Study of Patient Navigation to Reduce Social Inequalities

Study Overview
=================
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.

Official Title
-----------------
The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health

Conditions
-----------------
Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Other: Patient Navigation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With Patient Navigator<br>People in this arm receive the Intervention of a Patient Navigator | Other: Patient Navigation<br>* 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.<br>|
| No Intervention: Control - Without Patient Navigator<br>People in this arm receive just the usual care of colorectal cancer screening | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of colorectal cancer screening |  | 2 years | 
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 
| Evaluation of psychological mechanisms | Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer screening, Social inequalities, Patient Navigator