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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279055
• Other study ID #: 17-276
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: October 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Alex's Lemonade Stand Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Jun 22:e28506. doi: 10.1002/pbc.28506. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia symptoms	Insomnia symptom severity will be assessed using the Insomnia Severity Index	8 weeks
Secondary	Sleep efficiency	Sleep diary calculated sleep efficiency	6 weeks
Secondary	Quality of life	Measured with PedsQL	8 weeks
Secondary	Daytime sleepiness	Measured with Pediatric Daytime Sleepiness Scale	8 weeks