Stage IIIA Breast Cancer Clinical Trial
Official title:
A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
Verified date | February 2022 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 31, 2021 |
Est. primary completion date | October 23, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments - Concurrent endocrine therapy permissible - Ability to understand and the willingness to sign a written informed consent - Willingness to participate in CR program Exclusion Criteria: - Existing CVD - Existing diabetes - Contraindications to exercise - Metastatic breast cancer - Other concurrent malignancies except skin cancer - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements - Pregnant or nursing women - Unable to give informed consent - Any contraindication to cardiac stress testing - Travel distance greater than 50 miles |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of conducting a 14-week CR program | During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate. | 14 weeks | |
Secondary | Efficacy of CR in improving cardiorespiratory fitness | Analysis of follow-up VO2 max, in units of mL/kg/min, will be done using an analysis of covariance (ANCOVA) approach. If VO2 max values are missing at 14 weeks, will use the Duke Activity Status Index questionnaire responses to approximate VO2 max values. | At 14 weeks |
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