The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

Autor: da Silva LXN; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Postgraduate Program in Health Sciences (Cardiology and Cardiovascular Sciences), Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil., Leite JS; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Postgraduate Program in Health Sciences (Cardiology and Cardiovascular Sciences), Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil., Ignacio AC; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Postgraduate Program in Health Sciences (Cardiology and Cardiovascular Sciences), Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil., Massierer FD; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Postgraduate Program in Health Sciences (Cardiology and Cardiovascular Sciences), Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil., Pfeifer LO; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil., Dos Santos Cardoso LA; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Biomedicine School, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil., Alano TS; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil.; Medical School, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil., Umpierre D; LADD Lab, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.; Department of Public Health, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.; National Institute of Science and Technology for Health Technology Assessment (IATS/HCPA), Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.
Jazyk: angličtina
Zdroj: Pilot and feasibility studies [Pilot Feasibility Stud] 2023 Sep 26; Vol. 9 (1), pp. 165. Date of Electronic Publication: 2023 Sep 26.
DOI: 10.1186/s40814-023-01393-0
Abstrakt: 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.
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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