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Purpose: Co-creation, characterised by artists and patients creating a joint work of art, may support patients with the integration of life events, such as living with cancer, into their life story. In the process of co-creation, resonance relationships between patients, artists and material may evolve that support such integration. Using the framework of resonance theory, we aim to investigate if and how patients move through the three phases of resonance during a process of co-creation and explore the role of uncontrollability in this process., Methods: Ten patients who received cancer treatment with palliative intent completed co-creation processes, which were audio recorded. These recordings were imported in Atlas-Ti and analysed by applying content analysis. We searched for the three phases of resonance, Being affected, touched and moved; Self-efficacy and responding; Adaptive transformation. We additionally searched for signs of uncontrollability., Results: Patients used 4-8 sessions (median 5 sessions) with a duration 90-240 min per session (median duration 120 min). We found that patients move through the three phases of resonance during co-creation processes. Uncontrollability both presents a challenge and an invitation to integrate experiences of contingency into one's life narrative. Patients express self-recognition and the experience of contingency in their work of art., Conclusions: Integration of experiences of contingency into a life narrative can be supported by the process of co-creation of art, which invites patients to relate to their illness, their environment and themselves. The phases of resonance in combination with uncontrollability as a continuously present factor, provide a means to both study and support the integration of experiences of contingency into the life narrative., (© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Purpose: Clinical evidence is limited regarding palliative radiation therapy for relieving pancreatic cancer-related pain. We prospectively investigated pain response after short-course palliative radiation therapy in patients with moderate-to-severe pancreatic cancer-related pain., Methods and Materials: In this prospective phase 2 single center nonrandomized trial, 30 patients with moderate-to-severe pain (5-10, on a 0-10 scale) of pancreatic cancer refractory to pain medication, were treated with a short-course palliative radiation therapy; 24 Gy in 3 weekly fractions (2015-2018). Primary endpoint was defined as a clinically relevant average decrease of ≥2 points in pain severity, compared with baseline, within 7 weeks after the start of treatment. Secondary endpoint was global quality of life (QoL), with a clinically relevant increase of 5 to 10 points (0-100 scale). Pain severity reduction and QoL were assessed 9 times using the Brief Pain Inventory and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C15-PAL, respectively. Both outcomes were analyzed using joint modeling. In addition, acute toxicity based on clinician reporting and overall survival (OS) were assessed., Results: Overall, 29 of 30 patients (96.7%) received palliative radiation therapy. At baseline, the median oral morphine equivalent daily dose was 129.5 mg (range, 20.0-540.0 mg), which decreased to 75.0 mg (range, 15.0-360.0 mg) after radiation (P = .021). Pain decreased on average 3.15 points from baseline to 7 weeks (one-sided P = .045). Patients reported a clinically relevant mean pain severity reduction from 5.9 to 3.8 points (P = .011) during the first 3 weeks, which further decreased to 3.2 until week 11, ending at 3.4 (P = .006) in week 21 after the first radiation therapy fraction. Global QoL significantly improved from 50.5 to 60.8 during the follow-up period (P = .001). Grade 3 acute toxicity occurred in 3 patients and no grade 4 to 5 toxicity was observed. Median OS was 11.8 weeks, with a 13.3% 1-year actuarial OS rate., Conclusions: Short-course palliative radiation therapy for pancreatic cancer-related pain was associated with rapid, clinically relevant reduction in pain severity, and clinically relevant improvement in global QoL, with mostly mild toxicity., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Co-creation, characterized by artists and patients creating a joint work of art, may support patients with the integration of disruptive life events into their life story, such as living with cancer. Focusing on experiences of contingency and life goals could support this process. The research questions are: (1) 'how are patient's ultimate life goals and experiences of contingency expressed in the work of art as created in a process of co-creation?'; (2) 'how do the four phases of integration of experiences of contingency unfold during co-creation?', Methods: Ten patients who were in a palliative stage of cancer treatment completed co-creation processes. Audio recordings of these co-creation processes were imported in Atlas-Ti and analysed by applying directed content analysis. We searched for life goals and experiences of contingency in the four phases of co-creation; Art communications, Element compilation, Consolidation, Reflection., Results: Patients used 4-8 sessions (median 5 sessions) with a duration of 90-240 min each (median duration 120 min). All patients expressed their experience of contingency and their ultimate life goals within the four phases of co-creation and in their work of art. A case description is presented illustrating the co-creation process., Conclusions: During co-creation, patients move through four phases in which experiences of contingency and ultimate life goals can be made explicit through art making and can be expressed in the work of art, supporting integration of experiences of contingency into one's life narrative., (© 2023. The Author(s).)

Purpose: In daily practice, oncologists and nurses frequently need to decide whether or not to refer a patient for professional mental health care. We explored the indicators oncologists and nurses use to judge the need for professional mental health care in patients with cancer., Methods: In a qualitative study, oncologists (n = 8) and nurses (n = 6) were each asked to select patients who were or were not referred for professional mental health care (total n = 75). During a semi-structured interview, they reflected on their decision concerning the possible referral of the patient. Thematic analysis was used to analyze the data., Results: Respondents reported using a strategy when judging whether professional mental health care was needed. They allowed patients time to adjust, while monitoring patients' psychological well-being, especially if patients exhibited specific risk factors. Risk and protective factors for emotional problems included personal, social, and disease- and treatment-related factors. Respondents considered referral for professional mental health care when they noted specific indicators of emotional problems. These indicators included lingering or increasing emotions, a disproportionate intensity of emotions, and emotions with a negative impact on a patient's daily life or treatment., Conclusions: This study identified the strategy, risk and protective factors, and the indicators of emotional problems used by oncologists and nurses when judging the need for professional mental health care in patients with cancer., Implications for Cancer Survivors: Oncologists and nurses can play an important role in the identification of patients in need of professional mental health care., (© 2021. The Author(s).)

