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临床试验/NCT01849471
NCT01849471Unknown不适用

Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life

研究概览

简要总结

This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • minimal age 18
  • low, mediate and high-grade prostate cancer

排除标准

  • tumor recurrence
  • surgery as primary therapy
  • prior radiotherapy except conventional radiotherapy
  • patients with other malignancies

结局指标

主要结局

therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life

时间窗: Participants will be followed for the duration of therapy and for 1 year after the last study treatment

by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters

次要结局

  • adverse events(Participants will be followed for the duration of therapy and for 1 year after the last study treatment)
  • correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage(Participants will be followed for the duration of therapy and for 1 year after the last study treatment)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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