An interventional study of Mailed Reminders with Fecal Immunochemical Testing kits and Reminder letter only in Colorectal Cancer Screening and Colorectal Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed. Open to participants aged 52 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Screening
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 2,144 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention group will receive: 1. A reminder letter indicating need for screening 2. A FIT kit with completion instructions 3. 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) 4. A pre-paid return mailer for FIT Kit
Other: Mailed Reminders with Fecal Immunochemical Testing kits
Comparison group will receive: 1. A reminder letter indicating need for screening 2. Instructions for obtaining a FIT kit 3. A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD
Other: Reminder letter only
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.
Time frame: 21 months following baseline
Diagnoses of colorectal Cancer
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
Time frame: 21 months following baseline
Polypectomies
Number of polypectomies will be assessed through Medicaid claim data.
Time frame: 21 months following baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center