Purpose: Co-creation, characterised by artists and patients creating a joint work of art, may support patients with the integration of life events into their life story, such as living with cancer. In the process of co-creation, resonance relationships between patients, artists and material may evolve that support integration. We aim to investigate if and if so, how resonance relationships occur from the perspective of the artist., Methods: We used the first 10 audio recordings of supervision sessions between eight artists and their two supervisors on ongoing co-creation processes with cancer patients. By conducting a qualitative template analysis in AtlasTi, we searched for the presence of resonance, as defined by its four main characteristics, Being affected, touched and moved; Self-efficacy and responding; Moments of uncontrollability; and Adaptive transformation. In addition, two case descriptions are presented., Results: We found resonance relationships to be present in the studied co-creation processes where moments of uncontrollability can lead to a next step in the process of co-creation and as such form an important factor within co-creation., Conclusions: The current study suggests focus on elements of resonance relationships within co-creation, specifically practising with uncontrollability while working with art, could strengthen interventions targeting integration of life events in advanced cancer patients., (© 2023. The Author(s).)

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).)

Introduction: Talking about illness experience can be challenging for adolescents and young adults (AYAs) with cancer. Visual tools, in addition to spoken language, might make this easier, such as rich pictures and photovoice. We aimed to obtain a comprehensive view of the cancer experience of AYAs by using rich pictures and photovoice., Methods: AYAs (18-35 years old) who had any type of cancer, or were in remission from cancer, were eligible. AYAs drew rich pictures about their experience of living with cancer and explained these during subsequent interviews. Some of the AYAs also participated in photovoice and spent two days with a photographer to make photos about their illness experience. Rich pictures and photos were first analyzed separately, using open coding, after which the identified themes were compared., Results: Twelve AYAs made rich pictures (RPs), of whom seven also participated in photovoice. The two most predominant themes emerging from the data were struggles related to the future and defining one's identity. The AYAs expressed concerns for the future related to relationships, education, and employment. Relating to defining one's identity, many AYAs expressed that the cancer had a negative impact on their body- and self-image. The main themes were visible in the RPs as well as in the photovoice; however, subtle differences in sub-themes were found., Conclusions: We found that cancer has an effect on many aspects of AYAs' lives. Further research on how the identified themes play a role in the lives of AYAs with cancer is needed., (© 2021. The Author(s).)

Background: The combination of verbal and visual tools may help unravel the experiences of advanced cancer patients. However, most previous studies have focused on a specific symptom, at only one moment in time. We recently found that a specific visual tool, originating from systems thinking, that is, rich pictures (RPs), could provide a more comprehensive view of the experiences of patients with advanced cancer., Aims: To examine whether the repeated use of RPs can make changes in subjective experiences of patients living with advanced cancer visible over time., Methods and Results: We performed a prospective study with a generic qualitative approach that was mostly informed by the process of grounded theory. We invited patients to make an RP twice, at the start of the study, and again after 2 months. Both RP drawing sessions were directly followed by a semi-structured interview. Patients with all types of solid tumors, above the age of 18, and with a diagnosis of advanced, incurable cancer, were eligible. Eighteen patients participated and 15 patients were able to draw an RP twice. In eight RP-sets, considerable differences between the first and second RP were noticeable. Two patterns were distinguished: (1) a change (decline or improvement) in physical health (five patients), and/or (2) a change in the way patients related to cancer (three patients)., Conclusion: RPs are a valuable qualitative research method that can be used to explore the experiences of patients with advanced cancer, not only at a single point in time but also over time., (© 2021 The Authors. Cancer Reports published by Wiley Periodicals LLC.)

Background: Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients' quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue., Methods: The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients' needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2)., Discussion: To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way., Trial Registration: The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019., (© 2021. The Author(s).)

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.

The current approach to the management of emotions in patients with cancer is "distress screening and referral for the provision of psychosocial care." Although this approach may have certain beneficial effects, screening and referral programs have shown a limited effect on patient psychological well-being. We argue that this limited effect is due to a mismatch between patient needs and the provision of care, and that a fundamental reconceptualization of the clinical management of emotions in patients with cancer is needed. We describe the rationale and characteristics of "emotional support and case finding" as the approach to the management of emotions in patients with cancer. The two main principles of the approach are: (1) Emotional support: (a) The treating team, consisting of doctors, nurses, and allied health staff, is responsive to the emotional needs of patients with cancer and provides emotional support. (b) The treating team provides information on external sources of emotional support. (2) Case finding: The treating team identifies patients in need of mental health care by means of case finding, and provides a referral to mental health care as indicated. We present a novel perspective on how to organize the clinical management of emotions in patients with cancer. This is intended to contribute to a fruitful discussion and to inform an innovative research agenda on how to manage emotions in patients with cancer., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society of Behavioral Medicine.)

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.)

