Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavior Therapy for Insomnia | Behavioral | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Text Message-Based Navigation Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GROUP I (Cecebot intervention)
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behavior Therapy for Insomnia
- Other: Internet-Based Intervention
- Other: Medical Device Usage and Evaluation
- Other: Questionnaire Administration
- Other: Text Message-Based Navigation Intervention
- type
- EXPERIMENTAL
- label
- GROUP II (waitlist control, Cecebot intervention)
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behavior Therapy for Insomnia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (1)
- DERIVEDTsai 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 40658949