Status:
COMPLETED
Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
East Carolina University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Age younger than 45 years or older than 75 years
- 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 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
- 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)
- 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
- Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2024
Estimated Enrollment :
4318 Patients enrolled
Trial Details
Trial ID
NCT04406714
Start Date
July 7 2020
End Date
September 2 2024
Last Update
September 25 2024
Active Locations (2)
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1
Roanoke Chowan Community Health Center
Ahoskie, North Carolina, United States, 27910
2
Blue Ridge Health
Hendersonville, North Carolina, United States, 28792