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Active Not Recruiting
NCT04313114
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Conditions: Colorectal Cancer
Sex: All
Ages: 45 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 804
Sponsor: Louisiana State University Health Sciences Center Shreveport
Location: CommuniHealth (dba Morehouse Community Medical Centers, Inc.) Bastrop Louisiana
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.
Eligibility Criteria
Inclusion Criteria:
1. have been a patient at one of the participating FQHCs with at least one prior visit in the past 12 months;
2. age 45 to 75 (based on USPSTF guidelines);
3. English-speaking.
Exclusion Criteria:
1. have a previous history of cancer other than non-melanoma skin cancer;
2. are up-to-date with CRC screening according to USPSTF guidelines (FOBT in less than a year, sigmoidoscopy less than 5 years, or colonoscopy less than 10 years);
3. a family history that requires a more complete history and possible colonoscopy because of their risk factor;
4. have a documented or uncorrectable cognitive, hearing, or visual impairment;
5. are too ill to participate
Source: ClinicalTrials.gov (NCT04313114). StuddyBuddy aggregates publicly available trial information.