跳至主要内容
临床试验/NCT03331068
NCT03331068已完成不适用

Memorial Anxiety Scale for Patients With Prostate Cancer: French Validation, Links With Quality Of Life and Future Temporal Perspective.

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年4月26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
180
试验地点
1
主要终点
Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale)

研究概览

简要总结

A specific scale allowing the measure of anxiety of patients with protate cancer has been designed and validated but the French version needs to be validated. This study aims at validating the French translation of this scale.

详细描述

The psychological difficulties encountered by patients with prostate cancer are widely known. There are, however, problems in the identification of certain disorders that require appropriate psychological management. In order to diagnose patients with anxiety more finely, a prostate cancer-specific anxiety measurement scale (MAX-PC) was developed and validated. This scale includes three sub-dimensions: anxiety related to prostate cancer, anxiety related to the PSA assessment and fear of recurrence. This scale generally has good psychometric properties which are found in different populations and in different countries. The dimensions of the MAX-PC correlate with other anxiety measurement scales such as Beck or HADS, but do not show redundancy: it captures a specific anxiety related to the experience of patients with prostate cancer.

To date, this sclae is not validated in French, and its use in the frame of clinical trials or in routine practice require a first validation.

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
Male
接受健康志愿者

入选标准

  • Patients with prostate cancer diagnosed within 12 months

排除标准

  • 未提供

结局指标

主要结局

Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale)

时间窗: At inclusion

The scale is divided in 3 subscales: Prostate cancer Anxiety ; PSA anxiety and Fear of Recurrence. The total score of the scale ranges from 0 to 54, with 54 indicating maximum anxiety. Scores of the Prostate anxiety scale range from 0 to 33 ; with 33 indicating maximum anxiety. Scores of the PSA anxiety scale range from 0 to 9 ; with 9 indicating maximum anxiety. Score of the Fear of Recurrence scale range from 0 to 12; with 12 indicating maximum anxiety. The total score is the sum of the 3 subscales scores.

次要结局

  • Quality of Life (QoL) scores assessed by the SF-12 scale(At inclusion)
  • Anxiety score assessed by the HADS scale(At inclusion)
  • Depression score assessed by the HADS scale(At inclusion)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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