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