An Overview of Vaccination Coverage Among Patients Receiving Treatment for Breast Cancer at the ICO: Identifying Factors Associated With Vaccination Uptake and Improved Prevention (VAC-SEIN)

November 2, 2026 updated by: Institut Cancerologie de l'Ouest

Primary prevention, vaccination, ,state of vaccination coverage in oncology, , breast cancer patients, factors influencing adherence in order to improve prevention.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Primary prevention, defined by the WHO as a key strategy for reducing the incidence of disease, relies in part on vaccination, the individual and collective effectiveness of which is recognised. In France, despite vaccination coverage targets of 95 per cent for most vaccines, current studies highlight persistent gaps, particularly among at-risk populations, such as people aged over 65, those with compromised immune systems and cancer patients. Despite a high theoretical uptake rate (83.7 per cent), studies (COVARISQ, 2020 and Granger, 2022) have shown insufficient vaccination coverage (e.g. 9.5 per cent for pneumococcal vaccine, 40.2 per cent for influenza). The aim of this protocol is to assess the current state of vaccination coverage in oncology, particularly amongst breast cancer patients, and to identify factors influencing adherence in order to improve prevention.

Study Type

Observational

Enrollment (Estimated)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women currently undergoing intravenous chemotherapy for non-metastatic breast cancer, as part of adjuvant or neo-adjuvant treatment

Description

Inclusion Criteria:

  1. Non-metastatic breast cancer,
  2. Currently undergoing adjuvant or neoadjuvant intravenous chemotherapy,

Exclusion Criteria:

  1. Performance Status (PS) > 2,
  2. Multiple 'active cancers',
  3. Pregnant women,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer starting chemotherapy

Breast cancer starting chemotherapy

questionnaire on vaccination status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination coverage
Time Frame: 9 weeks

To estimate the proportion of female breast cancer patients, at the time of their initial assessment at an oncology day hospital (HDJ) as part of adjuvant or neoadjuvant systemic treatment, who are fully up to date with the recommended vaccinations against the following pathogens: pneumococcus, VZV (shingles), dTcaP and hepatitis B.

9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination uptake
Time Frame: 9 weeks

To identify the factors that promote vaccination uptake among women being treated for breast cancer in an oncology day centre whilst undergoing adjuvant or neoadjuvant systemic therapy

9 weeks
Vaccination coverage among patients aged 70 and over with that of other patients
Time Frame: 9 weeks

Compare vaccination coverage among patients aged 70 and over with that of other patients

9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandra BAFOURD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 12, 2026

Primary Completion (Estimated)

December 12, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 15, 2026

First Submitted That Met QC Criteria

October 15, 2026

First Posted (Actual)

October 22, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ICO-2025-24
  • 2026-A00640-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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