Cardiac Rehabilitation to Improve Breast Cancer Outcomes
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 Start (Actual) 19 March 2024
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 April 2023
  • First Submitted that Met QC Criteria 10 May 2023
  • First Posted 22 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 March 2024
  • Last Update Posted 26 March 2024
  • Last Verified March 2024