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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy for Insomnia	Receive sleep education
OTHER	Internet-Based Intervention	Receive access to website content modules
OTHER	Medical Device Usage and Evaluation	Wear activity tracker
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Text Message-Based Navigation Intervention	Receive sleep compression SMS conversations

Timeline

• Start date: 2024-10-04
• Primary completion: 2026-01-16
• Completion: 2026-05-31
• First posted: 2024-04-30
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States