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Older patients who are functionally compromised or frail may be at risk for loss of quality of life (QoL) after colorectal cancer (CRC) surgery. We prospectively studied health-related QoL (HRQoL) and its association with functional dependency on multiple time points before and after CRC surgery. Included were patients aged 70 years and older who underwent elective CRC surgery between 2014 and 2015 in combination with an oncogeriatric care path. HRQoL (EORTC QLQ-C30 and CR38) and activities of daily living (ADL, Barthel Index) were measured at four time-points; prior to (T0) and at 3 (T3), 6 (T6), and 12 (T12) months after surgery. Functional dependency was defined as a Barthel Index <19. Using mixed-model regression analysis associations between dependency, time and HRQoL outcomes were tested and corrected for confounders. Response rate was 67% (n = 106) to two or more questionnaires; 26 (25%) patients were functionally dependent. Overall, functionally independent patients experienced a higher HRQoL than dependent patients. Compared to T0, significant and clinically relevant improvements in HRQoL after surgery were observed in functionally dependent patients: better role functioning, a higher global health, a higher summary score, less fatigue and less gastrointestinal problems (p <.05). In functional independent patients, we observed no clinically relevant change in HRQoL. Colorectal surgery embedded in geriatric-oncological care has a positive impact on HRQoL in older functionally dependent patients with cancer. Moderate functional dependency should not be considered a generic reason for withholding surgical treatment. Information derived from this study could be used in shared decision making. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Cancer survivors often report comorbid diseases, but there are individual differences in risk. Type D personality is a general propensity to psychological distress that is related to poor cardiovascular outcomes. In this study, we examined whether type D was also related to comorbidity burden and health care utilization among cancer survivors. Methods: Individuals diagnosed with endometrial cancer or colorectal cancer between 1998 and 2007, or with lymphoma or multiple myeloma between 1999 and 2008 as registered in the Eindhoven Cancer Registry, received the Self-Administered Comorbidity Questionnaire, questions on health care utilization and the Type D personality scale; 69% (n=3080) responded. Results: Nineteen percent of survivors had a type D personality. Over a 12-month period, type D survivors significantly more often reported osteoarthritis, back pain, and depression than non–type D survivors. Also, type D survivors more often reported to feel bothered by high blood pressure, osteoarthritis, heart disease, depression, diabetes and lung disease during daily activities. Type D survivors more often visited their general practitioner than non–type D survivors (P<.001), also in relation to cancer (0 visits: 54% vs. 60%; 1–5: 28% vs. 22%; >5: 9% vs. 5%; P<.001), as well as their specialist (0 visits: 6% vs. 7%; 1–5 visits: 59% vs. 64%; >5 visits: 30% vs. 23%; P<.01). Conclusion: Type D personality is a vulnerability factor that may help to identify subgroups of cancer survivors who are at an increased risk for comorbidity burden and increased health care utilization. [Copyright &y& Elsevier]

Abstract: Objective: Irritable bowel syndrome (IBS) is a common, chronic, and often disabling disorder. Cognitive–behavioral therapy (CBT) has been shown to be effective in alleviating IBS symptoms. The aim of this study was to establish the feasibility and the efficacy of a cognitive-behavioral e-intervention using personal digital assistants (PDAs) on the self-management of IBS patients. Methods: A feasibility trial was conducted with 38 control group patients receiving standard care and 37 intervention group patients receiving standard care supplemented with a 4-week CBT intervention on PDAs. All patients fulfilled the diagnostic Rome III criteria for IBS. At baseline, 4-week, and 3-month follow-up, patients'' abdominal pain, dysfunctional cognitions, IBS quality of life, and pain catastrophizing thoughts were assessed using written questionnaires. Results: Between-group comparisons between baseline and 4 weeks showed more overall quality of life improvement, more improvement in catastrophizing thoughts, and more pain improvement in the intervention group. Only improvement in catastrophizing thoughts persisted in the long-term. No significant differences between groups were found for dysfunctional cognitions. As all 37 intervention group patients completed the intervention and completed diaries three times a day for 4 weeks, the e-health intervention seems feasible. Conclusions: A cognitive–behavioral intervention on pocket-type computers appears feasible and efficacious for improving IBS-related complaints and cognitions in the short-term. The intervention group improved on several aspects, but most on catastrophizing thoughts, and these improvements even persisted after 3 months. Future studies should focus on unravelling the effective components of this innovative e-health intervention. [Copyright &y& Elsevier]

