A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Julia Kristoferson Palmer
redinglab@uw.edu
206-459-4172
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: The Hope Foundation

This content was sourced from clinicaltrials.gov