Survivor-Sleep Health Information Program

NCT04863157 | Completed DMC

• 1 other identifier: 21-018
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Problem; Insomnia; Pediatric Cancer

Keywords

Sleep Problem; Insomnia; Pediatric Cancer; Behavioral Intervention

Outcome Measures

Primary Outcomes (2)

• 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

• Intervention feasibility

  Intervention feasibility will be assessed based on adherence rates to the intervention sessions.

  6 weeks

Secondary Outcomes (6)

• Sleep knowledge

  6 weeks

• Sleep habits

  6 weeks

• Sleep quality

  6 weeks

• General quality of life

  6 weeks

• Screen time

  6 weeks

Study Arms (1)

Survivor-SHIP

EXPERIMENTAL

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.

Behavioral: Survivor-SHIP

Interventions

Survivor-SHIP BEHAVIORAL

Parent/guardian education about healthy sleep practices to improve their child's sleep health.

Also known as: Survivor-Sleep Health Information Program

Survivor-SHIP

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Children's Cancer Research Fund: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Eric Zhou, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: May 24, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)