RecruitingNot ApplicableNCT06251401

Cardiac Rehabilitation for Breast Cancer Survivors

Cardiac Rehabilitation for Breast Cancer Survivors at Risk for Cardiovascular Disease Secondary to Cardiotoxic Treatment


Sponsor

Women's College Hospital

Enrollment

50 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured cardiac rehabilitation program (a supervised exercise and education program designed to improve heart health) benefits breast cancer survivors who were treated with specific chemotherapy drugs (anthracyclines) or targeted therapy (trastuzumab/Herceptin) that can affect the heart. **You may be eligible if...** - You are over 50 years old - You have completed breast cancer treatment that included anthracyclines (such as doxorubicin) and/or trastuzumab - You are able to participate in in-person cardiac rehabilitation sessions **You may NOT be eligible if...** - You have a medical condition that prevents safe exercise participation - You are unwilling to comply with the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIn-person supervised cardiac rehabilitation

In-person CR consists of weekly group-based supervised exercise training at Women's College Hospital, supplemented with home-based exercise training, with the goal of reaching Canadian Physical Activity Guidelines of 150 minutes a week of moderate-intensity exercise per week. Exercise prescriptions are individualized at baseline by the cardiac rehabilitation team. Both study arms get have the opportunity to attend weekly synchronous virtual group video education sessions for the duration of the 12-week cardiac rehab program with the focus on self-management education and support.

BEHAVIORALVirtual cardiac rehabilitation

Virtual CR consists of once-weekly telephone or video conferencing-based follow-ups (according to participant preference and access to internet/smart device) by one of the cardiac rehab providers. Similar to the in-person program, the virtual program also encourages participants to set goals to achieve 150 minutes a week of moderate-intensity exercise. The exercise prescription is individualized to each participant's ability and can vary in number of sessions per week and duration of each exercise session, as per the cardiac rehab provider's discretion. Unlike the in-person program, all these sessions are completed at home in an unsupervised manner. Both study arms get have the opportunity to attend weekly synchronous virtual group video education sessions for the duration of the 12-week cardiac rehab program with the focus on self-management education and support.


Locations(1)

Women's College Hospital

Toronto, Ontario, Canada

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NCT06251401


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