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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Participation; Other: Therapeutic education; Other: Collection of data concerning their sexuality

• Registration Number: NCT03572621
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Study Start: 2020-02-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07
• Primary Completion: 2023-02
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partner	Participation	Patient's partner.
Experimental group	Therapeutic education	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).
Control group	Collection of data concerning their sexuality	Patient without therapeutic education.

Primary Outcome Measures

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

Name	Time	Method
Patient Activation Measure (questionnaire PAM)	Month18
Depression level measured by the Hospital Anxiety and Depression (HAD) scale	Month 6 and18
Sexual function	Month 1, 6, 12 and 18	Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
Penis size (cm)	Month 1, 6, 12 and 18
Knowledge acquisition measured by quizz build for the study made of simulated cases	Month 1, 6, 12 and 18
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale	Month 6 and18
Sexual quality of life of the partner	Month 1, 6, 12 and 18	Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
General quality of life	Month 1, 6, 12 and 18	Signing of questionnaire EuroQol-D5 (EQ-D5)
Number of erections obtained in the last month	Month 1, 6, 12 and 18	Patient questionnaire to be filled every month at home by the patient and the partner
Erection Hardness Score (EHS)	Month 1, 6, 12 and 18
Continence: urinary handicap measurement scale (MHU)	Month 1, 6, 12 and 18
Number of intracavernous injections performed per week	Month18	Patient questionnaire to be filled every month at home by the patient and the partner
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases	Month 1, 6, 12 and 18
Number of reports deemed satisfactory	Month 1, 6, 12 and 18	Patient questionnaire to be filled every month at home by the patient and the partner

Trial Locations

Locations (2)

Hôpital Hédouard Herriot; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France