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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073120
• Other study ID #: CBYL719C2005
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hyperglycemia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Novartis Investigative Site	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia	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).	Throughout study completion, an average of 1 year
Secondary	Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia	Assessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).	Throughout study completion, an average of 1 year
Secondary	Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia	Assessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).	Throughout study completion, an average of 1 year
Secondary	Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia	Assessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).	Throughout study completion, an average of 1 year