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NCT04317742 · ClinicalTrials.gov registry record · NA
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
A NA study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- NA
- Development phase
- 1,554
- Enrollment target
NCT04317742: Completed NA study, sponsored by St. Jude Children's Research Hospital.
NCT04317742 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 1,554 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04317742, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,554 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Sleep Healthy Using the Internet (SHUTi) Intervention Group
- DEVICE Online Patient Education (PE) Control Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,554 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2025-01-15 |
| Phase | NA |
What the finished NCT04317742 record still lists
NCT04317742 is an interventional study that assigns participants to a tested intervention. Its 1,554 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which Sleep Healthy Using the Internet (SHUTi) Intervention Group is the first listed.
NCT04317742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04317742 about?
NCT04317742 is a clinical study titled "eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer". 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. H...
What is the current status of trial NCT04317742?
This trial is currently completed. It is a NA study. The enrollment target is 1,554 participants. The study started on 2020-12-15. Estimated completion is 2025-01-15.
What interventions are being tested in trial NCT04317742?
The interventions under investigation include: Sleep Healthy Using the Internet (SHUTi) Intervention Group (DEVICE), Online Patient Education (PE) Control Group (DEVICE).
Who is sponsoring clinical trial NCT04317742?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04317742's enrollment target sits among peer trials
1,554 64th of 2000 higher than 1,937 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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