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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Oncosexology program

Several workshops before and after the radical prostatectomy

Group Type EXPERIMENTAL

Oncosexology program

Intervention Type BEHAVIORAL

Thematic workshops throughout the year

Usual care

Usual care of the urology department for patients with prostate cancer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oncosexology program

Thematic workshops throughout the year

Intervention Type BEHAVIORAL

Eligibility Criteria

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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