Colorectal Cancer
Conditions
Keywords
screening, early detection, stool blood test
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.
Interventions
DIAGNOSTIC_TESTCologuard
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
DIAGNOSTIC_TESTFecal Immunochemical Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
Eligibility
Sex/Gender
ALL
Age
45 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Colorectal Cancer Screening | Within 3 months of randomization | 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) |
| Number of Participants With Abnormal Stool Blood Test Results | Within 3 months of randomization | Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result. |
| Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result | Within 6 months after stool blood test completion | Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy |
| Number of Participants With Assigned Screening Test Successfully Ordered | Within 3 months of randomization | Number of randomized participants for whom the assigned screening test order was successfully placed within the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Opting Out of the Pilot | Within 3 months of randomization | Measurement of feasibility of pilot to retain participants for the duration of study follow-up |
| Number of Adenomas Detected | Within 6 months after screening test completion | Number of participants with adenomas detected during study period |
| Number of Sessile Serrated Lesions Detected | Within 6 months after screening test completion | Number of participants with sessile serrated lesions detected during study period |
| Number of Participants With Colorectal Cancer Detected | Within 6 months after screening test completion | Number of participants diagnosed with colorectal cancer during the study period |
| Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate) | Within 3 months of randomization | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoshua Demb, PhD
Postdoctoral Researcher
Participant flow
Recruitment details
Recruitment occurred from May-Dec 2024 at UCSD Health primary care clinics. Eligible adults 45-49 were identified via EHR queries, mailed invitation letters, and follow-up calls.
Pre-assignment details
A total of 200 individuals were identified as potentially eligible via EHR queries and invited to participate. Of these, 12 individuals provided informed consent and were randomized to study arms (6 to mailed Cologuard outreach and 6 to mailed FIT outreach). Only participants who consented and were randomized are included in the Participant Flow module.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.5 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
None listed