NCT04048252
Completed
Not Applicable
Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study
Centre Hospitalier Universitaire de Nīmes1 site in 1 country18 target enrollmentSeptember 10, 2019
ConditionsProstate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Focus group creation
- Conditions
- Prostate Cancer
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Create a focus group
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Focus group
Intervention: Focus group creation
Workshop
Intervention: Workshop
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Patient quality of life(1 month after last workshop)
- Patient knowledge of their disease(End of workshops (max 2 months))
- Patient-reported satisfaction of programme(End of workshops (max 2 months))
- Patient-reported acceptability of programme(End of workshops (max 2 months))
- Patient medication adherence(End of workshops (max 2 months))
- Patient participation rate in workshops(End of workshops (max 2 months))
Study Sites (1)
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