Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
NCT ID: NCT01754896
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-04-30
2013-04-30
Brief Summary
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This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a field assessment to evaluate the effect of different distribution and return methods and pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18 months to complete, with patients being recruited through family physicians in patient enrollment model (PEM) family practices across the province of Ontario.
This Clinical Trials registration relates to Phase 2 of the study.
Detailed Description
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Currently, Ontario's CCC Program utilizes guaiac fecal occult blood testing (gFOBT) in persons at average risk of CRC. However, the program is currently considering a change to fecal immunochemical testing (FIT).
FIT, which comes in quantitative and qualitative formats, is superior to the gFOBT from a scientific perspective because it specifically detects human hemoglobin. gFOBT uses an indirect detection which depends on a peroxidase reaction not specific for human hemoglobin. FIT methodology is also both more convenient and superior from a participant perspective and multiple studies have demonstrated higher participation rates and improved detection of CRC precursors as well as invasive CRCs with FIT compared to gFOBT.
Organized CRC screening programs considering quantitative FIT face certain additional challenges, including uncertain stability over time and tolerance to variation in temperature following sample collection and prior to arrival in a testing laboratory. Prior to implementation of FIT in Ontario, there is a need for a laboratory and field assessment to validate and optimize its use in the Ontario climate and conditions (e.g., large geographic area) and to determine whether adjustments to the current structure of the CCC Program would be required.
This study consists of 2 phases. Phase 1, laboratory testing, assesses 2 quantitative and 3 qualitative FIT kits to evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a field assessment to evaluate the effect of different distribution and return methods and pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18 months to complete, with patients being recruited through family physicians in patient enrollment model (PEM) family practices across the province of Ontario. Data collection will take place for 6 months, starting on the day that screening kits and/or invitation letters are mailed to patients.
This Clinical Trials registration relates to Phase 2 of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Mail-out/Mail-back
Mailing of FIT kit directly to patient. Mailing completed kits in for processing.
mailing of FIT kit directly to patient
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
mailing completed kits in for processing
Patients mails completed kit in for processing using postage-paid reply envelope provided.
Mail-out/Drop-off
Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing.
mailing of FIT kit directly to patient
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
dropping completed kits at lab for processing
Patient takes completed FIT in to lab patient service centre for processing.
Pick-up/Mail-back
Mailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing.
mailed invitation to pick up lab requisition and then kit
Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.
mailing completed kits in for processing
Patients mails completed kit in for processing using postage-paid reply envelope provided.
Pick-up/Drop-off
Mailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing.
mailed invitation to pick up lab requisition and then kit
Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.
dropping completed kits at lab for processing
Patient takes completed FIT in to lab patient service centre for processing.
Interventions
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mailing of FIT kit directly to patient
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
mailed invitation to pick up lab requisition and then kit
Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.
mailing completed kits in for processing
Patients mails completed kit in for processing using postage-paid reply envelope provided.
dropping completed kits at lab for processing
Patient takes completed FIT in to lab patient service centre for processing.
Eligibility Criteria
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Inclusion Criteria
* patient: 50-74, Ontario resident, enrolled with physician
Exclusion Criteria
50 Years
74 Years
ALL
Yes
Sponsors
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Cancer Care Ontario
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Jill Tinmouth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Research Institute
Linda Rabeneck, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Cancer Care Ontario
Lawrence Paszat, MD, SM
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical Evaluative Studies (ICES)
Nancy Baxter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Michaels Hospital
Edward Randall, PhD, DCC
Role: PRINCIPAL_INVESTIGATOR
Eastern Health
Locations
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Dr. Jill Tinmouth
Toronto, Ontario, Canada
Countries
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Other Identifiers
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209-2011
Identifier Type: -
Identifier Source: org_study_id