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

NCT ID: NCT02379260

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-11-30

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interview

Patients and urologists will be interview by a sociologist.

Group Type: OTHER

Interview with a sociologist

Intervention Type: OTHER

Focus Groups

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).

Group Type: OTHER

Interview with a sociologist

Intervention Type: OTHER

Interventions

Interview with a sociologist

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Etienne TERRIER, MD

Role: PRINCIPAL_INVESTIGATOR

CH Lyon Sud

Locations

CH Lyon Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

2014-11

Identifier Type: -

Identifier Source: org_study_id