N/A
Completed N=4,318
Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
Source: ClinicalTrials.gov NCT04406714 ↗Enrolled (actual)
4,318
Serious AEs
—
Results posted
Jun 2024
Primary outcomePrimary: Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) — 598; 192 Participants
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 two age groups, 45-49 years and 50-75 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) |
598; 192 | — |
| SECONDARY Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days |
409 | — |
| SECONDARY Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy |
48; 18; 33; 8 | — |
| SECONDARY Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months |
22; 8 | — |
| SECONDARY Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment |
3.25; 0 | — |
| SECONDARY Number of Subjects Who Received Referral for Cancer Treatment |
4; 2 | — |
| SECONDARY Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach |
1372; 261; 116; 252 | — |
| SECONDARY Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75) |
— | — |
| SECONDARY The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening |
158; 158; 53; 45 | — |
| SECONDARY Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days |
34; 20 | — |
| SECONDARY Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy |
2; 1; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04406714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.