Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

This study is currently recruiting participants.

Verified January 2012 by Cancer Care Ontario

Sponsor:

Collaborator:

Canadian Institutes of Health Research (CIHR)

Information provided by (Responsible Party):

Paul Ritvo, Ph.D., Cancer Care Ontario

ClinicalTrials.gov Identifier:

NCT01506687

First received: June 27, 2011

Last updated: January 9, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2011

Last Updated Date

January 9, 2012

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks [ Time Frame: 48 weeks after baseline assessment ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01506687 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Behavioral: Health counselling by nurse navigator
Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral

Other Name: Nurse navigator assistance
Behavioral: Usual primary care counselling
Usual care health counselling on colorectal cancer and screening options

Other Name: Usual primary care

Study Arm (s)

Experimental: Navigator intervention
Intervention: Behavioral: Health counselling by nurse navigator
Active Comparator: Usual Care Control
Usual care

Intervention: Behavioral: Usual primary care counselling

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

750

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 74 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Brian Mitchell, MD

7057595561

Bmitchell@grouphealth.org

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01506687

Other Study ID Numbers ^ICMJE

10-163

Has Data Monitoring Committee

Responsible Party

Paul Ritvo, Ph.D., Cancer Care Ontario

Study Sponsor ^ICMJE

Cancer Care Ontario

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

Principal Investigator:

Paul Ritvo, PHD

Cancer Care Ontario

Information Provided By

Cancer Care Ontario

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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