Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-07 @ 4:25 AM
Study NCT ID:
NCT02369757
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2014-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients Navigator for Organized Colorectal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40774}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-26', 'studyFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation rates', 'timeFrame': '24 months', 'description': 'Participation rates between intervention areas and control areas before/after intervention'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients primary care peers take care of', 'timeFrame': '24 months'}, {'measure': 'Qualitative analysis', 'timeFrame': '1 hour', 'description': 'A questionnaire will be given to those contacted and some people will be interviewed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36609248', 'type': 'DERIVED', 'citation': 'Bourmaud A, Benoist Y, Tinquaut F, Allary C, Ramone-Louis J, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Rousseau S, Dumas A, Amiel P, Regnier V, Buthion V, Chauvin F. Patient navigation for colorectal cancer screening in deprived areas: the COLONAV cluster randomized controlled trial. BMC Cancer. 2023 Jan 6;23(1):21. doi: 10.1186/s12885-022-10169-3.'}, {'pmid': '27388807', 'type': 'DERIVED', 'citation': 'Allary C, Bourmaud A, Tinquaut F, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Benoist Y, Rousseau S, Regnier V, Buthion V, Chauvin F. ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol. BMC Cancer. 2016 Jul 7;16:416. doi: 10.1186/s12885-016-2469-9.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* person living in the IRIS intervention zones\n* person invited by the local management structure to participate in colorectal cancer screening\n\nExclusion Criteria:\n\n* person not living in the IRIS intervention zone\n* person not invited by the local management structure to participate to colorectal cancer screening'}, 'identificationModule': {'nctId': 'NCT02369757', 'acronym': 'COLONAV', 'briefTitle': 'Patients Navigator for Organized Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de la Loire'}, 'officialTitle': 'Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population', 'orgStudyIdInfo': {'id': '2012-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention of navigators', 'description': 'Navigators accompany the target population towards OCCS.', 'interventionNames': ['Behavioral: Navigator intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Population is not accompanied by navigators'}], 'interventions': [{'name': 'Navigator intervention', 'type': 'BEHAVIORAL', 'description': 'peers sharing common characteristics with the target population whose mission is to accompany towards OCCS', 'armGroupLabels': ['Intervention of navigators']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'overallOfficials': [{'name': 'Franck Chauvin, PhDMD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut de Cancérologie Lucien Neuwirth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, {'name': 'University of Lyon', 'class': 'OTHER'}, {'name': 'Centre Georges Francois Leclerc', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}