Clinical trial NCT03572621: Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Official title: Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostatectomy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change the quality of sexual life of patients treated with radical prostatectomy (PR)
timeFrame: 18 months
Secondary outcomes:
measure: Sexual function
timeFrame: Month 1, 6, 12 and 18
measure: General quality of life
timeFrame: Month 1, 6, 12 and 18
measure: Sexual quality of life of the partner
timeFrame: Month 1, 6, 12 and 18
measure: Number of erections obtained in the last month
timeFrame: Month 1, 6, 12 and 18
measure: Number of reports deemed satisfactory
timeFrame: Month 1, 6, 12 and 18
measure: Number of intracavernous injections performed per week
timeFrame: Month18
measure: Patient Activation Measure (questionnaire PAM)
timeFrame: Month18
measure: Erection Hardness Score (EHS)
timeFrame: Month 1, 6, 12 and 18
measure: Continence: urinary handicap measurement scale (MHU)
timeFrame: Month 1, 6, 12 and 18
measure: Penis size (cm)
timeFrame: Month 1, 6, 12 and 18
measure: Knowledge acquisition measured by quizz build for the study made of simulated cases
timeFrame: Month 1, 6, 12 and 18
measure: acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
timeFrame: Month 1, 6, 12 and 18
measure: Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
timeFrame: Month 6 and18
measure: Depression level measured by the Hospital Anxiety and Depression (HAD) scale
timeFrame: Month 6 and18
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Hédouard Herriot
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Etienne TERRIER, MD
role: PRINCIPAL_INVESTIGATOR
References: