Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-01 @ 6:10 AM
Study NCT ID:
NCT01555450
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2012-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Patient Navigation to Reduce Social Inequalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28929}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2012-03-13', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of colorectal cancer screening', 'timeFrame': '2 years'}, {'measure': 'Reduction of social inequalities', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Estimation of Cost effectiveness', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Evaluation of psychological mechanisms', 'timeFrame': '2 years', 'description': 'Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal cancer screening', 'Social inequalities', 'Patient Navigator'], 'conditions': ['Colorectal Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '21256688', 'type': 'BACKGROUND', 'citation': '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': '29909873', 'type': 'RESULT', 'citation': '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': '28823681', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insured people invited to the national french colorectal screening program are from 50 to 74 years old.\n* We select people who never do the screening test or are not compliant with it\n* Among these people we select those living in the randomized geographical areas.\n\nExclusion Criteria:\n\n* people who have already done the screening test at the two previous campaigns.\n* 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.\n* people with other severe disease or in incapacity to realize the screening test\n* people who have another exclusion criteria to realize the screening test.'}, 'identificationModule': {'nctId': 'NCT01555450', 'acronym': 'PRADO', 'briefTitle': 'Study of Patient Navigation to Reduce Social Inequalities', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health', 'orgStudyIdInfo': {'id': 'R10051EE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With Patient Navigator', 'description': 'People in this arm receive the Intervention of a Patient Navigator', 'interventionNames': ['Other: Patient Navigation']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Without Patient Navigator', 'description': 'People in this arm receive just the usual care of colorectal cancer screening'}], 'interventions': [{'name': 'Patient Navigation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['With Patient Navigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80048', 'city': 'Amiens', 'state': 'Region of Picardie', 'country': 'France', 'facility': 'The french screening organization', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '60312', 'city': 'Compiègne', 'state': 'Region of Picardie', 'country': 'France', 'facility': 'The french screening organization', 'geoPoint': {'lat': 49.41794, 'lon': 2.82606}}, {'zip': '02000', 'city': 'Laon', 'state': 'Region of Picardie', 'country': 'France', 'facility': 'The french screening organization', 'geoPoint': {'lat': 49.5631, 'lon': 3.62714}}], 'overallOfficials': [{'name': 'Guy Launoy, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU CAEN / INSERM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}