Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Suspended

• Conditions: Childhood Cancer; Autonomic Dysfunction

• Registration Number: NCT05132673
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study.

Primary Objective

Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions.

Secondary Objectives

Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.

Detailed Description

Potential participants will be recruited by email and phone. Survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. This data collection will take place in DatStat Connect, which is the online consenting and data collection tool utilized for the CCSS. Consented/enrolled SJLIFE participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a WHOOP® strap prior kit prior to scheduling a device setup session with a team member. The kit will include the WHOOP® strap, brief instructions for setup, and prepaid return mailing materials. The WHOOP® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Study Start: 2025-01
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Enrollment on the CCSS protocol.
• 18 years or older.
• Has a smartphone and is willing to download the WHOOP® app for the duration of study participation.
• Reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables.

Exclusion Criteria

• Unable to independently provide informed consent.
• Visual impairment that prevents participant from engaging with study materials.
• Unable to read or understand study materials in English.
• Mailing address outside the United States.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability	Measured over a 24 hour period	Standard deviation of NN (normal to normal RR) intervals (SDNN)

Secondary Outcome Measures

Name	Time	Method
Perceived health	Assessed at baseline	Self-reported perceived health via Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Sleep efficiency	Measured daily over 2 weeks	Sleep hygiene will be measured via wearable sleep tracker. Sleep efficient will be measured by dividing the minutes asleep by the total minutes in bed.
Cognitive status	Assessed at baseline	Childhood Cancer Survivor Study Neurocognitive Questionnaire, Minimum Value = 33, Maximum value = 99, Higher scores mean a worse outcome
Perceived stress	Assessed at baseline	Cohen's Perceived Stress Scale, Minimum value = 0, Maximum value = 40, Higher scores mean a worse outcome
Sleep Onset	Measured over 2 weeks	Sleep hygiene will be measured via wearable sleep tracker. Sleep onset will be measured in minutes.
Autonomic Symptoms	Assessed at baseline	Self-reported autonomic symptoms via the COMPASS31
Wake Onset	Measured daily over 2 weeks	Sleep hygiene will be measured via wearable sleep tracker. Wake onset will be measured in minutes.
Physical activity duration	Measured daily over 2 weeks	Intensity and duration of daily activity will be measured via wearable activity tracker. Activity duration will be measured in minutes.
Maximum heart rate	Measured daily over 2 weeks	Intensity and duration of daily activity will be measured via wearable activity tracker. Maximum heart rate will be calculated by subtracting age from 220 and is measured in beats per minute.
Average heart rate	Measured daily over 2 weeks	Intensity and duration of daily activity will be measured via wearable activity tracker. Average heart rate will be calculated as number of beats per minute.
Workout strain	Measured daily over 2 weeks	Intensity and duration of daily activity will be measured via wearable activity tracker. Workout strain will be calculated by the duration of time in personal heart rate zones, established from maximum heart rate.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States