Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

NCT01754896 | Completed

• 1 other identifier: 209-2011
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Prior to implementation of new colorectal cancer (CRC) screening technology (fecal immunochemical test - 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 ColonCancerCheck (CCC) Program would be required. 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; fecal immunochemical test; fecal occult blood test; screening

Outcome Measures

Primary Outcomes (1)

• FIT Kit uptake

  Comparing FIT kit uptake by patients invited to complete fecal occult blood screening for colorectal cancer using a Fecal Immunochemical Test (FIT), and provided with different kit distribution and return methods.

  September 2012 to April 2013

Secondary Outcomes (1)

• Rejection rates

  September 2012 to April 2013

Study Arms (4)

Mail-out/Mail-back

EXPERIMENTAL

Mailing of FIT kit directly to patient. Mailing completed kits in for processing.

Other: mailing of FIT kit directly to patient; Other: mailing completed kits in for processing

Mail-out/Drop-off

EXPERIMENTAL

Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing.

Other: mailing of FIT kit directly to patient; Other: dropping completed kits at lab for processing

Pick-up/Mail-back

EXPERIMENTAL

Mailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing.

Other: mailed invitation to pick up lab requisition and then kit; Other: mailing completed kits in for processing

Pick-up/Drop-off

EXPERIMENTAL

Mailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing.

Other: mailed invitation to pick up lab requisition and then kit; Other: dropping completed kits at lab for processing

Interventions

mailing of FIT kit directly to patient OTHER

Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.

Mail-out/Drop-off; Mail-out/Mail-back

mailed invitation to pick up lab requisition and then kit OTHER

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.

Pick-up/Drop-off; Pick-up/Mail-back

mailing completed kits in for processing OTHER

Patients mails completed kit in for processing using postage-paid reply envelope provided.

Mail-out/Mail-back; Pick-up/Mail-back

dropping completed kits at lab for processing OTHER

Patient takes completed FIT in to lab patient service centre for processing.

Mail-out/Drop-off; Pick-up/Drop-off

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician in Ontario with a patient enrollment model
• patient: 50-74, Ontario resident, enrolled with physician

You may not qualify if:

• patient: no personal or first degree relative family history of CRC, no FOBT within prior 5 years, colonoscopy within past 10 years, FOBT within past 2 years

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Cancer Care Ontario: collaborator

Study Sites (1)

Dr. Jill Tinmouth

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jill Tinmouth, MD, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

• Linda Rabeneck, MD, MPH

  Cancer Care Ontario

  PRINCIPAL INVESTIGATOR

• Lawrence Paszat, MD, SM

  Institute for Clinical Evaluative Studies (ICES)

  PRINCIPAL INVESTIGATOR

• Nancy Baxter, MD, PhD

  St. Michaels Hospital

  PRINCIPAL INVESTIGATOR

• Edward Randall, PhD, DCC

  Eastern Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

CA (1)