NCT05266313

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Mar 2022Dec 2026

First Submitted

Initial submission to the registry

February 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

February 21, 2022

Last Update Submit

March 26, 2026

Conditions

Prostatic Neoplasms

Keywords

Prostatic NeoplasmsOncosexologyParamedicsSexual rehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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 function: Questionnaire

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

    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 function: Questionnaire

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

    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

  • Evaluation of sexual function: Questionnaire

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

    12 months after the radical prostatectomy

Secondary Outcomes (4)

  • Evaluation of quality of life in its multidimensional aspect

    Before the radical prostatectomy

  • Evaluation of quality of life for localized forms of prostate cancer

    Before the radical prostatectomy

  • Evaluation of quality of life in its multidimensional aspect

    12 Month after the radical prostatectomy

  • Evaluation of quality of life for localized forms of prostate cancer

    12 Month after the radical prostatectomy

Study Arms (2)

Oncosexology program

EXPERIMENTAL

Several workshops before and after the radical prostatectomy

Behavioral: Oncosexology program

Usual care

NO INTERVENTION

Usual care of the urology department for patients with prostate cancer

Interventions

Oncosexology programBEHAVIORAL

Thematic workshops throughout the year

Oncosexology program

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients diagnosed with another tumor
  • Person under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 4, 2022

Study Start

March 31, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)