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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

Recruiting
Conditions
Breast Cancer
Interventions
Other: Piqray Prescriber's/HCP guide for hyperglycemia
Registration Number
NCT05073120
Lead Sponsor
Novartis Pharmaceuticals
Brief Summary

This is a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey will assess the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray. The survey will endeavor to collect a minimum to 30-50 completed surveys.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Has prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey.
  • Provides permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.
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Exclusion Criteria

HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Piqray Prescriber's/HCP receiving the guide for hyperglycemiaPiqray Prescriber's/HCP guide for hyperglycemiaHCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).
Primary Outcome Measures
NameTimeMethod
assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout 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 Measures
NameTimeMethod
Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout 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).

Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemiaThroughout 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).

Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout 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).

Trial Locations

Locations (1)

Novartis Investigative Site

🇨🇭

Basel, Switzerland

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