Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Insomnia
Conditions
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.
Interventions
BEHAVIORALCognitive Behavior Therapy for Insomnia
Receive sleep education
OTHERInternet-Based Intervention
Receive access to website content modules
OTHERMedical Device Usage and Evaluation
Wear activity tracker
OTHERQuestionnaire Administration
Ancillary studies
Receive sleep compression SMS conversations
Sponsors
University of Washington
The Hope Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Recruitment rates | Up to week 12 | Recruitment rate will be defined as the percentage of participants enrolled of those approached. |
| Enrollment rate | Up to week 12 | Enrollment rate will be defined as the percent enrolled of those eligible. |
| 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. |
| 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. |
| 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. |
| Adherence to physical activity (PA) recommendation | Up to week 12 | Adherence to PA recommendations will be defined as the percent who achieved PA goals. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKerryn Reding
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed