Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer (PEPs PROSTATE)

February 25, 2016 updated by: Institut de Cancérologie de la Loire

Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69310
        • CH Lyon sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interview
Patients and urologists will be interview by a sociologist.
Other: Interview with a sociologist
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).
Other: Interview with a sociologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thematic and comparative analysis of the recorded interviews
Time Frame: 2 hours
Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Collaborators

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Etienne TERRIER, MD, CH Lyon sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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