Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)

University of Michigan Rogel Cancer Center

Status: Terminated

Conditions: Breast Cancer; Cardiovascular Diseases

Treatments: Other: Cardiac Rehab

Study type: Interventional

Funder types: Other

Identifiers

NCT05867667

HUM00230386 (Other Identifier)

UMCC 2023.010

Details and patient eligibility

About

To develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. Considering this program is secondary to the Michigan Medicine Cardiac Rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer diagnosis stage I-III
• Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy)
• Age 18 years or older
• At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: >2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (>60 years) at cancer treatment, OR Left ventricular ejection fraction <50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab
• Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

• Planned surgery during the study period.
• Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction <35%)
• Metastatic cancer
• Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise)
• Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Cardiac Rehabilitation to Improve Breast Cancer Outcomes

Experimental group

Description:

12 weeks of Cardiac Rehab

Treatment:

Other: Cardiac Rehab