RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-04
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06392789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Prior diagnosis of stage I-III invasive breast cancer
  3. * Female gender
  4. * Clinically significant insomnia symptoms, defined as a Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8 T-score of 60 or greater
  5. * Insomnia complaints lasting ≥ 3 months
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating ability to perform activities of daily living
  7. * Own a smartphone with Internet connectivity
  8. * Willing and able to complete the intervention with personal smartphone
  9. * Proficient in speaking and reading English
  1. * Prior diagnosis of restless leg syndrome, periodic leg movement disorder, narcolepsy, or rapid eye movement (REM) behavior disorder
  2. * Current sleep apnea (treated or untreated)
  3. * Current shiftwork
  4. * Actively receiving chemotherapy or radiation (endocrine therapy permitted)
  5. * Previously received CBTi therapy with a professional therapist
  6. * Contraindications to CBTi including:
  7. * Active psychosis
  8. * Uncontrolled bipolar disorder
  9. * Severe depression
  10. * Active substance use disorder (moderate or greater severity)
  11. * Use of prescribed sleep medication \> 3 times per week
  12. * Previously participated in user testing of the study intervention (Cecebot)
  13. * Unwilling or unable to complete study procedures

Contacts and Locations

Study Contact

Julia Kristoferson Palmer
CONTACT
206-459-4172
redinglab@uw.edu

Principal Investigator

Kerryn Reding
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Kerryn Reding, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-10-04
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

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