STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS

Not Applicable

Completed

• Conditions: Patients Seen at a Urology Consultation
• Interventions: Other: Questionnaire

• Registration Number: NCT02080793
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

This study will be based on two questionnaires

1. One specific questionnaire that has already been developed from social sciences interviews conducted in men who have been treated for localized prostrate cancer, with a good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each scenario gathers in a random manner, the modalities of 7 possible characteristics of the management strategy for localized prostrate cancer, with a good or intermediate prognosis:

* the risk of death at 5 years (modalities: 5%, 15%),

* the risk of impotence (modalities: 0%, 25%, 50%, 75%),

* the presence of urinary leaks (modalities: no protection during the day, one protection pad per day, several protection pads per day),

* the duration and frequency of care provided (modalities: 2 days of care in your whole life, 7 days of care in your whole life, 5 half-days of care per week for 8 weeks, every 3 months for 2 years then every 6 months for life),

* ablation of the prostate (modalities: Yes, No),

* the existence of possible treatments in case of aggravation or recurrence (modalities: Yes, No),

* the nature of the technology used (modalities: innovative technology, standard technology).

The objective is to ask each participant of the study for each pair of scenarios, to choose from the two scenarios (binary-choice survey), the scenario he prefers.

2. The "Spielberger Inventory Trait" scale to evaluate stable characteristics in the propensity to anxiety in study participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-25
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2016-06-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

Men:

• aged 50 to 70 years
• seen at a urology consultation
• able to understand written and spoken French
• who have provided written informed consent

Exclusion Criteria

Men:

• under guardianship or wards of court
• who have already been diagnosed withor treated for prostrate cancer
• with recently diagnosed cancer or on treatment for this cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients phase pilote	Questionnaire	-
Patients phase réelle	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.	Baseline

Trial Locations

Locations (4)

Clinique St Marie; 🇫🇷 Chalon-sur-saone, France

Hôpital TENON; 🇫🇷 Paris, France

CHU de DIJON; 🇫🇷 Dijon, France

CHU de TOURS; 🇫🇷 Tours, France