Clinical trial · Interventional
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
| Late Effect | — | UNRESOLVED | — |
| Neurocognitive Impairment | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online Patient Education (PE) Control Group | Device | — | UNRESOLVED |
| Sleep Healthy Using the Internet (SHUTi) Intervention Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sleep Healthy Using the Internet (SHUTi) Intervention Group
- description
- Participants access and complete the SHUTi program for 9 weeks.
- interventionNames
- Device: Sleep Healthy Using the Internet (SHUTi) Intervention Group
- type
- ACTIVE_COMPARATOR
- label
- Online Patient Education (PE) Control Group
- description
- Participants access and review online patient education for 9 weeks.
- interventionNames
- Device: Online Patient Education (PE) Control Group
Primary outcomes (1)
- measure
- Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available