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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Primary completion date changed from estimate of Dec 1, 2025 to Mar 1, 2026
    • Study completion pushed from May 31, 2026 to May 31, 2027
    • Eligibility criteria expanded, about 8 words
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2025v10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 800 to confirmed 804
    • Study completion date: May 31, 2025 to May 31, 2026
    • Site details revised at 3 of 3 sites
  3. Enrollment target: 1200 to 800v9
  4. Re-verified, no change to tracked fieldsv8
  5. Start date: May 17, 2021 to Sep 20, 2021
    • Eligibility criteria revised
    • Site details revised at 1 of 3 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v6
  2. Start date: Feb 2021 to May 17, 2021
    • Primary completion date: Dec 2024 to Dec 1, 2024
    • Study completion date: Mar 2025 to May 31, 2025
    v5
  3. Start date: Sep 2020 to Feb 2021v4
  4. Start date: Jun 2020 to Sep 2020v3
  5. Study description expanded, about 4 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04313114
Lead Sponsor Louisiana State University Health Sciences Center Shreveport
Collaborators: National Cancer Institute (NCI), Northwestern University
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 804 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov