Clinical trial NCT06392789: A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors
Official title: A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Insomnia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Hope Foundation
First posted: 2024-04-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment discontinuation rate
timeFrame: Up to week 6 of intervention
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to week 12
measure: Recruitment rates
timeFrame: Up to week 12
measure: Enrollment rate
timeFrame: Up to week 12
measure: Lost to follow-up
timeFrame: Up to week 12
measure: AE rate
timeFrame: At week 6 of intervention
measure: Adherence to sleep recommendations
timeFrame: Up to week 12
measure: Adherence to physical activity (PA) recommendation
timeFrame: Up to week 12
measure: Data entry adherence
timeFrame: Up to week 12
measure: Intervention engagement
timeFrame: Up to week 12
measure: Sleep quality and the impact of insomnia
timeFrame: At week 0, 6 and 12
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Kerryn Reding
role: PRINCIPAL_INVESTIGATOR
References: