Study of Patient Navigation to Reduce Social Inequalities

Colorectal Cancer Screening Clinical Trial

— PRADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555450
• Other study ID #: R10051EE
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: February 23, 2015
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28929
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	The french screening organization	Amiens	Region of Picardie
France	The french screening organization	Compiegne	Region of Picardie
France	The french screening organization	Laon	Region of Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	National Cancer Institute, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of colorectal cancer screening		2 years	No
Primary	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	No
Secondary	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	No
Secondary	Evaluation of psychological mechanisms	Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation	2 years	No