Patients Navigator for Organized Colorectal Cancer Screening (COLONAV)

February 26, 2016 updated by: Institut de Cancérologie de la Loire

Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population

The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40774

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Priest-en-Jarez, France, 42270
        • institut de cancérologie Lucien Neuwirth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • person living in the IRIS intervention zones
  • person invited by the local management structure to participate in colorectal cancer screening

Exclusion Criteria:

  • person not living in the IRIS intervention zone
  • person not invited by the local management structure to participate to colorectal cancer screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention of navigators
Navigators accompany the target population towards OCCS.
Behavioral: Navigator intervention
peers sharing common characteristics with the target population whose mission is to accompany towards OCCS
No Intervention: No Intervention
Population is not accompanied by navigators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rates
Time Frame: 24 months
Participation rates between intervention areas and control areas before/after intervention
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients primary care peers take care of
Time Frame: 24 months
24 months
Qualitative analysis
Time Frame: 1 hour
A questionnaire will be given to those contacted and some people will be interviewed
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Collaborators

Gustave Roussy, Cancer Campus, Grand Paris
Centre Georges Francois Leclerc
University of Lyon

Investigators

  • Study Chair: Franck Chauvin, PhDMD, institut de cancérologie Lucien Neuwirth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-04 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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