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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Focus group creation; Other: Workshop

• Registration Number: NCT04048252
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-09-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-05
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focus group	Focus group creation	-
Workshop	Workshop	-

Primary Outcome Measures

Name	Time	Method
Create a focus group	Day 0	Transcribe interview and mark key points
Patient satisfaction	End of workshops (max 2 months)	Yes/no
Successful running of workshop	End of workshops (max 2 months)	Yes/no evaluated by the workshop leader

Secondary Outcome Measures

Name	Time	Method
Patient quality of life	1 month after last workshop	EQ-5D-3L
Patient knowledge of their disease	End of workshops (max 2 months)	In-house quiz: 7 multiple-choice questions
Patient-reported satisfaction of programme	End of workshops (max 2 months)	In-house questionnaire: 5 questions on 0-5 scale unsatisfied to very satisfied
Patient participation rate in workshops	End of workshops (max 2 months)
Patient-reported acceptability of programme	End of workshops (max 2 months)	In-house questionnaire: 4 questions on 0-5 scale unacceptable to very acceptable and 4 open questions
Patient medication adherence	End of workshops (max 2 months)	MMAS-9 questionnaire: good adherence is score = 8

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France