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

Primary Purpose

Prostatic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Oncosexology program
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Oncosexology, Paramedics, Sexual rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire de MartiniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oncosexology program

Usual care

Arm Description

Several workshops before and after the radical prostatectomy

Usual care of the urology department for patients with prostate cancer

Outcomes

Primary Outcome Measures

Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)

Secondary Outcome Measures

Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)

Full Information

First Posted
February 21, 2022
Last Updated
October 16, 2023
Sponsor
University Hospital Center of Martinique
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1. Study Identification

Unique Protocol Identification Number
NCT05266313
Brief Title
Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic Neoplasms, Oncosexology, Paramedics, Sexual rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncosexology program
Arm Type
Experimental
Arm Description
Several workshops before and after the radical prostatectomy
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care of the urology department for patients with prostate cancer
Intervention Type
Behavioral
Intervention Name(s)
Oncosexology program
Intervention Description
Thematic workshops throughout the year
Primary Outcome Measure Information:
Title
Evaluation of sexual Quality of Life: Questionnaire
Description
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Time Frame
Before the radical prostatectomy
Title
Evaluation of sexual Quality of Life: Questionnaire
Description
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Time Frame
1 Month after the radical prostatectomy
Title
Evaluation of sexual Quality of Life: Questionnaire
Description
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Time Frame
12 months after the radical prostatectomy
Secondary Outcome Measure Information:
Title
Evaluation of sexual function: Questionnaire
Description
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Time Frame
Before the radical prostatectomy
Title
Evaluation of sexual function: Questionnaire
Description
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Time Frame
1 Month after the radical prostatectomy
Title
Evaluation of sexual function: Questionnaire
Description
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Time Frame
12 months after the radical prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline MINCHACA-PERROCHAUD
Phone
05.96.48.88.60
Ext
+596
Email
celine-minchaca@chu-martinique.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mickaëlle ROSE
Phone
+596 596 59 26 23
Email
mickaelle.rose@chu-martinique.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline MINCHACA-PERROCHAUD
Phone
05.96.48.88.60
Email
celine-minchaca@chu-martinique.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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