Economic and Social Disparities and Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Other: Exposed; Other: Non exposed

• Registration Number: NCT02948478
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Study Start: 2016-12
• Primary Completion: 2021-02-23
• Study Completion: 2021-02-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 936

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Precarious patients	Exposed	Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)
Non precarious patients	Non exposed	Non precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index)

Primary Outcome Measures

Name	Time	Method
TNM stage	Baseline	TNM classification according to initial clinical and radiological assessment

Trial Locations

Locations (24)

Centre Hopitalier Victor Dupouy Argenteuil; 🇫🇷 Argenteuil, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

Hopital Privé Paule Egine; 🇫🇷 Champigny-sur-Marne, France

Centre Hospitalier de Pontoise; 🇫🇷 Cergy-Pontoise, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Intercommunal Créteil; 🇫🇷 Creteil, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Clinique Claude Bernard; 🇫🇷 Ermont, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CH de Lagny sur Marne; 🇫🇷 Lagny-sur-Marne, France

Institut de Cancérologie Hartmann; 🇫🇷 Levallois-Perret, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Institut Curie Hôpital de Paris; 🇫🇷 Paris, France

Hôpital Privé des Peupliers; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France

HEGP; 🇫🇷 Paris, France

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France

Institut de cancérologie Paris Nord; 🇫🇷 Sarcelles, France

Clinique de l'Estrée; 🇫🇷 Stains, France

Centre Hospitalier de Versailles; 🇫🇷 Versailles, France

Centre Hospitalier Intercommunal Poissy Saint Germain en Laye; 🇫🇷 Poissy, France

Institut Curie Hôpital René-Huguenin site Saint-Cloud; 🇫🇷 Saint-Cloud, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Centre Hospitalier Delafontaine; 🇫🇷 Saint-Denis, France