Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial.

Autor:	Short CE; Melbourne Centre for Behaviour Change, Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Australia.; Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia., Rawstorn JC; Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia., Jones TL; Melbourne Centre for Behaviour Change, Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Australia., Edbrooke L; Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia.; Department of Health Services Research, The Peter MacCallum Cancer Centre, Melbourne, Australia., Hayes SC; Cancer Council Queensland, Brisbane, Australia., Maddison R; Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia., Nightingale S; Department of Surgical Oncology, The Peter MacCallum Cancer Centre, Melbourne, Australia., Ismail H; Department of Anaesthesia, Pain and Perioperative Medicine, The Peter MacCallum Cancer Centre, Melbourne, Australia., De Boer R; Department of Surgical Oncology, The Peter MacCallum Cancer Centre, Melbourne, Australia., Hegi-Johnson F; Department of Radiation Oncology, The Peter MacCallum Cancer Centre, Melbourne, Australia.; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia., Sverdlov AL; Newcastle Centre of Excellence in Cardio-Oncology, The University of Newcastle, Hunter Medical Research Institute, Calvary Mater Newcastle, Newcastle, Australia.; College of Health, Medicine and Wellbeing, The University of Newcastle, Newcastle, Australia., Bell R; Consumer representative, Melbourne, Australia., Halligan I; Consumer representative, Melbourne, Australia., Denehy L; Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia.; Department of Health Services Research, The Peter MacCallum Cancer Centre, Melbourne, Australia.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2024 Apr 05; Vol. 13, pp. e53301. Date of Electronic Publication: 2024 Apr 05.
DOI:	10.2196/53301
Abstrakt:	Background: Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients 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 while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. Objective: This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. Methods: We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III 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 size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). 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-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Results: Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. Conclusions: The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx. International Registered Report Identifier (irrid): DERR1-10.2196/53301. (©Camille E Short, Jonathan C Rawstorn, Tamara L Jones, Lara Edbrooke, Sandra C Hayes, Ralph Maddison, Sophie Nightingale, Hilmy Ismail, Richard De Boer, Fiona Hegi-Johnson, Aaron L Sverdlov, Robyn Bell, Irene Halligan, Linda Denehy. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.04.2024.)
Databáze:	MEDLINE
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