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Search / Trial NCT06392789

A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors

Launched by UNIVERSITY OF WASHINGTON · Apr 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a tool called Cecebot, which is designed to help breast cancer survivors improve their sleep. Many women who have survived stage I-III breast cancer struggle with insomnia, which can lead to a lower quality of life. Cecebot uses text messages to provide personalized support, combining techniques to improve sleep habits and encourage physical activity, both of which have been shown to help with insomnia.

To participate in this trial, women must be at least 18 years old and have been diagnosed with stage I-III invasive breast cancer. They should be experiencing significant sleep problems for at least three months and be able to use a smartphone with internet access. Participants will engage in the Cecebot program and can expect to receive regular messages designed to help them manage their sleep better. It's important to note that individuals with certain sleep disorders or those currently receiving chemotherapy or radiation are not eligible for this study.

Gender

FEMALE

Eligibility 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

About University Of Washington

The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.

Locations

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Kerryn Reding

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported