Cardiac rehabilitation program for women with breast cancer
A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)
This study is testing a 16-week heart health program for women with early-stage breast cancer to see if it helps improve their overall health and well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05522959 on ClinicalTrials.gov |
What this trial studies
This observational study invites women with early-stage breast cancer to participate in a 16-week multimodal cardiac rehabilitation program at the Toronto Rehabilitation Institute. Participants will undergo assessments before and after the program to evaluate improvements in cardiometabolic health, including changes in VO₂peak measured by Cardiopulmonary Exercise Test (CPET). The study will also examine traditional cardiac risk factors, lifestyle behaviors, exercise adherence, health-related quality of life, and fatigue levels.
Who should consider this trial
Good fit: Ideal candidates are women with early-stage breast cancer who are currently receiving or have completed adjuvant therapy.
Not a fit: Patients with metastatic breast cancer or those unable to complete a cardiopulmonary exercise test may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the cardiovascular health and overall quality of life for women recovering from breast cancer.
How similar studies have performed: Other studies have shown positive outcomes with similar cardiac rehabilitation approaches in cancer patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of early-stage breast cancer (I-III) * Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies) * Able to communicate in English Exclusion Criteria: * Pregnancy * Metastatic disease (Stage IV) * Unable or unwilling to complete cardiopulmonary exercise test
Where this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amy Kirkham, PhD — University of Toronto
- Study coordinator: Amy A Kirkham, PhD
- Email: amy.kirkham@utoronto.ca
- Phone: (416) 946-4069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.