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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 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 1,554 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04317742
The ClinicalTrials.gov registry entry for NCT04317742 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,554 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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