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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic education
Collection of data concerning their sexuality
Participation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring Prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
  • affiliated to a social security scheme.
  • and having been informed and given informed consent to participation in the program.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hôpital Hédouard HerriotRecruiting
  • Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Experimental group

Control group

Partner

Arm Description

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).

Patient without therapeutic education.

Patient's partner.

Outcomes

Primary Outcome Measures

Change the quality of sexual life of patients treated with radical prostatectomy (PR)
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

Sexual function
Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
General quality of life
Signing of questionnaire EuroQol-D5 (EQ-D5)
Sexual quality of life of the partner
Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
Number of erections obtained in the last month
Patient questionnaire to be filled every month at home by the patient and the partner
Number of reports deemed satisfactory
Patient questionnaire to be filled every month at home by the patient and the partner
Number of intracavernous injections performed per week
Patient questionnaire to be filled every month at home by the patient and the partner
Patient Activation Measure (questionnaire PAM)
Erection Hardness Score (EHS)
Continence: urinary handicap measurement scale (MHU)
Penis size (cm)
Knowledge acquisition measured by quizz build for the study made of simulated cases
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
Depression level measured by the Hospital Anxiety and Depression (HAD) scale

Full Information

First Posted
June 4, 2018
Last Updated
March 4, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03572621
Brief Title
Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Acronym
PRODUCAN
Official Title
Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patient without therapeutic education.
Arm Title
Partner
Arm Type
Other
Arm Description
Patient's partner.
Intervention Type
Other
Intervention Name(s)
Therapeutic education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of data concerning their sexuality
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Participation
Intervention Description
Participation in a therapeutic education day.
Primary Outcome Measure Information:
Title
Change the quality of sexual life of patients treated with radical prostatectomy (PR)
Description
Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Sexual function
Description
Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
Time Frame
Month 1, 6, 12 and 18
Title
General quality of life
Description
Signing of questionnaire EuroQol-D5 (EQ-D5)
Time Frame
Month 1, 6, 12 and 18
Title
Sexual quality of life of the partner
Description
Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
Time Frame
Month 1, 6, 12 and 18
Title
Number of erections obtained in the last month
Description
Patient questionnaire to be filled every month at home by the patient and the partner
Time Frame
Month 1, 6, 12 and 18
Title
Number of reports deemed satisfactory
Description
Patient questionnaire to be filled every month at home by the patient and the partner
Time Frame
Month 1, 6, 12 and 18
Title
Number of intracavernous injections performed per week
Description
Patient questionnaire to be filled every month at home by the patient and the partner
Time Frame
Month18
Title
Patient Activation Measure (questionnaire PAM)
Time Frame
Month18
Title
Erection Hardness Score (EHS)
Time Frame
Month 1, 6, 12 and 18
Title
Continence: urinary handicap measurement scale (MHU)
Time Frame
Month 1, 6, 12 and 18
Title
Penis size (cm)
Time Frame
Month 1, 6, 12 and 18
Title
Knowledge acquisition measured by quizz build for the study made of simulated cases
Time Frame
Month 1, 6, 12 and 18
Title
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
Time Frame
Month 1, 6, 12 and 18
Title
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
Time Frame
Month 6 and18
Title
Depression level measured by the Hospital Anxiety and Depression (HAD) scale
Time Frame
Month 6 and18

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot Hospital for a Prostatectomy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. affiliated to a social security scheme. and having been informed and given informed consent to participation in the program. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien CARNICELLI, MD
Phone
04 72 67 88 01
Ext
+33
Email
damien.carnicelli@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Etienne TERRIER, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Hédouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CUZIN Béatrice, MD
First Name & Middle Initial & Last Name & Degree
Béatrice CUZIN, MD
First Name & Middle Initial & Last Name & Degree
Marc COLOMBEL, MD
First Name & Middle Initial & Last Name & Degree
Lionel BADET, MD
First Name & Middle Initial & Last Name & Degree
Sébastien CROUZET, MD
First Name & Middle Initial & Last Name & Degree
Ricardo CODAS DUARTE, MD
First Name & Middle Initial & Last Name & Degree
Emilien SEIZILLES DE MAZANCOURT, MD
First Name & Middle Initial & Last Name & Degree
Xavier MATILLON, MD
First Name & Middle Initial & Last Name & Degree
Hakim FASSI-FEHRI, MD
First Name & Middle Initial & Last Name & Degree
Haixia YE, MD
First Name & Middle Initial & Last Name & Degree
Said OURFALI, MD
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien CARNICELLI, MD
Email
damien.carnicelli@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Damien CARNICELLI, MD
First Name & Middle Initial & Last Name & Degree
Nicolas MOREL-JOURNEL, MD
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, MD

12. IPD Sharing Statement

Learn more about this trial

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

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