Objectives: Inclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials., Methods: All RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research-PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting., Results: Of 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers., Conclusions: Our review indicates not only that PRO-RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: To provide holistic care to patients with advanced cancer, health care professionals need to gain insight in patients' experiences across the different domains of health. However, describing such complex experiences verbally may be difficult for patients. The use of a visual tool, such as Rich Pictures (RPs) could be helpful. We explore the use of RPs to gain insight in the experiences of patients with advanced cancer., Methods: Eighteen patients with advanced cancer were asked to draw a RP expressing how they experienced living with cancer, followed by a semi-structured interview. Qualitative content analysis, including the examination of all elements in the drawings and their interrelationships, was used to analyze the RPs, which was further informed by the interviews., Results: The RPs clearly showed what was most important to an individual patient and made relations between elements visible at a glance. Themes identified included: medical aspects, the experience of loss, feelings related to loss, support from others and meaningful activities, and integration of cancer in one's life. The added value of RPs lies in the ability to represent these themes in one single snapshot., Conclusions: RPs allow for a complementary view on the experiences of advanced cancer patients, as they show and relate different aspects of patients' lives. A RP can provide health care professionals a visual summary of the experiences of a patient. For patients, telling their story to health care professionals might be facilitated when using RPs., (© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Introduction: Ecological momentary assessment (EMA) is an emerging method to assess an individual's current thoughts, affect, behaviour, physical states and contextual factors as they occur in real-time and in their natural environment. Whereas EMA is frequently used in mental health, little is known about the added value of EMA in oncology research. This review aimed to synthesise methodological information and results of studies that applied EMA among patients with cancer to inform future researchers about the opportunities and challenges., Methods: We included full-text articles on studies that: (a) were conducted among adult cancer patients; and (b) examined cancer and treatment-related experiences by EMA. Information from selected studies was synthesised: study designs, EMA data collection methods, response-related results and main findings., Results: Twelve studies were included, which all applied an observational design. The EMA data collection methods varied considerably and the reporting of response-related results were poor. Nevertheless, EMA was found feasible as no systematic patterns of problems were reported and reported response-related results were acceptable. Furthermore, EMA was found useful as it facilitated examination of real-time experiences and behaviour., Conclusion: Ecological momentary assessment is useful and feasible in oncology research. Future studies would benefit from guidelines for designing and reporting EMA studies., (© 2019 The Authors. European Journal of Cancer Care Published by John Wiley & Sons Ltd.)

Purpose: Little research has been done to identify possible cancer-related fatigue (CRF) subtypes and to classify cancer survivors accordingly. We aimed to identify CRF subtypes in a large population-based sample of (long term) stage I-III colorectal cancer survivors. We also identified factors associated with the CRF subtypes., Methods: Respondents completed the Multidimensional Fatigue Inventory and other validated questionnaires on anxiety and reduced positive affect (anhedonia), sleep quality, and lifestyle factors (body mass index and physical activity). Latent class analysis was used to derive the CRF subtypes. Factors associated with the derived CRF subtypes were determined with multinomial logistic regression., Results: Three CRF classes were identified: class 1 (no fatigue and distress, n = 644, 56%), class 2 (low fatigue, moderate distress, n = 256, 22%), and class 3 (high fatigue, moderate distress, n = 256, 22%). Multinomial logistic regression results show that survivors in class 3 were more likely to be female, were treated with radiotherapy, have comorbid diabetes mellitus, and be overweight/obese than survivors in class 1 (reference). Survivors in classes 2 and 3 were also more likely to have comorbid heart condition, report poorer sleep quality, experience anhedonia, and report more anxiety symptoms when compared with survivors in class 1., Conclusions: Three distinct classes of CRF were identified which could be differentiated with sleep quality, anxiety, anhedonia, and lifestyle factors., Implications for Cancer Survivors: The identification of CRF subtypes with distinct characteristics suggests that interventions should be targeted to the CRF subtype.

Introduction: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated., Methods and Analysis: Data will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30., Ethics and Dissemination: All patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID 'blue book' which will be made available online on the EORTC Quality of Life Group website as a free guideline document., Competing Interests: Competing interests: None declared., (© 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.)

We examined if serum concentrations Interferon gamma-induced protein (IP-10) is a potential clinical biomarker for cancer-related-fatigue (CRF). Fatigue scores and IP-10 concentrations were measured from curatively treated fatigued cancer patients randomized to either cognitive behavioral therapy (CBT, n = 26) or waiting-list (WL, n = 13). No correlation was found between baseline IP-10 level and fatigue severity and no significant differences in IP-10 serum levels were observed between fatigued and matched non-fatigued patients (n = 22). Relative changes in IP-10 concentrations from baseline to six-month follow-up were not significantly different between the CBT and WL conditions. In this study, IP-10 showed low potential as clinical CRF biomarker., Trial Registration: This study is registered at ClinicalTrials.gov (NCT01096641).

Adolescents facing cancer may need to adjust their personal life goals. Theories identified several goal adjustment strategies, but their use has not been tested. Therefore, this study operationalises goal adjustment strategies and examines their use. Adolescent cancer patients listed their goals 3 and 12 months post-diagnosis. Goals received scores on five goal characteristics: life domain, level of abstraction, importance, attainability and effort. Results showed that adolescents with cancer (N = 30, mean age: 14.2 years, 60% female) used four of five strategies described in theory, while one additional strategy was found. These findings suggest that adolescents with cancer use goal adjustment strategies as measured by goal characteristics over time., (© The Author(s) 2014.)

