Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Study Overview
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Brief Summary
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Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual. A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the Patient Navigator intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Health counselling by nurse navigator
* Behavioral: Usual primary care counselling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigator intervention<br> | Behavioral: Health counselling by nurse navigator<br>* Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral<br>* Other names: Nurse navigator assistance;|
| Active Comparator: Usual Care Control<br>Usual care | Behavioral: Usual primary care counselling<br>* Usual care health counselling on colorectal cancer and screening options<br>* Other names: Usual primary care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks | Completion of verified CRC screening events in experimental vs. control patients | 48 weeks after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening preferences; predictors of CRC screening and screening preference. |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer screening, 50 years or older