The “home-based exercise for BrEast and prostate caNcEr patients during treatment - a FeasIbility Trial” (BENEFIT CA Trial): rationale and methodological protocol.

Abstract

Background Physical activity promotes benefits regarding adjuvant cancer therapy. Although exercise interventions may be applied in several settings, most trials involve participants going to specific facilities to engage in interventions. However, such approaches tend to restrict the access to people living nearby exercise centers, also reducing the assessment of real-world effectiveness. Therefore, evaluating the feasibility and implementation of home-based models of exercise training, especially in low-to-middle income settings, may inform future physical activity trials and programs. We herein present the protocol for the BENEFIT CA trial, with its’ goal to assess the implementation of a remote exercise intervention for patients with breast cancer or prostate cancer, primarily aiming to quantify adherence to an exercise program. Methods This study consists of a 12-week non-randomized, single arm, feasibility trial assessing a home-based exercise training, remotely guided, without a restricted follow-up, as well as an educational component, about cancer and exercise. Forty patients diagnosed with breast cancer and 40 patients diagnosed with prostate cancer, both being under active hormonal treatment, are being recruited. The primary outcome is the level of adherence, indicated as the proportion of performed exercise episodes. Secondary outcomes are related to recruitment rates, fatigue and quality of life scores, and functional capacity assessments. Throughout the study, adverse events will be accounted for. Because this is a feasibility trial, the statistical analysis plan is based on descriptive statistics, which encompasses an intention-to-treat analysis and a plan for handling missing data. Discussion This is a low cost feasibility study to orient the design of a wide range, pragmatic phase-three trial based on remote exercise intervention. With this study, we aim to better understand the adherence and implementation strategies regarding home-based exercise for the proposed population and, in the near future, move forward to a randomized clinical trial. In addition, this trial may contribute to engage patients with cancer to exercise programs throughout their treatment and beyond. Trial registration: this trial has been approved by the Hospital de Clínicas de Porto Alegre Ethics Committee/IRB (48869621.9.0000.5327) and registered at the Clinicaltrials.gov (NCT05258526), registered on 25 February of 2022, prior to the beginning of the study, prior to the beginning of the study. Keywords: feasibility; home-based; physical activity; exercise; cancer.