Skip to content

Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy

Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04048252
Acronym
PROSTED
Enrollment
18
Registered
2019-08-07
Start date
2019-09-10
Completion date
2021-07-05
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

Interventions

OTHERFocus group creation

Patients will join with researchers for a 2 hour recorded group discussion to highlight themes identified to require educational intervention

Patients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfactionEnd of workshops (max 2 months)Yes/no
Successful running of workshopEnd of workshops (max 2 months)Yes/no evaluated by the workshop leader
Create a focus groupDay 0Transcribe interview and mark key points

Secondary

MeasureTime frameDescription
Patient-reported acceptability of programmeEnd of workshops (max 2 months)In-house questionnaire: 4 questions on 0-5 scale unacceptable to very acceptable and 4 open questions
Patient medication adherenceEnd of workshops (max 2 months)MMAS-9 questionnaire: good adherence is score = 8
Patient-reported satisfaction of programmeEnd of workshops (max 2 months)In-house questionnaire: 5 questions on 0-5 scale unsatisfied to very satisfied
Patient participation rate in workshopsEnd of workshops (max 2 months)%
Patient knowledge of their diseaseEnd of workshops (max 2 months)In-house quiz: 7 multiple-choice questions
Patient quality of life1 month after last workshopEQ-5D-3L

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNadine Houede

CHU Nimes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026