Informed shared decision making supported by decision coaches for women with ductal carcinoma in situ
| ISRCTN | ISRCTN46305518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46305518 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | German Aerospace Centre Project Management Agency |
| Funder | German Federal Ministry of Health |
- Submission date
- 04/06/2015
- Registration date
- 05/06/2015
- Last edited
- 26/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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?
Birte Berger-Höger
birte.berger-hoeger@medizin.uni-halle.de (updated 26/06/2019, previously: info@spupeo.de)
Contact information
Scientific
Magdeburger Str. 8
Halle
06112
Germany
 ORCID ID |
0000-0002-4704-4401 |
|---|---|
| Phone | +49 40 42838 7152 |
| birte.berger-hoeger@medizin.uni-halle.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Superiority cluster-randomized-controlled trial with a parallel group design and with 1:1 allocation ratio. |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Informed shared decision making supported by decision coaches for women with ductal carcinoma in situ: a cluster-randomized-controlled trial |
| Study acronym | SPUPEO |
| Study objectives | 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 approval(s) | Ethics committee of the German Society of Nursing Science - Witten, 19/05/2015, ref: EK 15-003 |
| Health condition(s) or problem(s) studied | Breast cancer, ductal carcinoma in situ, primary treatment decision, shared decision making |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Observer based rating of SDM-behaviour of patients alone (MAPPIN-Opatient) |
| Completion date | 30/09/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 192 |
| Total final enrolment | 67 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 31/01/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Informatics and Natural Sciences
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
20146
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of the cluster randomized controlled trial | 01/05/2019 | 26/06/2019 | Yes | No |
| Protocol article | protocol | 12/10/2015 | Yes | No | |
| Basic results | 26/06/2019 | 26/06/2019 | No | No | |
| Other publications | development and pilot testing of the intervention | 06/12/2017 | 26/06/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN46305518_BasicResults_26Jun2019.pdf
- uploaded 26/06/2019
Editorial Notes
26/06/2019: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The scientific contact address, email, and ORCID ID were updated.
3. Publication references added.
4. The total final enrolment was added.
5. The plain English summary was updated to reflect these changes.
08/05/2017: The overall trial end date has been updated from 31/03/2016 to 30/09/2017
16/10/2015: Publication reference added.
