Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
2 other identifiers
interventional
188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 24, 2024
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 23, 2026
April 1, 2026
1.3 years
December 12, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Heart rate variability (msec)
The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds
Up to 7 days after the on-campus study visit
Abbreviated Composite Autonomic Symptom Score (0-100)
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
During the on-campus study visit (Day 1)
Ewing Score (0-5)
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
During the on-campus study visit (Day 1)
Study Arms (2)
Screening (COMPASS31 + battery assessment + heart monitor)
EXPERIMENTALPatients 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.
Screening (battery assessment + COMPASS31 + heart monitor)
EXPERIMENTALPatients 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
Receive COMPASS31 questionnaire
Wear biosensensor heart monitor that remotely collects heart rate variability.
Undergo in-person Ewing battery assessment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirsten K Ness, PhD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 24, 2024
Study Start
February 3, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.