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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

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