Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 2, 2023
Date Accepted: Jan 19, 2024
Evaluating a Remotely delivered Cardio-Oncology Rehabilitation intervention for Breast cancer patients (REMOTE-COR-B): Protocol for a single arm, feasibility trial
ABSTRACT
Background:
Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among women with breast cancer. However, the evidence is primarily derived from programs based at exercise centres, with in-person supervised delivery. Conversely, most women report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching, whilst addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated non-inferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardio-respiratory fitness in people with cardiovascular disease compared to a centre-based program.
Objective:
This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for women with breast cancer at risk of cardiotoxicity (REMOTE-COR-B).
Methods:
A single-arm, feasibility study of the REMOTE-COR-B program will be conducted among women with breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24-months of completing primary definitive treatment. Participants (target sample; n=40) will receive an 8-week smartphone-based telerehabilitation exercise program, involving remotely delivered real-time supervision. Adherence to remotely supervised exercise sessions is the primary outcome. Secondary outcomes include additional trial feasibility indicators (e.g., recruitment), safety, satisfaction, usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post-intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post-intervention (2-months post-baseline assessment), and follow-up (5-months post-baseline assessment).
Results:
This trial is funded by a National Breast Cancer Foundation Grant and commenced recruitment in March 2023. The estimated completion date for the project is October 2024
Conclusions:
The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to breast cancer patients at risk of cardiotoxicity, who have unique needs and heightened safety risks. This project will provide important information on safety and adherence, which is necessary prior to larger scale research or clinical projects. Clinical Trial: Australian New Zealand Clinical Trials Registry Study ID number: ACTRN12621001557820. Registered 09 August 2021.
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