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Breast Cancer FemaleSENOVIENCT06503393

SENOVIE France - Therapeutic Mobility and Breast Cancer

An observational study of Breast Cancer Female, run by Institut de Recherche pour le Developpement at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
How many people
470 participants
Where
4 sitesFrance
Study dates
25 Mar 2024to 11 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • Robert Ballanger Hospital Aulnay-Sous-Bois

    Aulnay-sous-Bois

  • Avicenne University Hospital AP-HP

    Bobigny, 93000

  • Saint-Louis University Hospital AP-HP

    Paris

  • Delafontaine Hospital Saint-Denis

    Saint-Denis

Other trials in France

About this study

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.

Read more

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.

Read the detailed description

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

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 two components: a quantitative component and a qualitative component.

Quantitative component The quantitative component is based on a life event survey, a methodology successfully used in the field of HIV/Hepatitis B among immigrants in the greater Paris area by several members of this research. This innovative methodology has the great advantage of collecting longitudinal data while avoiding attrition which is very frequent in prospective cohorts among disadvantaged populations: women are surveyed one time and are asked retrospectively about their past trajectories. A close-ended question CAPI questionnaire and a biographical grid paper where the interviewer reports key elements and dates will be used for data collection. The biographical grid paper was shown to help to minimise memory biases because the interviewees can use both dates and age to remember the order of events and can place elements in perspective with one another (for example, a woman can ignore at what date she had access to medical insurance, but she would remember it occurred during her second pregnancy). This methodology has shown robustness in tracing back life and health trajectories.

This survey aims to recruit about 500 women, including 400 women born in France and 100 women born in sub-Saharan Africa. During the twelve months of the data collection, a CAPI patient questionnaire, a biographical grid paper (completed by interviewers recruited and trained by INED) and a medical questionnaire (completed by clinical researchers from partner hospitals) will be used to collect the following data:

The patient questionnaire and the biographical grid include the following modules:

  1. retrospective on the whole life (residential history, professional history),
  2. history of relationships and children,
  3. nationality, arrival in France and stay (for immigrant women),
  4. health coverage,
  5. violences,
  6. breast cancer (diagnosis, treatment, and impact on women's life),
  7. Covid period,
  8. economic consequences,
  9. health, sexuality and well-being.

The collection will be carried out in the context of a face-to-face interview. Within each health services, eligible patients will be identified by the healthcare professional during (or before) the consultation. The survey will be offered by the healthcare professional to all eligible patients. Patients who will agree to participate will be referred to the interviewers. Patients will be able to agree to participate in the survey immediately after their consultation or agree to participate by appointment. Those who will agree to participate by appointment will agree on a date for taking the questionnaire with the interviewers. In both cases, the questionnaire will be administered in the premises of the project's hospital partners (Saint-Louis University Hospital AP-HP ; Delafontaine Hospital Saint-Denis ; Robert Ballanger Hospital Aulnay-sous-Bois; Avicenne University Hospital AP-HP) in offices that guarantee the confidentiality of the interview. The individual questionnaires will be entered in real time on an INED secure LimeSurvey server. The biographical grids will be collected on paper before being entered by a dedicated operator on the same LimeSurvey server.

The medical questionnaire contains questions about the characteristics of the cancer and the treatments followed by women. It will be supplemented by hospital staff from partner centres. The entry will be done on the IRD's REDCap secure server.

In terms of statistical analysis, descriptive statistics will be used to precisely describe the medical status, social characteristics, and living conditions of women born in France and women born in Sub-Saharan Africa living with breast cancer in the greater Paris area. These statistics may also be age-standardized if, as expected, women from sub-Saharan Africa are younger than their native-French counterparts.

To measure the social consequences of breast cancer diagnosis and treatments, specific statistical methods for longitudinal data (sequence analysis, Cox models, discreet-time logistic regressions) that allow to take different temporalities into account (time since migration, since diagnosis, since treatment, etc.) will be used. A specific attention will be paid to how healthcare trajectories may have been impacted between 2020 and 2021 by the sanitary crisis, and also to examine whether all women were affected in the same way (missing medical follow-ups, delayed surgeries). Special attention will also be paid to the social determinants and social impacts of breast reconstruction.

Qualitative component

The objective of this qualitative component is to describe in depth the way in which women's health, social and migratory trajectories are articulated, and their involvement in the care of women born in Sub-Saharan Africa in French health services. This section aims to answer the following questions: which immigrant women circulate and under what conditions? What are the challenges and obstacles participants face? What are the administrative, material and social difficulties participants face? What levers can be activated ? To remove these obstacles, which actors can immigrant women rely on? What are the professional, family, conjugal, emotional and physical experiences of these women? To answer these questions, qualitative interviews will be conducted with women born in sub-Saharan Africa. The goal is to carry out about forty interviews in the greater Paris area. The exact number may vary depending on the principle of data saturation. The interviews will be recorded, pseudonymized and transcribed. They will be stored on a secure NextCloud server at Ceped. The interviews will be analyzed with a comprehensive approach that aims to analyze the experiences as they were lived by the participants.

Perspectives and expected results

This research will document the social and health trajectories of women with breast cancer and followed in certain hospitals in the greater Paris area with a comparative aim. It will provide scientific knowledge on the circumstances of cancer diagnosis in women born in France and those born in sub-Saharan Africa, on the experience of the disease and its consequences on different aspects of women's lives (economic, entourage, sexuality, couples, etc.).

This research will raise the awareness of patients' associations and perhaps help them to develop specific lines of action for immigrant women and to lobby political decision-makers to promote their access to care. These results could thus contribute to the improvement of medical and psychosocial care for women living with breast cancer.

Keywords
Life-event survey, Observational survey, Breast cancer, Immigrant, Women, Sub-saharan Africa, France, Trajectories, therapeutic itinerary, social inequalities, health
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06503393
Study groupRoleWhat they receive
Women born in sub-Saharan AfricaWomen born in sub-Saharan Africa and diagnosed with breast cancer
Women born in FranceWomen born in France and diagnosed with breast cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circumstances of breast cancer diagnosis

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

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

  2. 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

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

  3. Time between breast cancer diagnosis and access to care

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

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

  4. Breast cancer treatments

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

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

  5. 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

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

Secondary outcomes (4)
  1. 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

    Measured: At time of diagnosis, and then each year up 10 years

  2. 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

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

  3. 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

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

  4. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start25 Mar 2024
  3. Primary completion11 Jul 2025
  4. Study completion11 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06503393
Sponsor's protocol ID
IRD_2024_CEPED_SENOVIE
Acronym
SENOVIE
Status last verified
Mar 2026
First submitted
6 Jun 2024
Last updated
17 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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⟩

  • 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.

  • 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.

    PubMed 40180375

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Female, run by Institut de Recherche pour le Developpement at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circumstances of breast cancer diagnosis (time frame: From first signs until breast cancer diagnosis, up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06503393, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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