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

September 20, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nîmes, France, 30029
        • Recruiting
        • CHU de Nimes
        • Principal Investigator:
          • Nadine Houede
        • Sub-Investigator:
          • Alice Cuenant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Focus group
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
Other: Workshop
Patients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient participation rate in workshops
Time Frame: End of workshops (max 2 months)
End of workshops (max 2 months)
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
End of workshops (max 2 months)
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
End of workshops (max 2 months)
Patient knowledge of their disease
Time Frame: End of workshops (max 2 months)
In-house quiz: 7 multiple-choice questions
End of workshops (max 2 months)
Patient quality of life
Time Frame: 1 month after last workshop
EQ-5D-3L
1 month after last workshop
Patient medication adherence
Time Frame: End of workshops (max 2 months)
MMAS-9 questionnaire: good adherence is score = 8
End of workshops (max 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Nadine Houede, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2019/NH-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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