跳至主要内容
临床试验/NCT02379260
NCT02379260已完成不适用

Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy

Institut de Cancérologie de la Loire2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年5月1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
19
试验地点
2
主要终点
Thematic and comparative analysis of the recorded interviews

研究概览

简要总结

The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.

This study is carried out in two steps :

  • Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
  • Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.

详细描述

8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.

Focus groups will be conduct to :

  • Identify the representations associated with erectile dysfunction
  • Identify the representations related to treatments for erectile dysfunction.
  • Score patient knowledge about treatments and their managements.
  • Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
  • Assessing the needs and expectations of patients

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Patients followed in urology department Lyon Sud CH:
  • Aged over 18 year
  • Having a prostate cancer
  • Treated with radical prostatectomy with or without conservation strips neuro vascular
  • More than 1 month postoperative
  • Having a normal preoperative erectile function defined by a score IIEF EF ≥
  • And who signed the informed consent form for participation in the study

排除标准

  • Score preoperative IIEF EF <26
  • Refusal of participation, signed consent major patients protected under guardianship.
  • Patients unable to understand the course of the study
  • Patient (s) with a documented history of cognitive or psychiatric disorders.
  • Geographical remoteness of more than 100 Kms.

结局指标

主要结局

Thematic and comparative analysis of the recorded interviews

时间窗: 2 hours

Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.

次要结局

未报告次要终点

研究者

发起方
Institut de Cancérologie de la Loire
申办方类型
Other
责任方
Sponsor

研究点 (2)

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