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

Sponsor

University Hospital Center of Martinique (Other)

Overall Status

Recruiting

CT.gov ID

NCT05266313

Collaborator

(none)

136

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Behavioral: Oncosexology program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Mar 31, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oncosexology program Several workshops before and after the radical prostatectomy	Behavioral: Oncosexology program Thematic workshops throughout the year
No Intervention: Usual care Usual care of the urology department for patients with prostate cancer

Arm

Intervention/Treatment

Experimental: Oncosexology program

Several workshops before and after the radical prostatectomy

Behavioral: Oncosexology program

Thematic workshops throughout the year

No Intervention: Usual care

Usual care of the urology department for patients with prostate cancer

Outcome Measures

Primary Outcome Measures

Evaluation of sexual Quality of Life: Questionnaire [Before the radical prostatectomy]
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Evaluation of sexual Quality of Life: Questionnaire [1 Month after the radical prostatectomy]
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Evaluation of sexual Quality of Life: Questionnaire [12 months after the radical prostatectomy]
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)

Secondary Outcome Measures

Evaluation of sexual function: Questionnaire [Before the radical prostatectomy]
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Evaluation of sexual function: Questionnaire [1 Month after the radical prostatectomy]
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Evaluation of sexual function: Questionnaire [12 months after the radical prostatectomy]
Administration of sexual function questionnaire (IIEF-type validated questionnaires)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Martinique	Fort-de-France		Martinique	97261

Sponsors and Collaborators

University Hospital Center of Martinique

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Center of Martinique

ClinicalTrials.gov Identifier:

NCT05266313

Other Study ID Numbers:

21_RIPH2-06

First Posted:

Mar 4, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Center of Martinique

Prostatic Neoplasms

Oncosexology

Paramedics

Sexual rehabilitation

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Aug 5, 2022