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

University of Washington

Status: Active, not recruiting

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Insomnia; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8

Treatments: Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention; Behavioral: Cognitive Behavior Therapy for Insomnia; Other: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06392789

NCI-2024-03110 (Registry Identifier)

RG1123931

19784 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

GROUP I (Cecebot intervention)

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Text Message-Based Navigation Intervention

Behavioral: Cognitive Behavior Therapy for Insomnia

Other: Questionnaire Administration

Other: Internet-Based Intervention

GROUP II (waitlist control, Cecebot intervention)

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Text Message-Based Navigation Intervention

Behavioral: Cognitive Behavior Therapy for Insomnia

Other: Questionnaire Administration

Other: Internet-Based Intervention