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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: SHUTi

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Alex's Lemonade Stand Foundation
• Investigators: Principal Investigator: Eric Zhou, PhD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Zhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020 Sep;67(9):e28506. doi: 10.1002/pbc.28506. Epub 2020 Jun 22.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: September 9, 2017
• First Submitted That Met QC Criteria: September 9, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 17-276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No