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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279055
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Alex's Lemonade Stand Foundation
Information provided by (Responsible Party):
Eric Zhou, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: SHUTi Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHUTi
  • 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
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 Outcome Measures :
  1. Insomnia symptoms [ Time Frame: 8 weeks ]
    Insomnia symptom severity will be assessed using the Insomnia Severity Index


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279055


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Alex's Lemonade Stand Foundation
Investigators
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Principal Investigator: Eric Zhou, PhD Dana-Farber Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Zhou, Eric Zhou, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03279055    
Other Study ID Numbers: 17-276
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Zhou, Dana-Farber Cancer Institute:
Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders