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Clinical Trials/NCT01629004
NCT01629004CompletedNot Applicable

Increasing Uptake of Colorectal Cancer Screening in Ontario

Sunnybrook Health Sciences Centre1 site in 1 country5,155 target enrollmentStarted: April 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
5,155
Locations
1
Primary Endpoint
Uptake of appropriate CRC screening

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to 74 Years (Adult, Older Adult)
Sex
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
  • Presently institutionalized
  • Physician has declined participation in the study
  • Interval record of repeat FOBT (Recall arm only)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Uptake of lower gastrointestinal investigations(Within 12 months of the mailing)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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