mHealth for Breast Cancer Survivors With Insomnia

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    76
  • sponsor
    Medstar Health Research Institute
Updated on 3 May 2022
cancer
behavior therapy
cognitive behavioral therapy for insomnia
sleep treatment

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.

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.

Details
Condition Breast Cancer Survivor, Insomnia
Treatment Faster Asleep Smart Speaker Program, Faster Asleep Website
Clinical Study IdentifierNCT05233800
SponsorMedstar Health Research Institute
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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