Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy (RP): "Vitality", an Onco-sexology Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Evaluation of sexual Quality of Life: Questionnaire
研究概览
简要总结
The paramedic urology team at Martinique University Hospital has developed a "personalized rehabilitation oncosexology program for patients undergoing radical prostatectomy (RP) for localized prostate cancer". The aim of this project is to assess the effectiveness of this program by comparing the sexual quality of life 1 year after surgery between patients participating and those who do not.
详细描述
80% of patients undergoing radical prostatectomy report urinary incontinence and erectile dysfunction [Johanssen et al. 2011. Scandinavian Prostate Cancer Group Study]. In the West Indies, the incidence of prostate cancer is one of the highest in the world (World-standardized incidence in Martinique is 164.5 versus 88.8 per 100,000 person-years in Metropolitan France). Over 2007-2014 an average 530 new cases of prostate cancer were diagnosed each year in Martinique, representing 55% of all male cancers [Regional estimates report Public Health France, January 2018]. The prostate is a symbol of male vulnerability [French Association of Urology-Global Market Research and Public Opinion Specialist, 2006]. For other authors, virility is above all a cultural representation, and the "crisis of virility", a recomposition of male identity. Surgery on a sexual organ can alter body image and masculinity. According to Colson et al., patients treated for prostate cancer and their partners clearly place sex in first place in the importance of quality of life domains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men diagnosed with localized prostate cancer and consulting in the urology department of Mangot Vulcin site of the Martinique University Hospital
- •Patients newly diagnosed for prostate cancer and who will benefit from radical prostatectomy (regardless the technique : laparotomy, laparoscopy or robot-assisted micro-invasive surgery)
- •Fluent in French or Creole
- •Patients who give consent
- •Patients affiliated to social security
排除标准
- •Patients diagnosed with another tumor
- •Person under legal protection
结局指标
主要结局
Evaluation of sexual Quality of Life: Questionnaire
时间窗: 12 months after the radical prostatectomy
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Evaluation of sexual function: Questionnaire
时间窗: 12 months after the radical prostatectomy
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
次要结局
- Evaluation of quality of life in its multidimensional aspect(12 Month after the radical prostatectomy)
- Evaluation of quality of life for localized forms of prostate cancer(12 Month after the radical prostatectomy)