Device Feasibility and Acceptability to Improve Insomnia in Cancer

Trial Title: Device Feasibility and Acceptability to Improve Insomnia in Cancer

NCT ID: NCT05875129

Condition: Cancer
Insomnia Chronic

Conditions: Official terms:
Sleep Initiation and Maintenance Disorders

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Through the VAVA (an Amazon Alexa provided as part of the study), participants will verbally provide information about their sleep habits and sleep quality and receive suggestions about how to improve their sleep. Via the VAVA, these interactions will happen through the prototype software More SHEEP (MediaRez LLC). The recommendations provided by the More SHEEP software will be tailored to the individual participant, based on the data provided verbally by each participant. The participant will be asked to engage with the VAVA prototype daily for a 2-week period.

Primary purpose: Device Feasibility

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: VAVA prototype
Description: Cognitive behavioral therapy for insomnia
Arm group label: Intervention arm

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: MedStar Washington Hospital Center

Address:
City: Washington
Zip: 20010
Country: United States

Status: Recruiting

Contact:
Last name: Hunter Groninger, MD

Phone: 202-877-7445
Email: hunter.groninger@medstar.net

Investigator:
Last name: Hunter Groninger, MD
Email: Principal Investigator

Start date: July 20, 2023

Completion date: December 31, 2023

Lead sponsor:
Agency: Medstar Health Research Institute
Agency class: Other

Source: Medstar Health Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05875129