NCT01026753

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,395

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

December 2, 2009

Last Update Submit

June 7, 2013

Conditions

Keywords

colorectal cancerscreeningfecal occult blood testrandomized control trialprimary care oncologyweb siteprovincial health contact center

Outcome Measures

Primary Outcomes (1)

  • Fecal Occult Blood Test (FOBT) completion rate

    4 months

Secondary Outcomes (1)

  • 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.

    1 year

Study Arms (2)

FOBT by laboratory requisition or directly by PCP

NO INTERVENTION

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.

FOBT by lab req. or directly from PCP + study magnet

EXPERIMENTAL

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

Interventions

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.

FOBT by lab req. or directly from PCP + study magnet

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

Location

Related Publications (2)

  • Clouston K, Katz A, Martens PJ, Sisler J, Turner D, Lobchuk M, McClement S, Crow G; CIHR/CCMB Team in Primary Care Oncology (PCO-NET). Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial. BMC Cancer. 2014 Apr 16;14:263. doi: 10.1186/1471-2407-14-263.

  • Clouston K, Katz A, Martens PJ, Sisler J, Turner D, Lobchuk M, McClement S; CIHR/CCMB Team in Primary Care Oncology (PCO-NET). Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: A pragmatic cluster randomized controlled trial study protocol. BMC Cancer. 2012 May 17;12:182. doi: 10.1186/1471-2407-12-182.

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Alan Katz, MBChB, CCFP, MSc

    University of Manitoba

    PRINCIPAL INVESTIGATOR
  • Kathleen M Clouston, Ph.D.

    University of Manitoba

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Family Medicine Research

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 4, 2009

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations