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Purpose: Patients with advanced cancer can experience their disease as a contingent life event. The sudden interruption of their life stories can obscure life goals and disrupt meaning making. In the context of the research project "In search of stories," we aim to investigate the reading and discussion of selected stories which present ways of dealing with a contingent life event. In addition, we examine the use of a newly developed guide for reading these exemplary texts together with advanced cancer patients., Methods: This qualitative study describes the experiences of five patients with advanced cancer who participated in a guided reading and discussion about selected literary texts. The intervention consisted of reading a selected story, after which each patient was interviewed, using the reading guide as a conversation template. The interviews were then thematically analyzed for their conceptual content using a template analysis., Results: All five conversations showed some form of recognition in reaction to the chosen text, which led to personal identification of experiences of contingency, such as loss of life goals, impending death, or feelings of uncertainty. Besides the important role of identification, revealed by the responses to the questions in the reading guide, the discussion of the text helped them articulate their own experience and sources of meaning. Diverse worldviews came to the fore and concepts of meaning such as fate, life goals, quality of life, and death., Conclusions: First experiences with our newly developed reading guide designed to support a structured reading of stories containing experiences of contingency suggest that it may help patients to express their own experiences of contingency and to reflect on these experiences., Implications for Cancer Survivors: The intervention tested in this study may contribute to supportive care for survivors with advanced cancer, but further research is needed to evaluate its effect on quality of life., (© 2021. The Author(s).)

Purpose: While there is increasing evidence for the effectiveness of psychosocial support programs for cancer patients, little attention has been paid to creativity or art as a way of addressing their psychological problems and improving quality of life. This review provides an overview of interventional studies that investigate the effects of art therapy interventions on anxiety, depression, and quality of life in adults with cancer., Methods: We conducted a literature review with a systematic search. The databases PubMed/MEDLINE, PsycINFO, and EMBASE were searched for articles on art therapy among adult (18 years and above) cancer patients, published between September 2009 up to September 2019. Search terms were established for each database specifically. A total of 731 publications was assessed for relevance by title and abstract. The remaining 496 articles were examined using three inclusion criteria: interventions were guided by an artist or art therapist, participants were actively involved in the creative process, and anxiety, depression, and/or quality of life were included as outcome measures. Methodological quality of the included studies was appraised using specific checklists., Results: Seven papers met the inclusion criteria. Data was extracted from three non-randomized intervention studies and four randomized controlled trials. All studies used a quantitative design with validated outcome measures. Four articles described positive effects of art therapy on anxiety, depression, or quality of life in adults with cancer., Conclusion: Art therapy could possibly help decrease symptoms of anxiety and depression, and improve quality of life in adult cancer patients. However, because of the heterogeneity of the interventions and limited methodological quality of the studies, further research using stringent methods is needed.

Background: Targeted therapies (TTs) have revolutionised cancer treatment with their enhanced specificity of action. Compared with conventional therapies, TTs are delivered over a longer period and often have unusual symptom profiles. Patient-reported outcome measures such as symptom side-effect lists need to be developed in a time-efficient manner to enable a rapid and full evaluation of new treatments and effective clinical management OBJECTIVE: The aim of this study was to develop a set of TT-related symptoms and identify the optimal method for developing symptom lists., Patients and Methods: Symptoms from TT treatment in the context of Chronic Myeloid Leukaemia (CML), HER2-positive breast cancer, or Gastrointestinal Stromal Tumours (GIST) were identified through literature reviews, interviews with healthcare professionals (HCPs) and patients, and patient focus groups. The symptom set was then pilot tested in patients across the three cancer diagnoses: The number of items derived from each source (literature, patients, or HCPs) were compared., Results: A total of 316 patients and 86 HCPs from 16 countries participated. An initial set of 209 symptoms was reduced to 61 covering 12 symptom categories. Patient interviews made the greatest contribution to the item set., Conclusions: Symptom lists should be created based on input from patients. The item set described will be applicable to the assessment of new TTs, and in monitoring treatment.

Objectives: Patient-reported outcome (PRO) measurements used in cancer research can assess a number of health domains. Our primary objective was to investigate which broad types of PRO domains (namely, functional health, symptoms, and global quality of life [QoL]) most frequently yielded significant differences between treatments in randomized controlled trials (RCTs)., Methods: A total of 229 RCTs published between January 2004 and February 2019, conducted on patients diagnosed with the most common solid malignancies and assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, were considered. Studies were identified systematically using literature searches in key electronic databases. Unlike other PRO measurements typically used in RCTs, the scoring algorithm of the multidimensional EORTC QLQ-C30 allowed us to clearly distinguish the 3 broad types of PRO domains., Results: In total, 134 RCTs (58.5%) reported statistically significant differences between treatment arms for at least 1 of the QLQ-C30 domains. Most frequently, differences were reported for 2 or all 3 broad types of PRO domains (78 of 134 trials; 58.2%). In particular, 35 trials (26.1%) found significant differences for symptoms, functional health, and global QoL, 24 trials (17.9%) for symptoms and functional health, 11 trials (8.2%) for functional health and global QoL, and 8 trials (6.0%) for symptoms and global QoL. The likelihood of finding a statistically significant difference between treatment arms was not associated with key study characteristics, such as study design (ie, open-label vs blinded trials) and industry support., Conclusions: Our findings emphasize the importance of a multidimensional PRO assessment to most comprehensively capture the overall burden of therapy from the patients' standpoint., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objective: In the present study, we investigated individual differences in the outcome of patient-physician trust when confronted with cancer from an attachment theoretical perspective. We expected that lower levels of trust are associated with more emotional distress and more physical limitations within the first 15 months after diagnosis, especially in those who score relatively high on attachment anxiety. No such association was expected for more avoidantly attached individuals., Method: A group of 119 patients with different types of cancer (breast, cervical, intestinal and prostate) completed questionnaires concerning trust (short version of the Wake Forest Physician Trust Scale) and attachment (Experiences in Close Relationship scale Revised) at 3 months after diagnosis. Emotional distress (Hospital Anxiety and Depression Scale) and physical limitations (physical functioning subscales of the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C30) were assessed at 3, 9 and 15 months after diagnosis. To test the hypotheses, multiple hierarchical regression analyses were performed., Results: Lower levels of trust were associated with more emotional distress and more physical limitations at 3, 9 and 15 months after diagnosis in more anxiously attached patients, but not in less anxiously attached patients., Discussion: These results indicate an attachment-dependent effect of trust in one's physician. Explanations and clinical implications are discussed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To illustrate different perspectives on response shift with cancer patients' health-related quality-of-life (HRQL) data. In measurement perspective, the focus is on bias in the measurement of HRQL. In conceptual perspective, the focus is on bias in the explanation of HRQL., Study Design and Setting: Data came from a consecutive series of 202 newly diagnosed cancer patients, heterogeneous to cancer site, all undergoing surgery. A HRQL questionnaire was administered before and after surgery. Using structural equation modeling, biases and response shifts in measurement and explanation of HRQL were investigated with respect to patient's cancer site, health status, sex, age, optimism, and social comparison., Results: Six measurement biases were found, five of which were considered response shift. The "general health" (GH) scale appeared most susceptible to response shift. For example, GH scores were not fully determined by HRQL but also by optimism before surgery and female sex and downward social comparison after surgery. Additionally, two explanation biases were found, neither of which were considered response shift-before and after surgery the mental component of HRQL was not only affected by cancer site and health status but also by optimism and downward social comparison., Conclusion: Our approach enables the distinction and testing of biases and response shifts in the measurement and explanation of HRQL.

