NCT04918082

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2020Mar 2027

Study Start

First participant enrolled

October 28, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

June 2, 2021

Last Update Submit

March 26, 2026

Conditions

Breast NeoplasmsQuality of LifeSurvivorship

Keywords

Breast cancerQuality of lifeSurvivorshipSurvivalFrench West Indies

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Interventions

Quality of life questionnairesOTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with breast cancer followed at the Martinique University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate
  • Patient with insitu breast cancer
  • Patient with a second cancer
  • Patient who could not answer quality of life questionnaires
  • Patient not fluent in French
  • Person under legal protection (safeguard of justice, guardianship, curators , etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clarisse JOACHIM-CONTARET

    CHU Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

October 28, 2020

Primary Completion

January 20, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

MA(1)