Purpose: The structural equation modeling (SEM) approach for detection of response shift (Oort in Qual Life Res 14:587-598, 2005. doi: 10.1007/s11136-004-0830-y ) is especially suited for continuous data, e.g., questionnaire scales. The present objective is to explain how the SEM approach can be applied to discrete data and to illustrate response shift detection in items measuring health-related quality of life (HRQL) of cancer patients., Methods: The SEM approach for discrete data includes two stages: (1) establishing a model of underlying continuous variables that represent the observed discrete variables, (2) using these underlying continuous variables to establish a common factor model for the detection of response shift and to assess true change. The proposed SEM approach was illustrated with data of 485 cancer patients whose HRQL was measured with the SF-36, before and after start of antineoplastic treatment., Results: Response shift effects were detected in items of the subscales mental health, physical functioning, role limitations due to physical health, and bodily pain. Recalibration response shifts indicated that patients experienced relatively fewer limitations with "bathing or dressing yourself" (effect size d = 0.51) and less "nervousness" (d = 0.30), but more "pain" (d = -0.23) and less "happiness" (d = -0.16) after antineoplastic treatment as compared to the other symptoms of the same subscale. Overall, patients' mental health improved, while their physical health, vitality, and social functioning deteriorated. No change was found for the other subscales of the SF-36., Conclusion: The proposed SEM approach to discrete data enables response shift detection at the item level. This will lead to a better understanding of the response shift phenomena at the item level and therefore enhances interpretation of change in the area of HRQL.

Objective: The aim of this study was to examine the effect of spiritual interventions on quality of life of cancer patients., Methods: We conducted our search on June 6, 2014 in Medline, PsycINFO, Embase, and PubMed. All clinical trials were included that compared standard care with a spiritual intervention that addressed existential themes using a narrative approach. Study quality was evaluated by the Cochrane Risk of Bias Tool., Results: A total of 4972 studies were identified, of which 14 clinical trials (2050 patients) met the inclusion criteria, and 12 trials (1878 patients) were included in the meta-analysis. The overall risk of bias was high. When combined, all studies showed a moderate effect (d) 0.50 (95% CI = 0.20-0.79) 0-2 weeks after the intervention on overall quality of life in favor of the spiritual interventions. Meta-analysis at 3-6 months after the intervention showed a small insignificant effect (0.14, 95% CI = -0.08 to 0.35). Subgroup analysis including only the western studies showed a small effect of 0.17 (95% CI = 0.05-0.29). Including only studies that met the allocation concealment criteria showed an insignificant effect of 0.14 (95% CI = -0.05 to 0.33)., Conclusions: Directly after the intervention, spiritual interventions had a moderate beneficial effect in terms of improving quality of life of cancer patients compared with that of a control group. No evidence was found that the interventions maintained this effect up to 3-6 months after the intervention. Further research is needed to understand how spiritual interventions could contribute to a long-term effect of increasing or maintaining quality of life., (Copyright © 2015 John Wiley & Sons, Ltd.)

Objective: 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., Study Design and Setting: 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., Results: 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., Conclusion: 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.)

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers., Methods: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided., Results: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient- and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P < .001), vomiting (P = .01), nausea (P < .001), and constipation (P = .01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed., Conclusions: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Background: Cancer incidence increases exponentially with advancing age, cancer patients live longer than in the past, and many new treatments focus on stabilizing disease and HRQOL. The objective of this study is to examine how cancer affects patients' HRQOL and whether their HRQOL is age-dependent., Methods: Data from 25 EORTC randomized controlled trials was pooled. EORTC QLQ-C30 mean scores for the cancer cohort and five general population cohorts were compared to assess the impact of cancer on patients' HRQOL. Within the cancer cohort, multiple linear regressions (two-sided level P-value = 0.05 adjusted for multiple testing.) were used to investigate the association between age and HRQOL, adjusted for gender, WHO performance status (PS), distant metastasis and stratified by cancer site. A difference of 10 points on the 0-100 scale was considered clinically important., Results: Cancer patients generally have worse HRQOL compared to the general population, but the specific HRQOL domains impaired vary with age. When comparing the cancer versus the general population, young cancer patients had worse financial problems, social and role functioning, while the older cancer groups had more appetite loss. Within the cancer cohort, HRQOL was worse with increasing age for physical functioning and constipation, and better with increasing age for social functioning, insomnia and financial problems (all p < 0.05)., Conclusion: HRQOL is impaired in cancer patients compared to the general population, but the impact on specific HRQOL domains varies by age. Within the cancer population, some HRQOL components improve with age while others deteriorate. Optimal care for older cancer patients should target HRQOL domains most relevant to this population., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Due to physical hindrance and time spent in hospital, a cancer diagnosis can lead to disturbance of personally important goals. Goal disturbance in cancer patients has been related to poorer psychological well-being. However, the relation with physiological measures is yet unknown. The purpose of the current study is to examine the impact of goal disturbance on cortisol as a measure of response to stress over time, and a possibly moderating role of a DNA genotype associated with HPA-axis functioning, Catechol-O-Methyl transferase (COMT). We examined the predictive value of goal disturbance on Cortisol Awakening Response (CAR) and Diurnal Cortisol Slope (DCS) over two periods: 1-7 and 7-18 months post-diagnosis, and the moderating role of COMT during these periods. Hierarchical regression analyses showed that goal disturbance 7 months post-diagnosis significantly predicted a steeper CAR a year later. During that period, the slow COMT variant moderated the relation, in that patients reporting high goal disturbance and had the Met/Met variant, had a more flattened CAR. No other significant effects were found. As steeper CARs have been related to adverse health outcomes, and COMT genotype may modify this risk, these results indicate that goal disturbance and genotype may be important factors to consider in maintaining better psychological and physical health in the already vulnerable population of cancer patients.

Purpose: Setting and pursuing personal goals is a vital aspect of our identity and purpose in life. Cancer can put pressure on these goals and may be a reason for people to adjust them. Therefore, this paper investigates (1) changes in cancer patients' goals over time and (2) the extent to which illness characteristics relate to goal changes., Methods: At both assessment points (1 and 7 months post-diagnosis), colorectal cancer patients (n = 198) were asked to list their current goals and rate them on hindrance of illness, attainability, likelihood of success, temporal range and importance. All goals were coded by two independent raters on content (i.e. physical, psychological, social, achievement and leisure). Patients' medical data were obtained from the national cancer registry., Results: Over time, patients reported a decrease in illness-related hindrance, higher attainability and likelihood of success, a decrease in total number of goals, goals with a shorter temporal range, and more physical and fewer social goals. At both assessments, patients with more advanced stages of cancer, rectal cancer, a stoma, and receiving additional chemotherapy and/or radiotherapy reported more illness-related hindrance in goal attainment, but only patients with a stoma additionally reported lower attainability, likelihood of success and more short-term goals., Conclusions: The results of this study support the assumption that cancer patients adjust their goals to changing circumstances and additionally show how patients adjust their goals to their illness. Moreover, we demonstrate that illness variables impact on goal change.

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.)

Background: The objective of this study was to examine the prognostic value of baseline health-related quality of life (HRQOL) for survival with regard to different cancer sites using 1 standardized and validated patient self-assessment tool., Methods: In total, 11 different cancer sites pooled from 30 European Organization for Research and Treatment of Cancer (EORTC) randomized controlled trials were selected for this study. For each cancer site, univariate and multivariate Cox proportional hazards modeling was used to assess the prognostic value (P< .05) of 15 HRQOL parameters using the EORTC Core Quality of Life Questionnaire (QLQ-C30). Models were adjusted for age, sex, and World Health Organization performance status and were stratified by distant metastasis., Results: In total, 7417 patients completed the EORTC QLQ-C30 before randomization. In brain cancer, cognitive functioning was predictive for survival; in breast cancer, physical functioning, emotional functioning, global health status, and nausea and vomiting were predictive for survival; in colorectal cancer, physical functioning, nausea and vomiting, pain, and appetite loss were predictive for survival; in esophageal cancer, physical functioning and social functioning were predictive for survival; in head and neck cancer, emotional functioning, nausea and vomiting, and dyspnea were predictive for survival; in lung cancer, physical functioning and pain were predictive for survival; in melanoma, physical functioning was predictive for survival; in ovarian cancer, nausea and vomiting were predictive for survival; in pancreatic cancer, global health status was predictive for survival; in prostate cancer, role functioning and appetite loss were predictive for survival; and, in testis cancer, role functioning was predictive for survival., Conclusions: The current results demonstrated that, for each cancer site, at least 1 HRQOL domain provided prognostic information that was additive over and above clinical and sociodemographic variables., (© 2013 American Cancer Society.)

Purpose: The aim of this study was to evaluate the translated response categories used in eight translations of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire, which is used in many international clinical trials. Twenty-eight of the 30 items in the questionnaire have the same four response categories: "Not at all", "A little", "Quite a bit" and "Very Much"., Methods: People with knowledge of both English and one of eight European languages were asked to complete an Internet survey. The strength (intensity) of the translated categories was assessed using two separate approaches: one using a verbal response scale and the other a visual analogue scale (VAS)., Results: Two hundred and seventy-nine people participated in the survey. Most translations were rated similarly to English. The largest differences were for the German translation of "Quite a bit", which was rated 16.3 points lower than the corresponding English category on a 0-100 VAS., Conclusions: Most of the translated categories were found to be similar to the English versions and should continue to be used. We recommend that three translated categories should be considered for revision. Similar surveys could be used to assess the categories used in other translated quality of life instruments.

Background: It is widely recognized that spiritual care plays an important role in physical and psychosocial well-being of cancer patients, but there is little evidence based research on the effects of spiritual care. We will conduct a randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients., Methods/design: Based on the findings of our previous research, we have developed a brief interview model that allows spiritual counsellors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, we created an e-application for a PC or tablet. To examine whether this assisted reflection improves quality of life we will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counsellor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption., Discussion: Having insight into one's ultimate life goals may help integrating a life event such as cancer into one's life story. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients' quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counsellors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care., Trial Registration: The study is registered at ClinicalTrials.gov: NCT01830075.

Objective: This study aims to explain bodily pain using the Sprangers and Schwartz theoretical model (1999) on quality of life (QL) and response shift in its entirety. Response shift refers to the phenomenon that the meaning of a person's self-evaluation changes over time. In this model, response shift mediates effects of changes in health status (catalysts), stable characteristics of the person (antecedents), and coping mechanisms (mechanisms) on QL., Methods: Cancer patients (202) were assessed prior to and 3 months following surgery. Measures were for catalysts: type of operation and possibility of tumor resection; for antecedents: age, duration of pain, optimism, and rigidity; for mechanisms: post-traumatic growth, social comparisons, social support, denial, and acceptance; and for QL: bodily pain; for response shift: the pretest-minus-thentest bodily pain score, further referred to as recalibration response shift. Structural equation modeling and sequential regression analyses were used., Results: The final model reached close fit (RMSEA = 0.03; 90% CI = 0.000-0.071; χ2 (18) = 21.13; p = 0.27). Significant effects were found for catalysts on mechanisms, antecedents on mechanisms, mechanisms on response shift, and response shift on bodily pain. Four extra model effects had to be permitted. Using sequential regression analysis, recalibration response shift added 4.4% to the total amount of 29.8% explained variance of bodily pain., Conclusions: Many effects as hypothesized by the model were found. Recalibration response shift had a unique albeit small contribution to the explanation of bodily pain., (Copyright © 2012 John Wiley & Sons, Ltd.)

