Prostate CancerPROSTEDNCT04048252
Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy
An observational study of Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focus group creation and Workshop
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2019to 5 Jul 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic prostate cancer and receiving next-generation hormone therapy
Who may be able to join
- Patients with metastatic prostate cancer treated with enzalutamide or abiraterone acetate for at least 3 months
- The patient must have given their free and informed consent and signed the consent form
- The patient must be insured or the beneficiary of an insurance policy
Who cannot join
- The subject is not in a fit state to express their consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study
The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.
- Conditions
- Prostate Cancer
- Being tested
- Focus group creation, Workshop
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group creationOther
Patients will join with researchers for a 2 hour recorded group discussion to highlight themes identified to require educational intervention
WorkshopOther
Patients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition
| Study group | Role | What they receive |
|---|---|---|
| Focus group | Not described Receives: Other: Focus group creation | |
| Workshop | Not described Receives: Other: Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a focus group
Transcribe interview and mark key points
Measured: Day 0
Patient satisfaction
Yes/no
Measured: End of workshops (max 2 months)
Successful running of workshop
Yes/no evaluated by the workshop leader
Measured: End of workshops (max 2 months)
Secondary outcomes (6)
Patient participation rate in workshops
%
Measured: End of workshops (max 2 months)
Patient-reported acceptability of programme
In-house questionnaire: 4 questions on 0-5 scale unacceptable to very acceptable and 4 open questions
Measured: End of workshops (max 2 months)
Patient-reported satisfaction of programme
In-house questionnaire: 5 questions on 0-5 scale unsatisfied to very satisfied
Measured: End of workshops (max 2 months)
Patient knowledge of their disease
In-house quiz: 7 multiple-choice questions
Measured: End of workshops (max 2 months)
Patient quality of life
EQ-5D-3L
Measured: 1 month after last workshop
Patient medication adherence
MMAS-9 questionnaire: good adherence is score = 8
Measured: End of workshops (max 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start10 Sep 2019
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Houede, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048252
- Sponsor's protocol ID
- LOCAL/2019/NH-02
- Acronym
- PROSTED
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2019
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cuenant A, Eglin I, Ferreira V, Houede N. [Development of a therapeutic education program for prostate cancer patients undergoing new generation hormone therapy]. Bull Cancer. 2022 May;109(5):623-629. doi: 10.1016/j.bulcan.2021.11.014. Epub 2022 Jan 10. French.
PubMed 35027162
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study
- ClinicalTrials.gov ID
- NCT04048252
- Acronym / sponsor ID
- PROSTED / LOCAL/2019/NH-02
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 7 Aug 2019 (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.
The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus group | – | Other: Focus group creation |
| Workshop | – | Other: Workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic prostate cancer and receiving next-generation hormone therapy
Key inclusion criteria (3 listed)
- Patients with metastatic prostate cancer treated with enzalutamide or abiraterone acetate for at least 3 months
- The patient must have given their free and informed consent and signed the consent form
- The patient must be insured or the beneficiary of an insurance policy
Key exclusion criteria (3 listed)
- The subject is not in a fit state to express their consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
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 |
|---|---|---|
| Focus group creationPatients will join with researchers for a 2 hour recorded group discussion to highlight themes identified to require educational intervention | Other | Focus group |
| WorkshopPatients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition | Other | Workshop |
Primary outcome
Create a focus group
Time frame: Day 0
Transcribe interview and mark key points
Patient satisfaction
Time frame: End of workshops (max 2 months)
Yes/no
Successful running of workshop
Time frame: End of workshops (max 2 months)
Yes/no evaluated by the workshop leader
6 secondary outcomes
Patient participation rate in workshops
Time frame: End of workshops (max 2 months)
Patient-reported acceptability of programme
Time frame: End of workshops (max 2 months)
Patient-reported satisfaction of programme
Time frame: End of workshops (max 2 months)
Patient knowledge of their disease
Time frame: End of workshops (max 2 months)
Patient quality of life
Time frame: 1 month after last workshop
Patient medication adherence
Time frame: End of workshops (max 2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Results publication: PubMed 35027162Cuenant A, Eglin I, Ferreira V, Houede N. [Development of a therapeutic education program for prostate cancer patients undergoing new generation hormone therapy]. Bull Cancer. 2022 May;109(5):623-629. doi: 10.1016/j.bulcan.2021.11.014. Epub 2022 Jan 10. French.
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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.
Nadine Houede principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a focus group (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048252, which also lists 1 linked publication.
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 18 Feb 2026.