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临床试验/NCT05387863
NCT05387863招募中不适用

Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月12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
40
试验地点
1
主要终点
Knowledge Score

研究概览

简要总结

The objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. The study team will develop a decision aid (DA) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter.
  • Patients scheduled for standard-of-care clinical exams with the NYU Urology Department

排除标准

  • Stage IV cancer of any type
  • Inability to provide informed consent
  • Vulnerable subjects will not be recruited

结局指标

主要结局

Knowledge Score

时间窗: Pre-Counsel, 1 day Visit

Via a survey, patients will be asked general questions about kidney masses and their treatments. There are 10 questions, each scored as correct or incorrect (0 or 1), and the last question has 3 sub-components each scored 0-1. The total range of score is 0-10; a score of 10 indicates strongest knowledge on kidney masses/treatments.

Decision Satisfaction Score

时间窗: Post-Counsel, 1 day Visit

Via a survey, patients provide their opinion on 16 statements. Each statement is scored 1 (strongly disagree) to 5 (strongly agree). The total range of score is 1-80; a higher score indicates higher satisfaction.

Shared Decision Making

时间窗: Post-Counsel, 1 day Visit

This is a binary outcome measure. Patients will be asked whether or not they felt they participated in a shared decision making process: 0 for no, 1 for yes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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