Patients Seen at a Urology ConsultationCALIPSONCT02080793
STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
A study testing Questionnaire in people with Patients Seen at a Urology Consultation, run by Centre Hospitalier Universitaire Dijon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Patients Seen at a Urology Consultation
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 4 sitesFrance
- Study dates
- 25 May 2013to 28 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men:
- aged 50 to 70 years
- seen at a urology consultation
- able to understand written and spoken French
- who have provided written informed consent
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique St Marie
Chalon-sur-Saône, 71100
CHU de DIJON
Dijon, 21079
Hôpital TENON
Paris, 75020
CHU de TOURS
Tours, 37000
About this study
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:
Read more
- 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.
- Conditions
- Patients Seen at a Urology Consultation
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Patients phase pilote | Other | Not described Receives: Other: Questionnaire |
| Patients phase réelle | Other | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study start25 May 2013
- Primary completion28 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Seen at a Urology ConsultationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080793
- Sponsor's protocol ID
- LEJEUNE-CORMIER INCA 2012
- Acronym
- CALIPSO
- Status last verified
- May 2019
- First submitted
- 5 Mar 2014
- Last updated
- 7 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
- ClinicalTrials.gov ID
- NCT02080793
- Acronym / sponsor ID
- CALIPSO / LEJEUNE-CORMIER INCA 2012
- Conditions
- Patients Seen at a Urology Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 May 2013 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients phase pilote | Other | Other: Questionnaire |
| Patients phase réelle | Other | Other: Questionnaire |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 50 to 70 years
- seen at a urology consultation
- able to understand written and spoken French
- who have provided written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire | Other | Patients phase pilote, Patients phase réelle |
Primary outcome
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Patients Seen at a Urology Consultation, run by Centre Hospitalier Universitaire Dijon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.