NCT Number: NCT02080793
STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
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.
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Notify MeKey information
Conditions
Age range
50 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Clinique St Marie, Chalon-sur-Saône, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.
Time frame: Baseline
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Acronym: CALIPSO
Important dates
- Study start
- 2013
- Primary completion
- 2016
- First posted
- Mar 6, 2014
- Registry last updated
- May 7, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.