Background: The degree of trust in and satisfaction with the physician has been shown to have important implications for treatment outcomes. This study aims to examine individual differences in patients' trust, satisfaction and general distress from an attachment theoretical perspective., Material and Methods: One hundred and thirty recently diagnosed cancer patients of three medical hospitals were extensively interviewed by trained psychologists to assess attachment style. Patients completed standardized questionnaires three and nine months after diagnosis to assess trust, satisfaction and distress. t-tests and repeated measures ANOVAs were used to examine differences between securely and insecurely attached patients and changes over time. A mediation model based on a bootstrapping method was used to examine whether trust mediated between attachment and satisfaction, and attachment and distress., Results: Insecurely attached patients (N = 45, 35%) reported less trust in and satisfaction with their physician, and reported more general distress than securely attached patients three and nine months after diagnosis (p < 0.05). Trust and distress levels did not change over time. Trust mediated between attachment and satisfaction, but not between attachment and distress., Conclusion: Insecurely attached patients trusted their physician less than securely attached patients, and in turn were less satisfied with their physician. Their higher levels of general distress were not related to their lower levels of trust. Attachment theory provides a framework to interpret differences in patients' trust, satisfaction and distress, and may help physicians respond in such a way that their patients feel secure, which in turn is expected to result in better health outcomes.

Transition items are a popular approach to determine the clinical significance of patient-reported change. These items assume that patients (1) arrive at a change evaluation by comparing posttest and pretest functioning, and (2) accurately recall their pretest functioning. We conducted cognitive think-aloud interviews with 25 cancer patients prior to and following radiotherapy. Two researchers independently analysed their responses using an analysis scheme based on cognitive process models of Tourangeau et al. and Rapkin and Schwartz. In 112 of the 164 responses to transition items, patients compared current and prior functioning. However, in 104 of these responses, patients did not refer to their functioning at pretest and/or posttest according to transition design's first assumption, but rather used a variety of time frames. Additionally, in 79 responses, the time frame employed and/or description of prior functioning provided differed from those employed in the corresponding pretest items. Transition design's second assumption was therefore not in line with the patients' cognitive processes. Our findings demonstrate that in interpreting transition assessments, one needs to be aware that patients provide change assessments, which are not necessarily based on the cognitive processes intended by researchers and health care providers.

There are indications that in cancer patients quality of life is a better predictor of survival than clinical measures such as tumour response and stage of disease. In addition, health care professionals' expectations about the effect of a particular treatment on quality of life often do not correspond with the experience of the patient. These are all reasons for every oncological patient to complete a short questionnaire on quality of life. Using this questionnaire can improve communication between care provider and patient, and also give the care provider insight into the problems that are important to the patient at that time. This insight could subsequently lead to counseling tailored to the patient, and, if necessary, modification of treatment or referral for supportive care. A second aim is to link information on quality of life to clinical pathways and treatment guidelines.

Background: Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined., Methods: This cross-sectional study included 1933 patient-health care provider dyads, from 11 European countries. Patients reported symptoms by using the four-point scales of the European Organization of Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) version 3, and providers used corresponding four-point categorical scales. Level of agreement was addressed at the group level (Wilcoxon Signed-Rank test), by difference scores (provider score minus patient score), at the individual level (Intraclass Correlation Coefficients, ICCs) and visually by Bland-Altman plots. Absolute numbers and chi-square tests were used to investigate the relationship between agreement and demographic-, as well as disease-related factors., Results: The prevalence of symptoms assessed as moderate or severe by patients and providers, respectively, were for pain (67 vs.47%), fatigue (71 vs. 54%), generalized weakness (65 vs. 47%), anorexia (47 vs. 25%), depression (31 vs. 17%), constipation (45 vs. 30%), poor sleep (32 vs. 21%), dyspnea (30 vs. 16%), nausea (27 vs. 14%), vomiting (14 vs. 6%) and diarrhea (14 vs. 6%). Symptom scores were identical or differed by only one response category in the majority of patient-provider assessment pairs (79-93%). Providers underestimated the symptom in approximately one of ten patients and overestimated in 1% of patients. Agreement at the individual level was moderate (ICC 0.38 to 0.59). Patients with low Karnofsky Performance Status, high Mini Mental State-score, hospitalized, recently diagnosed or undergoing opioid titration were at increased risk of symptom underestimation by providers (all p < 0.001). Also, the agreement was significantly associated with drug abuse (p = 0.024), provider profession (p < 0.001), cancer diagnosis (p < 0.001) and country (p < 0.001)., Conclusions: Considerable numbers of health care providers underestimated symptom intensities. Clinicians in cancer care should be aware of the factors characterizing patients at risk of symptom underestimation.

