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
Novartis Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05073120
Collaborator
(none)
50
Enrollment
9.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Piqray Prescriber's/HCP guide for hyperglycemia

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Sep 5, 2022
Anticipated Study Completion Date :
Sep 5, 2022

Arms and Interventions

ArmIntervention/Treatment
Piqray Prescriber's/HCP receiving the guide for hyperglycemia

HCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).

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.

Outcome Measures

Primary Outcome Measures

  1. assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia [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 Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05073120
Other Study ID Numbers:
  • CBYL719C2005
First Posted:
Oct 11, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021