Study of Patient Navigation to Reduce Social Inequalities (PRADO)
Primary Purpose
Colorectal Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by

About this trial
This is an interventional screening trial for Colorectal Cancer Screening focused on measuring Colorectal cancer screening, Social inequalities, Patient Navigator
Eligibility Criteria
Inclusion Criteria:
- Insured people invited to the national french colorectal screening program are from 50 to 74 years old.
- We select people who never do the screening test or are not compliant with it
- Among these people we select those living in the randomized geographical areas.
Exclusion Criteria:
- people who have already done the screening test at the two previous campaigns.
- people who have done a colonoscopy in the previous five years or people with a family history with colorectal cancer and people who are following outside of the screening program.
- people with other severe disease or in incapacity to realize the screening test
- people who have another exclusion criteria to realize the screening test.
Sites / Locations
- The french screening organization
- The french screening organization
- The french screening organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With Patient Navigator
Control - Without Patient Navigator
Arm Description
People in this arm receive the Intervention of a Patient Navigator
People in this arm receive just the usual care of colorectal cancer screening
Outcomes
Primary Outcome Measures
Completion of colorectal cancer screening
Reduction of social inequalities
The participation rate to the colorectal cancer screening will be compared between privileged and deprived geographical areas for which the socio-economic status is measured with the Townsend index.
Secondary Outcome Measures
Estimation of Cost effectiveness
We will assess the mean cost to navigate one person and compared it to a non navigate person. We will measure the cost effectiveness of the intervention in order to have the cost of the arising of 1% of the participation rate.
Evaluation of psychological mechanisms
Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation
Full Information
NCT ID
NCT01555450
First Posted
March 13, 2012
Last Updated
February 23, 2015
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
National Cancer Institute, France
1. Study Identification
Unique Protocol Identification Number
NCT01555450
Brief Title
Study of Patient Navigation to Reduce Social Inequalities
Acronym
PRADO
Official Title
The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
National Cancer Institute, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colorectal cancer screening, Social inequalities, Patient Navigator
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
28929 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Patient Navigator
Arm Type
Experimental
Arm Description
People in this arm receive the Intervention of a Patient Navigator
Arm Title
Control - Without Patient Navigator
Arm Type
No Intervention
Arm Description
People in this arm receive just the usual care of colorectal cancer screening
Intervention Type
Other
Intervention Name(s)
Patient Navigation
Intervention Description
Insured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach.
Primary Outcome Measure Information:
Title
Completion of colorectal cancer screening
Time Frame
2 years
Title
Reduction of social inequalities
Description
The participation rate to the colorectal cancer screening will be compared between privileged and deprived geographical areas for which the socio-economic status is measured with the Townsend index.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Estimation of Cost effectiveness
Description
We will assess the mean cost to navigate one person and compared it to a non navigate person. We will measure the cost effectiveness of the intervention in order to have the cost of the arising of 1% of the participation rate.
Time Frame
2 years
Title
Evaluation of psychological mechanisms
Description
Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Insured people invited to the national french colorectal screening program are from 50 to 74 years old.
We select people who never do the screening test or are not compliant with it
Among these people we select those living in the randomized geographical areas.
Exclusion Criteria:
people who have already done the screening test at the two previous campaigns.
people who have done a colonoscopy in the previous five years or people with a family history with colorectal cancer and people who are following outside of the screening program.
people with other severe disease or in incapacity to realize the screening test
people who have another exclusion criteria to realize the screening test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Launoy, Pr
Organizational Affiliation
CHU CAEN / INSERM
Official's Role
Study Director
Facility Information:
Facility Name
The french screening organization
City
Amiens
State/Province
Region of Picardie
ZIP/Postal Code
80048
Country
France
Facility Name
The french screening organization
City
Compiegne
State/Province
Region of Picardie
ZIP/Postal Code
60312
Country
France
Facility Name
The french screening organization
City
Laon
State/Province
Region of Picardie
ZIP/Postal Code
02000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
21256688
Citation
Dejardin O, Berchi C, Mignon A, Pornet C, Guillaume E, Guittet L, Bouvier V, Sailly M, Salinas A, Christophe V, Launoy G. [Social inequalities in health from observational studies to intervention: can the patient navigator reduce social inequalities in cancer patients?]. Rev Epidemiol Sante Publique. 2011 Feb;59(1):45-51. doi: 10.1016/j.respe.2010.10.008. Epub 2011 Jan 21. French.
Results Reference
background
PubMed Identifier
29909873
Citation
De Mil R, Guillaume E, Guittet L, Dejardin O, Bouvier V, Pornet C, Christophe V, Notari A, Delattre-Massy H, De Seze C, Peng J, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. Value Health. 2018 Jun;21(6):685-691. doi: 10.1016/j.jval.2017.09.020. Epub 2017 Nov 10.
Results Reference
derived
PubMed Identifier
28823681
Citation
Guillaume E, Dejardin O, Bouvier V, De Mil R, Berchi C, Pornet C, Christophe V, Notari A, Delattre Massy H, De Seze C, Peng J, Guittet L, Launoy G. Patient navigation to reduce social inequalities in colorectal cancer screening participation: A cluster randomized controlled trial. Prev Med. 2017 Oct;103:76-83. doi: 10.1016/j.ypmed.2017.08.012. Epub 2017 Aug 16.
Results Reference
derived
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Study of Patient Navigation to Reduce Social Inequalities
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