- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918082
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique (Qualibreast-MQ)
October 16, 2023 updated by: University Hospital Center of Martinique
Cancer and its treatments can be factors that alter the quality of life of patients.
The induced alteration of the quality of life can influence compliance and impact survival.
Considering the after-effects of the treatment, carrying out such a survey will provide for the first time precise information on the main determinants of the quality of life as well as on the care pathway of patients with invasive breast cancer in the Martinique region.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Breast cancer is the second most common cancer in the West Indies and the leading cancer in women.
With 215 new cases in Guadeloupe, 204 in Martinique and 56 in French Guiana each year, it accounts for 37%, 33% and 26% of incident cancer cases in women respectively, but also affects men.
Its incidence, lower than in France, is increasing over the period 2008-2014.
The diagnostic and therapeutic management of cancer can have an impact on the quality of life of patients, taking into account the adverse effects occurring during and after treatment, both in the short and long term.
The European Organisation for Research and Treatment of Cancer (EORTC) has developed a series of questionnaires to assess the quality of life of cancer patients, including a general questionnaire (QLQ-C30) and specific modules for breast cancer (EORTC BREAST (EORTC QLQ-BR23)) with the objective of improving professional practices.
Study Type
Observational
Enrollment (Actual)
133
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fort-de-France, Martinique, 97261
- CHU Martinique
-
-
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
Probability Sample
Study Population
Patients with breast cancer followed at the Martinique University Hospital
Description
Inclusion Criteria:
- Patient over 18 years of age residing in Martinique with invasive breast cancer diagnosed from 2020 (single tumor at diagnosis)
- Patients who have read the information note and have indicated that they do not wish to participate in the study
- Patient with social security coverage.
Exclusion Criteria:
- Refusal to participate
- Patient with insitu breast cancer
- Patient with a second cancer
- Patient with cancer within 5 years prior to inclusion
- Patient who could not answer quality of life questionnaires
- Patient not fluent in French
- Person under legal protection (safeguard of justice, guardianship, curators , etc.).
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: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of global disorders in patients with breast cancer
Time Frame: 12 months after diagnosis
|
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
|
12 months after diagnosis
|
Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients
Time Frame: 12 months after diagnosis
|
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
|
12 months after diagnosis
|
Assessment of global disorders in patients with breast cancer
Time Frame: 36 months after diagnosis
|
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
|
36 months after diagnosis
|
Assessment of disorders specific to breast cancer patients
Time Frame: 36 months after diagnosis
|
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
|
36 months after diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Clarisse JOACHIM-CONTARET, 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)
October 28, 2020
Primary Completion (Estimated)
December 28, 2025
Study Completion (Estimated)
June 28, 2026
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 8, 2021
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20_RIPH3_06
- 2020-A01290-39 (Other Identifier: DGS, Ministry of Health)
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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