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临床试验/NCT06703567
NCT06703567招募中不适用

IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
2
主要终点
GEP Knowledge Evaluation

研究概览

简要总结

The primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

详细描述

Advances made in our understanding of the molecular biology of breast cancer have improved diagnostic testing and therapeutic options available to patients. Importantly results from genomic testing provide more accurate tailoring of treatments potentially enhancing the benefit to harm ratio by only offering adjuvant chemotherapy to those patients at highest risk of recurrence, and sparing those at lower risk the unwanted side effects of cytotoxic treatment. Conversations about risks and optimal treatments can be complex.

To aid understanding about GEP tests many clinical teams provide patients with information leaflets about GEP testing. Unfortunately these are often written by either academic or commercial sponsors and designed to meet certain ethical and regulatory guidelines rather than effectively educate the end-user.

There is some evidence that user-friendly patient information films might enhance patient knowledge and understanding and are more accessible to certain individuals, especially those with low literacy.

IMPARTER project has developed eight-minute film explaining why Oncotype DX GEP tests is used in EBC, what it is, and how the results help determine whether or not chemotherapy is recommended as a useful treatment option.

This study wish to examine the utility of the information film in the clinic setting with EBC patients identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • First presentation of early stage breast cancer with all known disease surgically removed
  • Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative
  • No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria
  • Consented to GEP testing
  • Able to give full informed consent to IMPARTER study
  • Good comprehension of the Italian language
  • Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer)

排除标准

  • Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic)
  • Unable to give fully informed consent
  • Under 18 years of age
  • Unable to understand and speak Italian
  • No access to internet connection or devices

结局指标

主要结局

GEP Knowledge Evaluation

时间窗: 1 week

Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)

次要结局

  • Anxiety assessment(1 week)
  • Decision making assessment(1 week)
  • Reaction to uncertain situations assessment(1 week)
  • Physician confidence/satisfaction assessment(1 week)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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