跳至主要内容
临床试验/DRKS00032764
DRKS00032764招募中Unknown

Building a nationwide safety net for oral antitumor therapy: SafetyFIRST – a cluster-randomized stepped-wedge trial - SafetyFIRST

Apotheke des Uniklinikums Erlangen0 个研究点目标入组 600 人开始时间: 2023年11月16日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
600

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Therapy initiation at one of the participating local sites with:
  • - A newer oral anti-tumor agent (substance authorized for use after February 2, 2001 = date of authorization for Capecitabine by the European Medicines Agency EMA), or
  • - Temozolomide (inclusion due to high clinical relevance despite approval before the approval date for Capecitabine).
  • - Planned duration of therapy: at least 4 months
  • - Estimated life expectancy: at least 4 months
  • - Ability to independently fill out questionnaires
  • - Tumor diagnosis / stages: no limitations
  • - Treatment setting: outpatient (or inpatient) treatment setting, outpatient follow-up care

排除标准

  • - Absence of sufficient German language skills (ability to understand written and spoken German)
  • - Pathological cognitive deficiencies (e.g., neurodegenerative diseases severely affecting patients' memory)
  • - Non-capable-of-consent patients
  • - Patients unable to take their medication independently
  • - Pregnant / breastfeeding patients
  • - Absence of written consent statement

研究者

发起方
Apotheke des Uniklinikums Erlangen

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Building a nationwide safety net for oral antitumor... | 临床试验