NCT04406714Completed
Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are implementing this study in two age groups, 45-49 years and 50-75 years.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 4318 (actual)
- First submitted
- 22 May 2020
- Start date
- 7 Jul 2020
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04406714
What you commit to
- Study type: Interventional
- Participants enrolled: 4318
- From 7 Jul 2020 to the primary completion date, 31 Mar 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease)
- Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
Age
- Age younger than 45 years or older than 75 years
- Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)
Other
- Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date
- Record of any CRC diagnosis or total colectomy
- Does not have a complete North Carolina mailing address in the EHR
- Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization
Who the study is looking for
- Age 45-75 years
- At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease)
- No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- No record of any CRC diagnosis or total colectomy
- No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
- Has a complete North Carolina mailing address in the EHR
- Active patient of the clinic (seen within the past 18 months) at the time of randomization
- No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only)
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roanoke Chowan Community Health Center Coordinator of this site? Confirm its status | Ahoskie | United States | Unknown status |
| Blue Ridge Health Coordinator of this site? Confirm its status | Hendersonville | United States | Unknown status |
Related publications
- Time to Follow-Up Colonoscopy After Positive Fecal Immunochemical Test with Centralized Patient Navigation: A Randomized Clinical Trial.J Gen Intern Med · 2026 · PMID 41639370
- What makes patient navigation work? Identifying functions and forms and conducting causal loop diagramming to specify components of a successful colorectal cancer patient navigation program.Implement Sci Commun · 2026 · PMID 41549310
This page is information, not medical advice. Discuss any trial with your doctor.