Internet-based insomnia treatment for adult survivors of childhood cancer
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial
This study is testing an online program to help adult survivors of childhood cancer who have trouble sleeping and brain function issues to see if it can improve their sleep and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04317742 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an internet-delivered cognitive behavioral therapy for insomnia (CBTi) program called SHUTi for adult survivors of childhood cancer who experience insomnia and neurocognitive impairment. Participants will be randomly assigned to either the SHUTi intervention or a sleep education control group and will complete assessments at baseline, post-intervention, and six months later. The study aims to measure changes in insomnia symptoms, neurocognitive function, and overall health-related quality of life through online questionnaires and activity monitoring. Home visits will also be conducted to assess cardiovascular health and neurocognitive performance.
Who should consider this trial
Good fit: Ideal candidates are adult survivors of childhood cancer aged 18 to 65 who have clinically significant insomnia and neurocognitive impairment.
Not a fit: Patients with a history of brain tumors, current sleep disorders, or those undergoing other treatments for insomnia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and cognitive function in adult survivors of childhood cancer, enhancing their overall quality of life.
How similar studies have performed: Other studies have shown positive outcomes with internet-based CBTi programs, suggesting that this approach may be effective for similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrollment in CCSS * Between the ages of 18 and 65 years old * Clinically significant insomnia (i.e. score \>15 on the Insomnia Severity Index) * 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 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 a schizophrenia or 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)
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Tara Brinkman, PhD — St. Jude Children's Research Hospital
- Study coordinator: Tara Brinkman, PhD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.