Borstkanker breast cancer Mamma carcinoma
Conditions
Interventions
Women who are randomized into the intervention group that are assessed with a
BI-RADS code 4 or 5 (suspicious for malignancy) will directly be referred to
full hospital assessment, as in current scr
or
virtually exclude this possibility (downgrade to BI-RADS 1, 2), in which case
the woman will be classified as *definite benign* and go home reassured.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All women referred to hospital on basis of a positive screening mammography.
Exclusion criteria
Exclusion criteria: Women who don*t understand the Dutch language, as well as women who are in a state of diminished responsibility or mentally disabled. they are not able to fill in the questionnaire and will not understand the information provided by the research assistant. They are therefore excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome parameter is the negative predictive value of preselection, which is interrelated to secondary outcome parameters such as hospital referral rate, detection rate, false-positive rate and the ultimate outcome survival (estimated through a microsimulation model). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional outcome parameters are quality of life, anxiety, satisfaction, productivity losses, patient time costs and volumes of care. The cost-effectiveness analysis will estimate the cost per QALY gained and cost per percentage increase in satisfaction with screening, or, if effects differ, the incremental cost per QALY gained as the long run modelling outcome. | — |
Countries
Netherlands
Outcome results
None listed