Survivor-Sleep Health Information Program

Insomnia Clinical Trial

Official title:

A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863157
• Other study ID #: 21-018
• Status: Completed
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 name of the intervention is Survivor-SHIP (Sleep Health Information Program).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Pediatric Cancer
• Sleep Initiation and Maintenance Disorders
• Sleep Problem

Intervention

Behavioral:
• Survivor-SHIP
Parent/guardian education about healthy sleep practices to improve their child's sleep health.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Children's Cancer Research Fund

Country where clinical trial is conducted

United States, 

Outcome

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