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Completed

NCT Number: NCT04048252

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus group creation

Other

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

Workshop

Other

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

Primary outcomes

  1. Create a focus group

    Time frame: Day 0

    Transcribe interview and mark key points

  2. Patient satisfaction

    Time frame: End of workshops (max 2 months)

    Yes/no

  3. Successful running of workshop

    Time frame: End of workshops (max 2 months)

    Yes/no evaluated by the workshop leader

Secondary outcomes

  1. Patient participation rate in workshops

    Time frame: End of workshops (max 2 months)

    %

  2. Patient-reported acceptability of programme

    Time frame: End of workshops (max 2 months)

    In-house questionnaire: 4 questions on 0-5 scale unacceptable to very acceptable and 4 open questions

  3. Patient-reported satisfaction of programme

    Time frame: End of workshops (max 2 months)

    In-house questionnaire: 5 questions on 0-5 scale unsatisfied to very satisfied

  4. Patient knowledge of their disease

    Time frame: End of workshops (max 2 months)

    In-house quiz: 7 multiple-choice questions

  5. Patient quality of life

    Time frame: 1 month after last workshop

    EQ-5D-3L

  6. Patient medication adherence

    Time frame: End of workshops (max 2 months)

    MMAS-9 questionnaire: good adherence is score = 8

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: PROSTED

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2019
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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