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Objectives: Many trials conclude "no clinically meaningful detriment" to health-related quality of life (HRQL) or function between arms, even when notable differential toxicity is observed. Mean change from baseline analyses of function or HRQL can possibly obscure important change in subgroups experiencing symptomatic toxicity. We evaluate the impact of diarrhea, a key treatment arm toxicity, on patient-reported HRQL and functioning in clinical trials submitted to US Food and Drug Administration.Methods: This study used 4 randomized, breast cancer trials (adjuvant to late-line metastatic) as case examples. Diarrhea, physical functioning (PF), and global health status and quality of life (GHS/QoL) from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 were analyzed at baseline and approximately 3 and 6 months.Results: Generally, patients reporting very much diarrhea at months 3 and 6 had worse PF (9-19 points lower) and GHS/QoL (16-19 points lower) than patients reporting no diarrhea regardless of treatment arm. In the change from baseline analysis, patients reporting very much diarrhea also experienced a greater decrease in PF (6-13 points) and GHS/QoL (6-16 points) versus patients reporting no diarrhea in both arms.Conclusions: In trials with moderate to large differences in symptomatic toxicity by arm, reporting "no meaningful difference in functioning and HRQL between arms" based on mean change from baseline analysis is insufficient and may obscure important impacts on subgroups experiencing symptomatic adverse events. Additional exploratory analyses with simple data visualizations evaluating functioning or HRQL in patient subgroups experiencing expected symptomatic toxicities can further inform the safety and tolerability of an investigational agent. [ABSTRACT FROM AUTHOR]

• BENECA mHealth improved cognitive symptoms after cancer. • mHealth plus multimodal rehabilitation at least doubled the effect size. • This study supports the role of occupational therapy in oncology. • Rehabilitation techniques should be individualised. Medical and surgical treatments for breast cancer have various adverse effects. Both mobile health and supervised intervention strategies have been implemented to overcome these effects, but some gaps remain to be addressed. Scientific evidence for the effectiveness of occupational therapy in cancer is limited. To compare the clinical effectiveness of the BENECA mHealth app used alone or combined with an integral supervised rehabilitation strategy that focused on cognitive performance, mood state, functional capacity, and cancer-related pain and fatigue in overweight women after breast cancer. In this secondary analysis of an assessor-blinded randomized controlled clinical trial, 80 overweight women after breast cancer (stage I-IIIA) were randomly allocated to an integral approach group (IA; n =40) or a control group (CG; n =40). All participants participated in an 8-week intervention. Assessments were performed at baseline, 8 weeks, and 6 months and included cognitive performance (Trial Making Test and Wechsler Adult Intelligence Scale), psychological state (Hospital Anxiety and Depression Scale), pain (Brief Pain Inventory), fatigue (Piper Fatigue Scale), and physical function (6 min walk test). An intention-to-treat analysis was conducted with analysis of covariance. Selective attention (TMT) was significantly higher in the IA group, with a moderate to large effect size for TMT A (T2: d=1.1; T 3: d=1.2), working memory and processing speed (WAIS), anxiety and general HADS score (d =1.6), and functional capacity at 8 weeks and 6 months (d =1.5). Fatigue perception (mean difference, -0.6; 95% CI -1.4 to 0.04; p =0.009) and pain (intensity level p <0.001; interference level p =0.002) were also significantly more improved in the IA group. An integral strategy involving the BENECA mHealth app with a supervised, multimodal intervention improved cognitive, psychological, and functional performance in women after breast cancer more than mHealth alone. Occupational therapy has a role to play in breast cancer rehabilitation. [ABSTRACT FROM AUTHOR]

Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions. We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes. Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38–0.65) and 0.52 (95 % CI 0.38–0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function. Supervised interventions, more than type or extensiveness of interventions, seem to increase effects. [Display omitted] • Exercise effectively increases quality of life, irrespective of exercise type. • Supervised exercise interventions are most effective. • Extensiveness of exercise interventions has very little influence on the effects. [ABSTRACT FROM AUTHOR]