Device Feasibility and Acceptability to Improve Insomnia in Cancer

Cancer Clinical Trial

Official title:

Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875129
• Other study ID #: STUDY00006301
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep disruption is common among young adult cancer survivors for a variety of reasons. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep disorders. This project will test the feasibility and acceptability of a new voice-activated virtual assistant (VAVA) device to deliver CBT-I to improve sleep among young adult cancer survivors with chronic sleep disorders.

Description:

Sleep is a complex biobehavioral event, impacted by interactions between the individual's physiology as well as their environment. Young adult cancer survivors (YACS; those between 18- 29 years of age) are a growing group of survivors, numbering close to 400,000 in the US. They are among those at highest risk for chronically insufficient sleep due to developmentally normative biological and social factors, compounded by their extensive medical treatment history. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended by the American College of Physicians as gold standard treatment for insomnia disorder and has been successfully adapted for YACS. Fundamental CBT-I strategies can be implemented to change the problematic sleep behaviors that result in insufficient sleep among young adults. However, it is essential that these evidence-based strategies be deployed to be responsive to the specific barriers to sleep for YACS. This feasibility/acceptability study will test the use of an integrated VAVA that offers the opportunity to implement intervention strategies in a way that repeatedly gives YACS the chance to make the right decision with respect to their sleep health in real time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• age between 18 and 29 years old
• history of cancer (any type, any stage)
• chronic sleep loss as evidence by self-report of receiving less sleep than recommended for their age by the National Sleep Foundation for >/= 3 months
• must have an internet router in their primary home that they have access to (can add a second router to for the system to work)

Exclusion Criteria:

• acute medical/psychiatric disorder requiring treatment
• developmental or congenital disorder
• life expectancy <12 months.

Related Conditions & MeSH terms

• Cancer
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• VAVA prototype
Cognitive behavioral therapy for insomnia

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of device use	Number of days that a participant interacted with the VAVA	14 days
Primary	Acceptability	Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale	14 days