The extent to which self-assessed work ability collected during treatment can predict return-to-work in cancer patients is unknown. In this prospective study, we consecutively included employed cancer patients who underwent treatment with curative intent at 6 months following the first day of sick leave. Work ability data (scores 0-10), clinical and sociodemographic data were collected at 6 months, while return-to-work was measured at 6, 12 and 18 months. Most of the 195 patients had been diagnosed with breast cancer (26%), cancer of the female genitals (22%) or genitourological cancer (22%). Mean current work ability scores improved significantly over time from 4.6 at 6 months to 6.3 and 6.7 at 12 and 18 months, respectively. Patients with haematological cancers and those who received chemotherapy showed the lowest work ability scores, while patients with cancer of urogenital tract or with gastrointestinal cancer had the highest scores. Work ability at 6 months strongly predicted return-to-work at 18 months, after correction for the influence of age and treatment (hazard ratio=1.37, CI 1.27-1.48). We conclude that self-assessed work ability is an important factor in the return-to-work process of cancer patients independent of age and clinical factors.

Background: Previous work highlighted a number of methodological constraints when reporting health-related quality of life (HRQOL) outcomes from randomized controlled trials (RCTs). Given this, the objective of this study was to investigate whether the quality of such HRQOL reports has improved over time., Materials and Methods: On the basis of a predefined set of criteria, 159 RCTs with a HRQOL end point, published between 1990 and 2004 were identified and analyzed. Each study was evaluated by a number of issues (e.g. sample size and industry sponsorship) and by the "minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials"., Results: The quality of HRQOL reports, as measured by the overall checklist score, was independently related to more recently published studies (P < 0.0001). This relationship was independent of industry funded, HRQOL end point (primary versus secondary), cancer disease site, size of the study and HRQOL difference between treatment arms. While only 39.3% of studies published between 1990 and 2000 (89/159 RCTs) were identified as being probably robust, thus likely to support clinical decision making, this percentage was 64.3% for studies published after 2000 (70/159 RCTs)., Conclusion: Since we found a significant learning curve in HRQOL trial reporting since 1990, it can be expected that HRQOL data will increasingly impact on clinical decision making and treatment policies in the near future.

Introduction: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used health-related quality of life instrument. The main aim of this study is to investigate whether there are international differences in response to the questionnaire that can be explained by cultural factors., Methods: Analyses involved a database of 106 separate studies including data from over 28,000 respondents. Differential item functioning (DIF) analyses using logistic regression were conducted for each item of the EORTC QLQ-C30 with respect to cultural/geographic group. Results were qualitatively compared with previously reported DIF analyses by translation to explore whether the source of the DIF was more likely to be linguistic or cultural in nature., Results: Although most response patterns were similar, there were a number of international differences in how the questionnaire was answered. The largest variations were found in the results for Eastern Europe and East Asia. Results for the UK, the US and Australia tended to be similar. Many of the European results followed patterns that were more clearly explained when grouped by translation than when grouped by geographical region., Discussion: Our results suggest that, in general, the EORTC QLQ-C30 is suitable for use in a wide variety of countries and settings. Some response variations that have the potential to affect the results of international studies were identified, but it was not always clear whether the source of the variation was primarily linguistic or cultural.

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is one of the most widely used quality of life instruments for cancer patients. The aim of this study was to assess whether there were linguistic differences in the way an international sample answered the EORTC QLQ-C30 questionnaire. Thirteen translations of the EORTC QLQ-C30, representing 22 countries, were investigated using a database of 27,891 respondents, incorporating 103 separate studies. Differential item functioning (DIF) analyses were conducted using logistic regression to identify items which, after controlling for subscale, were answered differently by language of administration. Both uniform and non-uniform DIF were assessed. Although most languages showed similar results to English, at least one instance of statistically significant DIF was identified for each translation, and a few of these differences were large. In some cases, the patterns were supported by the results of qualitative interviews with bilingual people. Although, overall, there appeared to be good linguistic equivalence for most of the EORTC QLQ-C30 items, several scales showed strongly discrepant results for some translations. Some of these effects are large enough to impact on the results of clinical trials. Based on our experience in this study, we suggest that validation of translations of health-related quality of life instruments should include exploration of DIF.

