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NCT Number: NCT06747910

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

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.

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Key information

Conditions

Childhood Cancer Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Kirsten K Ness, PhD

CONTACT

[email protected]

888-226-4343

Kirsten K Ness, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Intervention - Ewing Battery Assessment

Other

Undergo in-person Ewing battery assessment

Questionnaire Administration

Other

Receive COMPASS31 questionnaire

Medical Device Usage and Evaluation

Device

Wear biosensensor heart monitor that remotely collects heart rate variability.

Primary outcomes

  1. Heart rate variability (msec)

    Time frame: Up to 7 days after the on-campus study visit

    The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds

  2. Abbreviated Composite Autonomic Symptom Score (0-100)

    Time frame: During the on-campus study visit (Day 1)

    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

  3. Ewing Score (0-5)

    Time frame: During the on-campus study visit (Day 1)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten K Ness, PhD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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