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mHealth for Breast Cancer Survivors With Insomnia | Clinical Trials | Clareo Health

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COMPLETEDNANCT05233800

mHealth for Breast Cancer Survivors With Insomnia

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.

Lead sponsor: Medstar Health Research Institute•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Medstar Health Research Institute

Collaborators

Media Rez

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.

Age

18 - No limit years

Sex

FEMALE

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
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 24, 2025Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment76

Start dateApr 2022

Last updatedJan 24, 2025

Condition

Breast Cancer Survivor Insomnia

Locations shown

MedStar Washington Hospital Center

Washington D.C., District of Columbia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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