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.
Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment ...of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs greater than or equal to 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Because survival benefits of treatment with radiotherapy are questionable and such treatment can cause substantial damage to the brain over time, the optimum management strategy for low-grade gliomas ...remains controversial. We aimed to identify the specific effects of radiotherapy on objective and self-reported cognitive function, and on cognitive deterioration over time, in patients with low-grade gliomas treated with early radiotherapy.
195 patients with low-grade glioma (of whom 104 had received radiotherapy 1–22 years previously) were compared with 100 low-grade haematological patients and 195 healthy controls. Our analyses aimed to differentiate between the effects of the tumour (eg, disease duration, lateralisation) and treatment effects (neurosurgery, radiotherapy, antiepileptic drugs) on cognitive function and on relative risk of cognitive disability.
Low-grade glioma patients had lower ability in all cognitive domains than did low-grade haematological patients, and did even less well by comparison with healthy controls. Use of radiotherapy was associated with poorer cognitive function; however, cognitive disability in the memory domain was found only in radiotherapy patients who received fraction doses exceeding 2 Gy. Antiepileptic drug use was strongly associated with disability in attentional and executive function.
Our findings suggest that the tumour itself has the most deleterious effect on cognitive function and that radiotherapy mainly results in additional long-term cognitive disability when high fraction doses are used. Additionally, the effects of other medical factors, especially antiepileptic drug use, on cognitive function in glioma patients deserve attention.
In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients ...participating in international clinical trials.
We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included.
The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity.
The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe.
These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
Cancer survivorship has traditionally received little prioritisation and attention. For a long time, the treatment of cancer has been the main focus of healthcare providers’ efforts. It is time to ...increase the amount of attention given to patients’ long‐term well‐being and their ability to return to a productive and good life. This article describes the current state of knowledge and identifies research areas in need of development to enable interventions for improved survivorship for all cancer patients in Europe. The article is summed up with 11 points in need of further focus.
Cancer survivorship has traditionally received little attention. It is time to increase the amount of attention given to patients’ long‐term well‐being and their ability to return to a productive and good life. This article describes the current state of knowledge and identifies research areas in need of development to enable interventions for improved survivorship for all cancer patients in Europe.
To systematically review the methodologic quality of, and summarize the evidence from trials examining the effectiveness of physical exercise in improving the level of physical functioning and ...psychological well-being of cancer patients during and after medical treatment.
Thirty-four randomized clinical trials (RCTs) and controlled clinical trials were identified, reviewed for substantive results, and assessed for methodologic quality.
Four of 34 trials met all (seven of seven) methodologic criteria on the Delphi criteria list. Failure to conceal the sequencing of treatment allocation before patient recruitment, failure to blind the outcome assessor, and failure to employ an intention-to-treat analysis strategy were the most prevalent methodologic shortcomings. Various exercise modalities have been applied, differing in content, frequency, intensity, and duration. Positive results have been observed for a diverse set of outcomes, including physiologic measures, objective performance indicators, self-reported functioning and symptoms, psychological well-being, and overall health-related quality of life.
The trials reviewed were of moderate methodologic quality. Together they suggest that cancer patients may benefit from physical exercise both during and after treatment. However, the specific beneficial effects of physical exercise may vary as a function of the stage of disease, the nature of the medical treatment, and the current lifestyle of the patient. Future RCTs should use larger samples, use appropriate comparison groups to rule out the possibility of an attention-placebo effect, use a comparable set of outcome measures, pay greater attention to issues of motivation and adherence of patients participating in exercise programs, and examine the effect of exercise on cancer survival.
To assess and compare the quality of life of men with advanced prostate cancer who are in remission receiving treatment with a luteinizing hormone-releasing hormone (LHRH) agonist and flutamide or ...who are in progression.
We conducted a cross-sectional survey to measure health-related quality of life in a cohort of 113 patients with metastatic prostate cancer, 60 in remission and 53 with disease progression, using a battery of questionnaires, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, the Medical Outcomes Study Short Form Health Survey SF-36, and a prostate cancerspecific module.
Patients in remission receiving an LHRH agonist and flutamide reported a significantly better quality of life compared with patients with disease progression (
P < 0.011 ). Men with hormone-sensitive cancer had significantly less bodily pain, more vitality, more social interactions, and better mental health than patients with hormone-resistant disease. No differences were noted between the two groups concerning treatmentrelated problems such as diarrhea, constipation, urinary symptoms, sexual function, sexual satisfaction, or hot flashes, although men in remission tended to rate each of these items more favorably than did men with disease progression. Men in remission have a health-related quality of life that is similar to an equivalent norm for men in the United States general population as compared with men with disease progression, who demonstrate significant compromise in all domains measured.
Patients in remission receiving an LHRH agonist and flutamide have a quality of life that is indistinguishable from a matched male population without prostate cancer and a quality of life significantly better than that of men with androgen-resistant disease. Among patients who respond to total androgen ablation, flutamide and an LHRH agonist provide significant, measurable benefits to recipients independent of any possible improvement in longevity.
Purpose
Supervised exercise is a potentially promising supportive care intervention for people with metastatic breast cancer (MBC), but research on the patients’ perspective is limited. The aim of ...the current focus group study was to gain an in-depth understanding of MBC patients’ perceived barriers, facilitators, and preferences for supervised exercise programs.
Methods
Eleven online focus groups with, in total, 44 MBC patients were conducted in four European countries (Germany, Poland, Spain, Sweden). Main topics of the semi-structured discussions covered attitudes towards participation in supervised exercise programs, perceived facilitators, experienced barriers, and exercise preferences. Interviews were transcribed verbatim, translated into English, and coded based on a preliminary coding framework, supplemented by themes emerging during the sessions. The codes were subsequently examined for interrelations and re-organized into overarching clusters.
Results
Participants had positive attitudes towards exercise, but experienced physical limitations and insecurities that inhibited their participation. They expressed a strong desire for exercise tailored to their needs, and supervision by an exercise professional. Participants also highlighted the social nature of group training as an important facilitator. They had no clear preference for exercise type, but rather favored a mixture of different activities. Flexible training modules were considered helpful to increase exercise program adherence.
Conclusions
MBC patients were generally interested in supervised exercise programs. They preferred group exercise that facilitates social interaction, but also expressed a need for individualized exercise programs. This suggests the relevance to develop flexible exercise programs that are adjusted to the individual’s needs, abilities, and preferences.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and comprosised quality of life. Currently available toxicity ...grading systems typically use a combination of clinical and paraclinical parameters and relies on the judgment of clinicians and/or nurses. However, because many of the symptoms of CIPN are subjective in nature, it is only logical that an assessment of CIPN be based, at least in part, on patient self-report data. We report on the development of a patient self-report questionnaire, the CIPN20, intended to supplement the core quality of life questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). Following EORTC guidelines, relevant CIPN-related issues were identified from a literature survey and interviews with health professionals (
n
=
15) and patients (
n
=
112). The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents.
Patients who undergo hematopoietic SCT (HSCT) often experience physical and psychological problems, even long after treatment has been completed. This study was performed to evaluate the effects of a ...12-week outpatient physical exercise (PE) program, incorporating aerobic and strength exercises, as compared with a usual care control condition on patients' physical performance and psychosocial well-being. Patients who had completed HSCT up to 6 months earlier were randomly assigned to a supervised PE program (n=64) or a usual care control group (n=67). Primary outcomes were quantified physical performance and self-reported physical functioning. Secondary outcomes were body composition measurement, quantified walking activity and patient-reported outcomes (physical activity, fatigue and health-related quality of life). Assessments were at baseline, immediately after program completion and at 3-month follow-up. Significant intervention effects were observed at both posttreatment and follow-up on physical performance measures. No other outcomes yielded statistically significant group differences. PE should be considered in the management of HSCT recipients to improve physical performance after discharge from the hospital. Further research is needed to determine how the program can be enhanced so that improved physical performance also translates into improved physical and psychosocial functioning in daily life.