Viewing Study NCT02379260


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Study NCT ID: NCT02379260
Status: COMPLETED
Last Update Posted: 2016-02-26
First Post: 2015-02-27
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer
Sponsor: Institut de Cancérologie de la Loire
Organization:

Study Overview

Official Title: Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PEPs PROSTATE
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

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: