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临床试验/NCT06503393
NCT06503393已完成不适用

SENOVIE France - Therapeutic Mobility and Breast Cancer

Institut de Recherche pour le Developpement7 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
470
试验地点
7
主要终点
Circumstances of breast cancer diagnosis

研究概览

简要总结

Background

In France, there were 61,214 new cases of breast cancer in France in 2023 with an estimated prevalence in 2017 of 913,089 people. It is thus the most common cancer in women, with an incidence that has been increasing since 1990, due both to changes in screening but more recently to a moderate increase in relation to changes in risk factors.

Social inequalities in breast cancer are documented, but there are no data on immigrant women, and there is reason to believe that their trajectories may be different from those of women born in France (characteristics and age of cancer onset, problems of access to care, isolation, etc.).

The SENOVIE France project aims to better understand the impact of breast cancer on the life trajectories of women born in France and women born in sub-Saharan Africa.

Objectives

The SENOVIE France survey aims :

  • To understand how breast cancer (diagnosis, treatment, and breast reconstruction) impacts women's lives that are already affected by migration in many spheres (i.e., social consequences of breast cancer on spheres like family or occupation/financial situation).
  • To study the therapeutic itineraries (including self-reconstruction) of immigrant women living with breast cancer in the greater Paris area and understand their social determinants.
  • To observe how gender can shape women's medical and social outcomes in a migration context.

Methodology

The SENOVIE France survey is a mixed-methods survey with a quantitative and a qualitative component. The quantitative component consists of a quantitative, retrospective, life-event survey carried out among 500 women living with breast cancer and followed in four health services in the greater Paris area. Women born in France and sub-Saharan Africa will be surveyed. This survey consists of a CAPI patient questionnaire and a biographical grid paper (for the life-event data collection) administered face-to-face by specially trained interviewers, as well as a medical questionnaire completed by the team of the health services concerned. Statistical analyses adapted to longitudinal data will be used to study women's trajectories.

The qualitative component consists of a survey by semi-structured interviews with women living with breast cancer and followed in the greater Paris area. These interviews are the subject of an audio recording and then a pseudonymized transcription. Thematic analyses will be carried out with a comprehensive approach that aims to analyze women's experiences.

Perspectives and expected results

This survey will provide scientific knowledge on the diagnosis, treatment and experience of breast cancer and its impact on the life trajectories of women born in France and sub-Saharan Africa. These results could thus contribute to the improvement of medical and psychosocial care for women living with breast cancer.

详细描述

Background

In 2023, with 61,214 new cases diagnosed in France, breast cancer accounts for 33% of women's cancers and is the most common cancer in women. With an estimated prevalence in 2017 of 913089 people, studies also suggest an increase in the standardized incidence rate for several years, from 72.8 per 100,000 in 1990 to 99.2 per 100,000 in 2023. This increase is partly explained by the implementation of screening campaigns that promote the early detection of new cases, but also by the presence of risk factors that are responsible for a large proportion of breast cancers.

Studies on social inequalities in the face of breast cancer highlight several realities. Indeed, while breast cancer is considered one of the cancers with a better prognostic life due to the net survival rate of 88% observed five years after diagnosis, studies show that these rates vary by age and that women from lower social classes have a higher risk of death than women from privileged social classes. In addition, although immigrant women, especially those from sub-Saharan Africa, face several health problems and often live in precarious situations in France, few studies have documented the situation of these women with breast cancer compared to women born in France. The few studies carried out highlight inequalities in access to breast cancer screening and a life after breast cancer marked by significant social and administrative precariousness. Thus, it is possible to think that, in the face of breast cancer, the trajectories of women born in sub-Saharan Africa could be different from those of women born in France. For example, it is possible that immigrant women have a different age of cancer onset than non-immigrant women or that they encounter greater difficulties in accessing care.

The SENOVIE France project was designed to fill this knowledge gap. It aims to better understand the impact of breast cancer on the life trajectories of women born in France and women born in sub-Saharan Africa.

Objectives

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 or more
  • Women who consult in one of the partner hospitals of the study
  • For groups 1: women born in a country of sub-Saharan Africa
  • For group 2: women born in France
  • Have been diagnosed with breast cancer between the 1st of January 2014 and for more than three years at the time of the survey.

排除标准

  • Does not speak French
  • Under 18 years old
  • Have been diagnosed with breast cancer before 2014 and for less than three years at the time of the survey.

研究组 & 干预措施

Women born in sub-Saharan Africa

Women born in sub-Saharan Africa and diagnosed with breast cancer

Women born in France

Women born in France and diagnosed with breast cancer

结局指标

主要结局

Circumstances of breast cancer diagnosis

时间窗: From first signs until breast cancer diagnosis, up to 10 years

Proportion of women who declare, retrospectively, diagnosed following clinical signs, screening campaigns or medical prescription

Time between date of arrival in France and breast cancer diagnosis

时间窗: From arrival in France until the date of diagnosis, up to 10 years

Time to breast cancer diagnosis, from arrival in France, for women born in Sub-Saharan Africa

Breast cancer treatments

时间窗: At time of diagnosis, and then each year up to 10 years

Percentage of women who received surgery, radiotherapy, chemotherapy and/or hormone therapy as breast cancer treatment since diagnosis

Time between breast cancer diagnosis and access to care

时间窗: From date of diagnosis until date of first consultation for cancer care, and then each year up to 10 years

Time between diagnostic and entry into breast cancer care (surgery, radiotherapy, chemotherapy, hormone therapy)

Impact of the migration trajectory on access to breast cancer care

时间窗: From arrival in France until breast cancer diagnosis, and then each year up to 10 after breast cancer diagnosis

Percentage of undocumented women, women without health coverage after arrival in France and at the time of breast cancer diagnosis

次要结局

  • Breast cancer impact on women's lives(At time of diagnosis, and then each year up to 10 years)
  • Impact of the disease on the professional situation(At time of diagnosis, and then each year up to 10 years)
  • Breast cancer impact on sexuality(At time of diagnosis, and then each year up 10 years)
  • Impact of breast cancer and migration status on gender relations(At time of diagnosis, and then each year up to 10 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Clémence Schantz

PhD

Institut de Recherche pour le Developpement

研究点 (7)

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