Background: The clinical impact of trial-based quality of life (QL) outcomes is frequently underestimated due, in part, to prejudice and lack of knowledge by the medical community. The objectives of this paper are to show that QL assessments build upon an empirically based and stringent approach to measurement and QL outcomes should not be viewed nor handled differently than any other parameter in medical research., Material and Methods: Literature overview., Results: The objectives are substantiated with empirical evidence showing that: (1) existing QL measures are as reliable as most other clinical outcomes; (2) available guidelines improve the quality of trial-based QL data; (3) QL data have strong prognostic value for survival; (4) clinical significance of QL data can be established; and (5) accounting for response-shift effects in QL data over time is feasible. Finally, the investigation of the genetic disposition of QL is described as an emerging area of research., Discussion: It is a waste of effort and money and also unethical when collected trial-based QL data are not used to their full power. QL and other patient-reported outcomes deserve to be included in more trials, with full disclosure of all results, and standardized interpretation. Only the combined use of patient-reported and clinical outcomes will enable the examination of the extent to which cancer patients live a qualitatively good life as long as possible.

Background: Although individual studies show that baseline health-related quality of life (HRQOL) is a prognostic factor for survival, contradictory results have been published and very few meta-analyses have confirmed the finding. We examined whether HRQOL scores are associated with survival when pooled across a large sample of patients with different disease sites., Methods: We selected 30 randomised controlled trials from the European Organisation for Research and Treatment of Cancer (EORTC) started between 1986 and 2004, which included survival data for 10 108 patients with 11 different cancer sites. Patients were eligible for inclusion if they had completed a baseline HRQOL assessment with the EORTC core quality of life questionnaire (QLQ-C30; n=7417). Sociodemographic variables were age (60 years) and sex (men vs women), and clinical variables were WHO performance status (0-1 vs 2-3), distant metastases (no vs yes), and cancer site. We assessed prognostic significance of sociodemographic and clinical variables and the 15 QLQ-C30 scales with Cox proportional hazard models., Findings: In the stratified multivariate model including sociodemographic, clinical, and HRQOL data, the HRQOL parameters of physical functioning (hazard ratio 0.94, 95% CI 0.92-0.96; p<0.0001), pain (1.04, 1.02-1.06; p<0.0001), and appetite loss (1.05, 1.03-1.06; p<0.0001) provided significant prognostic information in addition to the parameters age (1.17, 1.06-1.28; p=0.0001), sex (0.74, 0.67-0.82; p<0.0001), and distant metastases (1.70, 1.49-1.93; p<0.0001), but not for WHO performance status (1.07, 0.97-1.19; p=0.11). Consideration of the three HRQOL parameters and sociodemographic and clinical data increased the predictive accuracy of prognosis of overall survival by 6% relative to sociodemographic and clinical characteristics alone (C statistic for concordance between predicted and observed overall survival 0.68 for sociodemographic and clinical variables, and 0.72 for sociodemographic, clinical, and HRQOL variables)., Interpretation: The results suggest that HRQOL scales provide prognostic information in addition to that of sociodemographic and clinical measures. This study shows that HRQOL data can help to predict survival in patients with cancer., Funding: Merck KGaA, EORTC Charitable Trust, and National Cancer Institute.

Objective: The objective of this study was to investigate the relationship between neuropsychological functioning and the ability to work in cancer survivors., Methods: The study involved a consecutive cohort of 45 patients who had received a primary diagnosis of cancer, were gainfully employed at baseline, and had been treated with curative intent. Twelve months after the first day of sick leave, they underwent a neuropsychological assessment that included executive function and verbal memory tests. Other clinical, person-related, and work-related factors were also assessed by questionnaire at this time. Ability to work was measured as perceived workability (0-10) and work status at 12 months of sick leave., Results: Fifteen participants (33%) showed neuropsychological impairments covering various domains. The mean workability score of cancer survivors with neuropsychological impairment was 4.9, whereas those without impairments had a mean score of 6.0 (raw beta = -0.19: 95% CI = -2.9 to 0.7; adjusted beta = -0.15; 95% CI = -2.5 to 0.8). More cancer survivors with neuropsychological impairments (7/15, 47%) than without (9/30, 30%) had not yet returned to work (raw OR 0.5: 95% CI: 0.1-1.8; adjusted OR 0.5; 95% CI: 0.1-2.1)., Conclusions: To date, this is the largest study to assess neuropsychological functioning objectively in combination with perceived workability and work status. Impaired neuropsychological functioning was found in one-third of the cancer survivors and was related to a lower vocational functioning, but the relationship was not statistically significant. More research is needed to test the relevance of neuropsychological impairments for vocational functioning.

Introduction: Differential item functioning (DIF) analyses can be used to explore translation, cultural, gender or other differences in the performance of quality of life (QoL) instruments. These analyses are commonly performed using "baseline" or pretreatment data. We previously reported DIF analyses to examine the pattern of item responses for translations of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 QoL instrument, using only data collected prior to cancer treatment. We now compare the consistency of these results with similar analyses of on-treatment and off-treatment assessments and explore whether item relationships differ from those at baseline., Methods: Logistic regression DIF analyses were used to examine the translation of each item in each multi-item scale at the three time points, after controlling for the overall scale score and other covariates. The consistency of results at the three time points was explored., Results: For most EORTC QLQ-C30 subscales, the DIF results were very consistent across the three time points. Results for the Nausea and Vomiting scale varied the most across assessments., Discussion: The results indicated that DIF analyses were stable across each time point and that the same DIF effects were usually found regardless of the treatment status of the respondent.

