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

Sponsor

Direction Centrale du Service de Santé des Armées (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117696

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: Animated video

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
control group Standard announcement system
video reinforced announcment group standard announcement system reinforced by animated videos	Other: Animated video delivery of written and oral information, supported by animated videos.

Arm

Intervention/Treatment

control group

Standard announcement system

video reinforced announcment group

standard announcement system reinforced by animated videos

Other: Animated video

delivery of written and oral information, supported by animated videos.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Collection of the patient's non-opposition prior to participation in the study.
Patient aged ≥ 18 years at inclusion.
Patient with newly diagnosed advanced or metastatic prostate cancer.
Patients due to start systemic therapy.
Patients undergoing consultation.
Patient affiliated to a social security scheme.
Patient capable, according to the physician-investigator, of communicating well, understanding and complying with the requirements of the study.
Patient with a smartphone or computer to review the video at home.

Exclusion Criteria:

Patient related to any member of the study staff or having a close relationship or conflict of interest with the sponsor.
Patient to receive only local treatment.
Patient who does not understand French.
Clinical follow-up impossible for psychological, family, social or geographical reasons.
Vulnerable patient: deprived of liberty by judicial or administrative decision, adult subject to legal protection or unable to express non-opposition.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Hartmann	Neuilly-sur-Seine	France	92200
2	HIA Bégin	Saint-Mandé	France	94160
3	CHU Pointe-à-Pître	Pointe-à-Pitre	Guadeloupe	97159

Sponsors and Collaborators

Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Direction Centrale du Service de Santé des Armées

ClinicalTrials.gov Identifier:

NCT06117696

Other Study ID Numbers:

2022PPRC12
2023-A00446-39

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Direction Centrale du Service de Santé des Armées

prostate cancer advanced or metastatic

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Nov 7, 2023