Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Animated video

• Registration Number: NCT06117696
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Start: 2024-03
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
video reinforced announcment group	Animated video	standard announcement system reinforced by animated videos

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-INFO25 score	Through study completion (30 days)	overall score of the EORTC QLQ-INFO25 questionnaire at D0 and D30 completed by the patient in each group

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-INFO25 score differences	Through study completion (30 days)	difference in EORTC QLQ-INFO25 global score between D0 and D30 in each group

Trial Locations

Locations (3)

HIA Bégin; 🇫🇷 Saint-Mandé, France

CHU Pointe-à-Pître; 🇬🇵 Pointe-à-Pitre, Guadeloupe

Clinique Hartmann; 🇫🇷 Neuilly-sur-Seine, France