Health BehaviorENTERNCT07472036
Improving Breast Cancer Screening Uptake Through Tailored Reminder Letters
A study testing Tailored reminder letter in people with Health Behavior and Breast Cancer Screening, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Breast Cancer Screening, Mammography
- What is being tested?
- Tailored reminder letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,947 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Apr 2024to 16 Dec 2025
- Phase
- Interventional
- 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 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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:
- To increase the inclusion of socioeconomically vulnerable individuals while maintaining representation from the broader screening population, participants are selected from the list of individuals invited at mammographic units located in municipalities with high deprivation scores, defined as meeting at least two of the following 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%.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University of Antwerp
Antwerp, 2000
Centre for Cancer Detection (CvKO)
Bruges
About this study
Official title: Equity in Breast Cancer Screening in Flanders: the Necessity of Tailored Reminders for Women With Low Socioeconomic Status
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:
Read more
- 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.
Read the detailed description
This study aims to evaluate the effectiveness of a culturally and linguistically tailored reminder letter in increasing mammography uptake within the Flemish Breast Cancer Screening Program (BCSP) among women who previously did not attend screening. The objectives are to:
- Quantify the difference in uptake between the intervention and control arms; and
- Assess whether the effect differs according to socioeconomic status (SES).
Study Setting:
The study is embedded within the Flemish BCSP, which is coordinated by the Centre for Cancer Detection (CvKO). The BCSP provides biennial screening mammography, free of charge, to eligible individuals aged 50-69 years registered as female in the Belgian national registry. Recruitment occurs through the routine program invitation process, where eligible individuals receive a mailed invitation letter indicating the time and location of their screening appointment.
Study design:
This study is a two-arm, parallel-group, superiority, randomized controlled trial (RCT) with partial blinding.
Study arms:
- Intervention arm: Participants allocated to the intervention arm receive two mailed communications: (1) the standard BCSP invitation letter, and (2) a tailored reminder letter, specifically designed to address linguistic and cultural barriers that may affect screening participation.
- Control arm: Participants allocated to the control arm receive the standard BCSP invitation letter only.
Detailed descriptions of study Arms and Intervention, Study Design (Masking, Allocation), Outcome Measures and Eligibility are provided in the designated sections.
Statistical analysis:
The primary analysis compares BC screening uptake between the intervention and control arms in the overall study population. The effect of the intervention is quantified using odds ratios (ORs) with corresponding 95% confidence intervals (CIs). Statistical significance is assessed using the likelihood-ratio chi-square test (x²), with two-sided p-value < 0.05. Stratified analyses are conducted by socioeconomic status (SES), age group, province of residence, and type of mammographic unit. Analyses are performed according to both intention-to-treat (ITT) and per-protocol (PP) principles, with ITT as the primary analytic approach and PP as a sensitivity analysis. The ITT population comprises all randomized participants, excluding records removed before analysis during routine quality control procedures (e.g., duplicate system entries or invalid identifiers). The PP population comprises participants who receive the allocated intervention as planned and for whom complete outcome data is available. Exclusion criteria for the PP analysis comprise withdrawal or opt-out from the BCSP prior to receipt of the assigned communication strategy and documented logistical issues affecting letters delivery in either study arm. Deaths or emigrations occurring prior to participation are not specifically addressed in the PP definition as they are assumed to be evenly distributed between study arms, in line with routine cross-checks with demographic registries. No multivariable adjusted analyses are performed. Stratified analyses are interpreted descriptively, and no formal correction for multiple comparisons is applied.
- Conditions
- Health Behavior, Breast Cancer Screening, Mammography
- Being tested
- Tailored reminder letter
- Keywords
- Breast cancer, Breast cancer screening, Health equity, Reminder, Reminder letter, Randomized controlled trial
- Medical subject headings
- Health Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored reminder letterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening uptake
Screening uptake, defined as the proportion of invited individuals who attend a mammographic appointment within the pre-specified time frame.
Measured: Within 40 days after invitation letter is sent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2024
- Primary completion30 Sep 2024
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7,947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas More University of Applied Sciences, Centre for Cancer Detection (CvKO), Intermutualistic Agency, Stichting tegen Kanker
- Responsible party
- Principal investigator, Allegra Ferrari, Universiteit Antwerpen
- Investigators
- Guido Van Hal, Study chair, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472036
- Sponsor's protocol ID
- CPR-2022/1888
- Acronym
- ENTER
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40369659Ferrari 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.
