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

Prostatic Neoplasms Clinical Trial

— VITALITE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266313
• Other study ID #: 21_RIPH2-06
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: Céline MINCHACA-PERROCHAUD
• Phone: 05.96.48.88.60
• Email: celine-minchaca[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Behavioral:
• Oncosexology program
Thematic workshops throughout the year

Locations

Country	Name	City	State
Martinique	Centre Hospitalier Universitaire de Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sexual Quality of Life: Questionnaire	Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)	Before the radical prostatectomy
Primary	Evaluation of sexual function: Questionnaire	Administration of sexual function questionnaire (IIEF-type validated questionnaires)	Before the radical prostatectomy
Primary	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
Primary	Evaluation of sexual function: Questionnaire	Administration of sexual function questionnaire (IIEF-type validated questionnaires)	1 Month after the radical prostatectomy
Primary	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
Primary	Evaluation of sexual function: Questionnaire	Administration of sexual function questionnaire (IIEF-type validated questionnaires)	12 months after the radical prostatectomy
Secondary	Evaluation of quality of life in its multidimensional aspect	Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)	Before the radical prostatectomy
Secondary	Evaluation of quality of life for localized forms of prostate cancer	Administration of QLQ-PR25 questionnaire (specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)	Before the radical prostatectomy
Secondary	Evaluation of quality of life in its multidimensional aspect	Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)	12 Month after the radical prostatectomy
Secondary	Evaluation of quality of life for localized forms of prostate cancer	Administration of QLQ-PR25 questionnaire ((specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)	12 Month after the radical prostatectomy