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Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Phase 3
50 Years
74 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Primary Outcome Measure:

Number of patients who receive a letter and patient navigation services and get screened
compared to the control group.

Secondary Outcome Measures:

Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and
screening preference.

Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary
care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be
screened for eligibility and those who are eligible and agree to participate in the study
will be randomized to either of the two study arms: intervention group or control group.

Inclusion Criteria:

- Average risk men and women aged 50 - 74

- Unscreened - Defined as no prior CRC screening

- Under-screened - Defined as no FOBT screening within the last two years

- No colonoscopy or barium enema screening within the last five years

- Willing to provide consent to participate in the study.

Exclusion Criteria:

- FOBT within the last two years

- colonoscopy within five years

- barium enema within five years

- flexible sigmoidoscopy within five years

- Bowel cancer.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks

Outcome Description:

Completion of verified CRC screening events in experimental vs. control patients

Outcome Time Frame:

48 weeks after baseline assessment

Safety Issue:


Principal Investigator

Paul Ritvo, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Care Ontario


Canada: Canadian Institutes of Health Research

Study ID:




Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer screening
  • 50 years or older
  • Colorectal Neoplasms