Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT02224768
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-18', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)', 'timeFrame': '6 months', 'description': 'Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups'}, {'measure': 'Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"', 'timeFrame': '6 months', 'description': 'Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups'}, {'measure': 'Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys', 'timeFrame': '6 months', 'description': 'Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data\n\n1. Total number of responses to the question including the proportions of correct answers to questions where appropriate\n2. Number or frequency and proportion of response options selected\n3. Percentage of responses/total responses per option\n4. Mean value and standard deviation (for appropriate questions)\n\nFrom the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed'}, {'measure': 'HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys', 'timeFrame': '6 months', 'description': 'For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show:\n\n1. Total of number of participants answering the question.\n2. Proportions of participants providing correct answers (to identify knowledge and comprehension)\n3. Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.\n4. Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.\n\nAnalysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients', 'detailedDescription': 'A total sample size of 160 to 200 HCPs and 160 to 200 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HCPs and Patients in EU member states where YERVOY has been marked for atleast six months', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose'}, 'identificationModule': {'nctId': 'NCT02224768', 'briefTitle': 'YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'YERVOY Risk Minimisation Tool Evaluation Survey', 'orgStudyIdInfo': {'id': 'CA184-242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCP and Patient inclusion', 'description': 'HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools\n\nPatient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials', 'interventionNames': ['Drug: Ipilimumab']}], 'interventions': [{'name': 'Ipilimumab', 'type': 'DRUG', 'armGroupLabels': ['HCP and Patient inclusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bristol-Myers Squibb', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': 'PE27 5BZ', 'city': 'St Ives', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.20861, 'lon': -5.4875}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}