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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Carmen Wilson, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-02
Participants
Target number of participants: 188
Treatments
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.
Related Therapeutic Areas
Acute Lymphoblastic Leukemia (ALL)
Leukemia
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov

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