An interventional study of Educational Intervention and Exercise Intervention in Cancer Survivor, Stage 0 Breast Cancer and Stage IA Breast Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
PRIMARY OBJECTIVES:
I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.
OUTLINE:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, rating of perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 25 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
Other: Educational Intervention · Behavioral: Exercise Intervention · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Attend weekly educational sessions
Also known as: Education for Intervention, Intervention, Educational
Participate in CR program
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: 14 weeks
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.
Time frame: At 14 weeks
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center