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

Sponsor
University Hospital Center of Martinique (Other)
Overall Status
Recruiting
CT.gov ID
NCT04918082
Collaborator
(none)
142
1
62
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life questionnaires

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 Design

Study Type:
Observational
Anticipated Enrollment :
142 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
Actual Study Start Date :
Oct 28, 2020
Anticipated Primary Completion Date :
Oct 28, 2023
Anticipated Study Completion Date :
Dec 28, 2025

Outcome Measures

Primary Outcome Measures

  1. Assessment of global disorders in patients with breast cancer [12 months after diagnosis]

    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30

  2. Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients [12 months after diagnosis]

    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23

  3. Assessment of global disorders in patients with breast cancer [36 months after diagnosis]

    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30

  4. Assessment of disorders specific to breast cancer patients [36 months after diagnosis]

    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Martinique Fort-de-France Martinique 97261

Sponsors and Collaborators

  • University Hospital Center of Martinique

Investigators

  • Principal Investigator: Clarisse JOACHIM-CONTARET, CHU Martinique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Center of Martinique
ClinicalTrials.gov Identifier:
NCT04918082
Other Study ID Numbers:
  • 20_RIPH3_06
  • 2020-A01290-39
First Posted:
Jun 8, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Center of Martinique
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022