Remote Identification of Autonomic Dysfunction in Childhood Cancer Survivors

This study is looking at new ways to find out if childhood cancer survivors, especially those who had acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL), have a condition called cardiac autonomic dysfunction (AD). AD affects how your body controls things like heart rate and blood pressure. The study wants to see if a remote method, using a special heart rate monitor you wear, can identify AD as accurately as in-person tests. You would complete an in-person assessment called the Ewing battery, wear a biosensor heart monitor for 7 days, and fill out a questionnaire. The goal is to find AD sooner and potentially reduce health risks. This study is currently recruiting 188 participants who are 18 years or older and are part of the St. Jude Lifetime Cohort (SJLIFE).

Study design
This is an interventional study with a planned enrollment of 188 participants. It compares remote heart rate variability measurements to in-person assessments to identify cardiac autonomic dysfunction.
What's involved
You would complete a 60-90 minute in-person Ewing battery assessment, wear a biosensor heart monitor for 7 days after your visit, and complete a 20-30 minute questionnaire.
Compensation
Not stated in the trial record.
Follow-up
Heart rate variability will be measured for up to 7 days after your on-campus visit. Other primary endpoints are measured during the on-campus visit.

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NCT06747910

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

Recruiting
NAAges 18+InterventionalScreening
St. Jude Children's Research Hospital
~188 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Exercise Intervention - Ewing Battery AssessmentQuestionnaire AdministrationMedical Device Usage and Evaluation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart rate variability (msec)
Measured over Up to 7 days after the on-campus study visit
+2 more outcomes measured
Childhood Cancer
1 sites across 1 states
Tennessee1
  • Kirsten K Ness, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

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Eligibility criteria

Inclusion

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

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.
  • Heart rate variability (msec)Up to 7 days after the on-campus study visit

    The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds

  • Abbreviated Composite Autonomic Symptom Score (0-100)During the on-campus study visit (Day 1)

    Symptom burden-based questionnaire of six weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal bladder and pupillomotor) Abbreviated Composite Autonomic Symptom Score: * This questionnaire, administered during Day 1, generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. Scores are determined by applying a simplified scoring algorithm. * Overall score interpretation: * \< 3 or less: Mild * 3-7: Moderate * \>7: Severe

  • Ewing Score (0-5)During the on-campus study visit (Day 1)

    Derived from sum of five individual autonomic test scores Ewing Battery Scoring: * This battery is administered during Day 1. Each test within the battery (5 tests total) is assigned a score of 0 (normal), 0.5 (borderline), or 1 (abnormal). * Overall score interpretation: * 0-1: Considered normal autonomic function * 1.5-2: Mild autonomic dysfunction * 2.5-3: Moderate autonomic dysfunction * 3.5-5: Severe autonomic dysfunction