At a glance
ClinicalIndex Comparison Record- ✓Enrolled in the Childhood Cancer Survivor Study (CCSS)
- ✓Age 18–65 years
- ✓Clinically significant insomnia (Insomnia Severity Index score ≥8) OR delayed sleep onset (cannot sleep within 30 minutes ≥3×/week) OR excessive wake after sleep onset (≥30 minutes total nightly awakening ≥3×/week)
- ✓Neurocognitive impairment (score >84th percentile of sibling normative data in ≥1 domain on CCSS-NCQ)
- ✕History of brain tumor
- ✕Irregular work schedule preventing intervention adherence (bedtime <8 PM or >2 AM, or wake time <4 AM or >10 AM)
- ✕Currently pregnant or breastfeeding
- ✕Behavioral insomnia treatment within past 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial
In Brief
A clinical study evaluating Sleep Healthy Using the Internet (SHUTi) Intervention Group and Online Patient Education (PE) Control Group for Childhood Cancer and 5 related conditions. Completed, enrolled 1,554 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
SHUTi is a fully automated, interactive and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is presented in six "Cores," metered out over time.
The online PE program provides static information about: insomnia symptoms; the impact, prevalence, and causes of insomnia; when to see a doctor; and basic lifestyle, environmental, and behavioral strategies to improve sleep.