Cardiac Autonomic Dysfunction in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Heart rate variability
时间窗: Measured over a 24 hour period
Standard deviation of NN (normal to normal RR) intervals (SDNN)
次要结局
- Cognitive status(Assessed at baseline)
- Perceived health(Assessed at baseline)
- Sleep efficiency(Measured daily over 2 weeks)
- Perceived stress(Assessed at baseline)
- Sleep Onset(Measured over 2 weeks)
- Autonomic Symptoms(Assessed at baseline)
- Wake Onset(Measured daily over 2 weeks)
- Physical activity duration(Measured daily over 2 weeks)
- Maximum heart rate(Measured daily over 2 weeks)
- Average heart rate(Measured daily over 2 weeks)
- Workout strain(Measured daily over 2 weeks)