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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT02080793

Collaborator

(none)

652

Enrollment

Locations

Arms

163

Patients Per Site

Study Details

Study Description

Brief Summary

This study will be based on two questionnaires

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.

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

Condition or Disease	Intervention/Treatment	Phase
Patients Seen at a Urology Consultation	Other: Questionnaire	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

652 participants

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 25, 2013

Actual Primary Completion Date :

Jun 28, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Patients phase pilote

Other: Questionnaire

Other: Patients phase réelle

Other: Questionnaire

Outcome Measures

Primary Outcome Measures

Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients. [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique St Marie	Chalon-sur-saone	France	71100
2	CHU de DIJON	Dijon	France	21079
3	Hôpital TENON	Paris	France	75020
4	CHU de TOURS	Tours	France	37000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02080793

Other Study ID Numbers:

LEJEUNE-CORMIER INCA 2012

First Posted:

Mar 6, 2014

Last Update Posted:

May 7, 2019

Last Verified:

May 1, 2019

Study Results

No Results Posted as of May 7, 2019