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

NCT ID: NCT02080793

Last Updated: 2019-05-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-25

Brief Summary

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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

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Conditions

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Patients Seen at a Urology Consultation

Study Design

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Primary Study Purpose

OTHER

Study Groups

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Patients phase pilote

Group Type OTHER

Questionnaire

Intervention Type OTHER

Patients phase réelle

Group Type OTHER

Questionnaire

Intervention Type OTHER

Interventions

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Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique St Marie

Chalon-sur-Saône, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

Hôpital TENON

Paris, , France

Site Status

CHU de TOURS

Tours, , France

Site Status

Countries

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France

Other Identifiers

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LEJEUNE-CORMIER INCA 2012

Identifier Type: -

Identifier Source: org_study_id

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