N/A
N=541
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
Childhood Cancer · Insomnia · Neurocognitive Impairment · Survivorship · Late Effect
Bottom Line
View on ClinicalTrials.gov: NCT04317742 ↗Enrolled (actual)
541
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline) — -6.30; -3.91 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Healthy Using the Internet (SHUTi) Intervention Group (Device); Online Patient Education (PE) Control Group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline) |
-6.30; -3.91 | — |
| SECONDARY Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline) |
-0.70; -0.41; -0.65; -0.36; -0.66; -0.43 | — |
| SECONDARY Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline) |
1.9; 3.5; 2.6; 0.1; 3.9; 3.3 | — |
| SECONDARY Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline) |
-2.7; -1.3 | — |
| SECONDARY Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline) |
-2.3; -1.4 | — |
| SECONDARY 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) |
2.5; 1.0; 2.6; 1.0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04317742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.