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OpenTrials
Completed

NCT Number: NCT01629004

Increasing Uptake of Colorectal Cancer Screening in Ontario

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.

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Key information

Conditions

Colorectal Disorders Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook HSC

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FOBT kit

Other

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

Other names: Mailed FOBT kit

Mailed invitation

Other

Mailed CRC screening invitation alone on behalf of family physician.

Other names: Mailed invitation alone

Primary outcomes

  1. Uptake of appropriate CRC screening

    Time frame: 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 outcomes

  1. Uptake of lower gastrointestinal investigations

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2012
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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