Increasing Uptake of Colorectal Cancer Screening in Ontario

December 19, 2014 updated by: Sunnybrook Health Sciences Centre
The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook HSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recipients of a mailed CRC screening invitation through the CCO Invitation Pilot project
  • No OHIP record of completion of FOBT since initial mailing (Non-responders arm only)
  • No OHIP of 'CRC Cancer Screening Exclusion' tracking code since initial mailing (Non-responders arm only)
  • An OHIP record of completion of FOBT 6 months since initial mailing (Recall arm only)
  • Negative result according to LRT or if not in LRT, no record of interval colonoscopy in CIRT or OHIP (Recall arm only)

Exclusion Criteria:

  • Age greater than 74 years at time of mailing
  • Interval diagnosis of colorectal cancer
  • Interval colonoscopy or flexible sigmoidoscopy
  • Interval departure from Pilot physician's practice
  • Death
  • Presently institutionalized
  • Physician has declined participation in the study
  • Interval record of repeat FOBT (Recall arm only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non-responders

Non-responders to an initial mailed CRC screening invitation from their family physician.

FOBT kit. Mailed invitation.
Other: FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Other Names:
  • Mailed FOBT kit
Other: Mailed invitation
Mailed CRC screening invitation alone on behalf of family physician.
Other Names:
  • Mailed invitation alone
Other: Recall patients

Those who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients).

FOBT kit. Mailed invitation.
Other: FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Other Names:
  • Mailed FOBT kit
Other: Mailed invitation
Mailed CRC screening invitation alone on behalf of family physician.
Other Names:
  • Mailed invitation alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of appropriate CRC screening
Time Frame: Within 6 months of the mailing
The primary outcome will be the uptake of appropriate screening (FOBT testing or if there is a positive family history, of colonoscopy) within 6 months of the mailing as determined by from OHIP and CCO data.
Within 6 months of the mailing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of lower gastrointestinal investigations
Time Frame: Within 12 months of the mailing
The secondary outcome will be the uptake of lower gastrointestinal investigations (colonoscopy for an indication other than family history or colonoscopy done outside of CIRT, flexible sigmoidoscopy, barium enema) within 12 months, respectively, of the mailing as determined by the administrative data (CIRT, OHIP procedure or radiology code).
Within 12 months of the mailing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Jill Tinmouth, MD, Sunnybrook HSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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