- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392789
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors
A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
Study Overview
Status
Conditions
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations once weekly (QW), and wear activity tracker daily on weeks 1-6.
GROUP II (WAITLIST CONTROL): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia Kristoferson Palmer
- Phone Number: 206-459-4172
- Email: redinglab@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch/University of Washington Cancer Consortium
-
Contact:
- Julia Kristoferson Palmer
- Phone Number: 206-459-4172
- Email: redinglab@uw.edu
-
Principal Investigator:
- Kerryn Reding
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Prior diagnosis of stage I-III invasive breast cancer
- Female gender
- Clinically significant insomnia symptoms, defined as a Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8 T-score of 60 or greater
- Insomnia complaints lasting ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating ability to perform activities of daily living
- Own a smartphone with Internet connectivity
- Willing and able to complete the intervention with personal smartphone
- Proficient in speaking and reading English
Exclusion Criteria:
- Prior diagnosis of restless leg syndrome, periodic leg movement disorder, narcolepsy, or rapid eye movement (REM) behavior disorder
- Current sleep apnea (treated or untreated)
- Current shiftwork
- Actively receiving chemotherapy or radiation (endocrine therapy permitted)
- Previously received CBTi therapy with a professional therapist
Contraindications to CBTi including:
- Active psychosis
- Uncontrolled bipolar disorder
- Severe depression
- Active substance use disorder (moderate or greater severity)
- Use of prescribed sleep medication > 3 times per week
- Previously participated in user testing of the study intervention (Cecebot)
- Unwilling or unable to complete study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
|
Ancillary studies
Receive sleep education
Other Names:
Receive access to website content modules
Wear activity tracker
Receive sleep compression SMS conversations
Other Names:
|
Experimental: GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
|
Ancillary studies
Receive sleep education
Other Names:
Receive access to website content modules
Wear activity tracker
Receive sleep compression SMS conversations
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment discontinuation rate
Time Frame: Up to week 6 of intervention
|
Defined as the proportion of all treatment participants who permanently stop the intervention prior to week 6 for any reason.
An all-cause discontinuation rate of 40% or less will be considered a threshold for acceptability.
|
Up to week 6 of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs)
Time Frame: Up to week 12
|
Intervention safety will be determined by reviewing and quantifying the number of adverse events, serious events and by reviewing the type and severity of AEs attributed to study procedures among each study group.
|
Up to week 12
|
Recruitment rates
Time Frame: Up to week 12
|
Recruitment rate will be defined as the percentage of participants enrolled of those approached.
|
Up to week 12
|
Enrollment rate
Time Frame: Up to week 12
|
Enrollment rate will be defined as the percent enrolled of those eligible.
|
Up to week 12
|
Lost to follow-up
Time Frame: Up to week 12
|
Lost to follow-up will be defined as the percent who dropped out of those enrolled.
A benchmark to determine feasibility is less than 40% loss to follow-up.
|
Up to week 12
|
AE rate
Time Frame: At week 6 of intervention
|
AE rate will be defined as the percentage of AEs during the intervention.
The number of participants experiencing an adverse event attributable to study procedures will be compared after the first 6 weeks to identify if any detectable differences are present between the treatment group and waitlist control group.
|
At week 6 of intervention
|
Adherence to sleep recommendations
Time Frame: Up to week 12
|
Adherence to sleep recommendations will be defined as the percent who reported wake time recommended by Cecebot.
Participant bed times and wake times will be compared to recommendations offered by Cecebot.
|
Up to week 12
|
Adherence to physical activity (PA) recommendation
Time Frame: Up to week 12
|
Adherence to PA recommendations will be defined as the percent who achieved PA goals.
|
Up to week 12
|
Data entry adherence
Time Frame: Up to week 12
|
Data entry adherence will be defined as the percent of sleep efficiency and PA data collection forms completed.
|
Up to week 12
|
Intervention engagement
Time Frame: Up to week 12
|
Intervention engagement will be defined as the percent of educational modules interacted with by the user providing text-based responses.
|
Up to week 12
|
Sleep quality and the impact of insomnia
Time Frame: At week 0, 6 and 12
|
The Insomnia Severity Index (ISI) and daily sleep diaries will be used to assess sleep quality and the impact of insomnia.
The ISI will be measured using a 5-point Likert scale of 7 questions yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
|
At week 0, 6 and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kerryn Reding, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1123931
- NCI-2024-03110 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 19784 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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