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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03279055
Collaborator
Alex's Lemonade Stand Foundation (Industry)
22
Enrollment
1
Location
1
Arm
16.3
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: SHUTi
 N/A

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
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 :
Aug 10, 2018
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Insomnia symptoms [8 weeks]

    Insomnia symptom severity will be assessed using the Insomnia Severity Index

Secondary Outcome Measures

  1. Sleep efficiency [6 weeks]

    Sleep diary calculated sleep efficiency

  2. Quality of life [8 weeks]

    Measured with PedsQL

  3. Daytime sleepiness [8 weeks]

    Measured with Pediatric Daytime Sleepiness Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 25 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dana-Farber Cancer Institute Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • Alex's Lemonade Stand Foundation

Investigators

  • Principal Investigator: Eric Zhou, PhD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eric Zhou, Eric Zhou, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT03279055
Other Study ID Numbers:
  • 17-276
First Posted:
Sep 12, 2017
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eric Zhou, Eric Zhou, PhD, Dana-Farber Cancer Institute
Insomnia
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 28, 2020