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Completed

NCT Number: NCT06392789

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy for Insomnia

Behavioral

Receive sleep education

Other names: CBT-I

Internet-Based Intervention

Other

Receive access to website content modules

Medical Device Usage and Evaluation

Other

Wear activity tracker

Questionnaire Administration

Other

Ancillary studies

Text Message-Based Navigation Intervention

Other

Receive sleep compression SMS conversations

Other names: Automated Text Message-Based Navigation, Text Message-Based Navigation

Primary outcomes

  1. Treatment discontinuation rate

    Time frame: Up to week 6 of intervention

    Defined as the proportion of all treatment participants who permanently stop the intervention prior to week 6 for any reason. An all-cause discontinuation rate of 40% or less will be considered a threshold for acceptability.

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to week 12

    Intervention safety will be determined by reviewing and quantifying the number of adverse events, serious events and by reviewing the type and severity of AEs attributed to study procedures among each study group.

  2. Recruitment rates

    Time frame: Up to week 12

    Recruitment rate will be defined as the percentage of participants enrolled of those approached.

  3. Enrollment rate

    Time frame: Up to week 12

    Enrollment rate will be defined as the percent enrolled of those eligible.

  4. Lost to follow-up

    Time frame: Up to week 12

    Lost to follow-up will be defined as the percent who dropped out of those enrolled. A benchmark to determine feasibility is less than 40% loss to follow-up.

  5. AE rate

    Time frame: At week 6 of intervention

    AE rate will be defined as the percentage of AEs during the intervention. The number of participants experiencing an adverse event attributable to study procedures will be compared after the first 6 weeks to identify if any detectable differences are present between the treatment group and waitlist control group.

  6. Adherence to sleep recommendations

    Time frame: Up to week 12

    Adherence to sleep recommendations will be defined as the percent who reported wake time recommended by Cecebot. Participant bed times and wake times will be compared to recommendations offered by Cecebot.

  7. Adherence to physical activity (PA) recommendation

    Time frame: Up to week 12

    Adherence to PA recommendations will be defined as the percent who achieved PA goals.

  8. Data entry adherence

    Time frame: Up to week 12

    Data entry adherence will be defined as the percent of sleep efficiency and PA data collection forms completed.

  9. Intervention engagement

    Time frame: Up to week 12

    Intervention engagement will be defined as the percent of educational modules interacted with by the user providing text-based responses.

  10. Sleep quality and the impact of insomnia

    Time frame: At week 0, 6 and 12

    The Insomnia Severity Index (ISI) and daily sleep diaries will be used to assess sleep quality and the impact of insomnia. The ISI will be measured using a 5-point Likert scale of 7 questions yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Hope Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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