Status:
COMPLETED
Survivor-Sleep Health Information Program
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Children's Cancer Research Fund
Conditions:
Sleep Problem
Insomnia
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
The purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. The ...
Detailed Description
This study will evaluate Survivor-SHIP in a single-arm trial of 20 off-treatment childhood cancer survivors (ages 5-12). The intervention is an adapted version of the family-centered Sleep Health Prog...
Eligibility Criteria
Inclusion
- Child aged 5-12 years, with a history of a cancer diagnosis (except non-melanoma skin cancer).
- No cancer therapy (excluding chemoprevention) in the past 6 months, and no further therapy planned.
- Child meets diagnostic criteria for insomnia disorder as determined by insomnia screening criteria (see Appendix A)
- Parent/guardian is able to read and write in English.
- Regular access to a computer/smartphone with internet access at home.
Exclusion
- Reports child has been diagnosed with a Seizure Disorder or has experienced a seizure in the past 12 months.
- Reports child has been diagnosed with a developmental disorder such as Autism Spectrum Disorder, Cerebral Palsy, Fragile X Syndrome, or Moderate to Profound Intellectual Disability.
- Reports child has been diagnosed with sleep apnea, and are not receiving recommended medical treatment for their sleep apnea.
- Intention to adjust (decrease or increase) child's use of any prescribed or over-the-counter sleep medications during the study period.
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the parent/guardian's ability to complete all study procedures independently.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04863157
Start Date
May 24 2021
End Date
December 31 2022
Last Update
January 18 2023
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215