Pilot Study of the Expansion of the DORA Breast Cancer Screening Programme to Women Aged 45-49 and 70-74 Years
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,150
- 试验地点
- 1
- 主要终点
- Screening Participation Rate
研究概览
简要总结
This prospective interventional clinical study evaluates the feasibility of expanding the Slovenian national breast cancer screening programme DORA to women aged 45-49 years and 70-74 years. Women from selected municipalities will be invited to screening mammography. The study will assess participation rates, the proportion of women referred for additional diagnostic assessment, and other indicators relevant to planning the future expansion of the DORA programme.
详细描述
The study is a prospective interventional cohort study conducted within the Slovenian national breast cancer screening programme DORA at the Institute of Oncology Ljubljana.
Women aged 45-49 years and 70-74 years will be selected from the Central Population Register and invited by mail to participate in screening mammography. Screening and any required additional diagnostic assessment will be performed according to the established procedures and quality standards of the DORA programme.
The primary objective is to evaluate key breast cancer screening quality indicators in the two age groups, including participation in screening and the proportion of screened women referred for additional assessment. The study will also collect information relevant to the development of age-specific communication strategies and to the planning of personnel, equipment, information systems, and infrastructure required for a possible expansion of the national screening programme to women aged 45-74 years.
The planned sample size is approximately 2,150 women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female sex
- •Age 45-49 years or 70-74 years
- •Permanent or temporary residence in one of the following municipalities in the Ljubljana regional unit of the Health Insurance Institute of Slovenia: Ljubljana, Grosuplje, Ivančna Gorica, Dobrepolje, Škofljica, Ig, or Medvode
- •Selected through random sampling from the Central Population Register and invited to participate in the study
- •Written informed consent to participate.
排除标准
- •No valid compulsory health insurance status or no valid Slovenian health insurance card
- •Previous diagnosis of invasive or non-invasive breast cancer and registration in the Slovenian Cancer Registry
- •For women aged 70-74 years: less than 2 years since the previous mammography within the DORA programme.
研究组 & 干预措施
Screening Mammography
Women aged 45-49 years and 70-74 years will be invited to undergo screening mammography within the DORA breast cancer screening programme. Screening and any required additional assessment will follow the established DORA programme procedures.
干预措施: Screening Mammography (Diagnostic Test)
结局指标
主要结局
Screening Participation Rate
时间窗: From invitation to the scheduled screening mammography appointment, approximately 3-4 weeks
Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Referral Rate for Additional Assessment
时间窗: At screening mammography, approximately 3-4 weeks after invitation
Percentage of screened women referred for additional diagnostic assessment after screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
次要结局
- Participant Satisfaction and Communication Needs(1 to 2 days after screening mammography)