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临床试验/NCT03279055
NCT03279055已完成不适用

Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Dana-Farber Cancer Institute2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Insomnia symptoms

研究概览

简要总结

This research study is evaluating a six-session online program designed to help insomnia (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.

详细描述

The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy Using the Internet), a six-session online program which has been found to be effective in other groups of people, will be useful in treating insomnia in adolescent and young adult cancer survivors.

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
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 14-25 years of age
  • History of a cancer diagnosis
  • No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently planned in the next 6 months
  • No surgery planned in the next 6 months
  • Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
  • Able to read and write in English
  • Has internet access at home
  • Motivated and able to follow the demands of the SHUTi program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep

排除标准

  • Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia
  • History of Bipolar Disorder diagnosis
  • History of a Seizure Disorder diagnosis or have experienced a seizure in the past 12 months
  • Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
  • Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated, or other sleep disorder
  • Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
  • Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep

结局指标

主要结局

Insomnia symptoms

时间窗: 8 weeks

Insomnia symptom severity will be assessed using the Insomnia Severity Index

次要结局

  • Daytime sleepiness(8 weeks)
  • Quality of life(8 weeks)
  • Sleep efficiency(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Zhou

Eric Zhou, PhD

Dana-Farber Cancer Institute

研究点 (2)

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