Study of Patient Navigation to Reduce Social Inequalities

NCT ID: NCT01555450

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28929 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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With Patient Navigator

People in this arm receive the Intervention of a Patient Navigator

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type OTHER

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.

Control - Without Patient Navigator

People in this arm receive just the usual care of colorectal cancer screening

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient Navigation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Launoy, Pr

Role: STUDY_DIRECTOR

CHU CAEN / INSERM

Locations

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The french screening organization

Amiens, Region of Picardie, France

Site Status

The french screening organization

Compiègne, Region of Picardie, France

Site Status

The french screening organization

Laon, Region of Picardie, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21256688 (View on PubMed)

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.

Reference Type RESULT
PMID: 29909873 (View on PubMed)

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.

Reference Type RESULT
PMID: 28823681 (View on PubMed)

Other Identifiers

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R10051EE

Identifier Type: -

Identifier Source: org_study_id

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