Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE) (SCORE)
Colorectal Cancer
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring Cancer Screening, Colonoscopy, Community Health Centers, Implementation Science, Patient Navigation
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)
Sites / Locations
- Roanoke Chowan Community Health Center
- Blue Ridge Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
Active Comparator
Trial Mailed FIT Intervention - Age Group 50-75
Trial Usual Care - Age Group 50-75
Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.