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Clinical Trials/NCT05875129
NCT05875129CompletedNot Applicable

Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors

Medstar Health Research Institute2 sites in 1 country15 target enrollmentStarted: July 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Locations
2
Primary Endpoint
Feasibility of device use

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Feasibility of device use

Time Frame: 14 days

Number of days that a participant interacted with the VAVA

Acceptability

Time Frame: 14 days

Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Medstar Health Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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