Condition category
Cancer
Date applied
04/06/2015
Date assigned
05/06/2015
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Birte Berger-Höger
info@spupeo.de

Trial website

www.spupeo.de

Contact information

Type

Scientific

Primary contact

Ms Birte Berger-Höger

ORCID ID

Contact details

Martin-Luther-King-Platz 6
Hamburg
20146
Germany
+49 40 42838 7152
Birte.Berger-Hoeger@uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

SPUPEO

Study hypothesis

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

Ethics committee of the German Society of Nursing Science - Witten, 19/05/2015, ref: EK 15-003

Study design

Superiority cluster-randomized-controlled trial with a parallel group design and with 1:1 allocation ratio.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format and only in German language. Please use the contact details to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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

01/10/2014

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

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

Participant type

Mixed

Age group

Adult

Gender

Female

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.

Participant 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

Recruitment start date

01/07/2015

Recruitment end date

31/01/2016

Locations

Countries of recruitment

Germany

Trial participating centre

University of Hamburg
Faculty of Mathematics Informatics and Natural Sciences Unit of Health Sciences and Education Martin-Luther-King-Platz 6
Hamburg
20146
Germany

Sponsor information

Organisation

German Aerospace Centre Project Management Agency

Sponsor details

Heinrich-Konen-Str. 1
Bonn
53227
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish and disseminate the results of the study after the study ended. Anticipated date is spring 2016.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26458964

Publication citations

Additional files

Editorial Notes

16/10/2015: Added publication reference.