Back to resultsPatients Navigator for Organized Colorectal Cancer Screening (COLONAV)
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Navigator intervention
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Institut de cancérologie Lucien Neuwirth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention of navigators
No Intervention
Arm Description
Navigators accompany the target population towards OCCS.
Population is not accompanied by navigators
Outcomes
Primary Outcome Measures
Participation rates
Participation rates between intervention areas and control areas before/after intervention
Secondary Outcome Measures
Percentage of patients primary care peers take care of
Qualitative analysis
A questionnaire will be given to those contacted and some people will be interviewed
Full Information
NCT ID
NCT02369757
First Posted
December 5, 2014
Last Updated
February 26, 2016
Sponsor
Institut de Cancérologie de la Loire
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris, University of Lyon, Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT02369757
Brief Title
Patients Navigator for Organized Colorectal Cancer Screening
Acronym
COLONAV
Official Title
Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris, University of Lyon, Centre Georges Francois Leclerc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40774 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention of navigators
Arm Type
Experimental
Arm Description
Navigators accompany the target population towards OCCS.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Population is not accompanied by navigators
Intervention Type
Behavioral
Intervention Name(s)
Navigator intervention
Intervention Description
peers sharing common characteristics with the target population whose mission is to accompany towards OCCS
Primary Outcome Measure Information:
Title
Participation rates
Description
Participation rates between intervention areas and control areas before/after intervention
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percentage of patients primary care peers take care of
Time Frame
24 months
Title
Qualitative analysis
Description
A questionnaire will be given to those contacted and some people will be interviewed
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Chauvin, PhDMD
Organizational Affiliation
Institut de Cancérologie Lucien Neuwirth
Official's Role
Study Chair
Facility Information:
Facility Name
Institut de cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27388807
Citation
Allary C, Bourmaud A, Tinquaut F, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Benoist Y, Rousseau S, Regnier V, Buthion V, Chauvin F. ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol. BMC Cancer. 2016 Jul 7;16:416. doi: 10.1186/s12885-016-2469-9.
Results Reference
derived
Learn more about this trial
Patients Navigator for Organized Colorectal Cancer Screening
We'll reach out to this number within 24 hrs