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

NCT02379260 | Completed

• 1 other identifier: 2014-11
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Study Arms (2)

Interview

OTHER

Patients and urologists will be interview by a sociologist.

Other: Interview with a sociologist

Focus Groups

OTHER

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

Interventions

Interview with a sociologist OTHER

Focus Groups; Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

CH Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-Etienne TERRIER, MD

  CH Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

FR (1)