Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT03561467
Status:
UNKNOWN
Last Update Posted:
2018-06-19
First Post:
2018-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Chemotherapy and Quality of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of dysfunctions', 'timeFrame': '3 months', 'description': 'Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course'}], 'secondaryOutcomes': [{'measure': 'Drug adherence', 'timeFrame': '3 months', 'description': "measured by Morisky-Green's questionnaire to the patient"}, {'measure': 'Drug adherence', 'timeFrame': '3 months', 'description': 'measured by Data on the refill of prescriptions with the National Health Insurance, and evaluated according to the Drug Possession Ratio'}, {'measure': 'Adverse events', 'timeFrame': '3 months', 'description': 'number'}, {'measure': 'Expenses related to the use of unplanned hospital care', 'timeFrame': '3 months', 'description': 'Expenses related to the use of unplanned hospital care during the follow-up period: number of oncologist consultations, transport spending, emergency rehospitalizations and additional examinations.'}, {'measure': 'Satisfaction of the patient', 'timeFrame': 'At month 3', 'description': 'RESOCAN questionnaire'}, {'measure': 'Satisfaction of the caregiver', 'timeFrame': 'At month 3', 'description': 'RESOCAN questionnaire'}, {'measure': 'Satisfaction of the local professionals', 'timeFrame': 'At month 3', 'description': 'RESOCAN questionnaire'}, {'measure': 'Quality of life of patients', 'timeFrame': 'At month 3', 'description': 'QLQC 30'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months).\n\nReferences used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients.\n\nParameters found are : information exchanged, ambulatory and hospital monitoring in case of adverse event and adherence to treatment. The study includes also a medico-economic evaluation (hospitalization and transport spending in case of dysfunction in the patient's journey). Deviations will be analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult outpatients treated by oral chemotherapy for a cancer disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old\n* Suffering from cancer (hematological malignancies, digestive tumors, thoracic tumors or cutaneous tumors)\n* With an oral anticancer chemotherapy initial prescription written by an oncologist or hematologist from the University Hospital of Caen, whatever the place of the drug dispensing (Community pharmacy or hospital pharmacy )\n\nExclusion Criteria:\n\n\\- Patient treated by oral anticancer chemotherapy for another pathology'}, 'identificationModule': {'nctId': 'NCT03561467', 'acronym': 'PARCOURS', 'briefTitle': 'Oral Chemotherapy and Quality of Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Community and Hospital Experiences for Patients Treated by Oral Chemotherapy at the University Hospital of Caen: Analysis of the Process and Its Dysfunctions', 'orgStudyIdInfo': {'id': '17-134'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Evaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie Chedru-Legros, PhD', 'role': 'CONTACT'}], 'facility': 'Caen University Hopsital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Valérie CHEDRU-LEGROS, PhD', 'role': 'CONTACT', 'email': 'chedru-v@chu-caen.fr', 'phone': '+332 31 06 46 66'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'MSD France', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}