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Not yet recruitingNCT06117696CartDiagPROSTUpdated Nov 7, 2023

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

An observational study in Prostate Cancer, sponsored by Direction Centrale du Service de Santé des Armées. Not yet recruiting at 3 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

Keywords

  • prostate cancer advanced or metastatic
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In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 90 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with newly diagnosed advanced or metastatic prostate cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • control group

    Standard announcement system

  • video reinforced announcment group

    standard announcement system reinforced by animated videos

    Other: Animated video

Interventions

  • OtherAnimated video

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

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What researchers measure

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

    Time frame: 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

    Time frame: Through study completion (30 days)

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Study locations

3 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2024; primary completion for Oct 2024, 7 months later.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 7 months is below that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2023
First posted
Nov 7, 2023
StartEst.
Mar 2024
Primary completionEst.
Oct 2024
CompletionEst.
Oct 2024
Last update
Nov 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06117696
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Mar 2024 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Carole Helissey
Contact
carole.helissey@intradef.gouv.fr
01 43 98 50 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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