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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392789
• Other study ID #: RG1123931
• Secondary ID: NCI-2024-0311019
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: Julia Kristoferson Palmer
• Phone: 206-459-4172
• Email: redinglab[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavior Therapy for Insomnia
Receive sleep education

Other:
• Internet-Based Intervention
Receive access to website content modules
• Medical Device Usage and Evaluation
Wear activity tracker
• Questionnaire Administration
Ancillary studies
• Text Message-Based Navigation Intervention
Receive sleep compression SMS conversations

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	The Hope Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to week 6 of intervention
Secondary	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.	Up to week 12
Secondary	Recruitment rates	Recruitment rate will be defined as the percentage of participants enrolled of those approached.	Up to week 12
Secondary	Enrollment rate	Enrollment rate will be defined as the percent enrolled of those eligible.	Up to week 12
Secondary	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.	Up to week 12
Secondary	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.	At week 6 of intervention
Secondary	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.	Up to week 12
Secondary	Adherence to physical activity (PA) recommendation	Adherence to PA recommendations will be defined as the percent who achieved PA goals.	Up to week 12
Secondary	Data entry adherence	Data entry adherence will be defined as the percent of sleep efficiency and PA data collection forms completed.	Up to week 12
Secondary	Intervention engagement	Intervention engagement will be defined as the percent of educational modules interacted with by the user providing text-based responses.	Up to week 12
Secondary	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.	At week 0, 6 and 12