Equity in Breast Cancer Screening in Flanders: the Necessity of Tailored Reminders for Women With Low Socioeconomic Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,947
- 试验地点
- 2
- 主要终点
- Screening uptake
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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%.
排除标准
- •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
研究组 & 干预措施
Tailored reminder letter
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.
干预措施: Tailored reminder letter (Behavioral)
Standard of care
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).
结局指标
主要结局
Screening uptake
时间窗: 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.
次要结局
未报告次要终点
研究者
Allegra Ferrari
Dr.
Universiteit Antwerpen