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

Civil Hospices of Lyon

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Other: Collection of data concerning their sexuality

Other: Participation

Other: Therapeutic education

Study type

Interventional

Funder types

Other

Identifiers

NCT03572621

69HCL17_0010

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 3 patient groups

Experimental group

Description:

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).

Treatment:

Other: Therapeutic education

Control group

Sham Comparator group

Description:

Patient without therapeutic education.

Treatment:

Other: Collection of data concerning their sexuality

Partner

Other group

Description:

Patient's partner.