Breast cancer, ductal carcinoma in situ, primary treatment decision, shared decision making Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Breast care centres are eligible if they are certified according to a German or European certification body (e.g. Onkozert, Äkzert or EUSOMA) Nurses are eligible if they have a one- or two-year long advanced training as breast care or oncology nurses or if they have been entrusted with the breast care nurses´ tasks for at least 6 months Women are eligible if: 1. they are aged 18 years or older 2. they have a primary, histologically confirmed DCIS 3. don't have invasive breast cancer or lobular carcinoma in situ 4. are facing a primary treatment decision 5. have sufficient language skills in German
Exclusion criteria
Exclusion criteria: Women who: 1. are pregnant 2. have a known BRCA 1/2 mutation 3. had a previous history of breast cancer or DCIS (irrespective if ipsi- or contralateral) 4. have a contra-indication for radiotherapy 5. are seeking a second opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is defined as the extent of informed shared decision making-behaviour (SDM-behaviour) of physicians, nurses and patients during the consultations and the decision coaching sessions. We will measure SDM-behaviour using the observer based instrument MAPPIN-O of the “multifocal approach to the ‘sharing’ in shared decision-making” (MAPPIN). It assesses the mutual SDM-behaviour of health care professionals and patients based video-recordings. In the control group the physician consultations will be rated, whereas in the intervention group nurse and physician encounters will be summed up. All ratings will be performed independently by two trained observers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Observer based rating of SDM-behaviour of patients alone (MAPPIN-Opatient) 2. Observer based rating of SDM-behaviour of physicians alone (MAPPIN-Ophysician) 3. Observer based rating of SDM-behaviour of nurses alone (MAPPIN-Onurses) 4. Patient based judgment about perceived SDM-behaviour 5. Nurse based judgment about perceived SDM-behaviour (only in the intervention group) 6. Physician based judgment about perceived SDM-behaviour 7. Concordance between professionals (nurses or physicians) and patient based judgment of SDM-behaviour 8. Informed choice (including the three subdimensions attitude, knowledge and uptake) 9. Decisional conflict 10. Duration of consultations | — |
Countries
Germany