Clinical trial NCT04863157: Survivor-Sleep Health Information Program
Official title: A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Problem
Insomnia
Pediatric Cancer
Keywords: Sleep Problem
Insomnia
Pediatric Cancer
Behavioral Intervention
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Children's Cancer Research Fund
First posted: 2021-04-28
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention acceptability
timeFrame: 6 weeks
measure: Intervention feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Sleep knowledge
timeFrame: 6 weeks
measure: Sleep habits
timeFrame: 6 weeks
measure: Sleep quality
timeFrame: 6 weeks
measure: General quality of life
timeFrame: 6 weeks
measure: Screen time
timeFrame: 6 weeks
measure: Sleep change
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References: