Breast Cancer Clinical Trial
Official title:
Cardiac Rehabilitation for Breast Cancer Survivors at Risk for Cardiovascular Disease Secondary to Cardiotoxic Treatment
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Women's College Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | Defined as number of patients who agree to participate relative to the number of patients approached. | 1 week after study completion | |
Primary | Intervention safety | Data on all intervention-related adverse events (as defined by the Common Terminology Criteria for Adverse Events [CTCAE]) will be collected and reported according to CTCAE-defined categories. Non-trial related adverse events during the intervention period will also be recorded given that they may significantly impact participation. | 1 week post-intervention | |
Primary | Study retention | Retention will be assessed by measuring attrition throughout the intervention period. | 1 week post-intervention | |
Primary | Reasons for drop-out | Reasons for dropout and/or non-compliance to assessment protocols will also be collected. | 1 week post-intervention | |
Primary | Intervention adherence | Exercise adherence will be collected as relative dose intensity (RDI; exercise dose performed in each session relative to prescribed exercise dose). | 1 week post-intervention | |
Primary | Participant satisfaction | Satisfaction with the intervention and participant experiences will be collected via an investigator-created survey. | 1 week post-intervention | |
Secondary | Estimated aerobic fitness | Estimated peak aerobic fitness using a prediction equation and symptom-limited stress test, using either the Bruce or modified Bruce protocol completed prior to the first cardiac rehab exercise session and at program completion. | 2 weeks before starting cardiac rehabilitation and 1 week after completing cardiac rehabilitation | |
Secondary | Left ventricular ejection fraction (LVEF) | Volumetric determination of LVEF assessed via electrocardiography in accordance with practice guidelines. | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Global longitudinal strain (GLS) | Determination of GLS via strain analysis assessed using electrocardiography | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | E/A ratio | Measure of diastolic dysfunction assessed via electrocardiography in accordance with practice guidelines. | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Duke Activity Status Index | Self-reported measure of physical activity | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Godin Leisure Time Exercise Questionnaire | Self-reported measure of physical activity | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Beck Depression Inventory | Self-reported assessment of depression | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Short-form survey (SF-36) | Self-reported measure of quality of life | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Work Limitations Questionnaire | Self-reported assessment of degree to which individual's condition affects ability to return to work | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Automated Self-Administered Dietary Assessment Tool (ASA24) | Self-reported measure assessing individual's diet | 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation | |
Secondary | Objective assessment of physical activity levels | Participants will be provided Fitbits for the duration of their participation in cardiac rehabilitation | 1 week after completing cardiac rehabilitation |
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