Clinical trial NCT06173375: Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
Official title: Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: screening
early detection
stool blood test
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
* ≥1 UCSD Health System health visit within the last year
* Resides in San Diego or Imperial County
* Currently not up to date with CRC screening
* Insured by private, public or other health insurance.

Exclusion Criteria:

* Up-to-date with screening
* Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
* Prior history of colectomy
* Lack of health insurance

Primary outcomes:
measure: Proportion of Colorectal cancer screening completion
timeFrame: Within 3 months of randomization
measure: Proportion of Abnormal stool blood test results
timeFrame: Within 3 months of randomization
measure: Proportion of Follow-up colonoscopy after abnormal stool blood test result
timeFrame: Within 6 months after stool blood test completion
Secondary outcomes:
measure: Number of participants opting out of the pilot
timeFrame: Within 3 months of randomization
measure: Number of participants with undeliverable FIT or Cologuard tests (mail fail rate)
timeFrame: Within 3 months of randomization
measure: Number of Adenomas detected
timeFrame: Within 6 months after screening test completion
measure: Number of sessile serrated lesions detected
timeFrame: Within 6 months after screening test completion
measure: Number of colorectal cancer cases detected
timeFrame: Within 6 months after screening test completion
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Postdoctoral Researcher
name: Joshua Demb, PhD
role: PRINCIPAL_INVESTIGATOR
References: