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mHealth for Breast Cancer Survivors With Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05233800
Recruitment Status : Recruiting
First Posted : February 10, 2022
Last Update Posted : June 18, 2023
Sponsor:
Collaborator:
Media Rez
Information provided by (Responsible Party):
Hannah Arem, Medstar Health Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivor Insomnia Behavioral: Faster Asleep Smart Speaker Program Behavioral: Faster Asleep Website Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
Actual Study Start Date : April 5, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Sleep efficiency [ Time Frame: 6 weeks ]
    Sleep efficiency is calculated by the total time sleeping over the total time in bed.

  2. Wake after sleep onset [ Time Frame: 6 weeks ]
    Amount of time awake during the night

  3. Sleep onset latency [ Time Frame: 6 weeks ]
    Time to fall asleep

  4. Total sleep time [ Time Frame: 6 weeks ]
    Total time asleep


Other Outcome Measures:
  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. Sleep quality [ Time Frame: 6 weeks ]
    5-item Likert scale from Very Poor to Very Good.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05233800


Contacts
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Contact: Hannah Arem, PhD 202-893-2430 Hannah.Arem@MedStar.net

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Claire Starling       Claire.M.Starling@medstar.net   
Sponsors and Collaborators
Medstar Health Research Institute
Media Rez
Investigators
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Principal Investigator: Hannah Arem, PhD Medstar Health Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hannah Arem, Scientific Director, Implementation Science, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT05233800    
Other Study ID Numbers: 4298
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannah Arem, Medstar Health Research Institute:
Breast Cancer Survivor
Insomnia
mHealth
Digital Health
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Additional relevant MeSH terms:
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Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders