Skip to main content
OpenTrials
Completed

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.

Completed

Looking for future studies?

Notify Me

Key information

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

Loading trial locations.

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

Questionnaire

Other

Primary outcomes

  1. 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.