Clinical trial NCT05266313: Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy
Official title: Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy (RP): "Vitality", an Onco-sexology Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Oncosexology
Paramedics
Sexual rehabilitation
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients diagnosed with another tumor
* Person under legal protection

Primary outcomes:
measure: Evaluation of sexual Quality of Life: Questionnaire
timeFrame: Before the radical prostatectomy
measure: Evaluation of sexual function: Questionnaire
timeFrame: Before the radical prostatectomy
measure: Evaluation of sexual Quality of Life: Questionnaire
timeFrame: 1 Month after the radical prostatectomy
measure: Evaluation of sexual function: Questionnaire
timeFrame: 1 Month after the radical prostatectomy
measure: Evaluation of sexual Quality of Life: Questionnaire
timeFrame: 12 months after the radical prostatectomy
measure: Evaluation of sexual function: Questionnaire
timeFrame: 12 months after the radical prostatectomy
Secondary outcomes:
measure: Evaluation of quality of life in its multidimensional aspect
timeFrame: Before the radical prostatectomy
measure: Evaluation of quality of life for localized forms of prostate cancer
timeFrame: Before the radical prostatectomy
measure: Evaluation of quality of life in its multidimensional aspect
timeFrame: 12 Month after the radical prostatectomy
measure: Evaluation of quality of life for localized forms of prostate cancer
timeFrame: 12 Month after the radical prostatectomy
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: Centre Hospitalier Universitaire de Martinique
Study officials:
References: