Increasing Uptake of Colorectal Cancer Screening in Ontario

Colorectal Disorders Clinical Trial

Official title:

Increasing Uptake of Colorectal Cancer Screening in Ontario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629004
• Other study ID #: 308-2010
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: December 19, 2014
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5155
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Disorders
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook HSC	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No