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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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GROUP I (Cecebot 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 QW, and wear activity tracker daily on weeks 1-6.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy for Insomnia

Intervention Type BEHAVIORAL

Receive sleep education

Internet-Based Intervention

Intervention Type OTHER

Receive access to website content modules

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear activity tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Text Message-Based Navigation Intervention

Intervention Type OTHER

Receive sleep compression SMS conversations

GROUP II (waitlist control, Cecebot 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 QW, and wear activity tracker daily on weeks 7-12.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy for Insomnia

Intervention Type BEHAVIORAL

Receive sleep education

Internet-Based Intervention

Intervention Type OTHER

Receive access to website content modules

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear activity tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Text Message-Based Navigation Intervention

Intervention Type OTHER

Receive sleep compression SMS conversations

Interventions

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Cognitive Behavior Therapy for Insomnia

Receive sleep education

Intervention Type BEHAVIORAL

Internet-Based Intervention

Receive access to website content modules

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear activity tracker

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Text Message-Based Navigation Intervention

Receive sleep compression SMS conversations

Intervention Type OTHER

Other Intervention Names

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CBT-I Automated Text Message-Based Navigation Text Message-Based Navigation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No