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

Phase

N/A

Condition

Leukemia

Neuroblastoma

Retinoblastoma

Treatment

Questionnaire Administration

Exercise Intervention - Ewing Battery Assessment

Medical Device Usage and Evaluation

Clinical Study ID

NCT06747910

READ

NCI-2025-00603

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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), orNon-Hodgkin's Lymphoma (Non-HL).
Not currently taking beta-blocker medication.

Exclusion

Exclusion Criteria:

Individuals who cannot speak, read, and/or understand English.
Individuals who are unable to follow directions/instructions in order to completethe Ewing battery.
Individuals with acute heart failure (new or worsening signs and symptoms of heartfailure, including a combination of the following: dyspnea, orthopnea, lower limbswelling, elevated jugular venous pressure, and pulmonary congestion).
Women who are currently pregnant.

Study Design

Questionnaire Administration

February 03, 2025

February 28, 2026

Study Description

Each participant will complete an in-person standardized clinical assessment for AD, called the Ewing battery. during the participants' Human Performance Lab during their SJLIFE functional exam. It is estimated it will take 60-90-minutes to complete the Ewing battery. The tests include monitoring heart rate variations during deep breathing and lying down to standing, as well as monitoring blood pressure variations when standing and maintaining hand grip. Participants will be asked to not consume aspirin, ibuprofen or acetaminophen 24-hours before the assessment. Additionally, participants will be asked to avoid alcohol or caffeine within 6-hours, and smoking 3-hours, before testing.

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.

Connect with a study center

St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
Site Not Available
St. Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168 38105
United States
Active - Recruiting

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