Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
NCT ID: NCT06747910
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
188 participants
INTERVENTIONAL
2025-02-03
2026-06-30
Brief Summary
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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.
Detailed Description
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After the in-person assessment, each participant will be given a wrist biosensor to remotely monitor heart rate variability for 7 days after they return home. Participants will also complete an AD symptom questionnaire, COMPASS31. The AD symptom questionnaire will be completed either before or after the in-person assessment. This questionnaire will take about 20-30 minutes to complete.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Carmen Wilson, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2025-00603
Identifier Type: OTHER
Identifier Source: secondary_id
READ
Identifier Type: -
Identifier Source: org_study_id