Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
NCT ID: NCT03572621
Last Updated: 2022-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2020-02-03
2024-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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).
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.
Control group
Patient without therapeutic education.
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.
Participation
Participation in a therapeutic education day.
Interventions
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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.
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).
Participation
Participation in a therapeutic education day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Jean-Etienne TERRIER, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital Hédouard Herriot
Lyon, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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CUZIN Béatrice, MD
Role: primary
Other Identifiers
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69HCL17_0010
Identifier Type: -
Identifier Source: org_study_id
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