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Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer.
BMJ Open. 2015 Mar 31; 5(3):e007698.BO

Abstract

BACKGROUND

The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting.

METHODS/DESIGN

This paper concerns a pre-implementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid.

ETHICS AND DISSEMINATION

This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT).

STUDY REGISTRATION NUMBER

NTR4879.

Authors+Show Affiliations

Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.Zuyd University of Applied Sciences, Heerlen, The Netherlands.Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.Department of Radiotherapy, Maastricht University Medical Center, Maastricht, The Netherlands.Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.Department of Family Medicine, Maastricht University, Maastricht, The Netherlands School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

25829374

Citation

Savelberg, Wilma, et al. "Protocol for a Pre-implementation and Post-implementation Study On Shared Decision-making in the Surgical Treatment of Women With Early-stage Breast Cancer." BMJ Open, vol. 5, no. 3, 2015, pp. e007698.
Savelberg W, Moser A, Smidt M, et al. Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer. BMJ Open. 2015;5(3):e007698.
Savelberg, W., Moser, A., Smidt, M., Boersma, L., Haekens, C., & van der Weijden, T. (2015). Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer. BMJ Open, 5(3), e007698. https://doi.org/10.1136/bmjopen-2015-007698
Savelberg W, et al. Protocol for a Pre-implementation and Post-implementation Study On Shared Decision-making in the Surgical Treatment of Women With Early-stage Breast Cancer. BMJ Open. 2015 Mar 31;5(3):e007698. PubMed PMID: 25829374.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer. AU - Savelberg,Wilma, AU - Moser,Albine, AU - Smidt,Marjolein, AU - Boersma,Liesbeth, AU - Haekens,Christel, AU - van der Weijden,Trudy, Y1 - 2015/03/31/ PY - 2015/4/2/entrez PY - 2015/4/2/pubmed PY - 2015/12/22/medline KW - Decision support Techniques KW - Patient participation KW - Patient preferences KW - Quality improvement KW - Shared decision making SP - e007698 EP - e007698 JF - BMJ open JO - BMJ Open VL - 5 IS - 3 N2 - BACKGROUND: The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. METHODS/DESIGN: This paper concerns a pre-implementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid. ETHICS AND DISSEMINATION: This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT). STUDY REGISTRATION NUMBER: NTR4879. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/25829374/Protocol_for_a_pre_implementation_and_post_implementation_study_on_shared_decision_making_in_the_surgical_treatment_of_women_with_early_stage_breast_cancer_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=25829374 DB - PRIME DP - Unbound Medicine ER -