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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: SHUTi


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHUTi<br>Participants will be provided with an individual access code for SHUTi SHUTi is delivered over 6 sessions, each taking 20-30 minutes SHUTi is delivered by a virtual therapist Participants will learn about the etiology and maintenance of their insomnia Participants will learn how to maintain their sleep log Participants will learn how to address lifestyle barriers that impact their sleep Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior Participants will be taught how to gradually expand their restricted sleep | Behavioral: SHUTi<br>* Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptoms | Insomnia symptom severity will be assessed using the Insomnia Severity Index | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Sleep diary calculated sleep efficiency | 6 weeks | 
| Quality of life | Measured with PedsQL | 8 weeks | 
| Daytime sleepiness | Measured with Pediatric Daytime Sleepiness Scale | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia