Shared Decision Making With Breast Cancer Patients

Danish Breast Cancer Cooperative Group, University of Southern Denmark, Danish Comprehensive Cancer Center

The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation. In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process. This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy. It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.

Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.

Patients will be informed by a doctor randomized to practice shared decision making and use the in-consultation PtDA during the consultation on adjuvant radiotherapy.

Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.

After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.

Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9.

The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9

The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire

The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire

The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire

The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire

The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire

The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30

Inclusion Criteria: Histologically verified breast cancer or ductal carcinoma in situ breast cancer Candidate for adjuvant radiotherapy Danish Breast Cancer Group type F after breast-conserving surgery for T1-2, N0-Nmi, M0 disease according to national guidelines. Signed confirmation of participation. Exclusion Criteria: Bilateral breast cancer or suspicion of disseminated cancer Unable to understand the information, the planned treatment or follow-up for any reason. Earlier radiotherapy towards the thoracic region.