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

St. Jude Children's Research Hospital

Status: Enrolling

Conditions: Childhood Cancer

Treatments: Other: Questionnaire Administration; Other: Exercise Intervention - Ewing Battery Assessment; Device: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06747910

READ

NCI-2025-00603 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Screening (COMPASS31 + battery assessment + heart monitor)

Experimental group

Description:

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.

Treatment:

Device: Medical Device Usage and Evaluation

Other: Exercise Intervention - Ewing Battery Assessment

Other: Questionnaire Administration

Screening (battery assessment + COMPASS31 + heart monitor)

Experimental group

Description:

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.

Treatment:

Device: Medical Device Usage and Evaluation

Other: Exercise Intervention - Ewing Battery Assessment

Other: Questionnaire Administration