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Study of Patient Navigation to Reduce Social Inequalities (PRADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555450
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 24, 2015
National Cancer Institute, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Other: Patient Navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28929 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Official Title: The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
Study Start Date : March 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: With Patient Navigator
People in this arm receive the Intervention of a Patient Navigator
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.

No Intervention: Control - Without Patient Navigator
People in this arm receive just the usual care of colorectal cancer screening

Primary Outcome Measures :
  1. Completion of colorectal cancer screening [ Time Frame: 2 years ]
  2. Reduction of social inequalities [ Time Frame: 2 years ]
    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.

Secondary Outcome Measures :
  1. Estimation of Cost effectiveness [ Time Frame: 2 years ]
    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. Evaluation of psychological mechanisms [ Time Frame: 2 years ]
    Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555450

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The french screening organization
Amiens, Region of Picardie, France, 80048
The french screening organization
Compiegne, Region of Picardie, France, 60312
The french screening organization
Laon, Region of Picardie, France, 02000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
National Cancer Institute, France
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Study Director: Guy Launoy, Pr CHU CAEN / INSERM

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01555450    
Other Study ID Numbers: R10051EE
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: March 2012
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Colorectal cancer screening
Social inequalities
Patient Navigator
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases