Clinical trial · Interventional
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: the PRIME-CRC Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| automated call reminders or automated texts | Behavioral | — | UNRESOLVED |
| health literacy appropriate education and demonstration | Behavioral | — | UNRESOLVED |
| shared decision making | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PRIME CRC
- description
- Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will also receive automated reminder calls and texts for both screening options to encourage screening.
- interventionNames
- Behavioral: health literacy appropriate education and demonstration
- Behavioral: shared decision making
- Behavioral: automated call reminders or automated texts
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will receive no reminder calls.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDavis TC, Morris JD, Reed EH, Curtis LM, Wolf MS, Davis AB, Arnold CL. Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve three-year adherence to colorectal cancer screening among patients cared for in rural community health centers. Contemp Clin Trials. 2022 Feb;113:106654. doi: 10.1016/j.cct.2021.106654. Epub 2021 Dec 11. PMID 34906745