Remote diagnosis of heart issues in childhood cancer survivors
Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
This study is testing if a new wrist biosensor can help find heart problems in childhood cancer survivors more easily than regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06747910 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether cardiac autonomic dysfunction (AD) can be accurately diagnosed remotely using biosensor technology, compared to traditional in-person assessments. Participants, who are survivors of acute lymphoblastic leukemia and Hodgkin's lymphoma, will undergo a standardized clinical assessment known as the Ewing battery, followed by a week of remote monitoring with a wrist biosensor. Additionally, they will complete a symptom questionnaire to assess autonomic dysfunction. The goal is to identify AD earlier and facilitate remote monitoring, potentially reducing health risks.
Who should consider this trial
Good fit: Ideal candidates are individuals over 18 years old who are survivors of acute lymphoblastic leukemia or Hodgkin's lymphoma and are not currently on beta-blocker medication.
Not a fit: Patients who cannot communicate in English, have acute heart failure, or are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification and management of cardiac autonomic dysfunction in childhood cancer survivors.
How similar studies have performed: Other studies have shown promise in using remote monitoring technologies for various health conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) \>18 years of age. * Primary diagnosis of acute lymphoblastic leukemia (ALL), Hodgkin's Lymphoma (HL), or Non-Hodgkin's Lymphoma (Non-HL). * Not currently taking beta-blocker medication. Exclusion Criteria: * Individuals who cannot speak, read, and/or understand English. * Individuals who are unable to follow directions/instructions in order to complete the Ewing battery. * Individuals with acute heart failure (new or worsening signs and symptoms of heart failure, including a combination of the following: dyspnea, orthopnea, lower limb swelling, elevated jugular venous pressure, and pulmonary congestion). * Women who are currently pregnant.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Kirsten K Ness, PhD — St. Jude Children's Research Hospital
- Study coordinator: Kirsten K Ness, PhD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
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.