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临床试验/NCT05729230
NCT05729230已完成不适用

Evaluation of the Patient-physician Relationship During the Initial Consultation Prior to the Introduction of a New Systemic Treatment for Advanced Hepatocellular Carcinoma: Information Needs, Prognostic Awareness, Treatment Expectations Regarding Efficacy and Side Effects

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Perception of prognosis and treatment side effects

研究概览

简要总结

I) Introduction Patients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process. Nevertheless, this kind of discussion is frequently lacking, and consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy.

II) Type of study:

Prospective, observational, non-interventional multicentric study

III) Outcomes III.1) Primary Outcome Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician.

III.2) Secondary Outcomes

  • Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.
  • Evaluation of patient satisfaction with the information received during the consultation
  • Assessment of patient-reported symptoms of anxiety and depression
  • Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.

IV) Recruitment All consecutive patients with a new systemic treatment prescribed for HCC in participating centres will be included for a period of 1 year.

详细描述

Patients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect frank yet sensitive discussions with their physicians about prognosis and treatment choices in order to be involved in the decision-making process. Nevertheless, this kind of discussion is frequently lacking, and consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study is to assess the perception of the expected prognosis and treatment side effects by the patient and his physician during the first consultation before the initiation of a new systemic therapy.

研究设计

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

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

  • diagnose of advanced hepatocellular carcinoma by histology or radiology using the EASL criteria
  • ≥ 18 years old
  • willing to participate in the study, being capable of consenting and sign the informed consent
  • not candidate for curative treatment or locoregional therapy
  • any line systemic therapy that has been validated by the local hepatic tumor board.

排除标准

  • Locoregional treatment combined with systemic treatment
  • Pregnancy in progress
  • Candidate for surgery or locoregional therapy
  • Patient with state medical aid (AME)

结局指标

主要结局

Perception of prognosis and treatment side effects

时间窗: 12 months

Evaluate the concordance between the patient's perception of his prognosis and treatment side effects with the one of his treating physician. Use of survey completed by the patient and the doctors to assess the primary endpoint

次要结局

  • Compare the patient's expectations for the aforementioned items to those of his physician and the degree of concordance between them.(12 months)
  • Assessment of patient-reported symptoms of anxiety and depression(12 months)
  • Evaluate the association between individual prognosis expectation (i.e., patient and physician) and data from the available literature.(12 months)
  • Evaluation of patient satisfaction with the information received during the consultation(12 months)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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