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mHealth for Breast Cancer Survivors With Insomnia

Primary Purpose

Breast Cancer Survivor, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Faster Asleep Smart Speaker Program
Faster Asleep Website
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Survivor focused on measuring Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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
  • 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

Sites / Locations

  • MedStar Washington Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Voice-Activated Smart Speaker Program

Website

Arm Description

Faster Asleep

Faster Asleep Website

Outcomes

Primary Outcome Measures

Insomnia Symptoms
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

Sleep efficiency
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Wake after sleep onset
Amount of time awake during the night
Sleep onset latency
Time to fall asleep
Total sleep time
Total time asleep

Full Information

First Posted
January 20, 2022
Last Updated
June 14, 2023
Sponsor
Medstar Health Research Institute
Collaborators
Media Rez
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1. Study Identification

Unique Protocol Identification Number
NCT05233800
Brief Title
mHealth for Breast Cancer Survivors With Insomnia
Official Title
Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Media Rez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivor, Insomnia
Keywords
Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voice-Activated Smart Speaker Program
Arm Type
Experimental
Arm Description
Faster Asleep
Arm Title
Website
Arm Type
Active Comparator
Arm Description
Faster Asleep Website
Intervention Type
Behavioral
Intervention Name(s)
Faster Asleep Smart Speaker Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Faster Asleep Website
Intervention Description
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 Outcome Measure Information:
Title
Insomnia Symptoms
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Time Frame
6 weeks
Title
Wake after sleep onset
Description
Amount of time awake during the night
Time Frame
6 weeks
Title
Sleep onset latency
Description
Time to fall asleep
Time Frame
6 weeks
Title
Total sleep time
Description
Total time asleep
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
System usability scale
Description
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.
Time Frame
6 weeks
Title
Sleep quality
Description
5-item Likert scale from Very Poor to Very Good.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Arem, PhD
Phone
202-893-2430
Email
Hannah.Arem@MedStar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Arem, PhD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Starling
Email
Claire.M.Starling@medstar.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
35729605
Citation
Starling CM, Greenberg D, Zhou E, Lewin D, Morrow AS, Lieberman D, Shaw C, Arem H. Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. BMC Med Inform Decis Mak. 2022 Jun 21;22(1):163. doi: 10.1186/s12911-022-01902-w.
Results Reference
derived

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mHealth for Breast Cancer Survivors With Insomnia

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