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OpenTrials
Completed

NCT Number: NCT02379260

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CH Lyon Sud

Pierre-Bénite, 69310, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interview with a sociologist

Other

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: PEPs PROSTATE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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