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

Prostate Cancer Clinical Trial

— CartDiagPROST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117696
• Other study ID #: 2022PPRC12
• Secondary ID: 2023-A00446-39
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Carole Helissey
• Phone: 01 43 98 50 00
• Email: carole.helissey[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Animated video
delivery of written and oral information, supported by animated videos.

Locations

Country	Name	City	State
France	Clinique Hartmann	Neuilly-sur-Seine
France	HIA Bégin	Saint-Mandé
Guadeloupe	CHU Pointe-à-Pître	Pointe-à-Pitre

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-INFO25 score	overall score of the EORTC QLQ-INFO25 questionnaire at D0 and D30 completed by the patient in each group	Through study completion (30 days)
Secondary	EORTC QLQ-INFO25 score differences	difference in EORTC QLQ-INFO25 global score between D0 and D30 in each group	Through study completion (30 days)