Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Health counselling by nurse navigator; Behavioral: Usual primary care counselling

• Registration Number: NCT01506687
• Lead Sponsor: Cancer Care Ontario

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigator intervention	Health counselling by nurse navigator	-
Usual Care Control	Usual primary care counselling	Usual care

Primary Outcome Measures

Name	Time	Method
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks	48 weeks after baseline assessment	Completion of verified CRC screening events in experimental vs. control patients

Secondary Outcome Measures

Name	Time	Method
Screening preferences; predictors of CRC screening and screening preference.	48 weeks

Trial Locations

Locations (1)

Group Health Centre; 🇨🇦 Sault Ste. Marie, Ontario, Canada