Quality of Life in Prostate Cancer Patients

Prostate Cancer Clinical Trial

— QoLProstateMQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357925
• Other study ID #: 19_RIPH3_08
• Secondary ID: 2019-A02116-51
• Status: Recruiting
• Start date: May 6, 2020
• Est. completion date: May 6, 2027

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: Clarisse CONTARET-JOACHIM
• Phone: +596 596 55 96 74
• Email: Clarisse.JOACHIM[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: May 6, 2027
• Est. primary completion date: May 6, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Martinique	CHU de Martinique	Fort de France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	European Regional Development Fund

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of overall Quality of Life: Questionnaire	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
Primary	Evaluation of overall Quality of Life: Questionnaire	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