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Increasing Uptake of Colorectal Cancer Screening in Ontario

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jill Tinmouth, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01629004
First received: June 25, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Disorders
 Other: FOBT kit
Other: Mailed invitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Increasing Uptake of Colorectal Cancer Screening in Ontario

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Uptake of appropriate CRC screening [ Time Frame: Within 6 months of the mailing ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Uptake of lower gastrointestinal investigations [ Time Frame: Within 12 months of the mailing ] [ Designated as safety issue: No ]
    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).


Enrollment: 5155
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non-responders
Non-responders to an initial mailed CRC screening invitation from their family physician
 Other: FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Other Name: Mailed FOBT kit
Other: Mailed invitation
Mailed CRC screening invitation alone on behalf of family physician.
Other Name: Mailed invitation alone
Recall patients
Those who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients).
 Other: FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Other Name: Mailed FOBT kit
Other: Mailed invitation
Mailed CRC screening invitation alone on behalf of family physician.
Other Name: Mailed invitation alone

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629004

Locations
Canada, Ontario
Sunnybrook HSC
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Jill Tinmouth, MD Sunnybrook HSC
  More Information

No publications provided

Responsible Party: Jill Tinmouth, MD, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01629004     History of Changes
Other Study ID Numbers: OICR
Study First Received: June 25, 2012
Last Updated: November 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
colorectal cancer
screening
fecal occult blood testing
mailed invitation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013