Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy

Study Overview
=================
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.

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

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Oncosexology program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncosexology program<br>Several workshops before and after the radical prostatectomy | Behavioral: Oncosexology program<br>* Thematic workshops throughout the year<br>|
| No Intervention: Usual care<br>Usual care of the urology department for patients with prostate cancer | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sexual Quality of Life: Questionnaire | Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship) | Before the radical prostatectomy | 
| Evaluation of sexual Quality of Life: Questionnaire | Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship) | 1 Month after the radical prostatectomy | 
| Evaluation of sexual Quality of Life: Questionnaire | Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship) | 12 months after the radical prostatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sexual function: Questionnaire | Administration of sexual function questionnaire (IIEF-type validated questionnaires) | Before the radical prostatectomy | 
| Evaluation of sexual function: Questionnaire | Administration of sexual function questionnaire (IIEF-type validated questionnaires) | 1 Month after the radical prostatectomy | 
| Evaluation of sexual function: Questionnaire | Administration of sexual function questionnaire (IIEF-type validated questionnaires) | 12 months after the radical prostatectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic Neoplasms, Oncosexology, Paramedics, Sexual rehabilitation