A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors (NCT06392789) | Clinical Trial Compass
CompletedNot Applicable
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors
United States60 participantsStarted 2024-10-04
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.