Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT05073120
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2021-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia", 'timeFrame': 'Throughout study completion, an average of 1 year', 'description': 'The primary endpoint was a composite endpoint based on the percentages of HCPs with correct responses to all questions included in the composite regarding the below information:\n\n* Risk of hyperglycemia and its potential risk factors\n* Signs and symptoms of hyperglycemia\n* Recommendations for monitoring for hyperglycemia prior to, and during, treatment with Piqray\n* Recommendations for managing hyperglycemia during treatment with Piqray. Specifically, the primary endpoint was a weighted composite knowledge score aggregated across the following survey questions: 4A, 5A-C, 6, 8A-C, 10, and 12-15. It was calculated as the number of all correctly answered questions divided by the number of all answered questions (i.e. questions that were answered either correct and not correct - unanswered questions are excluded).'}], 'secondaryOutcomes': [{'measure': "Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia", 'timeFrame': 'Throughout study completion, an average of 1 year', 'description': 'Assessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).'}, {'measure': "Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia", 'timeFrame': 'Throughout study completion, an average of 1 year', 'description': 'Assessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).'}, {'measure': "Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia", 'timeFrame': 'Throughout study completion, an average of 1 year', 'description': 'Assessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['educational material', 'PASS'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This was a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey assessed the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey.\n* Provided permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.\n\nExclusion Criteria:\n\nHCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.'}, 'identificationModule': {'nctId': 'NCT05073120', 'briefTitle': 'Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib', 'orgStudyIdInfo': {'id': 'CBYL719C2005'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Piqray Prescriber's/HCP receiving the guide for hyperglycemia", 'description': "HCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).", 'interventionNames': ["Other: Piqray Prescriber's/HCP guide for hyperglycemia"]}], 'interventions': [{'name': "Piqray Prescriber's/HCP guide for hyperglycemia", 'type': 'OTHER', 'description': "oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA were provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material). The educational material aimed to provide oncologists/HCPs prescribing Piqray with additional measures/guidance prior to, and during treatment with Piqray for the identification and management of hyperglycemia.", 'armGroupLabels': ["Piqray Prescriber's/HCP receiving the guide for hyperglycemia"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}