Economic and Social Disparities and Breast Cancer (DESSEIN)

December 20, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

936

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France
        • Centre Hopitalier Victor Dupouy Argenteuil
      • Bondy, France, 94143
        • Hôpital Jean Verdier
      • Cergy-Pontoise, France
        • Centre Hospitalier de Pontoise
      • Champigny-sur-Marne, France
        • Hopital Privé Paule Egine
      • Corbeil-Essonnes, France
        • CH SUd Francilien
      • Creteil, France, 94000
        • Centre Hospitalier Intercommunal Creteil
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Ermont, France
        • Clinique Claude Bernard
      • Lagny-sur-Marne, France, 77400
        • CH de Lagny sur Marne
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Levallois-Perret, France, 92300
        • Institut de Cancérologie Hartmann
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Paris, France, 75013
        • Hôpital Privé des Peupliers
      • Paris, France, 75015
        • HEGP
      • Paris, France
        • Groupe Hospitalier Paris Saint-Joseph
      • Paris, France, 75005
        • Institut Curie Hôpital de Paris
      • Poissy, France, 78300
        • Centre Hospitalier Intercommunal Poissy Saint Germain en Laye
      • Saint-Cloud, France, 92210
        • Institut Curie Hôpital René-Huguenin site Saint-Cloud
      • Saint-Denis, France, 93200
        • Centre Hospitalier Delafontaine
      • Sarcelles, France
        • Institut de Cancérologie Paris Nord
      • Stains, France
        • Clinique de l'Estrée
      • Versailles, France, 78157
        • Centre Hospitalier de Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients from Ile de France area having a breast cancer histologically proved and seeking for treatment. Any patient consulting for the first time in a specialized center for the treatment of breast cancer in Ile de France, whatever the stage of the disease, may potentially be recruited.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Precarious patients
Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)
Other: Exposed
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)
Other: Non exposed
Non precarious patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNM stage
Time Frame: Baseline
TNM classification according to initial clinical and radiological assessment
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation Ophtalmologique Adolphe de Rothschild
National Cancer Institute, France
Paris 12 Val de Marne University
Paris West University Nanterre La Défense

Investigators

  • Principal Investigator: Charlotte NGO, MD, AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 23, 2021

Study Completion (Actual)

February 23, 2021

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K160202
  • ID RCB 2016-A00589-42 (Other Identifier: Agence Nationale de Sécurité du Médicament et des Produits de Santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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