Breast Cancer Clinical Trial

mHealth for Breast Cancer Survivors With Insomnia

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

76

Study ID:

NCT05233800

Recruitment Status:

Recruiting

Sponsor:

Medstar Health Research Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States More Info
Claire Starling
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

76

Study ID:

NCT05233800

Recruitment Status:

Recruiting

Sponsor:


Medstar Health Research Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider