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

NCT06117696 | Unknown

• 2 other identifiers: 2022PPRC122023-A00446-39
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

prostate cancer advanced or metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EORTC QLQ-INFO25 score differences

  Through study completion (30 days)

Study Arms (2)

control group

Standard announcement system

video reinforced announcment group

standard announcement system reinforced by animated videos

Other: Animated video

Interventions

Animated video OTHER

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

video reinforced announcment group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with newly diagnosed advanced or metastatic prostate cancer

You may qualify if:

• Collection of the patient's non-opposition prior to participation in the study.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (3)

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

HIA Bégin

Saint-Mandé, 94160, France

Location

CHU Pointe-à-Pître

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carole Helissey

CONTACT

01 43 98 50 00; carole.helissey@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); FR (2)