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

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: Prostate Cancer
• Intervention / Treatment: Other: Therapeutic education; Other: Collection of data concerning their sexuality; Other: Participation

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damien CARNICELLI, MD; Phone Number: +33 04 72 67 88 01; Email: damien.carnicelli@chu-lyon.fr

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: Damien CARNICELLI, MD; Email: damien.carnicelli@chu-lyon.fr
    • Principal Investigator: Damien CARNICELLI, MD
    • Sub-Investigator: Nicolas MOREL-JOURNEL, MD
    • Sub-Investigator: Alain RUFFION, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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	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	Signing of questionnaire EuroQol-D5 (EQ-D5)	Month 1, 6, 12 and 18
Sexual quality of life of the partner	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	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	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	Patient questionnaire to be filled every month at home by the patient and the partner	Month18
Patient Activation Measure (questionnaire PAM)		Month18
Erection Hardness Score (EHS)		Month 1, 6, 12 and 18
Continence: urinary handicap measurement scale (MHU)		Month 1, 6, 12 and 18
Penis size (cm)		Month 1, 6, 12 and 18
Knowledge acquisition measured by quizz build for the study made of simulated cases		Month 1, 6, 12 and 18
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases		Month 1, 6, 12 and 18
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale		Month 6 and18
Depression level measured by the Hospital Anxiety and Depression (HAD) scale		Month 6 and18

Collaborators and Investigators

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

Study record dates

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: Prostatectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• 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