Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality (PRODUCAN)
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|ClinicalTrials.gov Identifier: NCT03572621|
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : December 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Therapeutic education Other: Collection of data concerning their sexuality Other: Participation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||August 2021|
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).
Participation in a therapeutic education day.
- 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.
- Sexual function [ Time Frame: Month18 ]Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
- General quality of life [ Time Frame: Month18 ]Signing of questionnaire EuroQol-D5 (EQ-D5)
- Sexual quality of life of the partner [ Time Frame: Month18 ]Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
- Number of erections obtained in the last month [ Time Frame: Month18 ]Patient questionnaire to be filled every month at home by the patient and the partner
- Number of reports deemed satisfactory [ Time Frame: Month18 ]Patient questionnaire to be filled every month at home by the patient and the partner
- 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
- Patient Activation Measure (questionnaire PAM) [ Time Frame: Month18 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572621
|Contact: Jean-Etienne TERRIER, MD||04 72 67 88 01 ext +email@example.com|
|Centre Hospitalier Lyon Sud||Recruiting|
|Contact: Jean-Etienne TERRIER, MD 04 72 67 88 01 ext +33 firstname.lastname@example.org|
|Principal Investigator: Jean-Etienne TERRIER, MD|
|Principal Investigator:||Jean-Etienne TERRIER, MD||Hospices Civils de Lyon|