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Informed shared decision making supported by decision coaches for women with ductal carcinoma in situ

Informed shared decision making supported by decision coaches for women with ductal carcinoma in situ: a cluster-randomized-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46305518
Enrollment
192
Registered
2015-06-05
Start date
2015-07-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, ductal carcinoma in situ, primary treatment decision, shared decision making Cancer

Interventions

1. Intervention group: SPUPEO programme comprising: 1.1. Evidence-based decision aid on the primary treatment of ductal carcinoma in situ 1.2. Nurse training (four da

Sponsors

German Aerospace Centre Project Management Agency
Lead Sponsor

Eligibility

Sex/Gender
Female

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026