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
• 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
• 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.).

Related Conditions & MeSH terms

• Breast Neoplasms
• Quality of Life
• Survivorship

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