Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Interview with a sociologist

• Registration Number: NCT02379260
• Lead Sponsor: Institut de Cancérologie de la Loire

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 Timeline

• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-04
• Study Start: 2015-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interview	Interview with a sociologist	Patients and urologists will be interview by a sociologist.
Focus Groups	Interview with a sociologist	Focus groups contain 5-7 patients. Groups will be stratified according to socio-economic levels and according to treatment (radical prostatectomy with conservation or without preservation of the neuro vascular strips).

Primary Outcome Measures

Name	Time	Method
Thematic and comparative analysis of the recorded interviews	2 hours	Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.

Trial Locations

Locations (1)

CH Lyon Sud; 🇫🇷 Pierre Bénite, France