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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Jude Children's Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention - Ewing Battery Assessment

    Other intervention

    Undergo in-person Ewing battery assessment

  • Questionnaire Administration

    Other intervention

    Receive COMPASS31 questionnaire

  • Medical Device Usage and Evaluation

    Device

    Wear biosensensor heart monitor that remotely collects heart rate variability.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Screening (COMPASS31 + battery assessment + heart monitor)Experimental treatment 3 interventions
Group B: Screening (battery assessment + COMPASS31 + heart monitor)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Heart rate variability (msec)

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

Time frame
Up to 7 days after the on-campus study visit
2

Abbreviated Composite Autonomic Symptom Score (0-100)

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

Time frame
During the on-campus study visit (Day 1)
3

Ewing Score (0-5)

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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