The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.
Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
12
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
University of California San Diego
La Jolla, California, United States
Number of Participants Completing Colorectal Cancer Screening
The number of participants who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Time frame: Within 3 months of randomization
Number of Participants With Abnormal Stool Blood Test Results
Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.
Time frame: Within 3 months of randomization
Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result
Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy
Time frame: Within 6 months after stool blood test completion
Number of Participants With Assigned Screening Test Successfully Ordered
Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.
Time frame: Within 3 months of randomization
Number of Participants Opting Out of the Pilot
Measurement of feasibility of pilot to retain participants for the duration of study follow-up
Time frame: Within 3 months of randomization
Number of Adenomas Detected
Number of participants with adenomas detected during study period
Time frame: Within 6 months after screening test completion
Number of Sessile Serrated Lesions Detected
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Number of participants with sessile serrated lesions detected during study period
Time frame: Within 6 months after screening test completion
Number of Participants With Colorectal Cancer Detected
Number of participants diagnosed with colorectal cancer during the study period
Time frame: Within 6 months after screening test completion
Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)
The number of participants who consented to participate who were intended to be mailed a FIT or Cologuard test, but the test was found to be undeliverable.
Time frame: Within 3 months of randomization