NCT07472036

Brief Summary

The goal of this trial is to learn whether a culturally and linguistically tailored reminder letter can increase participation in the Flemish Breast Cancer Screening Program among women who previously did not attend screening. The study also examines whether the effect differs between socioeconomic groups. The main questions it aims to answer are:

  • Does a tailored reminder letter increase participation among previous non-attenders?
  • Does the effect differ between women with lower and higher socioeconomic status? Researchers compare two groups:
  • Intervention group: receive the standard invitation letter plus an additional tailored reminder letter.
  • Control group: receive the standard invitation letter only. Participation in screening within 40 days of the invitation is measured using the program's registry. Participants are women aged 50-69 years who had previously been invited but had never attended screening. The reminder letter is sent as part of routine screening communication, and no additional medical procedures are involved.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,947

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 17, 2026

Last Update Submit

March 11, 2026

Conditions

Health BehaviorBreast Cancer ScreeningMammography

Keywords

Breast cancerBreast cancer screeningHealth equityReminderReminder letterRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Screening uptake

    Screening uptake, defined as the proportion of invited individuals who attend a mammographic appointment within the pre-specified time frame.

    Within 40 days after invitation letter is sent.

Study Arms (2)

Tailored reminder letter

EXPERIMENTAL

Participants allocated to the intervention arm receive two mailed communications: (1) the standard Breast Cancer Screening Program invitation letter, sent approximately three weeks before the scheduled screening appointment (±4 days); (2) an additional culturally and linguistically tailored reminder letter, sent approximately one week before the scheduled appointment (±4 days). The tailored reminder letter is specifically designed to address linguistic and cultural barriers that may affect screening participation.

Behavioral: Tailored reminder letter

Standard of care

NO INTERVENTION

Participants allocated to the control arm receive the standard BCSP invitation letter only, approximately three weeks before the scheduled screening appointment (±4 days), with no additional reminder. The content of the standard invitation letter is publicly available on the website of the Centre for Cancer Detection (CvKO).

Interventions

Tailored reminder letterBEHAVIORAL

The intervention development process is described in detail elsewhere (DOI: 10.1186/s13690-025-01591-7). A brief summary is provided below: The tailored reminder letter was developed using an iterative, participatory approach between April and October 2023. Three focus group discussions with 19 eligible women identified barriers to screening participation and limitations of the existing invitation letter. Based on these findings, a draft letter was refined through a Delphi process involving experts and stakeholders familiar with the screening program and target population. The letter was then improved during a co-creation session with 14 eligible women and validated through a final expert member check. The final reminder letter was designed for a low-literate audience, using simplified language and visual elements. It included essential appointment information and a QR code linking to translations in multiple languages to improve accessibility for linguistically diverse populations.

Tailored reminder letter

Eligibility Criteria

Age50 Years - 69 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe study does not independently apply sex- or gender-based eligibility criteria. However, inclusion is limited to individuals legally registered as female in the Belgian national population registry, as screening invitations are generated according to this administrative classification.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individual-level criteria:
  • Aged 50-69 years
  • Legally registered as female in the Belgian national population registry
  • No history of breast cancer in the previous 10 years
  • No bilateral mastectomy in the previous 10 years
  • Invited for mammography between April and June 2024
  • Classified as a non-attender, defined as (1) having received at least one previous screening invitation, and (2) never having participated in the screening program.
  • Area-level criteria:
  • Average income per capita \< EUR 20,000
  • Belgian Multiple Index of Deprivation score \< 6
  • Proportion of residents eligible for increased reimbursement for medical expenses \> 12%.

You may not qualify if:

  • Actively opted out of the screening program at the time of the study
  • Invited for screening in the previous year
  • Underwent mammographic screening in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Antwerp

Antwerp, 2000, Belgium

Location

Centre for Cancer Detection (CvKO)

Bruges, Belgium

Location

Related Publications (2)

  • Ferrari A, Van Bos L, Talboom S, van de Veerdonk W, D'haenens W, Pak M, Descan M, Parmentier S, Van Collie L, Sibiet P, Goossens M, Van Hal G. From barriers to participation: co-creating an effective reminder letter for breast cancer screening among underserved women in Flanders. Arch Public Health. 2025 May 14;83(1):132. doi: 10.1186/s13690-025-01591-7.

    PMID: 40369659BACKGROUND

  • Ferrari A, Jael Herrera D, Van De Veerdonk W, D'haenens W, Ruiz Alejos A, Yimer NB, Orwa S, Van Bos L, Talboom S, Ding L, Goossens M, Van Hal G. Advancing Mammographic Screening Among Underserved Groups: A Systematic Review and Meta-Analysis of Intervention Strategies to Increase Breast Cancer Screening Uptake. Public Health Rev. 2025 Apr 4;46:1607873. doi: 10.3389/phrs.2025.1607873. eCollection 2025.

    PMID: 40256640BACKGROUND

Related Links

MeSH Terms

Conditions

Health BehaviorBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Guido Van Hal

    Universiteit Antwerpen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are not informed of their inclusion in a randomized study, as the intervention is embedded within routine screening communications. They are unaware of group allocation. The allocation sequence is generated by an independent program manager and concealed from mailing personnel except for the list required to implement the intervention. Personnel responsible for mailing invitation letters and care providers at the study sites are aware only of participants assigned to receive the additional reminder letter. They do not have access to the full randomization list and are unaware of control group assignments. They have no access to outcome data and no role in data analysis. Outcome data are obtained from a centralized screening registry and collected independently of the study team. The data analyst has access to group allocation and is not blinded.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 16, 2026

Study Start

April 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 16, 2025

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The study protocol is made publicly available. Aggregated study results may be shared upon reasonable request. Individual participant data are derived from screening and health insurance registries and are subject to Belgian data protection regulations, requiring specific authorization from the competent authorities.

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be publicly available following publication of the primary results. Aggregated data may be shared upon reasonable request after publication.
Access Criteria
Aggregated data may be shared with researchers for scientific purposes upon reasonable request to the study investigators. Requests involving individual-level data must comply with Belgian regulations and require prior authorization from the competent data protection authorities \[e.g., Institutional Review Board, Information Security Committee (ISC)\].

Locations

BE(2)