Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth)

This study is a randomized controlled trial. Women undergoing primary treatment (during or after chemotherapy) for breast cancer (stages I –III) will be randomly assigned to MTHE (twice a week) or HE (once a week). MTHE components are mobility, aerobic, balance, resistance, and flexibility home-based exercises, supervised by video call. The primary study outcome is cancer-related fatigue. The secondary outcomes are quality of life, s ymptoms of depression and anxiety, physical activity level, cancer-related cognitive impairment, and functional capacity. Other outcomes are adherence to interventions and a follow-up questionnaire evaluating the individual perception in motivation, lifestyle changes, and main barriers to participat ion. All outcomes will be remotely assessed before and after intervention. Our analysis will follow the intention-to-treat approach and per-protocol criteria, with additional sub-group analysis.DiscussionTo our knowledge, this is the first randomized clinical trial in breast cancer patients using a face-to-face videoconference strategy to supervise physical exercise. Our hypothesis is of superiority for the effects of MTHE on primary and secondary outcomes compared to the effects of only the health education intervention.Trial registrationAdaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth), NCT04641377. Registered on 23 November 2021,https://clinicaltrials.gov/ct2/show/NCT04641377
Source: Trials - Category: Research Source Type: clinical trials