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

N/AActive Not RecruitingNCT06392789

University of Washington60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Interventions

Cognitive Behavior Therapy for InsomniaBEHAVIORAL

Receive sleep education

Internet-Based InterventionOTHER

Receive access to website content modules

Medical Device Usage and EvaluationOTHER

Wear activity tracker

Questionnaire AdministrationOTHER

Ancillary studies

Text Message-Based Navigation InterventionOTHER

Receive sleep compression SMS conversations

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to week 6 of intervention

Secondary Outcomes

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.

Time frame: Up to week 12

Recruitment rates

Recruitment rate will be defined as the percentage of participants enrolled of those approached.

Time frame: Up to week 12

Enrollment rate

Enrollment rate will be defined as the percent enrolled of those eligible.

Time frame: Up to week 12

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.

Time frame: Up to week 12

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.

Time frame: At week 6 of intervention

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.

Time frame: Up to week 12

Adherence to physical activity (PA) recommendation

Adherence to PA recommendations will be defined as the percent who achieved PA goals.

Time frame: Up to week 12

Data entry adherence

Data entry adherence will be defined as the percent of sleep efficiency and PA data collection forms completed.

Time frame: Up to week 12

Intervention engagement

Intervention engagement will be defined as the percent of educational modules interacted with by the user providing text-based responses.

Time frame: Up to week 12

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.

Time frame: At week 0, 6 and 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes