Clinical trial NCT02948478: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: precariousness
care pathways
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Paris West University Nanterre La Défense
name: Paris 12 Val de Marne University
name: Fondation Ophtalmologique Adolphe de Rothschild
First posted: 2016-10-28
Enrollment: 936
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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 criteria: 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

Primary outcomes:
measure: TNM stage
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hopitalier Victor Dupouy Argenteuil
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Cergy-Pontoise
country: France
facility: Centre Hospitalier de Pontoise
city: Champigny-sur-Marne
country: France
facility: Hopital Privé Paule Egine
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Ermont
country: France
facility: Clinique Claude Bernard
city: Lagny-sur-Marne
country: France
facility: CH de Lagny sur Marne
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Levallois-Perret
country: France
facility: Institut de Cancérologie Hartmann
city: Paris
country: France
facility: Institut Curie Hôpital de Paris
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Privé des Peupliers
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal Poissy Saint Germain en Laye
city: Saint-Cloud
country: France
facility: Institut Curie Hôpital René-Huguenin site Saint-Cloud
city: Saint-Denis
country: France
facility: Centre Hospitalier Delafontaine
city: Sarcelles
country: France
facility: Institut de cancérologie Paris Nord
city: Stains
country: France
facility: Clinique de l'Estrée
city: Versailles
country: France
facility: Centre Hospitalier de Versailles
Study officials:
affiliation: AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
name: Charlotte NGO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.