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Completed

NCT Number: NCT04863157

Survivor-Sleep Health Information Program

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).

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survivor-SHIP

Behavioral

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

Other names: Survivor-Sleep Health Information Program

Primary outcomes

  1. 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.

  2. Intervention feasibility

    Time frame: 6 weeks

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

Secondary outcomes

  1. Sleep knowledge

    Time frame: 6 weeks

    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.

  2. Sleep habits

    Time frame: 6 weeks

    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.

  3. Sleep quality

    Time frame: 6 weeks

    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

  4. General quality of life

    Time frame: 6 weeks

    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.

  5. Screen time

    Time frame: 6 weeks

    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. Sleep change

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Children's Cancer Research Fund

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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