Adults 18 to 65, any sex, with Childhood Cancer or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)Primary· 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.
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-6.30
± 5.04
Online Patient Education (PE) Control Group
-3.91
± 4.62
Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)Secondary· Baseline and Post-Intervention (approximately 10 weeks after Baseline)
The CCSS-NCQ was developed specifically to address neurocognitive concerns of adult survivors of childhood cancer and includes assessment of problems with memory, task efficiency, organization, and emotional regulation. The domains of memory, task efficiency, and emotional regulation are used in this study. Z-scores are calculated using sibling normative data (Mean=1, SD=0) with higher scores indicating worse problems. Changes in z-scores from baseline to post-intervention are reported.
Task efficiency
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-0.70
± 1.00
Online Patient Education (PE) Control Group
-0.41
± 0.92
Memory
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-0.65
± 1.01
Online Patient Education (PE) Control Group
-0.36
± 0.87
Emotional regulation
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-0.66
± 0.90
Online Patient Education (PE) Control Group
-0.43
± 0.81
Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)Secondary· Baseline and Post-Intervention (approximately 10 weeks after Baseline)]
This is a computerized assessment that measures 3 domains of cognitive function; Executive Function, Processing Speed and Memory. Age, sex, and race specific Standard Scores (M=100, SD=15) are calculated. Higher scores indicate better functioning. Changes in standard scores from baseline to post-intervention are reported.
Executive function
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
1.9
± 13.0
Online Patient Education (PE) Control Group
3.5
± 11.8
Memory
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
2.6
± 15.7
Online Patient Education (PE) Control Group
0.1
± 17.2
Processing speed
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
3.9
± 12.7
Online Patient Education (PE) Control Group
3.3
± 11.9
Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline)Secondary· Baseline and 6-Month Follow up (approximately 6 months after Baseline)
This questionnaire measures symptoms of depression. Scores range from 0 to 24 with higher scores indicating more severe symptoms. Changes in scores on a scale from baseline to 6-month follow-up are reported.
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-2.7
± 4.1
Online Patient Education (PE) Control Group
-1.3
± 4.3
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline)Secondary· Baseline and 6-Month Follow up (approximately 6 months after Baseline)
This questionnaire measures symptoms of anxiety with scores ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety. Changes in scores on a scale from baseline to 6-month follow-up are reported.
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
-2.3
± 4.0
Online Patient Education (PE) Control Group
-1.4
± 4.6
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)Secondary· Baseline and 6-Month Follow up (approximately 6 months after Baseline)
This questionnaire measures general health-related quality of life in the domains of physical and mental health. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life. The PROMIS scoring tables were used for scoring. Changes in T-scores from baseline to 6-month follow-up are reported.
Physical health
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
2.5
± 5.7
Online Patient Education (PE) Control Group
1.0
± 5.3
Mental health
Group
Value
95% CI
Sleep Healthy Using the Internet (SHUTi) Intervention Group
2.6
± 7.1
Online Patient Education (PE) Control Group
1.0
± 6.3
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
Last refreshed: 7 January 2026
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