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Innovative Tools to Improve Colorectal Cancer Screening Rates in Manitoba

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CancerCare Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01026753
First received: December 2, 2009
Last updated: March 14, 2011
Last verified: March 2011
History of Changes
  Purpose

The primary purpose of the study is to investigate the efficacy and effectiveness of a community-based nurse managed telephone support line (Provincial Health Contact Center; PHCC) and Colorectal Cancer Information and Screening Website in supporting Primary Care Providers (PCP) from Winnipeg, Manitoba (Canada) in their efforts to improve colorectal cancer (CRC) screening Fecal Occult Blood Test (FOBT) compliance in average risk men and women 50-74 years of age. Secondary outcomes of the study involve documenting and investigating common patient questions and comments about CRC and the FOBT during their PHCC communication(s)/Website visits as well as procuring feedback from PCP and patients related to their experiences with the study protocol (PCP), FOBT (patients) and PHCC/website (patients).


Condition Intervention
Colorectal Cancer
 Behavioral: Refrigerator Magnet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Innovative Tools to Improve Colorectal Cancer Screening Rates in Manitoba

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Fecal Occult Blood Test (FOBT) completion rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The most common patient questions and comments about colorectal cancer, screening, and the fecal occult blood test during the intervention(s). A patient and primary care provider survey. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: August 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: FOBT by laboratory requisition or directly by PCP
The family physician indicates fecal occult blood test on the patient's laboratory requisition (i.e. the patient receives the fecal occult blood test at the lab) or provides the patient with an FOBT kit.
Experimental: FOBT by lab req. or directly from PCP + study magnet
The family physician indicates fecal occult blood test on the patient's laboratory requisition (i.e. the patient receives the fecal occult blood test at the lab) or provides the patient with an FOBT kit. The family physician provides each patient with a study magnet containing a PHCC telephone number and study specific website address.
 Behavioral: Refrigerator Magnet
The refrigerator magnet contains a telephone number for a Provincial Health Contact Centre and a URL for a colorectal cancer Website that patients can access to learn more about colorectal cancer, screening and the fecal occult blood test. Patients can also have their questions answered.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Average risk men and women
  • between the ages of 50 to 74 years
  • no symptoms of colorectal cancer
  • no personal history of colorectal cancer, polyps or diseases of the colon requiring monitoring by colonoscopy
  • includes individuals with one first degree relative with cancer of adenomatous polyps affected at age greater than 60 or two or more second degree relatives with polyps or cancer

Exclusion Criteria:

  • walk-in patients
  • patients having had a flexible sigmoidoscopy or double contrast barium enema within the last 5 years
  • patients having had a colonoscopy within the last 10 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026753

Contacts
Contact: Kathleen M Clouston, Ph.D. 204-272-3086 kclousto@cc.umanitoba.ca
Contact: Alan Katz, MBChB, CCFP, MSc 204-789-3442 katz@cc.umanitoba.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0W3
Contact: Kathleen M Clouston, Ph.D.     204-272-3086     kclousto@cc.umanitoba.ca    
Contact: Alan Katz, MBChB, CCFP, MSc     204-789-3442     katz@cc.umanitoba.ca    
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
CancerCare Manitoba
Investigators
Principal Investigator: Alan Katz, MBChB, CCFP, MSc University of Manitoba
Study Director: Kathleen M Clouston, Ph.D. University of Manitoba
  More Information

No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Alan Katz, University of Manitoba
ClinicalTrials.gov Identifier: NCT01026753     History of Changes
Other Study ID Numbers: H2009:312
Study First Received: December 2, 2009
Last Updated: March 14, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
colorectal cancer
screening
fecal occult blood test
randomized control trial
 primary care oncology
web site
provincial health contact center

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013