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临床试验/NCT05548621
NCT05548621招募中不适用

A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
OPTION-5

研究概览

简要总结

The aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (RCC) on the decision-making process and the quality of the decision.

详细描述

Background: Treatment options for patients diagnosed with RCC depend on the stage of the disease, histopathology and patient's preferences and values regarding outcomes. For local (non-metastatic) disease, gold standard for treatment is surgical resection of the tumour. Besides this, ablative therapies or active surveillance could also be an option. For metastatic disease, targeted therapy and/or immunotherapy can be offered and new treatment options are being tested in clinical trials. The number of available treatment options for patients with RCC is increasing, but the availability of these options differs per hospital and the transparency about treatment options is limited, resulting in practice variation between hospitals.

Decision aids help patients to make decisions regarding treatment, particularly when there is not one medically superior treatment option. In this tools treatment options are explained, including outcome information such as possible side effects and benefits of therapy. Decision aids have proven to lead to increased patient knowledge, less anxiety in patients, improved health outcomes such as physical en mental health, reductions in unwarranted variation in care and costs, greater alignment of care with patients' values.

For patients with RCC, two decision aids are in development right now: one decision aid focussed on local disease and one decision aid focussed on metastatic disease. Using these decision aids, patients are encouraged to make a well-informed decision together with the healthcare professional.

Objective: To assess how the decision aids for RCC influence the quality of the decision-making processes for RCC, defined as the extent to which elements of shared decision-making (SDM) are observed.

Design, setting and participants: This study includes patients clinically diagnosed with RCC, facing a decision which is addressed in the decision aids. Study design will be a prospective multicenter pre-test post-test study.

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

  • Patients clinically diagnosed with RCC
  • Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
  • Written informed consent

排除标准

  • Patients who are not able to fill in a questionnaire or undergo an interview individually

结局指标

主要结局

OPTION-5

时间窗: During consultation

Observed patient involvement in decision-making

次要结局

  • SDM-Q-9(Health care professional: directly after consultatiion, patient: two weeks after consultation)
  • Decisional conflict scale(Two weeks and nine weeks after consultation)
  • Preparation for decision-making(Two weeks after consultation)
  • Control preference scale(Two weeks after consultation)
  • Knowledge check(Two weeks after consultation)
  • Implementation of the decision aids(Nine weeks after consultation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cato Bresser

Coordinating Investigator

St. Antonius Hospital

研究点 (1)

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