Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392789
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-25
Brief Title:
A Conversational Agent Cecebot to Improve Insomnia in Stage I-III Breast Cancer Survivors
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot a Conversational Agent for Insomnia After Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19784 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2024-03110 | REGISTRY | None | None |