Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Cancer Care Ontario

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Behavioral: Health counselling by nurse navigator; Behavioral: Usual primary care counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01506687

10-163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Navigator intervention

Experimental group

Treatment:

Behavioral: Health counselling by nurse navigator

Usual Care Control

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual primary care counselling