Increasing Uptake of Colorectal Cancer Screening in Ontario

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01629004

Enrollment

5155

Registered

2012-06-27

Start date

2011-04-30

Completion date

2013-12-31

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders

Keywords

colorectal cancer, screening, fecal occult blood testing, mailed invitation

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.

Interventions

OTHERFOBT kit

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

OTHERMailed invitation

Mailed CRC screening invitation alone on behalf of family physician.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 74 Years

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 * Death * Presently institutionalized * Physician has declined participation in the study * Interval record of repeat FOBT (Recall arm only)

Design outcomes

Primary

Measure	Time frame	Description
Uptake of appropriate CRC screening	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

Measure	Time frame	Description
Uptake of lower gastrointestinal investigations	Within 12 months of the mailing	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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026