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Home-Based Cardiac Rehabilitation for Thoracic Cancers
N/A
Recruiting
Led By Shahed Badiyan, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2
Planning to receive neo-adjuvant, adjuvant, or definitive radiation therapy to the thorax with curative intent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Awards & highlights
Study Summary
This trial will test the feasibility of a home-based, aerobic exercise intervention in patients with thoracic cancer at high risk for RIHD.
Who is the study for?
Adults with certain thoracic cancers like lung, esophageal, and various lymphomas who are set to receive radiation therapy. They must be able to walk, use a smartphone app for remote monitoring, and not have distant metastatic disease or other severe health issues that would prevent participation in home-based cardiac rehab.Check my eligibility
What is being tested?
The trial is testing if a home-based cardiac rehabilitation program can help reduce the negative effects on the heart from radiation therapy given for thoracic cancers. Participants will exercise at home and be monitored through an app.See study design
What are the potential side effects?
Since this trial involves aerobic exercise as part of cardiac rehabilitation, potential side effects may include muscle soreness, fatigue, and shortness of breath during physical activity. However, these are common reactions to starting an exercise regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am scheduled for radiation therapy to my chest area to try to cure my cancer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program
Secondary outcome measures
Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Home-based cardiac rehabilitationExperimental Treatment1 Intervention
The intervention consists of a prescribed course of home-based cardiac rehabilitation: 36 sessions, three times a week, one hour each, over a period of 12 weeks.
Each customized exercise session includes three phases:
a 5- to 10-minute warm-up which consists of stretching, flexibility movements, and aerobic activity which gradually raises the heart rate to the desired level
a conditioning or training phase, which consists of 20 to 45 minutes of continuous or discontinuous aerobic activity
a cool down for 5 to 10 minutes consisting of low-intensity exercise that permits a gradual recovery from the conditioning phase
The patient will complete a brief questionnaire on the teleHeart application after completing each exercise session on how well they tolerated the exercise. The patient's CR team will receive daily updates from the patient's teleHeart application. Based on feedback from the application, the CR team may modify the patient's exercise program going forward.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based cardiac rehabilitation
2013
N/A
~40
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,731 Total Patients Enrolled
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,756 Total Patients Enrolled
Shahed Badiyan, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
92 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to join a home cardiac rehab program and use a smartphone app for monitoring.I am unable to walk.My cancer has spread to distant parts of my body, but I don't have lymphoma.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with a specific type of cancer, such as lung, esophageal, lymphoma, sarcoma, thymoma, or left-sided breast cancer.I have been diagnosed with cancer in the upper part of my esophagus.I have received a heart transplant.I have unstable chest pain.I do not have health issues that prevent me from joining the study.I am scheduled for radiation therapy to my chest area to try to cure my cancer.My cancer is too advanced for me to handle physical rehab.I can understand and am willing to sign a consent form.I am 18 years old or older.You are not expected to live for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based cardiac rehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the scope of this trial expanded by participant inclusion?
"Affirmative. Clinicaltrials.gov confirms that this trial, which was published on the 15th of January 2021, is actively seeking volunteers. Currently they are looking for a total of 20 participants to be recruited from one location."
Answered by AI
Are volunteers still being accepted for this research endeavor?
"According to data on clinicaltrials.gov, this experiment is actively seeking participants as of August 9th 2022 and was initially made available on January 15th 2021."
Answered by AI
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