all systems ranged from 0.56-0.65, with sensitivities ranging from 0.04-0.44 and specificities from 0.74-0.99. The modified APCS scoring system had the highest c-statistics (0.65, 95% C.I. 0.58-0.72). The NNS (12-19) and NNR (5-10) were similar among the scoring systems. The existing scoring systems have variable capability to predict advanced neoplasia among asymptomatic Chinese subjects, and further external validation should be performed.

Assessment of three risk evaluation systems for patients aged ≥70 in East China: performance of SinoSCORE, EuroSCORE II and the STS risk evaluation system.

PubMed

Shan, Lingtong; Ge, Wen; Pu, Yiwei; Cheng, Hong; Cang, Zhengqiang; Zhang, Xing; Li, Qifan; Xu, Anyang; Wang, Qi; Gu, Chang; Zhang, Yangyang

2018-01-01

To assess and compare the predictive ability of three risk evaluation systems (SinoSCORE, EuroSCORE II and the STS risk evaluation system) in patients aged ≥70, and who underwent coronary artery bypass grafting (CABG) in East China. Three risk evaluation systems were applied to 1,946 consecutive patients who underwent isolated CABG from January 2004 to September 2016 in two hospitals. Patients were divided into two subsets according to their age: elderly group (age ≥70) with a younger group (age <70) used for comparison. The outcome of interest in this study was in-hospital mortality. The entire cohort and subsets of patients were analyzed. The calibration and discrimination in total and in subsets were assessed by the Hosmer-Lemeshow and the C statistics respectively. Institutional overall mortality was 2.52%. The expected mortality rates of SinoSCORE, EuroSCORE II and the STS risk evaluation system were 0.78(0.64)%, 1.43(1.14)% and 0.78(0.77)%, respectively. SinoSCORE achieved the best discrimination (the area under the receiver operating characteristic curve (AUC) = 0.829), followed by the STS risk evaluation system (AUC = 0.790) and EuroSCORE II (AUC = 0.769) in the entire cohort. In the elderly group, the observed mortality rate was 4.82% while it was 1.38% in the younger group. SinoSCORE (AUC = .829) also achieved the best discrimination in the elderly group, followed by the STS risk evaluation system (AUC = .730) and EuroSCORE II (AUC = 0.640) while all three risk evaluation systems all had good performances in the younger group. SinoSCORE, EuroSCORE II and the STS risk evaluation system all achieved positive calibrations in the entire cohort and subsets. The performance of the three risk evaluation systems was not ideal in the entire cohort. In the elderly group, SinoSCORE appeared to achieve better predictive efficiency than EuroSCORE II and the STS risk evaluation system.

Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS):a randomised, multicentre, open-label, phase 3 non-inferiority trial

PubMed Central

Donker, Mila; van Tienhoven, Geertjan; Straver, Marieke E; Meijnen, Philip; van de Velde, Cornelis J H; Mansel, Robert E; Cataliotti, Luigi; Westenberg, A Helen; Klinkenbijl, Jean H G; Orzalesi, Lorenzo; Bouma, Willem H; van der Mijle, Huub C J; Nieuwenhuijzen, Grard A P; Veltkamp, Sanne C; Slaets, Leen; Duez, Nicole J; de Graaf, Peter W; van Dalen, Thijs; Marinelli, Andreas; Rijna, Herman; Snoj, Marko; Bundred, Nigel J; Merkus, Jos W S; Belkacemi, Yazid; Petignat, Patrick; Schinagl, Dominic A X; Coens, Corneel; Messina, Carlo G M; Bogaerts, Jan; Rutgers, Emiel J T

2014-01-01

Summary Background If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. Methods Patients with T1–2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612. Findings Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1–8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00–0·92) after axillary lymph node dissection versus 1·19% (0·31–2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00–5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. Interpretation Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1–2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity. Funding EORTC Charitable Trust. PMID:25439688