Economic and Social Disparities and Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

936 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-02-23

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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precariousness care pathways

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Precarious patients

Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)

Exposed

Intervention Type OTHER

Precarious patients

Non precarious patients

Non precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index)

Non exposed

Intervention Type OTHER

Non precarious patients

Interventions

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Exposed

Precarious patients

Intervention Type OTHER

Non exposed

Non precarious patients

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte NGO, MD

Role: PRINCIPAL_INVESTIGATOR

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

Versailles, , France

Site Status

Countries

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France

References

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Ngo C, Dinut A, Bochaton A, Charreire H, Despres C, Baffert S, Lecuru F, Chatellier G. From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer. BMC Public Health. 2019 Nov 4;19(1):1450. doi: 10.1186/s12889-019-7611-6.

Reference Type DERIVED

PMID: 31684919 (View on PubMed)

Other Identifiers

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ID RCB 2016-A00589-42

Identifier Type: OTHER

Identifier Source: secondary_id

K160202

Identifier Type: -

Identifier Source: org_study_id

Economic and Social Disparities and Breast Cancer

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Precarious patients

Exposed

Non precarious patients

Non exposed

Interventions

Exposed

Non exposed

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Cancer Institute, France

Paris West University Nanterre La Défense

Paris 12 Val de Marne University

Fondation Ophtalmologique Adolphe de Rothschild

Assistance Publique - Hôpitaux de Paris

Responsible Party

Principal Investigators

Charlotte NGO, MD

Locations

Centre Hopitalier Victor Dupouy Argenteuil

Hôpital Jean Verdier

Centre Hospitalier de Pontoise

Hopital Privé Paule Egine

CH Sud Francilien

Centre Hospitalier Intercommunal Créteil

Hôpital Henri Mondor

Clinique Claude Bernard

CH de Lagny sur Marne

Hôpital Bicêtre

Institut de Cancérologie Hartmann

Institut Curie Hôpital de Paris

Hôpital Lariboisière

Hôpital Saint-Louis

Hôpital Privé des Peupliers

HEGP

Hôpital Tenon

Groupe Hospitalier Paris Saint-Joseph

Centre Hospitalier Intercommunal Poissy Saint Germain en Laye

Institut Curie Hôpital René-Huguenin site Saint-Cloud

Centre Hospitalier Delafontaine

Institut de cancérologie Paris Nord

Clinique de l'Estrée

Centre Hospitalier de Versailles

Countries

References

Other Identifiers

ID RCB 2016-A00589-42

K160202