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临床试验/NCT07156903
NCT07156903招募中不适用

Qualitative Erhebung Zur Erfassung Der Bedürfnisse Von Patienten Und Deren Angehörigen während Und Nach Einer Strahlentherapie Bei Prostatakarzinomerkrankung Und Deren Einstellung Und Wünsche bezüglich Einer Prähabilitationsmaßnahme

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Qualitative Evaluation of Interviews

研究概览

简要总结

Exploratory qualitative survey to assess the needs of patients and their relatives during and after radiotherapy for prostate cancer and their attitudes and wishes regarding prehabilitation measures

详细描述

Across Germany, more than 500,000 people are newly diagnosed with cancer each year (Center for Cancer Registry Data, RKI, 2020). Prostate cancer, the most common cancer in men, affects more than 65,000 patients annually (https://www.krebsinformationsdienst.de/prostatakrebs). The gold standard for the treatment of advanced prostate cancer is radiotherapy combined with anti-hormonal therapy. If the cancer is detected earlier, surgery can be performed. Both procedures are then considered to be oncologically equivalent. Despite the most modern treatment methods and techniques, severe acute and long-term side effects still occur, which patients can experience as extremely limiting. These include, among other things, loss of libido and erectile function, the development of bladder weakness and even incontinence, and changes in bowel function (e.g., diarrhea).

Currently, patients often only begin treatments designed to mitigate these side effects during their rehabilitation, at least 4-6 weeks after therapy. However, the investigators believe that greater effects can be achieved and even the occurrence of serious side effects can be potentially prevented if treatment is initiated before or during therapy. This concept is called prehabilitation.

In order to develop a suitable prehabilitation program for prostate cancer patients undergoing curative radiation therapy (either definitive or postoperative), the investigators will conduct interviews with patients and, if possible, their immediate family members (e.g., partners) to learn more about their experiences before, during, and after the treatment. The investigators would also like to learn more about their attitudes and wishes regarding prehabilitation measures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • •Diagnosed Prostate Cancer with curativ intended Radiotherapy
  • •min. 18 years
  • •sufficient knowledge of German language for participation in interviews
  • •Capacity to consent

排除标准

  • •age <18 years

研究组 & 干预措施

interviews

Experimental

Patients will be asked to participate in interviews

干预措施: Interview (Other)

结局指标

主要结局

Qualitative Evaluation of Interviews

时间窗: interviews will take place once either during radiotherapy or during follow up (planned 30 participants each); Each interview is expected to last 60 minutes.

This is an exploratory, qualitative study. The data will be coded or analyzed thematically.

Qualitative Evaluation of Interviews

时间窗: interviews will take place once either during radiotherapy or during follow up (planned 30 participants each); Each interview is expected to last 60 minutes.

This is an exploratory, qualitative study. The data will be coded or analyzed thematically.

次要结局

未报告次要终点

研究者

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

Prof. Dr. Franziska Hausmann

Principle Investigator

Charite University, Berlin, Germany

研究点 (2)

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