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

COMPLETEDNA

mHealth for Breast Cancer Survivors With Insomnia

Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors

NCT05233800•Medstar Health Research Institute

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) 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

April 5, 2022

Primary Completion Date

December 15, 2023

Completion Date

December 15, 2023

Last Updated

January 24, 2025

Enrollment

ACTUAL participants

Conditions

Breast Cancer SurvivorInsomnia

Interventions

Faster Asleep Smart Speaker Program

BEHAVIORAL

Faster Asleep Website

BEHAVIORAL

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

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Insomnia

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RECRUITINGNA

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

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Insomnia Chronic

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RECRUITING

Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

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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: March 29, 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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mHealth for Breast Cancer Survivors With Insomnia

Inclusion Criteria

Exclusion Criteria

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

Innovating CBT-I for Cancer Survivors: An Optimization Trial

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer