NCT01555450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28,929

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 4, 2025

Status Verified

March 1, 2012

Enrollment Period

2.7 years

First QC Date

March 13, 2012

Last Update Submit

November 26, 2025

Conditions

Colorectal Cancer Screening

Keywords

Colorectal cancer screeningSocial inequalitiesPatient Navigator

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Estimation of Cost effectiveness

    2 years

  • Evaluation of psychological mechanisms

    2 years

Study Arms (2)

With Patient Navigator

EXPERIMENTAL

People in this arm receive the Intervention of a Patient Navigator

Other: Patient Navigation

Control - Without Patient Navigator

NO INTERVENTION

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

Interventions

Patient NavigationOTHER

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.

With Patient Navigator

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The french screening organization

Amiens, Region of Picardie, 80048, France

Location

The french screening organization

Compiègne, Region of Picardie, 60312, France

Location

The french screening organization

Laon, Region of Picardie, 02000, France

Location

Related Publications (3)

  • 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.

    PMID: 21256688BACKGROUND

  • 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.

    PMID: 29909873RESULT

  • 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.

    PMID: 28823681RESULT

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Guy Launoy, Pr

    CHU CAEN / INSERM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 15, 2012

Study Start

March 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 4, 2025

Record last verified: 2012-03

Locations

FR(3)