Clinical trial NCT01629004: Increasing Uptake of Colorectal Cancer Screening in Ontario
Official title: Increasing Uptake of Colorectal Cancer Screening in Ontario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Keywords: colorectal cancer
screening
fecal occult blood testing
mailed invitation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 5155
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.


Eligibility 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)

Primary outcomes:
measure: Uptake of appropriate CRC screening
timeFrame: Within 6 months of the mailing
Secondary outcomes:
measure: Uptake of lower gastrointestinal investigations
timeFrame: Within 12 months of the mailing
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook HSC
state: Ontario
Study officials:
affiliation: Sunnybrook HSC
name: Jill Tinmouth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tinmouth J, Patel J, Austin PC, Baxter NN, Brouwers MC, Earle C, Levitt C, Lu Y, Mackinnon M, Paszat L, Rabeneck L. Increasing participation in colorectal cancer screening: results from a cluster randomized trial of directly mailed gFOBT kits to previous nonresponders. Int J Cancer. 2015 Mar 15;136(6):E697-703. doi: 10.1002/ijc.29191. Epub 2014 Sep 23.