Purpose: There is debate about the value of measuring health-related quality of life (HRQL) in clinical trials in oncology because of evidence suggesting that HRQL does not influence clinical decisions. Analysis of HRQL in surgical trials, however, may inform decision making because it provides detailed assessment of the immediate detrimental short-term impact of surgery on HRQL that needs to be considered against the long-term survival benefits and functional outcomes of surgery. This study evaluated whether HRQL in randomized trials in surgical oncology contributes to clinical decision making., Methods: A systematic review identified randomized trials in surgical oncology with HRQL. Trials were evaluated independently by two reviewers and the value of HRQL in clinical decision making was categorized in three ways: whether trial investigators reported that HRQL influenced final treatment recommendations, whether trial investigators reported that HRQL would be useful for informed consent, and whether HRQL was assessed robustly according to predefined criteria., Results: Thirty-three randomized trials with valid HRQL questionnaires were identified; 22 (67%) concluded that HRQL outcomes influenced treatment decisions or provided valuable data for informed consent, and seven of these trials had robust HRQL design. Another five trials had robust HRQL design but investigators reported that HRQL outcomes were not clinically important enough to influence treatment recommendations., Conclusion: In surgical trials in oncology, HRQL informed clinical decision making. It is recommended that HRQL be included in relevant surgical trials, and that information be used to inform clinicians and patients about the impact of surgery on short- and long-term HRQL.

Background and Objective: The goal was to develop a shortened version of the EORTC QLQ-C30 for use in palliative care. We wanted to keep as few items as possible in each scale while still being able to compare results with studies using the original scales. We examined the possibilities of shortening the physical functioning, cognitive functioning, fatigue, and nausea and vomiting scales., Study Design and Setting: The shortening was based on 2,366 (physical functioning) and 10,815 (three other scales) observations, respectively. We used item response theory to construct scoring algorithms for predicting scores on the original scales., Results: Evaluations showed that a three-item physical scale, a two-item fatigue scale, and a one-item nausea or vomiting scale predicted the scores on the original scales with excellent agreement and had measurement abilities similar to the original scales with no loss or only a little loss in power to detect group differences. The results of the cognitive functioning scale indicated problems when predicting scores from a shortened version., Conclusion: Given the favorable results for the physical functioning, fatigue, and nausea or vomiting scales we expect that the shortened versions of these scales will be included in the abbreviated version of the EORTC QLQ-C30 for palliative care.

Background: As part of a larger study whose objective is to develop an abbreviated version of the EORTC QLQ-C30 suitable for research in palliative care, analyses were conducted to determine the feasibility of generating a shorter version of the 4-item emotional functioning (EF) scale that could be scored in the original metric., Methods: We used data from 24 European cancer studies conducted in 10 different languages (n = 8242). Item selection was based on analyses by item response theory (IRT). Based on the IRT results, a simple scoring algorithm was developed to predict the original 4-item EF sum scale score from a reduced number of items., Results: Both a 3-item and a 2-item version (item 21 'Did you feel tense?' and item 24 'Did you feel depressed?') predicted the total score with excellent agreement and very little bias. In group comparisons, the 2-item scale led to the same conclusions as those based on the original 4-item scale with little or no loss of measurement efficiency., Conclusion: Although these results are promising, confirmatory studies are needed based on independent samples. If such additional studies yield comparable results, incorporation of the 2-item EF scale in an abbreviated version of the QLQ-C30 for use in palliative care research settings would be justified. The analyses reported here demonstrate the usefulness of the IRT-based methodology for shortening questionnaire scales.

