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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Therapeutic education
* Other: Collection of data concerning their sexuality
* Other: Participation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>|
| Sham Comparator: Control group<br>Patient without therapeutic education. | Other: Collection of data concerning their sexuality<br>* 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).<br>|
| Other: Partner<br>Patient's partner. | Other: Participation<br>* Participation in a therapeutic education day.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatectomy