Economic and Social Disparities and Breast Cancer (DESSEIN)
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|ClinicalTrials.gov Identifier: NCT02948478|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : September 10, 2019
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|
|Breast Cancer||Other: Exposed Other: Non exposed|
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).
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|
|Estimated Enrollment :||1040 participants|
|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 :||December 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)
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
- TNM stage [ Time Frame: Baseline ]TNM classification according to initial clinical and radiological assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948478
|Contact: Charlotte NGO, MD||0033 1 56 09 54 firstname.lastname@example.org|
|Contact: Hakima MANSEUR, MSc||0033 email@example.com|
|Principal Investigator:||Charlotte NGO, MD||AP - HP, Hôpital Européen Georges-Pompidou, Paris, France|