Breast Cancer SurvivorNCT05233800
mHealth for Breast Cancer Survivors With Insomnia
A study testing Faster Asleep Smart Speaker Program and Faster Asleep Website in people with Breast Cancer Survivor and Insomnia, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor, Insomnia
- What is being tested?
- Faster Asleep Smart Speaker Program and Faster Asleep Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Survivor, Insomnia
- Being tested
- Faster Asleep Smart Speaker Program, Faster Asleep Website
- Keywords
- Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster Asleep Smart Speaker ProgramBehavioural
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 WebsiteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Voice-Activated Smart Speaker Program | Experimental | Faster Asleep Receives: Behavioral: Faster Asleep Smart Speaker Program |
| Website | Active comparator | Faster Asleep Website Receives: Behavioral: Faster Asleep Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (4)
Six Week Change in Sleep Efficiency
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Measured: 6 weeks
Six Week Change in Wake After Sleep Onset
Amount of time awake during the night
Measured: 6 weeks
Six Week Change in Sleep Onset Latency
Time to fall asleep
Measured: 6 weeks
Six Week Change in Total Sleep Time
Total time asleep
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start5 Apr 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Media Rez
- Responsible party
- Principal investigator, Hannah Arem, Medstar Health Research Institute
- Investigators
- Hannah Arem, PhD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233800
- Sponsor's protocol ID
- 4298
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2022
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Starling CM, Greenberg D, Lewin D, Shaw C, Zhou ES, Lieberman D, Chou J, Arem H. Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435011. doi: 10.1001/jamanetworkopen.2024.35011.
PubMed 39316400Lewin D, Starling CM, Zhou ES, Greenberg D, Shaw C, Arem H. A novel voice interactive sleep log: concurrent validity with actigraphy and sleep diaries. J Clin Sleep Med. 2024 Feb 1;20(2):309-312. doi: 10.5664/jcsm.10878.
PubMed 37869974Starling 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.
PubMed 35729605
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05233800
- Acronym / sponsor ID
- 4298
- Conditions
- Breast Cancer Survivor, Insomnia
- Keywords
- Breast Cancer Survivor, Insomnia, mHealth, Digital Health, Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Media Rez
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voice-Activated Smart Speaker Program | Experimental | Behavioral: Faster Asleep Smart Speaker ProgramFaster Asleep |
| Website | Active comparator | Behavioral: Faster Asleep WebsiteFaster Asleep Website |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faster Asleep Smart Speaker ProgramParticipants 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. | Behavioural | Voice-Activated Smart Speaker Program |
| Faster Asleep WebsiteControls 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. | Behavioural | Website |
Primary outcome
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
4 secondary outcomes
Six Week Change in Sleep Efficiency
Time frame: 6 weeks
Six Week Change in Wake After Sleep Onset
Time frame: 6 weeks
Six Week Change in Sleep Onset Latency
Time frame: 6 weeks
Six Week Change in Total Sleep Time
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 39316400Starling CM, Greenberg D, Lewin D, Shaw C, Zhou ES, Lieberman D, Chou J, Arem H. Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435011. doi: 10.1001/jamanetworkopen.2024.35011.
- Derived from this study: PubMed 37869974Lewin D, Starling CM, Zhou ES, Greenberg D, Shaw C, Arem H. A novel voice interactive sleep log: concurrent validity with actigraphy and sleep diaries. J Clin Sleep Med. 2024 Feb 1;20(2):309-312. doi: 10.5664/jcsm.10878.
- Derived from this study: PubMed 35729605Starling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Arem, PhD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faster Asleep Smart Speaker Program and Faster Asleep Website in people with Breast Cancer Survivor and Insomnia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233800, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.