mHealth for Breast Cancer Survivors With Insomnia

Purpose

The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.

Conditions

  • Breast Cancer Survivor
  • Insomnia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep - Females; Age 18+ - Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1 - Completed curative treatment (surgery, radiation, chemotherapy) > 3 months prior to enrollment [ongoing adjuvant therapy permitted] - Has not undergone other behavioral sleep treatment within the prior 12 months - Score greater than or equal to 8 on the Insomnia Severity Index - Able to understand and speak English

Exclusion Criteria

  • Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea - Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol >2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.) - Shift-work in the prior three months or anticipated during the study time - Planned regular travel out of time zone (>1 hour) during the study period. - Currently or planning to become pregnant during the study period

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Voice-Activated Smart Speaker Program 		Faster Asleep
  • Behavioral: Faster Asleep Smart Speaker Program
    Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.
Active Comparator
Website 		Faster Asleep Website
  • Behavioral: Faster Asleep Website
    Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Claire Starling
Claire.M.Starling@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Hannah Arem, PhD
202-893-2430
Hannah.Arem@MedStar.net

Detailed Description

This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.