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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assess the effectiveness of HCP educational materials
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  PIQRAY
• Study drug International non-proprietary name (INN) or common name:
  ALPELISIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE) Protein kinase inhibitors

  Protein kinase inhibitors

Population studied

• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  103

Study design details

• Main study objective:
  Assess HCPs’ knowledge and understanding of the key information included in the Piqray Prescriber’s/HCP Guide for hyperglycemia, including -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.
• Outcomes:
  A composite based on the percentages of HCPs with correct responses to questions in the composite regarding the information below. -Risk of hyperglycemia and its potential risk factors -Signs and symptoms of hyperglycemia -Recommendations for monitoring hyperglycemia prior to and during treatment with Piqray -Recommendations for managing hyperglycemia during treatment with Piqray, - Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia - Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia - Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia
• Data analysis plan:
  Survey details (e.g. number of invited HCPs, number and percentage of responding HCPs, number and percentage of eligible vs. ineligible HCPs, and number and percentage of HCPs with partially vs. fully completed surveys) and analysis sets will be described overall and by country Respondent characteristics/covariates will be summarized overall and by country. Frequencies, percentages, and corresponding 95% 2-sided CI will be used to summarize primary and secondary endpoints overall and by country. Subgroup analyses of primary endpoints may be analyzed by specialty and experience with Piqray. For the primary endpoint, the point estimate of the weighted average composite percentage of HCPs who provide correct responses to key questions will be estimated and assessed against the 70% threshold. Where subgroup analyses have small sample sizes the results should be handled with caution. Although a 70% threshold is considered success, CI for small subgroups will be wide reflecting imprecision.