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Mailed Reminders Plus Fecal Immunochemical Testing

Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176082
Acronym
MFIT
Enrollment
2144
Registered
2017-06-05
Start date
2016-10-31
Completion date
2018-07-31
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Cancer Screening

Keywords

colorectal cancer screening, colorectal cancer

Brief summary

Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County.

Detailed description

Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County. Participants: Medicaid beneficiaries who are enrolled in Community Care of North Carolina, ages 52-64, currently living in Mecklenburg County, at average risk for colorectal cancer (CRC), with no record of recent CRC screening (FOBT within 12 months, colonoscopy within 10 years). Procedures (methods): Participants will be identified through the state Medicaid database and randomized to receive either: 1) a mailed reminder to complete CRC screening including a FIT kit, instructions for completion, and a return mailer, OR 2) a mailed reminder to complete CRC screening only. Any recipients testing positive will be guided by care managers from Community Care of North Carolina to ensure a follow-up colonoscopy is completed.

Interventions

OTHERMailed Reminders with Fecal Immunochemical Testing kits
OTHERReminder letter only

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
52 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

1. Current Medicaid beneficiary, 2. Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM), 3. 52-64 years old, 4. English or Spanish speaking, 5. No record of FOBT/FIT within 12 months or colonoscopy with 10 years, sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years, 6. No record of any CRC diagnosis or total colectomy

Exclusion criteria

1. \< 52 or \>64 years of age; 2. History of colorectal cancer or total colectomy (see attached table for codes), 3. Persons dually enrolled in Medicare, 4. Not enrolled in CCPGM, 5. Received FOBT or FIT within 12 months; colonoscopy within 10 years; sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •21 months following baselineScreening status will be assessed through participant response and Medicaid claim data.
Diagnoses of colorectal Cancer21 months following baselineDiagnoses of colorectal cancer will be assessed through Medicaid claim data.
Polypectomies21 months following baselineNumber of polypectomies will be assessed through Medicaid claim data.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026