Status:
TERMINATED
Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
The Foundation for Barnes-Jewish Hospital
Conditions:
Lung Cancer
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Other than optimizing medical management of cardiac risk factors, and reducing radiotherapy (RT) dose to the heart, there currently exist no interventions to mitigate or reverse the adverse cardiac ef...
Eligibility Criteria
Inclusion
- Pathologically confirmed or radiographically diagnosed non-small cell lung cancer, small cell lung cancer, esophageal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, sarcoma, thymoma, or left-sided breast cancer.
- Planning to receive neo-adjuvant, adjuvant, or definitive radiation therapy to the thorax with curative intent.
- Willing to participate in home-based cardiac rehabilitation program and be monitored remotely via smart phone application
- Possess a smart phone or tablet capable of supporting teleHeart application
- Willing and eligible to co-enroll in the Cardiovascular Toxicity in Cancer and Improvement in Recovery (SURVIVE) Registry Study (HRPO# 201801031).
- At least 18 years of age.
- ECOG performance status ≤ 2
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
- Presence of distant metastatic disease (except patients with lymphoma).
- Life expectancy less than 6 months
- Patient lives in skilled nursing facility, chronic care facility, nursing home, or palliative care or hospice facility
- Unable to walk
- Presence of significant cancer disease burden that would make patient unlikely to tolerate cardiac rehabilitation (CR)
- Diagnosis of primary cervical esophageal cancer.
- Presence of unstable angina.
- Recipient of heart transplant.
- Patient on cardiac transplant list or has a ventricular assist device
- Patient's baseline weight \> 300 lbs (due to weight limitations of the scale and bioelectrical impedance device)
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Other medical comorbidities that make the patient unable to participate in the CR program or other assessments involved with this study.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04072393
Start Date
January 15 2021
End Date
May 15 2024
Last Update
July 12 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110