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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Voice-Activated Smart Speaker Program |
Faster Asleep |
|
Active Comparator Website |
Faster Asleep Website |
|
Recruiting Locations
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute
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.