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Clinical Trials/NCT03279055
NCT03279055
Completed
Not Applicable

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

Dana-Farber Cancer Institute1 site in 1 country22 target enrollmentAugust 10, 2018
ConditionsInsomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Dana-Farber Cancer Institute
Enrollment
22
Locations
1
Primary Endpoint
Insomnia symptoms
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2018
End Date
December 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Zhou

Eric Zhou, PhD

Dana-Farber Cancer Institute

Eligibility Criteria

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)

Study Sites (1)

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