Prostate CancerCartDiagPROSTNCT06117696
Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
An observational study of Prostate Cancer, run by Direction Centrale du Service de Santé des Armées at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Animated video
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2024to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with newly diagnosed advanced or metastatic prostate cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Clinique Hartmann
Neuilly-sur-Seine, 92200
Anatole Cessot
HIA Bégin
Saint-Mandé, 94160
Carol Helissey, 01 43 98 50 00, carole.helissey@intradef.gouv.fr
About this study
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
- Being tested
- Animated video
- Keywords
- prostate cancer advanced or metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated videoOther
delivery of written and oral information, supported by animated videos.
| Study group | Role | What they receive |
|---|---|---|
| control group | Standard announcement system | |
| video reinforced announcment group | standard announcement system reinforced by animated videos Receives: Other: Animated video |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-INFO25 score
overall score of the EORTC QLQ-INFO25 questionnaire at D0 and D30 completed by the patient in each group
Measured: Through study completion (30 days)
Secondary outcomes (1)
EORTC QLQ-INFO25 score differences
difference in EORTC QLQ-INFO25 global score between D0 and D30 in each group
Measured: Through study completion (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startMar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117696
- Sponsor's protocol ID
- 2022PPRC12
- Other IDs
- 2023-A00446-39
- Acronym
- CartDiagPROST
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
- ClinicalTrials.gov ID
- NCT06117696
- Acronym / sponsor ID
- CartDiagPROST / 2022PPRC12
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer advanced or metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Standard announcement system |
| video reinforced announcment group | – | Other: Animated videostandard announcement system reinforced by animated videos |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with newly diagnosed advanced or metastatic prostate cancer
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animated videodelivery of written and oral information, supported by animated videos. | Other | video reinforced announcment group |
Primary outcome
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
1 secondary outcome
EORTC QLQ-INFO25 score differences
Time frame: Through study completion (30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Direction Centrale du Service de Santé des Armées at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carole Helissey (01 43 98 50 00, carole.helissey@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-INFO25 score (time frame: Through study completion (30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.