Text Size

Study of Patient Navigation to Reduce Social Inequalities (PRADO)

This study is currently recruiting participants.
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01555450
First received: March 13, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Colorectal Cancer Screening
 Other: Patient Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Screening
Official Title: The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Completion of colorectal cancer screening [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Reduction of social inequalities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Estimation of Cost effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation


Estimated Enrollment: 14670
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555450

Locations
France
The french screening organization Recruiting
Amiens, Region of Picardie, France, 80048
Contact: Helene Delattre-Massy, MD         adema.80@wanadoo.fr    
The french screening organization Recruiting
Compiegne, Region of Picardie, France, 60312
Contact: Chantal DeSeze, MD         adcaso.60@orange.fr    
The french screening organization Recruiting
Laon, Region of Picardie, France, 02000
Contact: Jérome Peng, MD         jpeng-aisne.preventis@wanadoo.fr    
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
National Cancer Institute, France
Investigators
Study Director: Guy Launoy, Pr CHU CAEN / INSERM
  More Information

Publications:

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01555450     History of Changes
Other Study ID Numbers: R10051EE
Study First Received: March 13, 2012
Last Updated: March 20, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013