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
1. assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia (Time Frame - Throughout study completion, an average of 1 year): The primary endpoint is a composite endpoint based on the percentages of HCPs with correct responses to all questions included in the composite regarding the below information:
Risk of hyperglycemia and its potential risk factors
Signs and symptoms of hyperglycemia
Recommendations for monitoring for hyperglycemia prior to, and during, treatment with Piqray
Recommendations for managing hyperglycemia during treatment with Piqray. Specifically, the primary endpoint is a weighted composite knowledge score aggregated across the following survey questions: 4A, 5A-C, 6, 8A-C, 10, and 12-15. It is 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).
Secondary outcome:
1. Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia (Time Frame - Throughout study completion, an average of 1 year): Assessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).
2. Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia (Time Frame - Throughout study completion, an average of 1 year): Assessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).
3. Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia (Time Frame - Throughout study completion, an average of 1 year): Assessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).
Piqray Prescriber's/HCP guide for hyperglycemia: oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA will be provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material). The educational material aims to provide oncologists/HCPs prescribing Piqray with additional measures/guidance prior to, and during treatment with Piqray for the identification and management of hyperglycemia.
Quelle: ClinicalTrials.gov
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