Health-related quality of life (HRQoL) in patients with cutaneous lymphoma (CL) is negatively impacted by a large burden of disease symptoms including intractable itch, pain, discomfort and socially stigmatising cosmetic disfigurement which may adversely affect patient self-esteem and interpersonal relationships. There is currently no cure for CL and as such, accurate determination of patient HRQoL is of paramount importance. To date, the impact of both skin disease and of a cancer diagnosis on patient HRQoL in CL is assessed using separate, non-CL-specific questionnaires. A composite HRQoL questionnaire addressing all aspects of the disease is lacking. The EORTC Quality of Life Group questionnaire development guidelines were followed. For phase I, semi-structured interviews were conducted in 15 patients with early-stage mycosis fungoides (IA–IIA), 30 patients with late-stage mycosis fungoides/Sézary syndrome (IIB–IVB) (15 patients <3 years and >3 years from diagnosis) and 15 patients with cutaneous B cell lymphoma. Collaborators communicated during the patient recruitment to ensure balanced patient selection with respect to age, gender, stage, duration of the disease, and number of (previous) treatments. Patients were recruited in 5 countries (6 centres) across Europe. So far, 62 patients participated (target 60) from each of the following representative patient groups: early MF (stage IA–IIA), late MF (stage IIB–IVB) and cutaneous B cell lymphoma. Data from patient interviews and questionnaires is being analyzed using basic quantitative analyses, including generation of descriptive statistics (e.g., %missing data, means and standard deviations, floor and ceiling effects, etc.), prevalence (number of patients who experienced each complaint i.e. who scored 2, 3 or 4, divided by the total number of patients who completed that item, multiplied by 100), priority ratings (number of patients and professionals who have given priority ratings to each item) and range of responses for each item. The data from the debriefing questions will be reported both quantitatively and qualitatively (in narrative form). Once completed, phase I issues will be operationalised into items and any new items created in a style and format compatible with the EORTC quality of life group translation guidelines (phase II). The preliminary module will be pre-tested in phase III followed by large-scale international field-testing in phase IV. A comprehensive HRQoL questionnaire (module) for patients with CL is being developed to more accurately measure assessment of the impact of HRQoL in patients with skin lymphomas. [ABSTRACT FROM AUTHOR]

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients. Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored. Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts. The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer. • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 is widely used to measure quality of life in oncology. • Content validity is evidence that an instrument measures the concept of interest. • Measures should demonstrate content validity directly from patients. • This study demonstrates content validity across a broad range of cancers and stages. • The European Organisation for Research and Treatment of Cancer measurement model remains valid today for use in research. [ABSTRACT FROM AUTHOR]

Objectives: The estimation of lifetime quality-adjusted life-years (QALYs) requires the extrapolation of both length and quality of life (QoL). The extrapolation of QoL has received little attention in the literature. Here we explore the predictive value of "time to death" (TTD) for extrapolating QoL in oncology.Methods: We used QoL and survival data from the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry, which is linked to The Netherlands Cancer Registry. QoL was assessed with EQ-5D and SF-6D. We tested the relationship between TTD and QoL using linear, 2-part, and beta regression models. Incremental QALYs were compared using the TTD approach and an annual age-related disutility approach using artificial survival data with varying mortality rates.Results: A total of 6 samples with >100 patients each were used for the analysis. A declining pattern in QoL was observed when patients were closer to death, confirming the predictive value of TTD for QoL. The declining pattern in QoL was most pronounced when QoL was measured with SF-6D. Proximity to death had a larger impact on QoL than age. Incremental QALYs were higher using the TTD approach than annual age-related disutility, ranging from +0.139 to +0.00003 depending on mortality rates.Conclusions: TTD is a predictor variable for QoL. Using TTD allows cost-effectiveness models that lack QoL data to extrapolate morbidity using overall survival estimates. The TTD approach generates more incremental QALYs than an annual age-related disutility, most notably for longer survival periods. [ABSTRACT FROM AUTHOR]

Previous reports highlight the greater number of side effects that women experience during cancer treatment, but little is known about sex differences in symptoms and functioning in long-term survivors. We investigated sex differences in the prevalence of physical (EORTC QLQ-C30) and emotional symptoms (Hospital Anxiety and Depression Scale) and loss of functioning (EORTC QLQ-C30) in 5339 cancer survivors (55% males). General linear models were computed to assess the differences in symptoms and functioning between female and male cancer survivors and between survivors and an age-matched reference population. The direct comparison between female and male cancer survivors identified more symptoms, such as nausea and vomiting (M = 5.0 versus. 3.2), insomnia (M = 26.1 versus. 15.9), anxiety (M = 5.2 versus. 4.2), and lower physical (M = 77.5 versus. 82.5) and emotional functioning (M = 83.4 versus. 86.3), in female survivors. However, comparison with an age-matched reference population demonstrated that several symptoms, such as fatigue, dyspnea, anxiety and depression, appeared to be more frequent in male patients. The investigation of functioning domains — compared with a reference population — highlighted further sex-specific differences. Female survivors experienced a moderate net loss in physical and cognitive functioning (−6.1 [95% CI = −8.1; −4,1] and −5.2 respectively [95% CI = −7; −3.5]), whereas male survivors displayed a significant net loss in role and social functioning compared to the reference population (−9.9 [95% CI = −11.2; −8.6] and −7.7 [95% CI = −9.6; −7.6] respectively). To adequately capture sex differences in symptoms and functioning in long-term cancer survivors, a comparison with a reference population should always be considered. In our study population, this adjustment highlighted a significant and unexpected long-term impact on male patients. Role and social functioning were especially impacted in male patients, emphasizing the need to further investigate these gendered domains. • Long-term cancer survivors report sex-specific symptoms and functional impairments. • Comparison with age-and sex-matched reference group showed more impairment in males. • Loss of role and social functioning in males could represent a loss of gender role. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high-intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues. [ABSTRACT FROM AUTHOR]