Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-25 @ 12:02 PM
Study NCT ID:
NCT04045561
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2019-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluating the understanding', 'timeFrame': 'Day 1', 'description': 'Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.'}, {'measure': 'evaluating understanding', 'timeFrame': 'Day 1', 'description': 'Questionnaire. qualitative variables: measurement of their number and'}, {'measure': 'evaluating the quality of information', 'timeFrame': 'Day 1', 'description': 'Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.'}, {'measure': 'evaluating quality of information', 'timeFrame': 'Day 1', 'description': 'Questionnaire. qualitative variables: measurement of their number and percentage.'}], 'secondaryOutcomes': [{'measure': 'The time required for the pharmaceutical consultation', 'timeFrame': 'Day 1', 'description': 'minutes'}, {'measure': 'satisfaction des patients', 'timeFrame': 'Day 1', 'description': 'by an Analogue Visual Scale (0-10-very satisfied)'}]}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.\n\nThe aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is at least 18 years old\n* The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.\n\nCriteria for non-inclusion\n\n* The subject is participating in another study\n* The subject is in an exclusion period determined by a previous study\n* The subject is under the protection of justice, guardianship or curatorship\n* It is impossible to give informed information about\n* The patient is pregnant, parturient, or breastfeeding\n* The patient receives a follow-up by a home nurse for the administration of oral medication\n* The patient is treated only with oral chemotherapy in the city\n* The patient has early dementia.\n\nTranslated with www.DeepL.com/Translator\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04045561', 'briefTitle': 'Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Elaboration of a Standardized Referential Guide of the Information to Optimize the Adherence to be Given During an Initial Pharmaceutical Consultation (CP) to the Patient Suffering From Multiple Myeloma in Primocure Chemotherapy Per os', 'orgStudyIdInfo': {'id': 'LOCAL/2015/MF-01'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}