PubMed 40256640
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity in Breast Cancer Screening in Flanders: the Necessity of Tailored Reminders for Women With Low Socioeconomic Status
- ClinicalTrials.gov ID
- NCT07472036
- Acronym / sponsor ID
- ENTER / CPR-2022/1888
- Conditions
- Health Behavior, Breast Cancer Screening, Mammography
- Keywords
- Breast cancer, Breast cancer screening, Health equity, Reminder, Reminder letter, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,947 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Thomas More University of Applied Sciences, Centre for Cancer Detection (CvKO), Intermutualistic Agency, Stichting tegen Kanker
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate the effectiveness of a culturally and linguistically tailored reminder letter in increasing mammography uptake within the Flemish Breast Cancer Screening Program (BCSP) among women who previously did not attend screening. The objectives are to:
- Quantify the difference in uptake between the intervention and control arms; and
- Assess whether the effect differs according to socioeconomic status (SES).
Study Setting:
The study is embedded within the Flemish BCSP, which is coordinated by the Centre for Cancer Detection (CvKO). The BCSP provides biennial screening mammography, free of charge, to eligible individuals aged 50-69 years registered as female in the Belgian national registry. Recruitment occurs through the routine program invitation process, where eligible individuals receive a mailed invitation letter indicating the time and location of their screening appointment.
Study design:
This study is a two-arm, parallel-group, superiority, randomized controlled trial (RCT) with partial blinding.
Study arms:
- Intervention arm: Participants allocated to the intervention arm receive two mailed communications: (1) the standard BCSP invitation letter, and (2) a tailored reminder letter, specifically designed to address linguistic and cultural barriers that may affect screening participation.
- Control arm: Participants allocated to the control arm receive the standard BCSP invitation letter only.
Detailed descriptions of study Arms and Intervention, Study Design (Masking, Allocation), Outcome Measures and Eligibility are provided in the designated sections.
Statistical analysis:
The primary analysis compares BC screening uptake between the intervention and control arms in the overall study population. The effect of the intervention is quantified using odds ratios (ORs) with corresponding 95% confidence intervals (CIs). Statistical significance is assessed using the likelihood-ratio chi-square test (x²), with two-sided p-value < 0.05. Stratified analyses are conducted by socioeconomic status (SES), age group, province of residence, and type of mammographic unit. Analyses are performed according to both intention-to-treat (ITT) and per-protocol (PP) principles, with ITT as the primary analytic approach and PP as a sensitivity analysis. The ITT population comprises all randomized participants, excluding records removed before analysis during routine quality control procedures (e.g., duplicate system entries or invalid identifiers). The PP population comprises participants who receive the allocated intervention as planned and for whom complete outcome data is available. Exclusion criteria for the PP analysis comprise withdrawal or opt-out from the BCSP prior to receipt of the assigned communication strategy and documented logistical issues affecting letters delivery in either study arm. Deaths or emigrations occurring prior to participation are not specifically addressed in the PP definition as they are assumed to be evenly distributed between study arms, in line with routine cross-checks with demographic registries. No multivariable adjusted analyses are performed. Stratified analyses are interpreted descriptively, and no formal correction for multiple comparisons is applied.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored reminder letter | Experimental | Behavioral: Tailored reminder letterParticipants 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. |
| 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). |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored reminder letterThe 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. | Behavioural | Tailored reminder letter |
Primary outcome
Screening uptake
Time frame: Within 40 days after invitation letter is sent.
Screening uptake, defined as the proportion of invited individuals who attend a mammographic appointment within the pre-specified time frame.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 40369659Ferrari 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.
- Background: PubMed 40256640Ferrari 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.
- Information Security Committee Deliberation n. 25/044 (01/04/2025) regarding the linking of pseudonimized health insurance data from the intermutualistic Agency to mammography data from the Centre for Cancer Detection in the context of the ENTER study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Van Hal study chair
Universiteit Antwerpen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored reminder letter in people with Health Behavior and Breast Cancer Screening, run by Universiteit Antwerpen at 2 sites in Belgium.
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 12 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Screening uptake (time frame: Within 40 days after invitation letter is sent.). 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 NCT07472036, which also lists 2 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 16 Mar 2026.