SENOVIE France - Therapeutic Mobility and Breast Cancer
NCT Number: NCT06503393
Acronym: SENOVIE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female
Sponsor: Institut de Recherche pour le Developpement
Collaborators: The French Institute for Demographic Studies (INED)|Saint-Louis Hospital, Paris, France|Centre Hospitalier de Saint-Denis|Centre Hospitalier Intercommunal Robert Ballanger|The French National Cancer Institute|The French Collaborative Institute on Migrations|Ceped UMR 196|Université Paris Cité
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-25
Completion Date: 2025-03-31
Locations: Robert Ballanger Hospital Aulnay-Sous-Bois, Aulnay-Sous-Bois, France|Saint-Louis University Hospital AP-HP, Paris, France|Delafontaine Hospital Saint-Denis, Saint-Denis, France

Summary:
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 1000 women living with breast cancer and followed in three 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.

Primary Outcome Measures: Circumstances of breast cancer diagnosis, Proportion of women who declare, retrospectively, diagnosed following clinical signs, screening campaigns or medical prescription, From first signs until breast cancer diagnosis, up to 10 years|Time between date of arrival in France and breast cancer diagnosis, Time to breast cancer diagnosis, from arrival in France, for women born in Sub-Saharan Africa, From arrival in France until the date of diagnosis, up to 10 years|Time between breast cancer diagnosis and access to care, Time between diagnostic and entry into breast cancer care (surgery, radiotherapy, chemotherapy, hormone therapy), From date of diagnosis until date of first consultation for cancer care, and then each year up to 10 years|Breast cancer treatments, Percentage of women who received surgery, radiotherapy, chemotherapy and/or hormone therapy as breast cancer treatment since diagnosis, At time of diagnosis, and then each year up to 10 years|Impact of the migration trajectory on access to breast cancer care, Percentage of undocumented women, women without health coverage after arrival in France and at the time of breast cancer diagnosis, From arrival in France until breast cancer diagnosis, and then each year up to 10 after breast cancer diagnosis
Secondary Outcome Measures: Breast cancer impact on sexuality, Proportion of women who declare, retrospectively, change in the frequency of sexual intercourse, sexual libido and in the intention to have a child since diagnosis, At time of diagnosis, and then each year up 10 years|Impact of breast cancer and migration status on gender relations, Proportion of women who declare, retrospectively, ongoing unions at the time of diagnosis, change in the ongoing union (strengthening, deterioration of unions), and proportion of women who declare, retrospectively, being supported by their partners following breast cancer diagnosis, At time of diagnosis, and then each year up to 10 years|Breast cancer impact on women's lives, Proportion of women who report physical limitations following breast cancer diagnosis and treatments, and proportion of women who report being supported by someone other than their partner (for those who declare a partner) following breast cancer diagnosis, At time of diagnosis, and then each year up to 10 years|Impact of the disease on the professional situation, Percentage of women employed at the time of diagnosis and then each year up to 10 years or at the time of data collection, At time of diagnosis, and then each year up to 10 years