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Trial Title:
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors
NCT ID:
NCT06392789
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Insomnia
Conditions: Official terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive Behavior Therapy for Insomnia
Description:
Receive sleep education
Arm group label:
GROUP I (Cecebot intervention)
Arm group label:
GROUP II (waitlist control, Cecebot intervention)
Other name:
CBT-I
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Receive access to website content modules
Arm group label:
GROUP I (Cecebot intervention)
Arm group label:
GROUP II (waitlist control, Cecebot intervention)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear activity tracker
Arm group label:
GROUP I (Cecebot intervention)
Arm group label:
GROUP II (waitlist control, Cecebot intervention)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
GROUP I (Cecebot intervention)
Arm group label:
GROUP II (waitlist control, Cecebot intervention)
Intervention type:
Other
Intervention name:
Text Message-Based Navigation Intervention
Description:
Receive sleep compression SMS conversations
Arm group label:
GROUP I (Cecebot intervention)
Arm group label:
GROUP II (waitlist control, Cecebot intervention)
Other name:
Automated Text Message-Based Navigation
Other name:
Text Message-Based Navigation
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Kristoferson Palmer
Phone:
206-459-4172
Email:
redinglab@uw.edu
Investigator:
Last name:
Kerryn Reding
Email:
Principal Investigator
Start date:
October 4, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
The Hope Foundation
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06392789
