Increasing Uptake of Colorectal Cancer Screening in Ontario

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01629004
Collaborator
(none)
5,155
1
2
32
160.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: FOBT kit
  • Other: Mailed invitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5155 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
Increasing Uptake of Colorectal Cancer Screening in Ontario
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Uptake of appropriate CRC screening [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.

    Secondary Outcome Measures

    1. Uptake of lower gastrointestinal investigations [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sunnybrook HSC Toronto Ontario Canada

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Jill Tinmouth, MD, Sunnybrook HSC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT01629004
    Other Study ID Numbers:
    • 308-2010
    First Posted:
    Jun 27, 2012
    Last Update Posted:
    Dec 23, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Sunnybrook Health Sciences Centre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 23, 2014