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

October 31, 2023 updated by: Direction Centrale du Service de Santé des Armées

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Neuilly-sur-Seine, France, 92200
        • Clinique Hartmann
        • Contact:
          • Anatole Cessot
      • Saint-Mandé, France, 94160
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe, 97159
        • CHU Pointe-à-Pitre
        • Contact:
          • Laurent Brureau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with newly diagnosed advanced or metastatic prostate cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-INFO25 score
Time Frame: Through study completion (30 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-INFO25 score differences
Time Frame: Through study completion (30 days)
difference in EORTC QLQ-INFO25 global score between D0 and D30 in each group
Through study completion (30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PPRC12
  • 2023-A00446-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe