Clinical trial NCT02379260: Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer
Official title: Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2015-03-04
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.

This study is carried out in two steps :

* Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
* Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.

Detailed description: 8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.

Focus groups will be conduct to :

* Identify the representations associated with erectile dysfunction
* Identify the representations related to treatments for erectile dysfunction.
* Score patient knowledge about treatments and their managements.
* Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
* Assessing the needs and expectations of patients

Eligibility criteria: Inclusion Criteria:

* Patients followed in urology department Lyon Sud CH:
* Aged over 18 year
* Having a prostate cancer
* Treated with radical prostatectomy with or without conservation strips neuro vascular
* More than 1 month postoperative
* Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.
* And who signed the informed consent form for participation in the study

Exclusion Criteria:

* Score preoperative IIEF EF \<26
* Refusal of participation, signed consent major patients protected under guardianship.
* Patients unable to understand the course of the study
* Patient (s) with a documented history of cognitive or psychiatric disorders.
* Geographical remoteness of more than 100 Kms.

Primary outcomes:
measure: Thematic and comparative analysis of the recorded interviews
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: CH Lyon Sud
Study officials:
affiliation: CH Lyon Sud
name: Jean-Etienne TERRIER, MD
role: PRINCIPAL_INVESTIGATOR
References: