Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Childhood Cancer Clinical Trial

Official title:

Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05132673
• Other study ID #: WEARIT
• Secondary ID: NCI-2022-00145
• Status: Suspended
• Start date: January 2025
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 6000
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Childhood Cancer
• Primary Dysautonomias

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Standard deviation of NN (normal to normal RR) intervals (SDNN)	Measured over a 24 hour period
Secondary	Autonomic Symptoms	Self-reported autonomic symptoms via the COMPASS31	Assessed at baseline
Secondary	Perceived health	Self-reported perceived health via Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)	Assessed at baseline
Secondary	Perceived stress	Cohen's Perceived Stress Scale, Minimum value = 0, Maximum value = 40, Higher scores mean a worse outcome	Assessed at baseline
Secondary	Cognitive status	Childhood Cancer Survivor Study Neurocognitive Questionnaire, Minimum Value = 33, Maximum value = 99, Higher scores mean a worse outcome	Assessed at baseline
Secondary	Sleep Onset	Sleep hygiene will be measured via wearable sleep tracker. Sleep onset will be measured in minutes.	Measured over 2 weeks
Secondary	Wake Onset	Sleep hygiene will be measured via wearable sleep tracker. Wake onset will be measured in minutes.	Measured daily over 2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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