Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05132673
Other study ID # WEARIT
Secondary ID NCI-2022-00145
Status Suspended
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04202094 - Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems N/A
Active, not recruiting NCT03336931 - PRecISion Medicine for Children With Cancer
Not yet recruiting NCT05048771 - Fertility and Temporality in Pediatric Oncology
Completed NCT05982379 - Motivation Program for Children With Cancer N/A
Completed NCT04066218 - Sexual Function Screening in Childhood Cancer Survivors
Completed NCT03934060 - Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients N/A
Active, not recruiting NCT03938324 - Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions N/A
Active, not recruiting NCT04032743 - Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
Active, not recruiting NCT04328350 - Social Experiences of Adolescents and Young Adults With Cancer
Not yet recruiting NCT05457153 - Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care N/A
Recruiting NCT05641961 - Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care N/A
Completed NCT06179914 - Resilience Models in Adolescence and Youth With Cancer in Taiwan
Completed NCT03951246 - Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors N/A
Not yet recruiting NCT04902313 - Cultivating Resilience in Oncology Practice N/A
Completed NCT03160768 - Feasibility of Isolating P16 Expression
Recruiting NCT06053268 - Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors N/A
Recruiting NCT06411704 - Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer
Withdrawn NCT02130934 - Cardiac 3D MRI in Pediatric Cancer Patients N/A
Completed NCT02216604 - Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment N/A
Recruiting NCT03852758 - Green Exercise for Cancer - Creating Opportunities for Survivors N/A