Cardio-Oncology Rehabilitation Exercise

Study Overview
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Brief Summary
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Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.

Official Title
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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)

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary Fitness | VO2peak assessed using cardiopulmonary exercise test | post-intervention (16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral adipose tissue | Measured only in a subset (n=30) of participants via 1.5T MRI. | post-intervention (16 weeks) | 
| Left ventricular ejection fraction | Measured only in a subset (n=30) of participants via 1.5T MRI. | post-intervention (16 weeks) | 
| Native myocardial T1 time | Measured only in a subset (n=30) of participants via 1.5T MRI. | post-intervention (16 weeks) | 
| Left ventricular mass | Measured only in a subset (n=30) of participants via 1.5T MRI. | post-intervention (16 weeks) | 
| lipid profile | Assessed via fasting blood draw | post-intervention (16 weeks) | 
| Fasting glucose | Assessed via fasting blood draw | post-intervention (16 weeks) | 
| hemoglobin A1c | Assessed via fasting blood draw | post-intervention (16 weeks) | 
| Cancer-specific, health-related quality of life | Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life. | post-intervention (16 weeks) | 
| Depressive symptoms | Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms. | post-intervention (16 weeks) | 
| Psychosocial Stress | Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress. | post-intervention (16 weeks) | 
| Cancer-related fatigue | Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue. | post-intervention (16 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Rehabilitation, Cardio-oncology, Cardiometabolic Health, Cardiovascular Disease Risk