跳至主要内容
临床试验/NCT05073120
NCT05073120已完成不适用

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

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia

研究概览

简要总结

This was a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey assessed the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey.
  • Provided permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.

排除标准

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

结局指标

主要结局

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

时间窗: Throughout study completion, an average of 1 year

The primary endpoint was 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 was a weighted composite knowledge score aggregated across the following survey questions: 4A, 5A-C, 6, 8A-C, 10, and 12-15. It was 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).

次要结局

  • 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)
  • Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia(Throughout study completion, an average of 1 year)
  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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