NCT03279055CompletedNot Applicable
Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
Dana-Farber Cancer Institute2 sites in 1 country22 target enrollmentStarted: August 10, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Insomnia symptoms
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Insomnia symptoms
Time Frame: 8 weeks
Insomnia symptom severity will be assessed using the Insomnia Severity Index
Secondary Outcomes
- Daytime sleepiness(8 weeks)
- Quality of life(8 weeks)
- Sleep efficiency(6 weeks)
Investigators
Eric Zhou
Eric Zhou, PhD
Dana-Farber Cancer Institute
Study Sites (2)
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