eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,554
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
研究概览
简要总结
There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions.
Primary Objective
To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer.
Secondary Objectives
To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer.
To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment.
To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.
详细描述
Participants with clinically significant insomnia and neurocognitive impairment are eligible for the current study. Participants will complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education, depending on randomized group assignment. Participants will complete home-based assessments at 3 time points (baseline, post-intervention, 6 months). These assessments will include online questionnaires measuring insomnia symptoms, neurocognitive problems, fatigue, daytime sleepiness, and health related quality of life. In addition, at each time point participants will be asked to wear an activity monitor for one week to measure physical activity and sleep patterns. Each assessment time point will also include assessment of cardiovascular biomarkers (dried blood spot cards) and neurocognitive function (CNS Vital Signs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in CCSS
- •Between the ages of 18 and 65 years old
- •Meeting at least one of the following three insomnia criteria:
- •Clinically significant insomnia (i.e. score ≥8 on the Insomnia Severity Index)
- •Delayed sleep onset latency (SOL) (i.e. cannot get to sleep within 30 minutes, three or more times a week)
- •Excessive wake after sleep onset (WASO) (i.e. nighttime awakenings lasting a total of at least 30 minutes, three or more times per week)
- •Neurocognitive impairment (i.e. score >84th %ile of sibling normative data in at least one domain on the CCSS-NCQ)
- •Regular access to the internet (at least 2-3 days per week)
- •Ability to read and speak English
- •Access to a desktop computer or a laptop
- •Access to a smart phone (android or iPhone), tablet or iPad with Bluetooth Low Energy BLE 4.2 or higher
排除标准
- •History of a brain tumor
- •An irregular schedule that would prevent adoption of intervention strategies (i.e. work schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM)
- •Currently pregnant or breast feeding
- •Behavioral treatment for insomnia in the past 12 months
- •Diagnosis of schizophrenia or a psychotic disorder
- •Alcohol or drug abuse in past year
- •Other concurrent sleep disorders, including narcolepsy, obstructive/central sleep apnea, or restless leg syndrome
- •Current treatment or intervention for cognitive impairment (i.e. stimulant medication, transcranial direct current stimulation)
研究组 & 干预措施
Sleep Healthy Using the Internet (SHUTi) Intervention Group
Participants access and complete the SHUTi program for 9 weeks.
干预措施: Sleep Healthy Using the Internet (SHUTi) Intervention Group (Device)
Online Patient Education (PE) Control Group
Participants access and review online patient education for 9 weeks.
干预措施: Online Patient Education (PE) Control Group (Device)
结局指标
主要结局
Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
时间窗: Baseline and Post-Intervention (approximately 10 weeks after Baseline)]
This is a 7-item, Likert scale, self-report questionnaire assessing perception of sleep and consequences of insomnia. The scores range from 0 to 28 with higher values indicating increasing symptom burden. Changes in scores on a scale from baseline to post-intervention are reported.
次要结局
- Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)(Baseline and Post-Intervention (approximately 10 weeks after Baseline))
- Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline)(Baseline and 6-Month Follow up (approximately 6 months after Baseline))
- Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)(Baseline and Post-Intervention (approximately 10 weeks after Baseline)])
- Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline)(Baseline and 6-Month Follow up (approximately 6 months after Baseline))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire (HRQoL) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline)(Baseline and 6-Month Follow up (approximately 6 months after Baseline))