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

Prostate Cancer Clinical Trial

— PRODUCAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572621
• Other study ID #: 69HCL17_0010
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: September 2024

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: Damien CARNICELLI, MD
• Phone: 04 72 67 88 01
• Email: damien.carnicelli[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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).
• Participation
Participation in a therapeutic education day.

Locations

Country	Name	City	State
France	Hôpital Hédouard Herriot	Lyon
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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