Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
NCT ID: NCT03279055
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2018-08-10
2019-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
14 Years
25 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alex's Lemonade Stand Foundation
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eric Zhou
Eric Zhou, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric Zhou, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-276
Identifier Type: -
Identifier Source: org_study_id