Status:
COMPLETED
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Cancer
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 p...
Detailed Description
Participants with clinically significant insomnia and neurocognitive impairment are eligible for the current study. Participants will complete a 9-week internet-based insomnia treatment program (SHUTi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
1554 Patients enrolled
Trial Details
Trial ID
NCT04317742
Start Date
December 15 2020
End Date
January 15 2025
Last Update
January 7 2026
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105