Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors

The Ohio State University

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage IIIC Breast Cancer; Stage IA Breast Cancer; Cancer Survivor; Stage 0 Breast Cancer

Treatments: Other: Educational Intervention; Other: Quality-of-Life Assessment; Behavioral: Exercise Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03039140

OSU-14060

NCI-2015-00810 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Supportive care (CR program)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Educational Intervention

Behavioral: Exercise Intervention