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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03110 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19784 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Hope Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP I (Cecebot intervention) | Experimental | 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. |
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| GROUP II (waitlist control, Cecebot intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy for Insomnia | Behavioral | Receive sleep education |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Recruitment rates |
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Inclusion Criteria:
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:
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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| Name | Affiliation | Role |
|---|---|---|
| Kerryn Reding | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40658949 | Derived | Tsai CS, Szewczyk W, Drerup M, Liao J, Vasbinder A, Greenlee H, Heffner JL, Yung R, Reding KW. A Personalized, Texting-Based Conversational Agent to Address Sleep Disturbance in Individuals Who Have Survived Breast Cancer: Protocol for a Pilot Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 14;14:e62712. doi: 10.2196/62712. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2024 | Jan 14, 2026 |
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| Internet-Based Intervention | Other | Receive access to website content modules |
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| Medical Device Usage and Evaluation | Other | Wear activity tracker |
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| Questionnaire Administration | Other | Ancillary studies |
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| Text Message-Based Navigation Intervention | Other | Receive sleep compression SMS conversations |
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Recruitment rate will be defined as the percentage of participants enrolled of those approached. |
| Up to week 12 |
| Enrollment rate | Enrollment rate will be defined as the percent enrolled of those eligible. | 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. | 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. | 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. | Up to week 12 |
| Adherence to physical activity (PA) recommendation | Adherence to PA recommendations will be defined as the percent who achieved PA goals. | 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. | 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. | 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. | At week 0, 6 and 12 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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