Study to Increase Colorectal Screening
- Sponsor
- University of California, San Diego
- Study ID
- NCT02870049
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Inreach strategy — BEHAVIORALInreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
- Outreach strategy — BEHAVIORALOutreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
- Both Inreach and Outreach strategies — BEHAVIORALBoth Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
- Usual care — BEHAVIORALUsual care: FIT kit delivery as part of usual care
Study Details
The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.
Key Dates
- Start date
- Aug 31, 2016
- Status verified
- Aug 2025
- Primary completion
- Jul 9, 2018
- Completion
- Aug 30, 2019
Study Design
- Enrollment
- 673 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- SCREENING
Arms
- Experimental: Inreach strategyThis consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
- Experimental: Outreach strategyThis consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
- Experimental: Both Inreach and Outreach strategiesThis is a combination of the above two strategies: Inreach and Outreach combined.
- Active Comparator: Usual careUsual care in the clinic using the fecal immunochemical test (FIT) kit.
Primary Outcome Measure
Screening Completion Rate [ Time Frame: 23 months ]
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer PatientsRecruiting · Vanderbilt University Medical Center · Nashville, Tennessee
- ColoCare Study - Colorectal Cancer CohortRecruiting · University of Utah · Los Angeles, California
- Feasibility of the LUM Imaging System for Detection of Gastrointestinal CancersPHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts