Short summary

As participants in a multicenter trial, oncologists are randomly assigned to either continue usual practice or practice shared decision making supported by a patient decision aid known as the Decision Helper. This aim of this study is to enlighten and analyze oncologists' and nurses' experiences of shared decision making and the Decision Helper.

Rationale

In the national strategy for oncology care in Denmark from 2016, the politicians state that shared decision making (SDM) should be implemented for all cancer patients in Denmark. In 2020 nine out of ten cancer patients in Denmark should be engaged in decisions regarding their treatment (1).

Shared decision making is a clinical process in which clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences (2). Shared decision making may increase patient involvement by making the patient comfortable in taking active part in decision making in situations where there is more than one option and neither is clearly better. Furthermore, SDM may help physicians respect the fact that patients value potential benefits or harms of a certain option differently. One way of practicing SDM is with the help of a Patient Decision Aid (PtDA)(3).

Patient Decision Aids are tools developed to support the process of SDM. A PtDA presents options in a clear, understandable, evidence based order and facilitates the clarification of the patient's values (4). The use of PtDAs has, in oncology and beyond, proven to improve patients' knowledge of options, make patients more clear about what matters to them, and decrease their decisional conflict (5,6).

In Denmark, approximately 4.800 women are annually diagnosed with breast cancer and 1.200 patients die of breast cancer (7-9). The primary treatment of breast cancer is most commonly surgery. Thereafter, the patient is most often offered adjuvant treatment such as radiotherapy (RT) or medical treatment involving chemotherapy, endocrine therapy or biologic targeted treatment. All the adjuvant treatments offered have side effects, some of these side effects are acute and will pass, while others may be long term side effects. Calculations of expected side effects and expected gain are essential in recommendations for adjuvant treatment (10-12).

The Danish Breast Cancer cooperative Group Radiotherapy Committee (DBCG RT) has initiated a national, randomized trial, the DBCG RT SDM trial, in cooperation with the Center for Shared Decision Making at Vejle Hospital. The aim of the DBCG RT SDM trial is to elucidate whether the clinical use of SDM and PtDA will influence patient engagement in the decision process about adjuvant radiotherapy for patients operated with breast conservation for early node-negative breast cancer or ductal carcinoma in situ.

As participants in a national, randomized trial, oncologists are randomly assigned to either continue usual practice or practice shared decision making supported by a patient decision aid known as the Decision Helper (DH). Enrollment has started at Vejle Hospital, Aarhus University Hospital, Odense University Hospital and Aalborg University Hospital. So far, 262 patients are enrolled in the randomized trial.

Much research on shared decision making focus on patient-reported outcomes, quantitatively as well as qualitatively. The present study is set up with the aim of investigating the oncologists' and nurses' experience of shared decision making and the DH. The setting for this is unique as half the oncologists at each department is randomly assigned to practice shared decision making with the support of the DH; the other half continue as usual. The nurses participate in consultations in both arms. The knowledge from this study will be of interest in the further implementation of shared decision making and the DH in oncology and beyond.

This aim of this study is to enlighten and analyze oncologists' and nurses' experiences of shared decision making and the DH.

References: 1. Danish Health Authority. Cancer action plan [Internet]. 2016 [cited 2020 Oct 6]. Available from: https://www.sst.dk/da/viden/kraeft/kraeftplaner/kraeftplan-iv

2. Coulter A. Patient engagement-what works? J Ambul Care Manage. 2012;35(2):80-9.

3. Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: A model for clinical practice. J Gen Intern Med. 2012;27(10):1361-7.

4. Sepucha KR, Abhyankar P, Hoffman AS, Bekker HL, LeBlanc A, Levin CA, et al. Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist. BMJ Qual Saf [Internet]. 2017;(December):bmjqs-2017-006986. Available from: http://qualitysafety.bmj.com/lookup/doi/10.1136/bmjqs-2017-006986

5. Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane database Syst Rev [Internet]. 2017 Apr 12 [cited 2020 Mar 6];4(4):CD001431. Available from: http://doi.wiley.com/10.1002/14651858.CD001431.pub5

6. McAlpine K, Lewis KB, Trevena LJ, Stacey D. What Is the Effectiveness of Patient Decision Aids for Cancer-Related Decisions? A Systematic Review Subanalysis. JCO Clin Cancer Informatics. 2018;(2):1-13.

7. Colditz GA. Epidemiology and Prevention of Breast Cancer. Cancer Epidemiol Biomarkers & Prev [Internet]. 2005 Apr 1;14(4):768 LP - 772. Available from: http://cebp.aacrjournals.org/content/14/4/768.abstract

8. Sundhedsdatastyrelsen. Tabel over nye kræfttilfælde [Internet]. 2016 [cited 2019 Jan 4]. Available from: http://www.esundhed.dk/sundhedsregistre/CAR/CAR01/Sider/Tabel.aspx

9. Engholm G, Ferlay J CN et al. N. Cancer Incidence, Mortality, Prevalence and Survival in the Nordic Countries, Version 8.1 Association of the Nordic Cancer Registries. Danish Cancer Society. [Internet]. 2018 [cited 2019 Jan 4]. Available from: https://www.ancr.nu/cancer-data/

10. DBCG. Danish Breast Cancer Cooperative Group (DBCG) Guidline on Adjuvant radiotherapy [Internet]. 2016 [cited 2020 Oct 6]. Available from: https://dbcg.dk/PDF/kap-5-postoperativ-straalebehandling-22062016.pdf

11. Tao JJ, Visvanathan K, Wolff AC. Long term side effects of adjuvant chemotherapy in patients with early breast cancer. Breast [Internet]. 2015;24(2015):S149-53. Available from: http://dx.doi.org/10.1016/j.breast.2015.07.035

12. DBCG. Danish Breast Cancer Group The DBCG RT Natural trial : Partial breast versus no irradiation for women ≥ 60 years operated with breast conservation for early breast cancer. ClinicalTrials.gov Identifier: NCT03646955. 2018.

Description of the cohort

Sampling strategy. We will ask oncologists and nurses at Vejle Hospital, Aarhus University Hospital and Odense University Hospital to participate as part of their contribution to the DBCG RT SDM trial. We hope to include 12 oncologists and 8 nurses. Participation is based on oral and written consent.

Data collection. After a minimum of six months of patient enrolment in the DBCG RT SDM trial, oncologists and nurses at Vejle Hospital, Aarhus University Hospital and Odense University Hospital will be invited to participate in the present study.

Data and biological material

The departments' previous experience with SDM. At the initiation of the DBCG RT SDM trial, all participating oncologists answered eight questions on previous experience with and attitude towards SDM. The answers from these questionnaire will be analysed for potential differences in experience and attitudes towards SDM between the three departments.

The Self-efficacy in patient-centeredness questionnaire (SEPCQ). Oncologists will answer the SEPCQ questionnaire, which evaluates confidence in exhibiting patient-centered behaviors.

The incorpoRATE questionnaire. Oncologists will answer the incorpoRATE questionnaire, which evaluates physicians' willingness to incorporate SDM in daily clinical practice.

Interviews. Semi structured interviews will be conducted based on an interview guide with mainly open-ended questions covering the foci of the research questions. This part of the study is inspired by Kvale and Brinkmann (26). Interviews will take place by zoom and last approximately 30 minutes. The interviews will be recorded and subsequently transcribed verbatim into NVivo.

The main topic of the interview guides will be the clinician's (oncologist or nurse) experience of and attitude towards shared decision making and the DH.

Collaborating researchers and departments

Department of Oncology, Vejle Hospital

Department of Oncology, Aarhus University Hospital

Department of Oncology, Odense University Hospital