Fatigue is a highly prevalent and debilitating symptom in cancer survivors. The aim of this study was to assess the impact of fatigue and other cancer-related symptoms on the return to work of cancer survivors. A prospective inception cohort study with 12 months of follow-up was initiated. At 6 months following the first day of sick leave, levels of fatigue, depression, sleep problems, physical complaints, cognitive dysfunction and psychological distress were assessed, in addition to clinical, sociodemographic and work-related factors. Data were obtained from one academic hospital and two general hospitals in the Netherlands. 235 patients who had a primary diagnosis of cancer and underwent treatment with curative intent were included. The rate of return to work was measured at 6, 12 and 18 months. Hazard ratios (HRs) for the duration of sick leave up to 18 months following the first day of sick leave were calculated. The rate of return to work increased from 24% at 6 months to 64% at 18 months following the first day of sick leave. Fatigue, diagnosis, treatment type, age, gender, depression, physical complaints and workload were all related to the time taken to return to work. Fatigue scores were also strongly related to diagnosis, physical complaints, and depression scores. Fatigue at 6 months predicted a longer sick leave with a hazard ratio of 0.71 (95% Confidence Interval (C.I.) 0.59-0.85), adjusted for diagnosis, treatment type, age and gender. In a multivariate Cox regression analysis, diagnosis, treatment, age, physical complaints and workload remained the only significant predictors of duration of the sick leave. 64% of cancer survivors returned to work within 18 months. Fatigue levels predicted the return to work. This was independent of the diagnosis and treatment, but not of other cancer-related symptoms. Better management of cancer-related symptoms is therefore needed to facilitate the return to work of cancer patients.

Aims: To describe and assess the quality of rehabilitation of cancer survivors by occupational physicians and to relate the quality of the process of occupational rehabilitation to the outcome of return to work., Methods: One hundred occupational physicians of a cohort of cancer survivors were interviewed about return to work management. Quality of rehabilitation was assessed by means of four indicators that related to performance in knowledge of cancer and treatment, continuity of care, patients complaints, and relations at work. The cohort of patients was prospectively followed for 12 months to assess time to return to work and rate of return to work. Patients' and physicians' satisfaction with care was also assessed. The relation between performance and these outcome measures was studied in a multivariate analysis, taking into account the influence of other work and disease related factors that could potentially predict return to work., Results: For knowledge of cancer and treatment, only 3% had optimal performance because occupational physicians did not communicate with treating physicians. For continuity of care, patient complaints, and relations at work, performance was optimal for 55%, 78%, and 60% of the physicians respectively. After adjustment for other prognostic factors, overall physician's performance (hazard ratio (HR) 0.5, 95% CI 0.3 to 0.8) and continuity of care (HR 0.5, 95% CI 0.3 to 0.9) were related to the return to work of patients. Overall optimal performance was also related to a small but significant higher level of satisfaction with care, both for patients and physicians., Conclusion: Quality of occupational rehabilitation of cancer survivors can be improved substantially, especially with regard to communication between physicians and continuity of care. There is a need for the development of more effective rehabilitation procedures which should be evaluated in a randomised controlled trial.

The Clinical Significance Consensus Meeting Group of the Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients produced 6 articles regarding the clinical significance of quality of life (QOL) assessments in oncology. The 6 articles deal with the methods used to date: group-vs-individual clinical significance; single items vs summated scores; patient, clinician, and population perspectives; assessment of changes over time; and communication of results. The articles were produced by a team of 30 QOL research experts assembled in a consensus writing meeting held at the Mayo Clinic, Rochester, Minn, October 6 and 7, 2000. This introduction describes the need for the articles, definitions of key terms, and plans for the future. It is hoped that this series of articles will serve as a resource for individuals conducting cancer QOL research and for clinicians considering incorporation of QOL assessment in the treatment of patients with neoplastic diseases. A secondary goal is to stimulate further discussion and research in the interpretation of QOL assessments.

If patients experience extreme fatigue during treatment, they may judge the level of fatigue following this experience differently from how they would have judged it before. This change in internal standard is referred to as a response shift. We explored whether a response shift might have occurred in patients receiving radiotherapy (n = 199). Fatigue was assessed before and after radiotherapy. Following completion of the post-test, a thentest was administered where patients had to provide a renewed judgment of their pre-treatment level of fatigue. Response shift was assessed by the mean difference between the pre-test and thentest scores. Comparing the thentest with the pretest scores, patients retrospectively minimized their pre-treatment level of fatigue. The thentest-post-test difference was significant, whereas the conventional pretest-post-test difference was not. These results are in line with the occurrence of a response shift. Additional hypotheses regarding response shift were partially supported. It is concluded that the potentially large implications of response shift justify further research.

