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 has been shown to benefit patients undergoing adjuvant cancer therapy. Although exercise interventions may be applied in several settings, most trials have focused on specialized facilities for their interventions. While these approaches benefit the access for individuals living near exercise centers, it hampers 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. In this article, we present the protocol for the BENEFIT CA trial, which aims to assess the implementation of a remote exercise intervention for patients with breast cancer or prostate cancer, primarily quantifying adherence to an exercise program. Methods This is a 12-week study, utilizing a non-randomized, single-arm design to assess the feasibility of a home-based exercise training. The intervention is remotely guided, and participants also receive an educational component about cancer and exercise. The study aims to recruit 40 patients diagnosed with breast cancer and 40 patients diagnosed with prostate cancer, all of whom undergoing active hormonal treatment. The primary outcome is the level of adherence, indicated as the proportion of performed exercise episodes. Secondary outcomes include recruitment rates, fatigue, quality of life, and functional capacity. Adverse events will be monitored throughout the study. 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 3 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 in 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 (48,869,621.9.0000.5327), and it is registered at Clinicaltrials.gov (NCT05258526), registered on February 25, 2022, prior to the beginning of the study.

Effect of a Long-Term Online Home-Based Supervised Exercise Program on Physical Fitness and Adherence in Breast Cancer Patients: A Randomized Clinical Trial

“…Physical exercise has been recognized as an important strategy for prevention and treatment during the cancer continuum [5], with the development of international guidelines [6]. In addition to the association with reduced risk of different types of cancer [7], exercise has been demonstrated during and after cancer treatment to improve overall fitness, as well as to counterbalance side effects from pharmacological and surgical treatments [8,9]. Different studies have also been exploring the influence of physical exercise on the reduced risk of breast cancer recurrence [9,10], highlighting the importance of an active lifestyle for individuals living with and beyond cancer [8].…”

“…In addition to the association with reduced risk of different types of cancer [7], exercise has been demonstrated during and after cancer treatment to improve overall fitness, as well as to counterbalance side effects from pharmacological and surgical treatments [8,9]. Different studies have also been exploring the influence of physical exercise on the reduced risk of breast cancer recurrence [9,10], highlighting the importance of an active lifestyle for individuals living with and beyond cancer [8]. Despite this fact, a large percentage of the patients (93%) are not sufficiently active [11].…”