- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863157
Survivor-Sleep Health Information Program
A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Program designed at Seattle Children's Hospital. The program offers parents information about how to utilize evidence-based strategies for their child's sleep, and has demonstrated success in a community-based sample of children with behavioral sleep problems. Sessions will focus on providing parents with education about healthy sleep and setting targets for modifiable behaviors that can improve their child's sleep health.
The study will include 3 education sessions taking place over videoconference. Families will be asked to track their child's sleep using sleep diaries during the course of the program. Prior to, and following the program, families will be asked to complete study questionnaires.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Survivor-SHIP
Parents/guardians will take part in 3 education sessions over a one month period.
During the sessions, they will learn more about common sleep problems following cancer treatment and ways to understand their child's unique patterns.
They will then be educated about behavioral changes they can make to improve their child's sleep.
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Parent/guardian education about healthy sleep practices to improve their child's sleep health.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability
Time Frame: 6 weeks
|
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.
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6 weeks
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Intervention feasibility
Time Frame: 6 weeks
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Intervention feasibility will be assessed based on adherence rates to the intervention sessions.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep knowledge
Time Frame: 6 weeks
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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.
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6 weeks
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Sleep habits
Time Frame: 6 weeks
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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.
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6 weeks
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Sleep quality
Time Frame: 6 weeks
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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
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6 weeks
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General quality of life
Time Frame: 6 weeks
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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.
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6 weeks
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Screen time
Time Frame: 6 weeks
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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.
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6 weeks
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Sleep change
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Zhou, PhD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-018 (Truman Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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