Clinical trial NCT01555450: Study of Patient Navigation to Reduce Social Inequalities
Official title: The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colorectal cancer screening
Social inequalities
Patient Navigator
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: National Cancer Institute, France
First posted: 2012-03-15
Enrollment: 28929
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Completion of colorectal cancer screening
timeFrame: 2 years
measure: Reduction of social inequalities
timeFrame: 2 years
Secondary outcomes:
measure: Estimation of Cost effectiveness
timeFrame: 2 years
measure: Evaluation of psychological mechanisms
timeFrame: 2 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: The french screening organization
state: Region of Picardie
city: Compiegne
country: France
facility: The french screening organization
state: Region of Picardie
city: Laon
country: France
facility: The french screening organization
state: Region of Picardie
Study officials:
affiliation: CHU CAEN / INSERM
name: Guy Launoy, Pr
role: STUDY_DIRECTOR
References:
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.
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.
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.