Insomnia Clinical Trial
Official title:
A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
NCT number | NCT04863157 |
Other study ID # | 21-018 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | December 31, 2022 |
Verified date | January 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 name of the intervention is Survivor-SHIP (Sleep Health Information Program).
Status | Completed |
Enrollment | 16 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Children's Cancer Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention acceptability | Intervention acceptability will be assessed using the Satisfaction subscale of the Usability, Satisfaction, and Ease of use (USE) scale. Total scores will range from 0-11, with higher scores indicating better acceptability. | 6 weeks | |
Primary | Intervention feasibility | Intervention feasibility will be assessed based on adherence rates to the intervention sessions. | 6 weeks | |
Secondary | Sleep knowledge | The Parent Sleep Knowledge questionnaire is a 10-item questionnaire assessing the parents' knowledge about children's sleep. The scale is scored from 0 to 10, with a higher score indicating more knowledge. | 6 weeks | |
Secondary | Sleep habits | The Children's Sleep Habits Questionnaire (CSHQ) is a 33-item questionnaire that will assess the child's overall sleep habits. A Total Sleep Disturbances score is calculated as the sum of all scored questions, and can range from 33 to 99, with higher scores indicating more sleep disturbance. | 6 weeks | |
Secondary | Sleep quality | The Patient-reported outcomes measurement information system (PROMIS) pediatric sleep scales are an 8-item measure that assesses the child's sleep quality. A total score will range from 8 to 40, with higher scale scores indicating poorer sleep health | 6 weeks | |
Secondary | General quality of life | The child's quality of life will be evaluated by the Pediatric Quality of Life Inventory (PedsQL), a 23-item scale measuring core physical, mental, and social health dimensions. Scores are transformed on a scale from 0 to 100, with higher scores indicating better function. | 6 weeks | |
Secondary | Screen time | The extent of the child's electronic screen use will be assessed by a set of 9 questions that were developed specifically for this study by the Principal Investigator. They assess the duration of electronics usage across different devices and timing of usage. | 6 weeks | |
Secondary | Sleep change | The investigators will assess whether the family implemented any non-intervention advised changes to their child's sleep routine, such as increasing medication for their sleep during the intervention period. This set of 5 questions will be assessed only at the post-intervention timepoint. | 6 weeks |
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