Overview

This trial is active, not recruiting.

Condition colorectal disorders
Treatments fobt kit, mailed invitation
Sponsor Sunnybrook Health Sciences Centre
Start date April 2011
End date December 2012
Trial size 5155 participants
Trial identifier NCT01629004, OICR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose screening
Arm
(Other)
Non-responders to an initial mailed CRC screening invitation from their family physician
fobt kit Mailed FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
mailed invitation Mailed invitation alone
Mailed CRC screening invitation alone on behalf of family physician.
(Other)
Those who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients).
fobt kit Mailed FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
mailed invitation Mailed invitation alone
Mailed CRC screening invitation alone on behalf of family physician.

Primary Outcomes

Measure
Uptake of appropriate CRC screening
time frame: Within 6 months of the mailing

Secondary Outcomes

Measure
Uptake of lower gastrointestinal investigations
time frame: Within 12 months of the mailing

Eligibility Criteria

Male or female participants from 50 years up to 74 years old.

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)

Additional Information

Official title Increasing Uptake of Colorectal Cancer Screening in Ontario
Principal investigator Jill Tinmouth, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre.