Quality of Life in Prostate Cancer Patients (QoLProstateMQ)

October 16, 2023 updated by: University Hospital Center of Martinique

Quality of Life in Prostate Cancer Patients: Challenges and Prospects for Reducing Disparities in the Caribbean

Recording cancer data in cancer registries is essential for producing reliable population-based data for service planning, monitoring and evaluation. Prostate cancer (PCa) remains the most frequent type of cancer in terms of incidence and mortality in men in the Caribbean. The quality of life PCa cohort will assess quality of life and patient outcomes in Martinique using a digital platform for patient-reported outcome measures.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The Martinique Cancer Registry database is the largest clinical database among the French population-based cancer registries in the Caribbean, including more than 38 000 cancer cases, with 1650 new cancer cases per year, including 550 new PCa cases per year (2010-2014 latest period). In 2020, follow-up will include vital status, assessment of quality of life with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 and the Prostate cancer module QLQ-PR25. Urinary incontinence and erectile dysfunction recorded prior to treatment will be analysed 1, 3 and 5 years after treatment.

Study Type

Observational

Enrollment (Estimated)

304

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 Contact Backup

Study Locations

  • Martinique
      • Fort de France, Martinique
        • Recruiting
        • CHU de Martinique
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

Patients with prostate cancer diagnosed in Martinique in differents units care.

Description

Inclusion Criteria:

  • Age>18 years and residing in Martinique, with prostate cancer diagnosed from 2020
  • The patient has provided informed consent
  • Patient with social security coverage

Exclusion Criteria:

  • Refusal to participate
  • Patient with a second cancer, five years after diagnosis
  • Patient who could not answer the quality of life questionnaires
  • Patient not fluent in French
  • Person under legal protection

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of overall Quality of Life: Questionnaire
Time Frame: At the date of diagnosis of the disease, at 1 year, 3 years and 5 years
Change of quality of life questionnaire related to sexual dysfunction
At the date of diagnosis of the disease, at 1 year, 3 years and 5 years
Evaluation of overall Quality of Life: Questionnaire
Time Frame: At the date of diagnosis of the disease, at 1 year, 3 years and 5 years
Change of quality of life questionnaire related to urinary troubles
At the date of diagnosis of the disease, at 1 year, 3 years and 5 years

Collaborators and Investigators

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

Sponsor

University Hospital Center of Martinique

Collaborators

European Regional Development Fund

Investigators

  • Study Director: Clarisse CONTARET-JOACHIM, CHU Martinique

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)

May 6, 2020

Primary Completion (Estimated)

May 6, 2025

Study Completion (Estimated)

May 6, 2027

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19_RIPH3_08
  • 2019-A02116-51 (Other Identifier: ANSM)

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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