A Personalized, SMS-Based Conversational Agent to Address Sleep Disturbance in Breast Cancer Survivors: Protocol for a Pilot Waitlist Randomized Controlled Trial (Preprint)

BACKGROUND Sleep disturbance is one of the most common health concerns reported by breast cancer (BC) survivors and is associated with poor quality of life (QoL) and greater mortality after treatment. Cognitive behavior therapy for insomnia (CBTi) has shown efficacy for improving sleep and quality of life for BC survivors. Considered the gold standard insomnia treatment, CBTi can be delivered remotely, including via digital intervention. Despite the potential for wider dissemination of CBTi via digital means, these modalities have unique challenges, including technology barriers and poor adherence. We developed a conversational agent (CA) to deliver CBTi via short message service (SMS), supported by mobile-ready web content. Named “Cecebot”, this CA delivers sleep education, implements sleep compression, provides just-in-time intervention on sleep-disrupting behaviors, and includes enhanced support for physical activity (PA) beyond what is typically included in CBTi. This represents a novel modality for a CBTi and PA intervention in BC survivors. OBJECTIVE We aim to examine the safety and acceptability of the Cecebot intervention for BC survivors with symptoms of insomnia and explore intervention efficacy. METHODS This trial will recruit 60 BC survivors who are experiencing moderate to severe sleep disturbance. Participants will be assigned to the Cecebot intervention or waitlist control group at a 1:1 ratio. The treatment group will receive Cecebot intervention during weeks 1-6 of the study, while the waitlist control condition will receive the Cecebot intervention during weeks 6-12. The Cecebot intervention utilizes SMS technology paired with Fitbit. Participants will be assessed at baseline, week 6, and week 12. Measurements will include feasibility and acceptability, and explore the effect of a Cecebot intervention. RESULTS Recruitment of participants began in Spring 2024. The completion of data collection is anticipated to be by Winter 2025. CONCLUSIONS The study results will give insight into the potential for an SMS-based conversational agent to improve sleep in BC survivors with sleep disturbances.