Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Change the quality of sexual life of patients treated with radical prostatectomy (PR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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).
Intervention: Therapeutic education (Other)
Control group
Patient without therapeutic education.
Intervention: Collection of data concerning their sexuality (Other)
Partner
Patient's partner.
Intervention: Participation (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of reports deemed satisfactory(Month 1, 6, 12 and 18)
- Sexual function(Month 1, 6, 12 and 18)
- Patient Activation Measure (questionnaire PAM)(Month18)
- 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)
- Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale(Month 6 and18)
- Sexual quality of life of the partner(Month 1, 6, 12 and 18)
- Depression level measured by the Hospital Anxiety and Depression (HAD) scale(Month 6 and18)
- General quality of life(Month 1, 6, 12 and 18)
- Number of erections obtained in the last month(Month 1, 6, 12 and 18)
- Erection Hardness Score (EHS)(Month 1, 6, 12 and 18)
- Continence: urinary handicap measurement scale (MHU)(Month 1, 6, 12 and 18)
- Number of intracavernous injections performed per week(Month18)
- acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases(Month 1, 6, 12 and 18)