Colorectal Cancer ScreeningMFITNCT03176082
Mailed Reminders Plus Fecal Immunochemical Testing
A study testing Mailed Reminders with Fecal Immunochemical Testing kits and Reminder letter only in people with Colorectal Cancer Screening and Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 52 to 64 years
- Conditions the study is for
- Colorectal Cancer Screening, Colorectal Cancer
- What is being tested?
- Mailed Reminders with Fecal Immunochemical Testing kits and Reminder letter only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,144 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- < 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
About this study
Official title: Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries 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.
Read the 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.
- Conditions
- Colorectal Cancer Screening, Colorectal Cancer
- Being tested
- Mailed Reminders with Fecal Immunochemical Testing kits, Reminder letter only
- Keywords
- colorectal cancer screening, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed Reminders with Fecal Immunochemical Testing kitsOther
Reminder letter onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Other: Mailed Reminders with Fecal Immunochemical Testing kits |
| Comparison Group | Active comparator | 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 Receives: Other: Reminder letter only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 months following baseline
Diagnoses of colorectal Cancer
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
Measured: 21 months following baseline
Polypectomies
Number of polypectomies will be assessed through Medicaid claim data.
Measured: 21 months following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startOct 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Brenner, PhD, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176082
- Sponsor's protocol ID
- 16-0875
- Acronym
- MFIT
- Status last verified
- Dec 2018
- First submitted
- 5 May 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County
- ClinicalTrials.gov ID
- NCT03176082
- Acronym / sponsor ID
- MFIT / 16-0875
- Conditions
- Colorectal Cancer Screening, Colorectal Cancer
- Keywords
- colorectal cancer screening, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,144 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mailed Reminders with Fecal Immunochemical Testing kitsIntervention 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 |
| Comparison Group | Active comparator | Other: Reminder letter onlyComparison 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 |
Who may qualify
- Ages
- 52 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed Reminders with Fecal Immunochemical Testing kits | Other | Intervention Group |
| Reminder letter only | Other | Comparison Group |
Primary outcome
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
Time frame: 21 months following baseline
Screening status will be assessed through participant response and Medicaid claim data.
Diagnoses of colorectal Cancer
Time frame: 21 months following baseline
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
Polypectomies
Time frame: 21 months following baseline
Number of polypectomies will be assessed through Medicaid claim data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Brenner, PhD, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Mailed Reminders with Fecal Immunochemical Testing kits and Reminder letter only in people with Colorectal Cancer Screening and Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, • (time frame: 21 months following baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.