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

Prostate Cancer Clinical Trial

— PROSTED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048252
• Other study ID #: LOCAL/2019/NH-02
• Status: Recruiting
• Start date: September 10, 2019
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Nadine Houede
• Phone: 04.66.68.33.01
• Email: nadine.houede[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Focus group creation
Patients will join with researchers for a 2 hour recorded group discussion to highlight themes identified to require educational intervention
• Workshop
Patients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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)