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

NCT ID: NCT06117696

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2024-10-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

Standard announcement system

No interventions assigned to this group

video reinforced announcment group

standard announcement system reinforced by animated videos

Animated video

Intervention Type OTHER

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

Interventions

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Animated video

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Hartmann

Neuilly-sur-Seine, , France

Site Status

HIA Bégin

Saint-Mandé, , France

Site Status

CHU Pointe-à-Pître

Pointe-à-Pitre, , Guadeloupe

Site Status

Countries

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France Guadeloupe

Central Contacts

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Carole Helissey

Role: CONTACT

01 43 98 50 00

Facility Contacts

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Anatole Cessot

Role: primary

Carol Helissey

Role: primary

01 43 98 50 00

Laurent Brureau

Role: primary

Other Identifiers

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2023-A00446-39

Identifier Type: OTHER

Identifier Source: secondary_id

2022PPRC12

Identifier Type: -

Identifier Source: org_study_id

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