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Completed

NCT Number: NCT03279055

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

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.

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Key information

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHUTi

Behavioral

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.

Primary outcomes

  1. Insomnia symptoms

    Time frame: 8 weeks

    Insomnia symptom severity will be assessed using the Insomnia Severity Index

Secondary outcomes

  1. Sleep efficiency

    Time frame: 6 weeks

    Sleep diary calculated sleep efficiency

  2. Quality of life

    Time frame: 8 weeks

    Measured with PedsQL

  3. Daytime sleepiness

    Time frame: 8 weeks

    Measured with Pediatric Daytime Sleepiness Scale

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Alex's Lemonade Stand Foundation

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2017
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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