Summary

for females ages 18 years and up (full criteria)
at Bondy,and other locations
study started
estimated completion:

Description

Summary

Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context. Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation. The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient. These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.

Official Title

Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area

Details

All patients seeking treatment for breast cancer, regardless of the stage, can be included in the study. Three scores of precariousness will be applied to all patients (EPICES score, Pascal score and the European Deprivation Index). Patients identified as precarious by at least one of those three scales will be in the exposed group. The others will be in the non-exposed group.

Baseline assessment T0:

Are required only the clinical examination and radiological evaluation with the tumor size and node involvement according to TNM classification. A questionnaire will be distributed including EPICES score, Pascal score and European Deprivation Index. The baseline questionnaire will also assess the socio-economic characteristics of patients and the care trajectory before arriving in the center (see appendix).

Follow-up visits:

The following questionnaire will be distributed during a consultation that is scheduled in the routine care. There will be no additional consultation imposed on the patient.

  • T1: questionnaire at 3 months after inclusion
  • T2: questionnaire at 6 months after inclusion
  • T3: questionnaire at 12 months after inclusion

Questionnaires will be focused on direct-costs and out-of-pocket costs, socio-economical characteristics, rehabilitation, return to work.

Keywords

Breast Cancer precariousness care pathways Breast Neoplasms Exposed Non exposed

Eligibility

You can join if…

Open to females ages 18 years and up

  • Patients ? 18 years old having a breast cancer histologically proved

You CAN'T join if...

  • Patients with a history of cancer treated in the previous five years, or with another associated untreated cancer

Locations

  • Hôpital Jean Verdier not yet accepting patients
    Bondy 94143 France
  • Centre Hopitalier Victor Dupouy Argenteuil in progress, not accepting new patients
    Argenteuil France
  • Centre Hospitalier de Pontoise accepting new patients
    Cergy-Pontoise France
  • Hopital Privé Paule Egine accepting new patients
    Champigny-sur-Marne France
  • CH Sud Francilien accepting new patients
    Corbeil-Essonnes France
  • Centre Hospitalier Intercommunal Créteil not yet accepting patients
    Creteil 94000 France
  • Hôpital Henri Mondor not yet accepting patients
    Créteil 94010 France
  • Clinique Claude Bernard accepting new patients
    Ermont France
  • CH de Lagny sur Marne accepting new patients
    Lagny-sur-Marne 77400 France
  • Hôpital Bicêtre accepting new patients
    Le Kremlin-Bicêtre France
  • Institut de Cancérologie Hartmann accepting new patients
    Levallois-Perret 92300 France
  • Institut Curie Hôpital de Paris not yet accepting patients
    Paris 75005 France
  • Hôpital Lariboisière accepting new patients
    Paris 75010 France
  • Hôpital Saint-Louis accepting new patients
    Paris 75010 France
  • Hôpital Privé des Peupliers accepting new patients
    Paris 75013 France
  • HEGP accepting new patients
    Paris 75015 France
  • Hôpital Tenon not yet accepting patients
    Paris 75020 France
  • Groupe Hospitalier Paris Saint-Joseph in progress, not accepting new patients
    Paris France
  • Centre Hospitalier Intercommunal Poissy Saint Germain en Laye accepting new patients
    Poissy 78300 France
  • Institut Curie Hôpital René-Huguenin site Saint-Cloud not yet accepting patients
    Saint-Cloud 92210 France
  • Centre Hospitalier Delafontaine accepting new patients
    Saint-Denis 93200 France
  • Institut de cancérologie Paris Nord accepting new patients
    Sarcelles France
  • Clinique de l'Estrée accepting new patients
    Stains France
  • Centre Hospitalier de Versailles accepting new patients
    Versailles 78157 France

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris
ID
NCT02948478
Study Type
Observational
Last Updated
May 15, 2018