Cardiac Rehabilitation to Improve Breast Cancer Outcomes

NCT ID: NCT05867667

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2024-08-13

Brief Summary

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.

Conditions

Breast Cancer; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cardiac Rehabilitation to Improve Breast Cancer Outcomes

12 weeks of Cardiac Rehab

Group Type: EXPERIMENTAL

Cardiac Rehab

Intervention Type: OTHER

Cardiac Rehab 2x per week and home exercise 1x per week: weeks 1-4 Cardiac Rehab 1x per week and home exercise 2x per week: weeks 5-8, Home exercise 3x per week: weeks 9-12

Interventions

Cardiac Rehab

Cardiac Rehab 2x per week and home exercise 1x per week: weeks 1-4 Cardiac Rehab 1x per week and home exercise 2x per week: weeks 5-8, Home exercise 3x per week: weeks 9-12

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Lipps, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00230386

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2023.010

Identifier Type: -

Identifier Source: org_study_id