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Anatomic Stage I Breast Cancer AJCC v8NCT06392789

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

A study testing Cognitive Behavior Therapy for Insomnia, Internet-Based Intervention and Medical Device Usage and Evaluation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Cognitive Behavior Therapy for Insomnia, Internet-Based Intervention and Medical Device Usage and Evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
4 Oct 2024to 29 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cognitive Behavior Therapy for Insomnia, Internet-Based Intervention, Medical Device Usage and Evaluation, Questionnaire Administration, Text Message-Based Navigation Intervention
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavior Therapy for InsomniaBehavioural

    Also called CBT-I

    Receive sleep education

  • Internet-Based InterventionOther

    Receive access to website content modules

  • Medical Device Usage and EvaluationOther

    Wear activity tracker

  • Questionnaire AdministrationOther

    Ancillary studies

  • Text Message-Based Navigation InterventionOther

    Also called Automated Text Message-Based Navigation, Text Message-Based Navigation

    Receive sleep compression SMS conversations

Study groups in NCT06392789
Study groupRoleWhat they receive
GROUP I (Cecebot intervention)ExperimentalPatients 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.
Receives: Behavioral: Cognitive Behavior Therapy for Insomnia; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention
GROUP II (waitlist control, Cecebot intervention)ExperimentalPatients 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.
Receives: Behavioral: Cognitive Behavior Therapy for Insomnia; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment discontinuation rate

    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.

    Measured: Up to week 6 of intervention

Secondary outcomes (10)

  1. Incidence of adverse events (AEs)

    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.

    Measured: Up to week 12

  2. Recruitment rates

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

    Measured: Up to week 12

  3. Enrollment rate

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

    Measured: Up to week 12

  4. Lost to follow-up

    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.

    Measured: Up to week 12

  5. AE rate

    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.

    Measured: At week 6 of intervention

  6. Adherence to sleep recommendations

    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.

    Measured: Up to week 12

  7. Adherence to physical activity (PA) recommendation

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

    Measured: Up to week 12

  8. Data entry adherence

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

    Measured: Up to week 12

  9. Intervention engagement

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

    Measured: Up to week 12

  10. Sleep quality and the impact of insomnia

    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.

    Measured: At week 0, 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start4 Oct 2024
  3. Primary completion16 Jan 2026
  4. Study completion29 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06392789
Sponsor's protocol ID
RG1123931
Other IDs
NCI-2024-03110, 19784
Status last verified
Jun 2026
First submitted
25 Apr 2024
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsai CS, Szewczyk W, Drerup M, Liao J, Vasbinder A, Greenlee H, Heffner JL, Yung R, Reding KW. A Personalized, Texting-Based Conversational Agent to Address Sleep Disturbance in Individuals Who Have Survived Breast Cancer: Protocol for a Pilot Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 14;14:e62712. doi: 10.2196/62712.

    PubMed 40658949

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavior Therapy for Insomnia, Internet-Based Intervention and Medical Device Usage and Evaluation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment discontinuation rate (time frame: Up to week 6 of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06392789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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