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Spots Global Cancer Trial Database for Economic and Social Disparities and Breast Cancer

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Trial Identification

Brief Title: Economic and Social Disparities and Breast Cancer

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

Study ID: NCT02948478

Conditions

Breast Cancer

Interventions

Exposed
Non exposed

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centre Hopitalier Victor Dupouy Argenteuil, Argenteuil, , France

Hôpital Jean Verdier, Bondy, , France

Centre Hospitalier de Pontoise, Cergy-Pontoise, , France

Hopital Privé Paule Egine, Champigny-sur-Marne, , France

CH Sud Francilien, Corbeil-Essonnes, , France

Centre Hospitalier Intercommunal Créteil, Creteil, , France

Hôpital Henri Mondor, Créteil, , France

Clinique Claude Bernard, Ermont, , France

CH de Lagny sur Marne, Lagny-sur-Marne, , France

Hôpital Bicêtre, Le Kremlin-Bicêtre, , France

Institut de Cancérologie Hartmann, Levallois-Perret, , France

Institut Curie Hôpital de Paris, Paris, , France

Hôpital Lariboisière, Paris, , France

Hôpital Saint-Louis, Paris, , France

Hôpital Privé des Peupliers, Paris, , France

HEGP, Paris, , France

Hôpital Tenon, Paris, , France

Groupe Hospitalier Paris Saint-Joseph, Paris, , France

Centre Hospitalier Intercommunal Poissy Saint Germain en Laye, Poissy, , France

Institut Curie Hôpital René-Huguenin site Saint-Cloud, Saint-Cloud, , France

Centre Hospitalier Delafontaine, Saint-Denis, , France

Institut de cancérologie Paris Nord, Sarcelles, , France

Clinique de l'Estrée, Stains, , France

Centre Hospitalier de Versailles, Versailles, , France

Contact Details

Name: Charlotte NGO, MD

Affiliation: AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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