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Increasing Uptake of Colorectal Cancer Screening in Ontario

NCT ID: NCT01629004

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Colorectal Disorders

Keywords

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colorectal cancer screening fecal occult blood testing mailed invitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-responders

Non-responders to an initial mailed CRC screening invitation from their family physician.

FOBT kit. Mailed invitation.

Group Type OTHER

FOBT kit

Intervention Type OTHER

Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.

Mailed invitation

Intervention Type OTHER

Mailed CRC screening invitation alone on behalf of family physician.

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.

Group Type OTHER

FOBT kit

Intervention Type OTHER

Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.

Mailed invitation

Intervention Type OTHER

Mailed CRC screening invitation alone on behalf of family physician.

Interventions

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FOBT kit

Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.

Intervention Type OTHER

Mailed invitation

Mailed CRC screening invitation alone on behalf of family physician.

Intervention Type OTHER

Other Intervention Names

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Mailed FOBT kit Mailed invitation alone

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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Tinmouth, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook HSC

Locations

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Sunnybrook HSC

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 25195923 (View on PubMed)

Other Identifiers

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308-2010

Identifier Type: -

Identifier Source: org_study_id