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NCT04918082 Clinical Trial

Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique

Quality of Life Clinical Trial

— Qualibreast-MQ  

Official title:
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04918082
Other study ID # 20_RIPH3_06
Secondary ID 2020-A01290-39
Status Active, not recruiting
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date June 28, 2026

Study information
Verified date October 2023
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 133
Est. completion date June 28, 2026
Est. primary completion date December 28, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Quality of life questionnaires
Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.

Locations
Country Name City State
Martinique CHU Martinique Fort-de-France

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of global disorders in patients with breast cancer Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30 12 months after diagnosis
Primary Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23 12 months after diagnosis
Primary Assessment of global disorders in patients with breast cancer Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30 36 months after diagnosis
Primary Assessment of disorders specific to breast cancer patients Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23 36 months after diagnosis
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