Clinical Trial

The PRIME-CRC Trial to Promote CRC Screening in Rural Communities

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated January 29, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-03-16; most recent amendment 2025-01-27.
Status change: Recruiting → Active, Not Recruiting 2025-01-27
Status change: Not Yet Recruiting → Recruiting 2021-06-01
Trial Details
NCT Number NCT04313114
Lead Sponsor Louisiana State University Health Sciences Center Shreveport
Collaborators: National Cancer Institute (NCI), Northwestern University
Conditions Colorectal Cancer
Enrollment 804 participants
Start Date 2021-09-20
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-29