Back to resultsSurvivor-Sleep Health Information Program
Primary Purpose
Sleep Problem, Insomnia, Pediatric Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survivor-SHIP
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Problem focused on measuring Sleep Problem, Insomnia, Pediatric Cancer, Behavioral Intervention
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.
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Survivor-SHIP
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Intervention feasibility
Intervention feasibility will be assessed based on adherence rates to the intervention sessions.
Secondary Outcome Measures
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.
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.
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
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.
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.
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.
Full Information
NCT ID
NCT04863157
First Posted
April 21, 2021
Last Updated
January 16, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Children's Cancer Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT04863157
Brief Title
Survivor-Sleep Health Information Program
Official Title
A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Children's Cancer Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem, Insomnia, Pediatric Cancer
Keywords
Sleep Problem, Insomnia, Pediatric Cancer, Behavioral Intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Survivor-SHIP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Survivor-SHIP
Other Intervention Name(s)
Survivor-Sleep Health Information Program
Intervention Description
Parent/guardian education about healthy sleep practices to improve their child's sleep health.
Primary Outcome Measure Information:
Title
Intervention acceptability
Description
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.
Time Frame
6 weeks
Title
Intervention feasibility
Description
Intervention feasibility will be assessed based on adherence rates to the intervention sessions.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sleep knowledge
Description
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.
Time Frame
6 weeks
Title
Sleep habits
Description
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.
Time Frame
6 weeks
Title
Sleep quality
Description
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
Time Frame
6 weeks
Title
General quality of life
Description
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.
Time Frame
6 weeks
Title
Screen time
Description
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.
Time Frame
6 weeks
Title
Sleep change
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Zhou, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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Survivor-Sleep Health Information Program
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