Status:
COMPLETED
mHealth for Breast Cancer Survivors With Insomnia
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Media Rez
Conditions:
Breast Cancer Survivor
Insomnia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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.
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) compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05233800
Start Date
April 5 2022
End Date
December 15 2023
Last Update
January 24 2025
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010