Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

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.

Study Overview

• Status: Withdrawn
• Conditions: Childhood Cancer; Autonomic Dysfunction

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Those who meet the eligibility criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants; Those who meet the Eligibility Criteria will be asked to complete online questionnaires and wear a device on your wrist for two weeks that measures your heart rate, physical activity, and sleep. A WHOOP® wrist monitor and charging equipment will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	Standard deviation of NN (normal to normal RR) intervals (SDNN)	Measured over a 24 hour period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic Symptoms	Self-reported autonomic symptoms via the COMPASS31	Assessed at baseline
Perceived health	Self-reported perceived health via Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)	Assessed at baseline
Perceived stress	Cohen's Perceived Stress Scale, Minimum value = 0, Maximum value = 40, Higher scores mean a worse outcome	Assessed at baseline
Cognitive status	Childhood Cancer Survivor Study Neurocognitive Questionnaire, Minimum Value = 33, Maximum value = 99, Higher scores mean a worse outcome	Assessed at baseline
Sleep Onset	Sleep hygiene will be measured via wearable sleep tracker. Sleep onset will be measured in minutes.	Measured over 2 weeks
Wake Onset	Sleep hygiene will be measured via wearable sleep tracker. Wake onset will be measured in minutes.	Measured daily over 2 weeks
Sleep efficiency	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.	Measured daily over 2 weeks
Physical activity duration	Intensity and duration of daily activity will be measured via wearable activity tracker. Activity duration will be measured in minutes.	Measured daily over 2 weeks
Workout strain	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.	Measured daily over 2 weeks
Maximum heart rate	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.	Measured daily over 2 weeks
Average heart rate	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.	Measured daily over 2 weeks

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Kirsten W. Ness, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: childhood cancer survivors; cardiac
• Additional Relevant MeSH Terms: Nervous System Diseases; Autonomic Nervous System Diseases; Neoplasms; Primary Dysautonomias
• Other Study ID Numbers: WEARIT; NCI-2022-00145 (Registry Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No