Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

NCT ID: NCT05132673

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-07-01

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)

Conditions

Autonomic Dysfunction; Childhood Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Ness, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2022-00145

Identifier Type: REGISTRY

Identifier Source: secondary_id

WEARIT

Identifier Type: -

Identifier Source: org_study_id