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NCT06392789 | RECRUITING | Anatomic Stage I Breast Cancer AJCC v8

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

University of Washington

Brief 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.

Condition or disease

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage III Breast Cancer AJCC v8

Insomnia

Intervention/treatment

Cognitive Behavior Therapy for Insomnia

Internet-Based Intervention

Medical Device Usage and Evaluation

Questionnaire Administration

Text Message-Based Navigation Intervention

Phase

NA

Detailed Description:

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (INTERVENTION): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations once weekly (QW), and wear activity tracker daily on weeks 1-6. GROUP II (WAITLIST CONTROL): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
Actual Study Start Date : 2024-10-04
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors

Location Details

NCT06392789

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Locations

RECRUITING

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109