NCT02080793

Brief Summary

This study will be based on two questionnaires

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
652

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2016

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3.1 years

First QC Date

March 5, 2014

Last Update Submit

May 6, 2019

Conditions

Patients Seen at a Urology Consultation

Outcome Measures

Primary Outcomes (1)

  • Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.

    Baseline

Study Arms (2)

Patients phase pilote

OTHER
Other: Questionnaire

Patients phase réelle

OTHER
Other: Questionnaire

Interventions

QuestionnaireOTHER
Patients phase pilotePatients phase réelle

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique St Marie

Chalon-sur-Saône, 71100, France

Location

CHU de DIJON

Dijon, 21079, France

Location

Hôpital TENON

Paris, 75020, France

Location

CHU de TOURS

Tours, 37000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Purpose
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 6, 2014

Study Start

May 25, 2013

Primary Completion

June 28, 2016

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

FR(4)