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
3 other identifiers
interventional
60
1 country
1
Brief Summary
This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedStudy Start
First participant enrolled
October 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJanuary 28, 2026
January 1, 2026
1.3 years
April 25, 2024
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment discontinuation rate
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 Outcomes (10)
Incidence of adverse events (AEs)
Up to week 12
Recruitment rates
Up to week 12
Enrollment rate
Up to week 12
Lost to follow-up
Up to week 12
AE rate
At week 6 of intervention
- +5 more secondary outcomes
Study Arms (2)
GROUP I (Cecebot intervention)
EXPERIMENTALPatients 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.
GROUP II (waitlist control, Cecebot intervention)
EXPERIMENTALPatients 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.
Interventions
Receive sleep education
Receive access to website content modules
Wear activity tracker
Ancillary studies
Receive sleep compression SMS conversations
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years and ≤ 80 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 55 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
- Completed breast cancer treatment within past 5 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- The Hope Foundationcollaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Related Publications (1)
Tsai CS, Szewczyk W, Drerup M, Liao J, Vasbinder A, Greenlee H, Heffner JL, Yung R, Reding KW. A Personalized, Texting-Based Conversational Agent to Address Sleep Disturbance in Individuals Who Have Survived Breast Cancer: Protocol for a Pilot Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 14;14:e62712. doi: 10.2196/62712.
PMID: 40658949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerryn Reding
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2024
First Posted
April 30, 2024
Study Start
October 4, 2024
Primary Completion
January 16, 2026
Study Completion
March 31, 2026
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share