Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06747910
Status
Recruiting
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Conditions

  • Childhood Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention - Ewing Battery Assessment — OTHER
    Undergo in-person Ewing battery assessment
  • Questionnaire Administration — OTHER
    Receive COMPASS31 questionnaire
  • Medical Device Usage and Evaluation — DEVICE
    Wear biosensensor heart monitor that remotely collects heart rate variability.

Study Details

This study seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Childhood cancer survivors, particularly survivors of acute lymphoblastic leukemia (ALL) and Hodgkins's lymphoma (HL), appear to be at increased risk for AD. Primary Objectives: * To determine the sensitivity and specificity of heart rate variability (HRV), measured remotely with biosensor technology (Actigraph LEAP), compared to in-person assessment using the Ewing battery as the reference standard to identify cardiac autonomic dysfunction (AD) among survivors of leukemia and lymphoma. * To determine the sensitivity and specificity of the Composite Autonomic Symptom Scale 31 (COMPASS31) compared to the Ewing battery to identify AD among leukemia and lymphoma survivors.

Key Dates

Start date
Feb 3, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Screening (COMPASS31 + battery assessment + heart monitor)
    Patients complete the COMPASS31 questionnaire and undergo an in-person Ewing battery assessment over 60-90 minutes on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study.
  • Experimental: Screening (battery assessment + COMPASS31 + heart monitor)
    Patients undergo an in-person Ewing battery assessment over 60-90 minutes and complete the COMPASS31 questionnaire on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study.

Primary Outcome Measure

Heart rate variability (msec) [ Time Frame: Up to 7 days after the on-campus study visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Kirsten K Ness, PhD
[email protected]
888-226-4343
Kirsten K Ness, PhD (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN

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