Economic and Social Disparities and Breast Cancer

Breast Cancer Clinical Trial

— DESSEIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948478
• Other study ID #: K160202
• Secondary ID: ID RCB 2016-A005
• Status: Completed
• Start date: December 2016
• Est. completion date: February 23, 2021

Study information

• Verified date: December 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 936
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Exposed
Precarious patients
• Non exposed
Non precarious patients

Locations

Country	Name	City	State
France	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	Groupe Hospitalier Paris Saint-Joseph	Paris
France	HEGP	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Privé des Peupliers	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris
France	Institut Curie Hôpital de Paris	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

Sponsors (5)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation Ophtalmologique Adolphe de Rothschild, National Cancer Institute, France, Paris 12 Val de Marne University, Paris West University Nanterre La Défense

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNM stage	TNM classification according to initial clinical and radiological assessment	Baseline