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临床试验/NCT03950180
NCT03950180已完成不适用

Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction

Benaroya Research Institute0 个研究点目标入组 277 人开始时间: 2013年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
277
主要终点
Traditional Decisional Conflict Scale (DCS)

研究概览

简要总结

The purpose of this study was to determine whether providing patients with life expectancy (LE) information in the form of their Prostate Cancer Comorbidity Index (PCCI) scores impacted their decisional conflict or anxiety about prostate cancer or death.

详细描述

Patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (SOC) versus the same counseling plus provision of their specific LE (PCCI). Patients were blinded to the specific content of their counseling session. After counseling, patients completed the Decisional Conflict Scale (DCS), Death Anxiety Scale (DAS), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Patient Satisfaction Questionnaire (PSQ-18). Treatment preferences were assessed.

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
Single (Participant)

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

  • Men 18 years and older
  • Newly diagnosed prostate cancer

排除标准

  • Non-English speaking
  • Prior history of prostate cancer

研究组 & 干预措施

PCCI group

Active Comparator

In addition to standard of care counseling the additional provision of the patient's specific Prostate Cancer Comorbidity Index score and life expectancy estimation was provided.

干预措施: Prostate Cancer Comorbidity Index (PCCI) score (Other)

Standard care

No Intervention

Standard of care was defined as prostate cancer counseling reflecting the best practices of a multidisciplinary team of urologists, radiation oncologists and medical oncologists.

结局指标

主要结局

Traditional Decisional Conflict Scale (DCS)

时间窗: within 120 days of receiving counseling

This is to assess the ability to implement decisions. Each of the 16 questions range from strongly agree (a score of 1), to strongly disagree (a score of 5). The total score could be as low as 16 or as high as 80. A lower total score represents a better outcome, with a score of \<25 associated with the ability to implement decisions and a score of \>37.5 associated with decision delay and feeling unsure.

次要结局

  • The Modified 18-item Memorial Anxiety Scale for Prostate Cancer(within 120 days of receiving counseling)

研究者

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

John Corman, MD

Principal Investigator

Benaroya Research Institute

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