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Mailed Reminders Plus Fecal Immunochemical Testing (MFIT)

Primary Purpose

Colorectal Cancer Screening, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mailed Reminders with Fecal Immunochemical Testing kits
Reminder letter only
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring colorectal cancer screening, colorectal cancer

Eligibility Criteria

52 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Comparison Group

    Arm Description

    Intervention group will receive: A reminder letter indicating need for screening A FIT kit with completion instructions A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the Mecklenburg County Public Health Department (MCPHD) A pre-paid return mailer for FIT Kit

    Comparison group will receive: A reminder letter indicating need for screening Instructions for obtaining a FIT kit A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD

    Outcomes

    Primary Outcome Measures

    Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
    Screening status will be assessed through participant response and Medicaid claim data.
    Diagnoses of colorectal Cancer
    Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
    Polypectomies
    Number of polypectomies will be assessed through Medicaid claim data.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2017
    Last Updated
    December 18, 2018
    Sponsor
    UNC Lineberger Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03176082
    Brief Title
    Mailed Reminders Plus Fecal Immunochemical Testing
    Acronym
    MFIT
    Official Title
    Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UNC Lineberger Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Screening, Colorectal Cancer
    Keywords
    colorectal cancer screening, colorectal cancer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Intervention group will receive: A reminder letter indicating need for screening A FIT kit with completion instructions A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the Mecklenburg County Public Health Department (MCPHD) A pre-paid return mailer for FIT Kit
    Arm Title
    Comparison Group
    Arm Type
    Active Comparator
    Arm Description
    Comparison group will receive: A reminder letter indicating need for screening Instructions for obtaining a FIT kit A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD
    Intervention Type
    Other
    Intervention Name(s)
    Mailed Reminders with Fecal Immunochemical Testing kits
    Intervention Type
    Other
    Intervention Name(s)
    Reminder letter only
    Primary Outcome Measure Information:
    Title
    Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
    Description
    Screening status will be assessed through participant response and Medicaid claim data.
    Time Frame
    21 months following baseline
    Title
    Diagnoses of colorectal Cancer
    Description
    Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
    Time Frame
    21 months following baseline
    Title
    Polypectomies
    Description
    Number of polypectomies will be assessed through Medicaid claim data.
    Time Frame
    21 months following baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    52 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Current Medicaid beneficiary, Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM), 52-64 years old, English or Spanish speaking, 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, No record of any CRC diagnosis or total colectomy Exclusion Criteria: < 52 or >64 years of age; History of colorectal cancer or total colectomy (see attached table for codes), Persons dually enrolled in Medicare, 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alison Brenner, PhD, MPH
    Organizational Affiliation
    UNC Lineberger Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mailed Reminders Plus Fecal Immunochemical Testing

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