Using a chatbot to help breast cancer survivors with insomnia
A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
This study tests if a chatbot can help breast cancer survivors who have trouble sleeping by providing them with sleep tips and activity tracking over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06392789 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Cecebot, a conversational agent, in improving insomnia among survivors of stage I-III breast cancer. Participants are randomized into two groups: one receiving immediate access to sleep education and activity tracking, and the other serving as a waitlist control. The intervention combines cognitive behavioral therapy for insomnia (CBTi) and physical activity strategies delivered via SMS over a 12-week period. The goal is to enhance sleep quality and overall quality of life for breast cancer survivors experiencing insomnia.
Who should consider this trial
Good fit: Ideal candidates for this study are female breast cancer survivors aged 18 and older who have clinically significant insomnia symptoms.
Not a fit: Patients with sleep disorders such as sleep apnea or those currently undergoing chemotherapy or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and quality of life for breast cancer survivors suffering from insomnia.
How similar studies have performed: Other studies have shown positive outcomes with similar CBTi approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Kerryn Reding — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Julia Kristoferson Palmer
- Email: redinglab@uw.edu
- Phone: 206-459-4172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.