Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Study Overview
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Brief Summary
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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
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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)

Official Title
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Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

Conditions
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Autonomic Dysfunction, Childhood Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood cancer survivors, cardiac