mHealth for Breast Cancer Survivors With Insomnia

December 18, 2024 updated by: Hannah Arem, Medstar Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voice-Activated Smart Speaker Program
Faster Asleep
Behavioral: Faster Asleep Smart Speaker Program
Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.
Active Comparator: Website
Faster Asleep Website
Behavioral: Faster Asleep Website
Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Symptoms
Time Frame: 6 weeks
Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (≤14) among >80% of the intervention participants
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Week Change in Sleep Efficiency
Time Frame: 6 weeks
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
6 weeks
Six Week Change in Wake After Sleep Onset
Time Frame: 6 weeks
Amount of time awake during the night
6 weeks
Six Week Change in Sleep Onset Latency
Time Frame: 6 weeks
Time to fall asleep
6 weeks
Six Week Change in Total Sleep Time
Time Frame: 6 weeks
Total time asleep
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 6 weeks
A 10-item scale on general usability of technology. This provides a score of 0-100, with above 68 indicating better than average usability, where higher is better. This is a normalized score and not a percentage.
6 weeks
End of Study Self-reported Sleep Quality
Time Frame: 6 weeks
5-item Likert scale from Very Poor (5) to Very Good (1).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Media Rez

Investigators

  • Principal Investigator: Hannah Arem, PhD, Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4298

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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