Prostate Cancer Clinical Trial
— PROSTEDOfficial 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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nimes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Create a focus group | Transcribe interview and mark key points | Day 0 | |
Primary | Patient satisfaction | Yes/no | End of workshops (max 2 months) | |
Primary | Successful running of workshop | Yes/no evaluated by the workshop leader | End of workshops (max 2 months) | |
Secondary | Patient participation rate in workshops | End of workshops (max 2 months) | ||
Secondary | Patient-reported acceptability of programme | In-house questionnaire: 4 questions on 0-5 scale unacceptable to very acceptable and 4 open questions | End of workshops (max 2 months) | |
Secondary | Patient-reported satisfaction of programme | In-house questionnaire: 5 questions on 0-5 scale unsatisfied to very satisfied | End of workshops (max 2 months) | |
Secondary | Patient knowledge of their disease | In-house quiz: 7 multiple-choice questions | End of workshops (max 2 months) | |
Secondary | Patient quality of life | EQ-5D-3L | 1 month after last workshop | |
Secondary | Patient medication adherence | MMAS-9 questionnaire: good adherence is score = 8 | End of workshops (max 2 months) |
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