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临床试验/NCT02032550
NCT02032550已完成不适用

Treatment Preference and Patient Centered Prostate Cancer Care

University of Pennsylvania6 个研究点 分布在 1 个国家目标入组 743 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
743
试验地点
6
主要终点
Change in Satisfaction With Care

研究概览

简要总结

The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

详细描述

The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Newly diagnosed with non-metastatic prostate cancer
  • Has not yet started radiation or surgery
  • Provide informed consent

排除标准

  • Distant, metastatic prostate cancer at diagnosis
  • Has already begun treatment for prostate cancer
  • Unable to communicate in English

结局指标

主要结局

Change in Satisfaction With Care

时间窗: baseline, 3, 6, 12 and 24 months

The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care.

次要结局

  • Depression(baseline, 3, 6, 12, and 24 months)
  • Generic Health Related Quality of Life (HRQoL)(baseline to 24 month)
  • Anxiety(baseline, 3, 6, 12, and 24 months)
  • Urinary Symptoms(baseline, 3, 6, 12, and 24 months)
  • Prostate Specific Health Related Quality of Life (HRQoL)(Baseline to 24 month)
  • Treatment Choice(6 months)
  • Satisfaction With Decision(baseline, 3, 6, 12, and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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