NCT04317742

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,554 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Childhood Cancer
• Insomnia
• Neurocognitive Impairment
• Survivorship
• Late Effect
• Sleep

Interventions

Type	Name	Description
DEVICE	Sleep Healthy Using the Internet (SHUTi) Intervention Group	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.
DEVICE	Online Patient Education (PE) Control Group	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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2020-03-23
• Last updated: 2026-01-07
• Results posted: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study