Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

NCT05132673 | Withdrawn

• 2 other identifiers: WEARITNCI-2022-00145
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysfunction; Childhood Cancer

Keywords

childhood cancer survivors; cardiac

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Standard deviation of NN (normal to normal RR) intervals (SDNN)

  Measured over a 24 hour period

Secondary Outcomes (11)

• Autonomic Symptoms

  Assessed at baseline

• Perceived health

  Assessed at baseline

• Perceived stress

  Assessed at baseline

• Cognitive status

  Assessed at baseline

• Sleep Onset

  Measured over 2 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those who meet the eligibility criteria

You may qualify if:

• Enrollment on the CCSS protocol.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Related Links

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

MeSH Terms

Conditions

Primary Dysautonomias; Neoplasms

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Kirsten W. Ness, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 24, 2021
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)