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

• DOI: 10.2196/53301
• Publication Date: 2024-01-19T05:52:48Z
• Authors: 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
• Keywords: Telerehabilitation; mHealth

Background Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence primarily derived from programs based at exercise centers in-person supervised delivery. Conversely, most report preference home-based rehabilitation. As such, there clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence cardiac has demonstrated noninferiority of smartphone-based telerehabilitation approach (REMOTE-CR) improve cardiorespiratory fitness in people compared center-based program. Objective This study aims assess feasibility, safety, preliminary efficacy REMOTE-CR program adapted cancer cardiotoxicity (REMOTE-COR-B). We will also satisfaction usability REMOTE-COR-B. Methods conduct single-arm feasibility REMOTE-COR-B stage I-III who are (taking treatment type dose, as well other common factors into account) within 24 months completing primary definitive treatment. Participants (target sample size 40) receive an 8-week involving remotely delivered behavior change support. The platform comprises smartphone wearable heart rate monitor, custom-built app web application. be able attend monitored sessions during set operating hours each week, scheduled both morning evening. Adherence outcome trial, assessed through number attended trial target (ie, 3 per week). Secondary outcomes include additional indicators (eg, recruitment retention), satisfaction, usability, objective patient-reported (cardiovascular fitness, quality life, fatigue, self-reported exercise, self-efficacy, habit strength, motivation). Adherence, safety intervention period; post intervention; baseline, (2-month postbaseline assessment), follow-up (5-month assessment). Results Recruitment this commenced March 2023, 7 participants had been recruited submission manuscript. estimated completion date project October 2024, results expected published mid-2025. Conclusions novel providing therapy have unique needs heightened risks. important information on extent which satisfactory cancer, safe, potentially effective, 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