Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality (PRODUCAN)

March 4, 2022 updated by: Hospices Civils de Lyon

Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.

There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hôpital Hédouard Herriot
        • Contact:
          • CUZIN Béatrice, MD
        • Principal Investigator:
          • Béatrice CUZIN, MD
        • Sub-Investigator:
          • Marc COLOMBEL, MD
        • Sub-Investigator:
          • Lionel BADET, MD
        • Sub-Investigator:
          • Sébastien CROUZET, MD
        • Sub-Investigator:
          • Ricardo CODAS DUARTE, MD
        • Sub-Investigator:
          • Emilien SEIZILLES DE MAZANCOURT, MD
        • Sub-Investigator:
          • Xavier MATILLON, MD
        • Sub-Investigator:
          • Hakim FASSI-FEHRI, MD
        • Sub-Investigator:
          • Haixia YE, MD
        • Sub-Investigator:
          • Said OURFALI, MD
      • Pierre-Bénite, France
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Damien CARNICELLI, MD
        • Sub-Investigator:
          • Nicolas MOREL-JOURNEL, MD
        • Sub-Investigator:
          • Alain RUFFION, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:

  • Aged over 18
  • presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips.
  • affiliated to a social security scheme.
  • and having been informed and given informed consent to participation in the program.

Exclusion Criteria:

  • Refusal of participation, signature of consent,
  • protected major patients, under guardianship or curators.
  • Patients unable to understand the course of the study
  • Patient with a documented history of cognitive or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients in the experimental group are offered to participate in a 6-session therapeutic education program on sexuality, ranging from 15 days before surgery to approximately 3 months after. This in addition to the current care by the teams of care about sexual rehabilitation (information and medication prescriptions).
Other: Therapeutic education

Patients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half.

Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation.

Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation.

Session 3: Presentation of available treatments, start intracavernous injections.

Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised.

Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid.
Sham Comparator: Control group
Patient without therapeutic education.
Other: Collection of data concerning their sexuality
Patients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions).
Other: Partner
Patient's partner.
Other: Participation
Participation in a therapeutic education day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change the quality of sexual life of patients treated with radical prostatectomy (PR)
Time Frame: 18 months
Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual function
Time Frame: Month 1, 6, 12 and 18
Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
Month 1, 6, 12 and 18
General quality of life
Time Frame: Month 1, 6, 12 and 18
Signing of questionnaire EuroQol-D5 (EQ-D5)
Month 1, 6, 12 and 18
Sexual quality of life of the partner
Time Frame: Month 1, 6, 12 and 18
Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
Month 1, 6, 12 and 18
Number of erections obtained in the last month
Time Frame: Month 1, 6, 12 and 18
Patient questionnaire to be filled every month at home by the patient and the partner
Month 1, 6, 12 and 18
Number of reports deemed satisfactory
Time Frame: Month 1, 6, 12 and 18
Patient questionnaire to be filled every month at home by the patient and the partner
Month 1, 6, 12 and 18
Number of intracavernous injections performed per week
Time Frame: Month18
Patient questionnaire to be filled every month at home by the patient and the partner
Month18
Patient Activation Measure (questionnaire PAM)
Time Frame: Month18
Month18
Erection Hardness Score (EHS)
Time Frame: Month 1, 6, 12 and 18
Month 1, 6, 12 and 18
Continence: urinary handicap measurement scale (MHU)
Time Frame: Month 1, 6, 12 and 18
Month 1, 6, 12 and 18
Penis size (cm)
Time Frame: Month 1, 6, 12 and 18
Month 1, 6, 12 and 18
Knowledge acquisition measured by quizz build for the study made of simulated cases
Time Frame: Month 1, 6, 12 and 18
Month 1, 6, 12 and 18
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
Time Frame: Month 1, 6, 12 and 18
Month 1, 6, 12 and 18
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
Time Frame: Month 6 and18
Month 6 and18
Depression level measured by the Hospital Anxiety and Depression (HAD) scale
Time Frame: Month 6 and18
Month 6 and18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Etienne TERRIER, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe