Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06747910

Conditions

Childhood Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention - Ewing Battery Assessment

Questionnaire Administration

Medical Device Usage and Evaluation

Study Details

Brief summary:

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.

Conditions

Childhood Cancer

Study ID

NCT06747910

Start date

Feb 3, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Exercise Intervention - Ewing Battery Assessment

Undergo in-person Ewing battery assessment

Questionnaire Administration

Receive COMPASS31 questionnaire

Medical Device Usage and Evaluation

Wear biosensensor heart monitor that remotely collects heart rate variability.

Primary outcome measure

  • Heart rate variability (msec) [ Time Frame: Up to 7 days after the on-campus study visit ]
  • Abbreviated Composite Autonomic Symptom Score (0-100) [ Time Frame: During the on-campus study visit (Day 1) ]
  • Ewing Score (0-5) [ Time Frame: During the on-campus study visit (Day 1) ]

Central Contacts and Locations

Central contacts

Kirsten K Ness, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Kirsten K Ness, PhD

888-226-4343referralinfo@stjude.org

Principal Investigator:

Kirsten K Ness, PhD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Survivor
  • Acute lymphoblastic leukemia
  • Hodgkins's lymphoma
  • Autonomic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-16.