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Trial record 12 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality (PRODUCAN)

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ClinicalTrials.gov Identifier: NCT03572621
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.

There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Therapeutic education Other: Collection of data concerning their sexuality Other: Participation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Experimental group
Patients in the experimental group are offered to participate in a 6-session therapeutic education program on sexuality, ranging from 15 days before surgery to approximately 3 months after. This in addition to the current care by the teams of care about sexual rehabilitation (information and medication prescriptions).
Other: Therapeutic education

Patients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half.

Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation.

Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation.

Session 3: Presentation of available treatments, start intracavernous injections.

Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised.

Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid.


Sham Comparator: Control group
Patient without therapeutic education.
Other: Collection of data concerning their sexuality
Patients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions).

Partner
Patient's partner.
Other: Participation
Participation in a therapeutic education day.




Primary Outcome Measures :
  1. Change the quality of sexual life of patients treated with radical prostatectomy (PR) [ Time Frame: 18 months ]
    Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18.


Secondary Outcome Measures :
  1. Sexual function [ Time Frame: Month18 ]
    Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.

  2. General quality of life [ Time Frame: Month18 ]
    Signing of questionnaire EuroQol-D5 (EQ-D5)

  3. Sexual quality of life of the partner [ Time Frame: Month18 ]
    Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.

  4. Number of erections obtained in the last month [ Time Frame: Month18 ]
    Patient questionnaire to be filled every month at home by the patient and the partner

  5. Number of reports deemed satisfactory [ Time Frame: Month18 ]
    Patient questionnaire to be filled every month at home by the patient and the partner

  6. Number of intracavernous injections performed per week [ Time Frame: Month18 ]
    Patient questionnaire to be filled every month at home by the patient and the partner

  7. Patient Activation Measure (questionnaire PAM) [ Time Frame: Month18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot Hospital for a Prostatectomy
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:

  • Aged over 18
  • presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips.
  • Having a normal preoperative erectile function defined by an EF (International Index of Erectile Function) score ≥ 26
  • affiliated to a social security scheme.
  • and having been informed and given informed consent to participation in the program.

Exclusion Criteria:

  • Preoperative score IIEF EF <26
  • Refusal of participation, signature of consent,
  • protected major patients, under guardianship or curators.
  • Patients unable to understand the course of the study
  • Patient with a documented history of cognitive or psychiatric disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572621


Contacts
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Contact: Jean-Etienne TERRIER, MD 04 72 67 88 01 ext +33 jean-etienne.terrier01@chu-lyon.fr

Locations
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France
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Jean-Etienne TERRIER, MD    04 72 67 88 01 ext +33    jean-etienne.terrier01@chu-lyon.fr   
Principal Investigator: Jean-Etienne TERRIER, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jean-Etienne TERRIER, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03572621     History of Changes
Other Study ID Numbers: 69HCL17_0010
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Prostatectomy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases