Plain English Summary
Background and study aims
Women with breast cancer want to participate in treatment decision making. SDM includes a mutual decision making process between patients and healthcare professionals considering all relevant information on treatment options and patients´ preferences. It enables patients to make informed decisions. Up to now implementation of SDM has failed due to e.g. limited resources of physicians and lack of evidence-based decision aids. We developed an SDM programme for women with primary ductal carcinoma in situ (DCIS). It includes an evidence-based patient decision aid, training of specialized breast care and oncology nurses, workshop for physicians, and decision coaching for women. The programme aims at supporting involvement in decision making and informed choices.
In this study we investigate if women receiving evidence based decision aids and decision coaching by specialised nurses will be more involved in treatment decision making than women receiving standard care.
Who can participate?
Women are eligible if they are at least 18 years old, have no known BRCA1/2-mutation, are not pregnant and have a primary DCIS. All participants need sufficient German language skills.
What does the study involve?
The trial compares the SDM programme with standard care. 16 certified breast care centres will be included recruiting 192 women with primary DCIS. Two study groups (intervention and control group) are compared. The intervention includes a four day training programme in SDM for specialised nurses, a two hour-lasting workshop in SDM for physicians and an evidence-based patient decision aid and decision coaching for women. Women in the control group receive standard care.
What are the possible benefits and risks of participating?
It is expected that the provision of an evidence-based patient decision aid combined with decision coaching will increase women´s involvement in decision making and informed choices. The intervention will reduce women’s decisional conflicts and the duration of physician encounters. We expect no harm for participating women.
Where is the study run from?
The study will include 16 certified breast care centres in the following federal states of Germany: Schleswig-Holstein, Hamburg, Bremen, North Rhine-Westphalia, Hessen, Saxony-Anhalt, Mecklenburg-West Pomerania and Lower Saxony.
When is the study starting and how long is it expected to run for?
October 2014 to March 2016
Who is funding the study?
German Ministry of Health
Who is the main contact?
firstname.lastname@example.org (updated 26/06/2019, previously: email@example.com)
Informed shared decision making supported by decision coaches for women with ductal carcinoma in situ: a cluster-randomized-controlled trial
The main hypothesis is that patients facing a primary treatment decision on ductal carcinoma in situ (DCIS) who receive an evidence-based decision aid combined with decision coaching by specialized nurses are more involved in treatment decision making compared to patients receiving standard care. The extent of physicians’, patients’ and nurses’ shared decision making-behaviour will be assessed using the observer-based rating of the `multifocal approach to the sharing in shared decision making´ (MAPPIN-SDM). In addition, we hypothesize that in the intervention group informed choices will increase, decisional conflict will decrease and the duration of physician consultations will be shortened.
Ethics committee of the German Society of Nursing Science - Witten, 19/05/2015, ref: EK 15-003
Superiority cluster-randomized-controlled trial with a parallel group design and with 1:1 allocation ratio.
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Not available in web format and only in German language. Please use the contact details to request a patient information sheet.
Breast cancer, ductal carcinoma in situ, primary treatment decision, shared decision making
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 days divided into two modules)
1.3. Workshop for physicians (two hours) and
1.4. At least one decision coaching session for the participating patients.
2. Control group: The health care professionals in the control group receive no intervention and will deliver standard care.
Primary outcome measure
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 outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
16 clusters (breast care centres) will be recruited and randomized. Each cluster will include 12 participants. The total sample size comprises 192 participants.
Total final enrolment
Participant exclusion criteria
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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Hamburg
Faculty of Mathematics Informatics and Natural Sciences Unit of Health Sciences and Education Martin-Luther-King-Platz 6
German Federal Ministry of Health
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
We intend to publish and disseminate the results of the study after the study ended.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
See additional file (ISRCTN46305518_BasicResults_26Jun2019) (added 26/06/2019)
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26458964
2017 development and pilot testing of the intervention in https://www.ncbi.nlm.nih.gov/pubmed/29212475 (added 26/06/2019)
2019 results of the cluster randomized controlled trial in https://www.ncbi.nlm.nih.gov/pubmed/30925280 (added 26/06/2019)
- ISRCTN46305518_BasicResults_26Jun2019.pdf uploaded 26/06/2019