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

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.

Study Overview

• Status: Completed
• Conditions: Patients Seen at a Urology Consultation
• Intervention / Treatment: Other: Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chalon-sur-saone, France, 71100
    • Clinique St Marie
  • Dijon, France, 21079
    • CHU de Dijon
  • Paris, France, 75020
    • Hopital Tenon
  • Tours, France, 37000
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients phase pilote	Other: Questionnaire
Other: Patients phase réelle	Other: Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2013
• Primary Completion (Actual): June 28, 2016

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: LEJEUNE-CORMIER INCA 2012