Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer (PEPs PROSTATE)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interview with a sociologist
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
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.
Sites / Locations
- CH Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Interview
Focus Groups
Arm Description
Patients and urologists will be interview by 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).
Outcomes
Primary Outcome Measures
Thematic and comparative analysis of the recorded interviews
Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
Secondary Outcome Measures
Full Information
NCT ID
NCT02379260
First Posted
February 27, 2015
Last Updated
February 25, 2016
Sponsor
Institut de Cancérologie de la Loire
Collaborators
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02379260
Brief Title
Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer
Acronym
PEPs PROSTATE
Official Title
Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire
Collaborators
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interview
Arm Type
Other
Arm Description
Patients and urologists will be interview by a sociologist.
Arm Title
Focus Groups
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Interview with a sociologist
Primary Outcome Measure Information:
Title
Thematic and comparative analysis of the recorded interviews
Description
Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Etienne TERRIER, MD
Organizational Affiliation
CH Lyon Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
12. IPD Sharing Statement
Learn more about this trial
Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer
We'll reach out to this number within 24 hrs