The European Organization for Research and Treatment of Cancer (EORTC) has taken a leading role in the development of the methodology of quality of life (QL) measurement. In the EORTC Quality of Life Study Group (QLSG) valid instruments to assess QL in a general manner and disease-specific modules have been developed to be used in oncological clinical trials. Statistical and methodological aspects of QL research are discussed. The application of QL assessments in clinical trials represents a subsequent challenge. To improve the practice of QL assessment in clinical trials an 'EORTC model' has been developed. This model requires the collaboration of liaison persons, the EORTC Cooperative Tumour Groups and the EORTC Data Centre Quality of Life Unit (QL Unit). Cooperation between these parties, protocol development and advantages and concerns of the model are mentioned in this paper. Finally, suggestions for improvement are proposed.

This study examined the usefulness of caregiver ratings of cancer patients' quality of life (QOL), an issue of relevance to both adequate patient care and to the possible use of proxy QOL raters in clinical studies. We compared QOL ratings of 90 cancer patients receiving inpatient chemotherapy with those provided by their significant others (most often the spouse), physicians and nurses. During patients' scheduled appointment for receiving chemotherapy on a clinical ward, all raters completed independently the Dartmouth COOP Functional Health Assessment charts/WONCA, an instrument developed by a cooperative group of primary care physicians to briefly assess a core set of seven QOL domains (physical fitness, feelings, daily and social activities, overall health, pain and quality of life) by single items with five response options. With few exceptions, mean scores of the proxy raters were equivalent or similar to those of the patients. Most patient-proxy correlations varied between 0.40 and 0.60, indicating a moderate level of agreement at the individual level. Of all comparisons made, 41% were in exact agreement and 43% agreed within one response category, leaving 17% more profound patient-proxy discrepancies. Disagreement was not dependent on the type of proxy rater, or on raters' background characteristics, but was influenced by the QOL dimension under consideration and the clinical status of the patient. Better patient-proxy agreement was observed for more concrete questions (daily activities, pain) and for patients with either a very good (ECOG 0) or poor (ECOG 3) performance status. The results indicate that both significant others and health care providers can be useful sources of information about cancer patients' QOL.

In this study we examined whether response shift resulting from changes in internal standards occurs in cancer patients undergoing radiotherapy. Ninety-nine newly diagnosed patients undergoing radiotherapy were administered two standardized self-report measures of fatigue prior to receiving radiotherapy. After completion of radiotherapy, patients filled out these questionnaires as a conventional posttest and in reference to how they perceived themselves as they were prior to radiotherapy (a so-called 'thentest'). A transition (direct change) score on fatigue was used as a stratification measure. Patients were subsequently interviewed about their responses. The pattern of mean scores indicative of response-shift effects was found in two distinct subgroups: patients experiencing diminishing levels of fatigue and patients facing early stages of adaptation to increased levels of fatigue. Since response shift may adversely affect the results of self-reported outcomes in clinical trials or other longitudinal research, further research is very much needed.

The aim of this study was to examine whether significant others can provide useful proxy information on the health-related quality of life (QL) of cancer patients. We examined the level and pattern of agreement between patient and proxy ratings of the EORTC QLQ-C30, the reliability and validity of both types of information, and the influence of several factors on the extent of agreement. QL ratings were obtained for 307 and 224 patient-proxy pairs (at baseline and follow-up, respectively). Agreement was moderate to good (ICC = 0.42 to 0.79). Multitrait-multimethod analysis showed good convergence and discrimination of specific QL domains. Comparison of mean scores revealed a small but systematic bias between patient and proxy ratings. The maximum level of disagreement was found at intermediate levels of QL, with smaller discrepancies noted for patients with either a relatively poor or good QL. Both patient and proxy QL ratings were reliable and responsive to changes over time. Several characteristics of the patients and their significant others were found to be associated with the level of agreement, but explained less than 15% of the variance in patient-proxy differences. In conclusion, the present findings lend support to the viability of employing significant others as proxy respondents of cancer patients' quality of life where this is necessary.

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to be supplemented by more specific subscales ('modules') to assess aspects of QoL of particular importance to specific subgroups of patients. Since individual members of the study group were to be involved in module development, guidelines were established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called 'EORTC modules'. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed.

Purpose: To evaluate the usefulness of caregiver ratings of cancer patients' quality of life (QL), we examined the following: (1) the comparability of responses to a brief standardized QL questionnaire provided by patients, physicians, and informal caregivers; and (2) the relative validity of these ratings., Methods: The study sample included cancer patients receiving chemotherapy, their treating physicians, and significant others involved closely in the (informal) care of the patients. During an early phase of treatment and 3 months later, patients and caregivers completed independently the COOP/WONCA charts, covering seven QL domains. At baseline, all sources of information were available for 295 of 320 participating patients (92%). Complete follow-up data were obtained for 189 patient-caregiver triads., Results: Comparison of mean scores on the COOP/WONCA charts revealed close agreement between patient and caregiver ratings. At the individual patient level, exact or global agreement was observed in the majority of cases (73% to 91%). Corrected for chance agreement, moderate intraclass correlations (ICC) were noted (0.32 to 0.72). Patient, physician, and informal caregiver COOP/WONCA scores were all responsive to changes over time in specific QL domains, but differed in their relative performance. Relative to the patients, the physicians were more efficient in detecting changes over time in physical fitness and overall health, but less so in relation to social function and pain., Conclusion: For studies among patient populations at risk of deteriorating self-report capabilities, physicians and informal caregivers can be useful as alternative or complementary sources of information on cancer patients' QL.

A revision of the Quality of Life Questionnaire (QLQ-C30) of the European Organization for Research and Treatment of Cancer (EORTC) was undertaken to improve low internal consistency estimates (Cronbach's alpha) and content validity for the role functioning scale and a conceptual difficulty (undue emphasis on physical functioning) in the global quality of life (QOL) scale. The role functioning items were reworded and a four-category response format was substituted for the previous dichotomous format. A new item asking about 'overall health' was substituted for the 'overall physical condition' item in the global QOL domain. The original and new versions were tested at three time points in a total of 1,181 patients with cancer in Canada (n = 696) and the Netherlands (n = 485). In both samples there was a marked improvement in internal consistency for the role functioning scale (Cronbach's alpha s ranging from 0.78-0.88) in the new version. In the global QOL scale, the substitution of the new item for the previous one did not alter internal consistency (Cronbach's alpha's ranging from 0.81-0.92). The revised versions of the role functioning and global QOL domains have been incorporated into the QLQ-C30 (version 2.0).

Background: The primary objective was to investigate the validity and reliability of the Cancer Rehabilitation Evaluation System-Short Form (the CARES-SF) as a quality of life instrument in clinical trials [10]., Patients and Methods: A heterogeneous sample of 485 cancer patients completed the CARES-SF before treatment (T1), one month later (T2), and three months following T2 (T3). At T3 the patients completed the questionnaire either by mail, in a telephone interview, or in the clinic. A sub-sample of patients completed the CARES-SF a fourth time (T4) one week following T3, for purposes of test-retest reliability estimation., Results: On average, the CARES-SF required 11 minutes for completion and could be completed by 90% of the patients without assistance. However, 82% of the patients reported difficulty with at least one item. Multitrait scaling analysis and factor analysis generally confirmed the hypothesized scale structure. Internal consistency reliability coefficients exceeded the 0.70 criterion for four of six multi-item scales. The test-retest reliability coefficients of the six scales were above 0.70. No systematic differences were found in the psychometrics of the CARES-SF across administration conditions. In the mail condition the proportion of missing items was significantly higher, and patients reported having significantly more problems than in both the telephone and in-clinic condition. According to expectation, selective scales distinguished clearly between patients differing in disease stage, performance status, treatment modality and tumor response. Additionally, selective scales were responsive to changes in health status over time., Conclusion: These results lend support to the reliability and validity of the CARES-SF in assessing the quality of life of patients with cancer. At the same time, efforts to refine the questionnaire are recommended.

The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A 'core' instrument-the QLQ-C30-has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales ('modules') to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term 'module' is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.