Device Feasibility and Acceptability to Improve Insomnia in Cancer

Not Applicable

Recruiting

• Conditions: Cancer; Insomnia Chronic
• Interventions: Device: VAVA prototype

• Registration Number: NCT05875129
• Lead Sponsor: Medstar Health Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-25
• Study Start: 2023-07-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	VAVA prototype	Participants (N=15) will will be provided with the VAVA prototype along with installation instructions to embed the VAVA within their homes. We provide them with a smart speaker running our intervention, a smart lamp, and a new router. They will be asked to trial the VAVA for a period of 2 weeks, a duration consistent with the primary stage of CBT-I treatment.

Primary Outcome Measures

Name	Time	Method
Feasibility of device use	14 days	Number of days that a participant interacted with the VAVA
Acceptability	14 days	Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale

Trial Locations

Locations (1)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States