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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
2,150
Participants will undergo breast cancer screening with mammography according to the established procedures of the Slovenian DORA screening programme. Women with findings requiring further evaluation will undergo additional diagnostic assessment according to the DORA protocol.
Institute of Oncology Ljubljana
Ljubljana, Slovenia
Screening Participation Rate
Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Time frame: From invitation to the scheduled screening mammography appointment, approximately 3-4 weeks
Referral Rate for Additional Assessment
Percentage of screened women referred for additional diagnostic assessment after screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Time frame: At screening mammography, approximately 3-4 weeks after invitation
Participant Satisfaction and Communication Needs
Participant-reported satisfaction with the screening process assessed using an anonymous SMS questionnaire. Items are rated on a 5-point scale from 1 (Very poor) to 5 (Excellent), with higher scores indicating greater satisfaction.
Time frame: 1 to 2 days after screening mammography
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