Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Oct 12:16:452.
doi: 10.1186/s13063-015-0991-8.

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

Birte Berger-Höger  1 , Katrin Liethmann  2 , Ingrid Mühlhauser  3 , Burkhard Haastert  4 , Anke Steckelberg  5
Affiliations
Randomized Controlled Trial

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

Birte Berger-Höger et al. Trials. .

Abstract

Background: Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices. In this trial, the informed shared decision-making program will be evaluated in breast care centers.

Methods/design: A cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2 hours) and specialized breast care and oncology nurses (4 days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited. Primary outcome is the extent of patients' involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted.

Discussion: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers.

Trial registration: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Participant timeline
See this image and copyright information in PMC

References

    1. Hamann J, Neuner B, Kasper J, Vodermaier A, Loh A, Deinzer A, et al. Participation preferences of patients with acute and chronic conditions. Health Expect. 2007;10:358–63. doi: 10.1111/j.1369-7625.2007.00458.x. - DOI - PMC - PubMed
    1. Mühlhauser I, Meyer G, Steckelberg A. Patients demand informed participation in medical decision making, but the information data base and structures are not available. Z Allg Med. 2010;86:10–5.
    1. Brown R, Butow P, Wilson-Genderson M, Bernhard J, Ribi K, Juraskova I. Meeting the decision-making preferences of patients with breast cancer in oncology consultations: impact on decision-related outcomes. J Clin Oncol. 2012;30:857–62. doi: 10.1200/JCO.2011.37.7952. - DOI - PubMed
    1. Kreienberg R, Albert U-S, Follmann M, Kopp I, Kühn T, Wöckel A, et al. Interdisciplinary S3-guideline on diagnostics, therapy and follow up of breast cancer. In: German guideline program in oncology. 3rd ed. Berlin: AWMF, DKG, Deutsche Krebshilfe; 2012. http://leitlinienprogramm-onkologie.de/uploads/tx_sbdownloader/S3-Brustk.... Accessed 17 July 2014.
    1. Stacey D, Samant R, Bennett C. Decision making in oncology: a review of patient decision aids to support patient participation. CA Cancer J Clin. 2008;58:293–304. doi: 10.3322/CA.2008.0006. - DOI - PubMed

Publication types

MeSH terms

Associated data