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

NCT03572621 | Unknown

• 1 other identifier: 69HCL17_0010
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (14)

• Sexual function

  Month 1, 6, 12 and 18

• General quality of life

  Month 1, 6, 12 and 18

• Sexual quality of life of the partner

  Month 1, 6, 12 and 18

• Number of erections obtained in the last month

  Month 1, 6, 12 and 18

• Number of reports deemed satisfactory

  Month 1, 6, 12 and 18

Study Arms (3)

Experimental group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

Patient without therapeutic education.

Other: Collection of data concerning their sexuality

Partner

OTHER

Patient's partner.

Other: Participation

Interventions

Therapeutic education OTHER

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.

Experimental group

Collection of data concerning their sexuality OTHER

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).

Control group

Participation OTHER

Participation in a therapeutic education day.

Partner

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot Hospital for a Prostatectomy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Hédouard Herriot

Lyon, 69003, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Etienne TERRIER, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien CARNICELLI, MD

CONTACT

04 72 67 88 01; damien.carnicelli@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 28, 2018
• Study Start: February 3, 2020
• Primary Completion: February 1, 2023
• Study Completion: September 1, 2024
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

FR (2)