A Sleep Intervention for Children After Cancer: Survivor Sleep Health Information Program (Survivor-SHIP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intervention acceptability
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Survivor-SHIP
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.
干预措施: Survivor-SHIP (Behavioral)
结局指标
主要结局
Intervention acceptability
时间窗: 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.
Intervention feasibility
时间窗: 6 weeks
Intervention feasibility will be assessed based on adherence rates to the intervention sessions.
次要结局
- Sleep knowledge(6 weeks)
- Sleep habits(6 weeks)
- Sleep quality(6 weeks)
- General quality of life(6 weeks)
- Screen time(6 weeks)
- Sleep change(6 weeks)
研究者
Eric Zhou, PhD
Principal Investigator
Dana-Farber Cancer Institute