Increasing Uptake of Colorectal Cancer Screening in Ontario

Study Overview
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Brief Summary
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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.

Official Title
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Increasing Uptake of Colorectal Cancer Screening in Ontario

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Other: FOBT kit
* Other: Mailed invitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-responders<br>Non-responders to an initial mailed CRC screening invitation from their family physician. FOBT kit. Mailed invitation. | Other: FOBT kit<br>* Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.<br>* Other names: Mailed FOBT kit;Other: Mailed invitation<br>* Mailed CRC screening invitation alone on behalf of family physician.<br>* Other names: Mailed invitation alone;|
| Other: Recall patients<br>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<br>* Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.<br>* Other names: Mailed FOBT kit;Other: Mailed invitation<br>* Mailed CRC screening invitation alone on behalf of family physician.<br>* Other names: Mailed invitation alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of appropriate CRC screening | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, screening, fecal occult blood testing, mailed invitation