Recruiting

Cardiac Rehabilitation

Sponsor:

Women's College Hospital

Code:

NCT06251401

Conditions

Breast Cancer

Cardiovascular Diseases

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

In-person supervised cardiac rehabilitation

Virtual cardiac rehabilitation

Study Details

Brief 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.

Conditions

Breast Cancer

Cardiovascular Diseases

Study ID

NCT06251401

Start date

Mar 21, 2023

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age > 50 years
  • previous receipt of anthracyclines and/or trastuzumab for breast cancer
  • ability to participate in in-person cardiac rehabilitation

Exclusion Criteria:

  • medical contraindications that preclude safe exercise participation17
  • unwillingness to comply with study protocols.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: In-person cardiac rehabilitation

Those randomized to in-person cardiac rehabilitation group

experimental: Virtual cardiac rehabilitation

Those randomized to the virtual, home-based rehabilitation group

Interventions

In-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.

Virtual 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.

Primary outcome measure

  • Recruitment rate [ Time Frame: 1 week after study completion ]
  • Intervention safety [ Time Frame: 1 week post-intervention ]
  • Study retention [ Time Frame: 1 week post-intervention ]
  • Reasons for drop-out [ Time Frame: 1 week post-intervention ]
  • Intervention adherence [ Time Frame: 1 week post-intervention ]
  • Participant satisfaction [ Time Frame: 1 week post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B3

More Information

Sponsor

Women's College Hospital

Last update posted

Mar 8, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2024-03-08.