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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00145 | Registry Identifier | NCI |
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This protocol was placed on hold in January 2023 as funding was not received to support study activities and recruitment was never initiated. This protocol will be fully closed as new projects are underway that support similar outcome measures.
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Standard deviation of NN (normal to normal RR) intervals (SDNN) | Measured over a 24 hour period |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Those who meet the eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten W. Ness, PhD | St. Jude Children's Research Hospital | Principal Investigator |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |