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

NCT04048252 | Completed

• 1 other identifier: LOCAL/2019/NH-02
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Create a focus group

  Transcribe interview and mark key points

  Day 0

• Patient satisfaction

  Yes/no

  End of workshops (max 2 months)

• Successful running of workshop

  Yes/no evaluated by the workshop leader

  End of workshops (max 2 months)

Secondary Outcomes (6)

• Patient participation rate in workshops

  End of workshops (max 2 months)

• Patient-reported acceptability of programme

  End of workshops (max 2 months)

• Patient-reported satisfaction of programme

  End of workshops (max 2 months)

• Patient knowledge of their disease

  End of workshops (max 2 months)

• Patient quality of life

  1 month after last workshop

Study Arms (2)

Focus group

Other: Focus group creation

Workshop

Other: Workshop

Interventions

Focus group creation OTHER

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

Focus group

Workshop OTHER

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

Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic prostate cancer and receiving next-generation hormone therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Cuenant A, Eglin I, Ferreira V, Houede N. [Development of a therapeutic education program for prostate cancer patients undergoing new generation hormone therapy]. Bull Cancer. 2022 May;109(5):623-629. doi: 10.1016/j.bulcan.2021.11.014. Epub 2022 Jan 10. French.

  PMID: 35027162 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nadine Houede

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: September 10, 2019
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (1)