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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Exercise Intervention - Ewing Battery Assessment
Other interventionUndergo in-person Ewing battery assessment
Questionnaire Administration
Other interventionReceive COMPASS31 questionnaire
Medical Device Usage and Evaluation
DeviceWear biosensensor heart monitor that remotely collects heart rate variability.
Treatment groups
Trial outcomes
Primary outcomes
Heart rate variability (msec)
The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds
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
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
Sponsors and contacts
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