Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 6:29 PM
Study NCT ID:
NCT02080793
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALIPSO
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: