SENOVIE France - Therapeutic Mobility and Breast Cancer

NCT06503393 | Completed

• 1 other identifier: IRD_2024_CEPED_SENOVIE
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Breast Cancer Female

Keywords

Life-event survey; Observational survey; Breast cancer; Immigrant; Women; Sub-saharan Africa; France; Trajectories; therapeutic itinerary; social inequalities; health

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women born in sub-Saharan Africa and in France who have been diagnosed with breast cancer between the 1st of January 2014 and for more than three years at the time of the survey, and visiting four hospitals (Saint-Louis University Hospital AP-HP; Delafontaine Hospital Saint-Denis; Robert Ballanger, Hospital, Aulnay-sous-Bois; Avicenne University Hospital AP-HP) in the greater Paris area.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• The French Institute for Demographic Studies (INED): collaborator
• Hospital Avicenne: collaborator
• Saint-Louis Hospital, Paris, France: collaborator
• Centre Hospitalier de Saint-Denis: collaborator
• Centre Hospitalier Intercommunal Robert Ballanger: collaborator
• The French National Cancer Institute: collaborator
• The French Collaborative Institute on Migrations: collaborator
• Ceped UMR 196: collaborator
• Université Paris Cité: collaborator

Study Sites (4)

Robert Ballanger Hospital Aulnay-Sous-Bois

Aulnay-sous-Bois, France

Location

Avicenne University Hospital AP-HP

Bobigny, 93000, France

Location

Saint-Louis University Hospital AP-HP

Paris, France

Location

Delafontaine Hospital Saint-Denis

Saint-Denis, France

Location

Related Publications (3)

• Anne Gosselin, Karna Coulibaly, Joseph Larmarange, Clémence Schantz. Plan de gestion des données du projet SENOVIE France. Institut de Recherche pour le Développement (IRD). 2024. ⟨hal-04563793⟩

  BACKGROUND

• Louise Ludet, Luis Teixeira, Gaëtan des Guetz, Clémence Schantz, for the SENOVIE group. Therapeutic mobility and breast cancer in France: Experiences of African women. SSM - Qualitative Research in Health, Volume 4, 2023. https://doi.org/10.1016/j.ssmqr.2023.100314.

  BACKGROUND

• Coulibaly K, Schantz C, Teixeira L, Degrees du Lou A, Des Guetz G, Hocini H, Zelek L, Larmarange J, Gosselin A; SENOVIE study group; SENOVIE study group. A Life course approach to investigate breast cancer and migration in the greater Paris area: the SENOVIE study protocol. BMJ Open. 2025 Apr 2;15(4):e095759. doi: 10.1136/bmjopen-2024-095759.

  PMID: 40180375 DERIVED

Related Links

• Data management plan

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 16, 2024
• Study Start: March 25, 2024
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-03

Locations

FR (4)