Objective: To develop an analysis scheme capturing the cognitive processes underlying QoL assessment to increase our understanding on how to interpret responses to QoL items. Tourangeau et al.'s (The psychology of survey response, 2000) and Rapkin and Schwartz' (Health Qual Life Outcomes 2:14, 2004) cognitive process models form the basis for this analysis scheme., Methods: We conducted think aloud interviews with six cancer patients prior to and following radiotherapy to elicit the cognitive processes underlying the assessment of 7 EORTC QLQ-C30 items. Content analysis was carried out by two to four researchers independently. Eighty text fragments were analyzed inductively and combined in an iterative process with deductive analyses based on both models., Results: We have developed a comprehensive analysis scheme feasible for analyzing the cognitive processes underlying QoL assessment qualitatively. All cognitive components of both models could be distinguished in our data. The cognitive component 'reporting and response selection' needed extension to fully capture the cognitive processes used., Conclusion: The two models combined are useful in describing the cognitive processes cancer patients use in answering QoL items, and as such facilitate insight into patients' self-reported QoL assessments. Interestingly, the content of the cognitive processes not only differed between patients but also between items within patients and over time.

Objective: To investigate whether geographic and cultural factors influence the relationship between the global health status quality of life (QL) scale score of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire and seven other subscales representing fatigue, pain, physical, role, emotional, cognitive, and social functioning., Study Design and Setting: A large international database of QLQ-C30 responses was assembled. A linear regression model was developed predicting the QL scale score and including interactions between geographical/cultural groupings and the seven other scale scores., Results: The pain subscale appeared to have relatively greater influence and fatigue relatively lower influence for those from other European regions compared with respondents from the UK when predicting overall quality of life (QoL). For Scandinavia physical functioning appeared to contribute relatively less. There was evidence of greater emphasis on cognitive functioning for those from South Asia and Latin America compared with the UK, whereas for those from Islamic countries, the role functioning scale appeared to have less influence and physical and social functioning more influence., Conclusion: These results provide evidence that different cultural groups may emphasize different aspects of their QoL. This has implications for studies using QoL questionnaires in international comparisons.

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.

Background: For employed cancer survivors, returning to work and maintaining employment is an important aspect of their quality of life. We developed an intervention aimed at enhancing this by means of (a) providing the patient with an educational leaflet on return to work and (b) enhancing communication between attending and occupational physicians. The purpose of this study is to test the feasibility of this intervention and to examine the relation of patient adherence to the advice of the leaflet and return to work., Methods: A patient series of 35 employed cancer survivors was used to evaluate the intervention. Survivors completed a baseline questionnaire prior to their treatment. Survivors and occupational physicians were interviewed by telephone eight weeks following all curative treatment. Our measure of feasibility included satisfaction of survivors with the intervention, adherence to the advice, time to return to work, satisfaction of occupational physicians with the intervention, and perceived influence on their rehabilitation efforts., Results: Interviews of 26 survivors and 24 occupational physicians, revealed that those groups perceived the leaflet as useful (i.e., 7 on a 0-10 scale. Also seven out of ten suggestions in the leaflet was adhered to and half of the occupational physicians perceived the guidance they provided was helpful. However there was no effect of level of adherence on actual return to work., Conclusion: This pilot study demonstrated the feasibility of the approach used. However level of adherence to educational leaflet was not associated with an improvement in return to work in cancer survivors.

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 Objectives: Newly diagnosed cancer patients waiting for initial surgery experience a stressful time. Study objectives were (1) to examine the quality of life (QL) of these patients by comparing QL (a) between the four diagnostic groups included in this study, (b) to the QL of the general population, (2) to determine the factors that contribute most to patients' overall QL., Methods: One hundred ninety six patients with lung, periampullary, oesophageal and cervical cancer completed questionnaires on generic QL (SF-36), overall QL, cancer-site specific symptoms (EORTC-modules), anxiety (STAI), health expectations, demographics and comorbidity., Results: Between diagnostic groups no significant differences were found on generic QL. As compared to the general population, generic QL was impaired on all aspects except bodily pain. Using stepwise regression analysis, 46% of the variance in overall QL was explained with the SF-36 scales vitality (Beta = 0.43) and mental health (Beta = 0.23) being the most important predictors., Conclusions: The QL of these patients is seriously impaired. In this stage, not cancer-site specific aspects but fatigue and emotions colour their lives. It is recommended to keep the waiting period brief. In addition, suggestions are offered by which physicians might help their patients in alleviating the distress., (Copyright 2006 Wiley-Liss, Inc.)

This study aimed at developing a shortened version of the EORTC QLQ-C30, one of the most widely used health-related quality of life questionnaires in oncology, for palliative care research. The study included interviews with 41 patients and 66 health care professionals in palliative care to determine the appropriateness, relevance and importance of the various domains of the QLQ-C30. Item response theory methods were used to shorten scales. Patients and health care professionals rated pain, physical function, emotional function, fatigue, global health status/quality of life, nausea/vomiting, appetite, dyspnoea, constipation, and sleep as most important. Therefore, these scales/items were retained in the questionnaire. Four scales were shortened without reducing measurement precision. Important dimensions not covered by the questionnaire were identified. The resulting 15-item EORTC QLQ-C15-PAL is a 'core questionnaire' for palliative care. Depending on the research questions, it may be supplemented by additional items, modules or questionnaires.

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.