DESSEIN: Economic and Social Disparities and Breast Cancer

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02948478

Collaborator

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

936

Enrollment

Locations

50.8

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Exposed Other: Non exposed

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 Design

Study Type:

Observational

Actual Enrollment :

936 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Feb 23, 2021

Actual Study Completion Date :

Feb 23, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

TNM stage [Baseline]
TNM classification according to initial clinical and radiological assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hopitalier Victor Dupouy Argenteuil	Argenteuil	France
2	Hôpital Jean Verdier	Bondy	France	94143
3	Centre Hospitalier de Pontoise	Cergy-Pontoise	France
4	Hopital Privé Paule Egine	Champigny-sur-Marne	France
5	CH Sud Francilien	Corbeil-Essonnes	France
6	Centre Hospitalier Intercommunal Créteil	Creteil	France	94000
7	Hôpital Henri Mondor	Créteil	France	94010
8	Clinique Claude Bernard	Ermont	France
9	CH de Lagny sur Marne	Lagny-sur-Marne	France	77400
10	Hôpital Bicêtre	Le Kremlin-Bicêtre	France
11	Institut de Cancérologie Hartmann	Levallois-Perret	France	92300
12	Institut Curie Hôpital de Paris	Paris	France	75005
13	Hôpital Lariboisière	Paris	France	75010
14	Hôpital Saint-Louis	Paris	France	75010
15	Hôpital Privé des Peupliers	Paris	France	75013
16	HEGP	Paris	France	75015
17	Hôpital Tenon	Paris	France	75020
18	Groupe Hospitalier Paris Saint-Joseph	Paris	France
19	Centre Hospitalier Intercommunal Poissy Saint Germain en Laye	Poissy	France	78300
20	Institut Curie Hôpital René-Huguenin site Saint-Cloud	Saint-Cloud	France	92210
21	Centre Hospitalier Delafontaine	Saint-Denis	France	93200
22	Institut de cancérologie Paris Nord	Sarcelles	France
23	Clinique de l'Estrée	Stains	France
24	Centre Hospitalier de Versailles	Versailles	France	78157

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT02948478

Other Study ID Numbers:

K160202
ID RCB 2016-A00589-42

First Posted:

Oct 28, 2016

Last Update Posted:

Dec 21, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris

precariousness

care pathways

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Dec 21, 2021