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Trial Title:
Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
NCT ID:
NCT06117696
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer advanced or metastatic
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Animated video
Description:
delivery of written and oral information, supported by animated videos.
Arm group label:
video reinforced announcment group
Summary:
In hospitals, the standard prostate cancer announcement system is based on oral and
written information. To improve this system, we have developed animated videos that
retrace the patient's care path.
This is an exploratory, controlled, before-and-after, multicenter study designed to
assess the effect of a standard announcement system reinforced by animated videos on
patients' level of understanding of prostate cancer diagnosis and treatment. Patients'
perception of information will be assessed using the EORTC QLQ-INFO25 questionnaire.
Criteria for eligibility:
Study pop:
Patient with newly diagnosed advanced or metastatic prostate cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Collection of the patient's non-opposition prior to participation in the study.
2. Patient aged ≥ 18 years at inclusion.
3. Patient with newly diagnosed advanced or metastatic prostate cancer.
4. Patients due to start systemic therapy.
5. Patients undergoing consultation.
6. Patient affiliated to a social security scheme.
7. Patient capable, according to the physician-investigator, of communicating well,
understanding and complying with the requirements of the study.
8. Patient with a smartphone or computer to review the video at home.
Exclusion Criteria:
1. Patient related to any member of the study staff or having a close relationship or
conflict of interest with the sponsor.
2. Patient to receive only local treatment.
3. Patient who does not understand French.
4. Clinical follow-up impossible for psychological, family, social or geographical
reasons.
5. Vulnerable patient: deprived of liberty by judicial or administrative decision,
adult subject to legal protection or unable to express non-opposition.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Hartmann
Address:
City:
Neuilly-sur-Seine
Zip:
92200
Country:
France
Contact:
Last name:
Anatole Cessot
Facility:
Name:
HIA Bégin
Address:
City:
Saint-Mandé
Zip:
94160
Country:
France
Contact:
Last name:
Carol Helissey
Phone:
01 43 98 50 00
Email:
carole.helissey@intradef.gouv.fr
Facility:
Name:
CHU Pointe-à-Pître
Address:
City:
Pointe-à-Pitre
Zip:
97159
Country:
Guadeloupe
Contact:
Last name:
Laurent Brureau
Start date:
March 2024
Completion date:
October 2024
Lead sponsor:
Agency:
Direction Centrale du Service de Santé des Armées
Agency class:
Other
Source:
Direction Centrale du Service de Santé des Armées
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117696