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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anatomic Stage I Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Seattle

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

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

Study Record Dates

2025-06-30