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Completed

NCT Number: NCT05233800

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.

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Key information

Conditions

Breast Cancer Survivor Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faster Asleep Smart Speaker Program

Behavioral

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.

Faster Asleep Website

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Six Week Change in Wake After Sleep Onset

    Time frame: 6 weeks

    Amount of time awake during the night

  3. Six Week Change in Sleep Onset Latency

    Time frame: 6 weeks

    Time to fall asleep

  4. Six Week Change in Total Sleep Time

    Time frame: 6 weeks

    Total time asleep

Other outcomes

  1. 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.

  2. End of Study Self-reported Sleep Quality

    Time frame: 6 weeks

    5-item Likert scale from Very Poor (5) to Very Good (1).

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Media Rez

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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