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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.
 
ClinicalTrials.gov Identifier: NCT01555450
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 24, 2015
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date February 24, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • Completion of colorectal cancer screening [ Time Frame: 2 years ]
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Completion of colorectal cancer screening [ Time Frame: 2 years ]
  • Reduction of social inequalities [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • 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.
  • Evaluation of psychological mechanisms [ Time Frame: 2 years ]
    Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Estimation of Cost effectiveness [ Time Frame: 2 years ]
  • Evaluation of psychological mechanisms [ Time Frame: 2 years ]
    Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Patient Navigation to Reduce Social Inequalities
Official Title  ICMJE The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer Screening
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: With Patient Navigator
    People in this arm receive the Intervention of a Patient Navigator
    Intervention: Other: Patient Navigation
  • No Intervention: Control - Without Patient Navigator
    People in this arm receive just the usual care of colorectal cancer screening
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2015)
28929
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
14670
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01555450
Other Study ID Numbers  ICMJE R10051EE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE National Cancer Institute, France
Investigators  ICMJE
Study Director: Guy Launoy, Pr CHU CAEN / INSERM
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP