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New treatment option for Cardiovascular Complication
Official title At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
ClinicalTrials.gov ID: NCT06826534
What this study is testing
- What it's testing
- The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 21
You may be able to join if
- Patients aged of 10-21 years at enrollment
- Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
- History of anthracycline exposure +/- radiation
- Currently in remission, with at least 6 months off chemotherapy
- Able to perform CPET
You likely can't join if
- Inability to obtain consent/assent
- Unable to accurately perform quality of life survey independently
- No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic...
- Contraindication to moderate activity (\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF...
- Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
- Unable to perform mild activity for at least 0.5h/day and at least 2x/week
See the full eligibility criteria
- Patients aged of 10-21 years at enrollment
- Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
- History of anthracycline exposure +/- radiation
- Currently in remission, with at least 6 months off chemotherapy
- Able to perform CPET
- Baseline CPET with VO2 \<80% (at start of study, or CPET at CHLA after January 2020)
- Smartphone compatible with Fitbit (own or parent/legal guardian's)
- Ability to complete and send diary and Fitbit information on a weekly basis
- Ability to participate in monthly virtual check-in visits
- Baseline activity prior to intervention \<30min/day, 2x/week
- Inability to obtain consent/assent
- Unable to accurately perform quality of life survey independently
- No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery
- Contraindication to moderate activity (\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D)
- Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
- Unable to perform mild activity for at least 0.5h/day and at least 2x/week
- Unable to come to hospital for study visits at 0 and 6 months
- Unable to complete study-related surveys
- Unable to complete and send diary and Fitbit information on a weekly basis
- Unable to check-in monthly on virtual platform
- On beta blockade
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.