At-home cardiac rehabilitation for adolescents at risk for heart failure
This study is testing whether an at-home exercise and nutrition program can help young cancer survivors aged 10-21 improve their heart health and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06826534 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an at-home cardio-oncology rehabilitation program on cardiovascular fitness and psychosocial wellness in pediatric cancer survivors aged 10-21. The study aims to evaluate the efficacy of this program, adherence rates to exercise recommendations, and the value of specific resources in promoting sustainable lifestyle changes. Participants will engage in a structured exercise regimen and dietary recommendations while receiving support from a multidisciplinary team. The hypothesis is that these interventions will lead to improved health outcomes for adolescents who have undergone treatment for cancer.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-21 who have a history of anthracycline exposure, are currently in remission, and have limited physical activity prior to the intervention.
Not a fit: Patients with other primary medical diagnoses or contraindications to moderate activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance cardiovascular health and overall wellness in adolescent cancer survivors.
How similar studies have performed: Other studies have shown promising results with similar rehabilitation approaches in improving health outcomes for cancer survivors, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION 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 EXCLUSION CRITERIA * 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
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Su, MD — Children's Hospital Los Angeles
- Study coordinator: Obdulio Carreras
- Email: ocarreras@chla.usc.edu
- Phone: (323) 361-4663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.