Back to resultsIncreasing Uptake of Colorectal Cancer Screening in Ontario
Primary Purpose
Colorectal Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FOBT kit
Mailed invitation
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Disorders focused on measuring colorectal cancer, screening, fecal occult blood testing, mailed invitation
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)
Sites / Locations
- Sunnybrook HSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Non-responders
Recall patients
Arm Description
Non-responders to an initial mailed CRC screening invitation from their family physician. FOBT kit. Mailed invitation.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01629004
First Posted
June 25, 2012
Last Updated
December 19, 2014
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01629004
Brief Title
Increasing Uptake of Colorectal Cancer Screening in Ontario
Official Title
Increasing Uptake of Colorectal Cancer Screening in Ontario
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Disorders
Keywords
colorectal cancer, screening, fecal occult blood testing, mailed invitation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-responders
Arm Type
Other
Arm Description
Non-responders to an initial mailed CRC screening invitation from their family physician.
FOBT kit. Mailed invitation.
Arm Title
Recall patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FOBT kit
Other Intervention Name(s)
Mailed FOBT kit
Intervention Description
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Intervention Type
Other
Intervention Name(s)
Mailed invitation
Other Intervention Name(s)
Mailed invitation alone
Intervention Description
Mailed CRC screening invitation alone on behalf of family physician.
Primary Outcome Measure Information:
Title
Uptake of appropriate CRC screening
Description
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.
Time Frame
Within 6 months of the mailing
Secondary Outcome Measure Information:
Title
Uptake of lower gastrointestinal investigations
Description
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).
Time Frame
Within 12 months of the mailing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Tinmouth, MD
Organizational Affiliation
Sunnybrook HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook HSC
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25195923
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.
Results Reference
derived
Learn more about this trial
Increasing Uptake of Colorectal Cancer Screening in Ontario
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