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

Not Applicable

Recruiting

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

• Registration Number: NCT06392789
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Status Verified: 2024-10
• Study Start: 2024-10-04
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GROUP I (Cecebot intervention)	Internet-Based 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 I (Cecebot intervention)	Medical Device Usage and Evaluation	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 II (waitlist control, Cecebot intervention)	Text Message-Based Navigation 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 I (Cecebot intervention)	Questionnaire Administration	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 I (Cecebot intervention)	Text Message-Based Navigation 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 I (Cecebot intervention)	Cognitive Behavior Therapy for Insomnia	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 II (waitlist control, Cecebot intervention)	Medical Device Usage and Evaluation	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 II (waitlist control, Cecebot intervention)	Cognitive Behavior Therapy for Insomnia	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 II (waitlist control, Cecebot intervention)	Internet-Based 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 II (waitlist control, Cecebot intervention)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Treatment discontinuation rate	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 Outcome Measures

Name	Time	Method
AE rate	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.
Incidence of adverse events (AEs)	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.
Enrollment rate	Up to week 12	Enrollment rate will be defined as the percent enrolled of those eligible.
Recruitment rates	Up to week 12	Recruitment rate will be defined as the percentage of participants enrolled of those approached.
Lost to follow-up	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.
Adherence to physical activity (PA) recommendation	Up to week 12	Adherence to PA recommendations will be defined as the percent who achieved PA goals.
Intervention engagement	Up to week 12	Intervention engagement will be defined as the percent of educational modules interacted with by the user providing text-based responses.
Adherence to sleep recommendations	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.
Data entry adherence	Up to week 12	Data entry adherence will be defined as the percent of sleep efficiency and PA data collection forms completed.
Sleep quality and the impact of insomnia	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States