Introduction: Patient engagement is continuously being promoted by patients as well as politicians and healthcare professionals. One way of increasing patient engagement is by using shared decision-making (SDM), which is a joint effort of clinicians and patients making decisions together.When planning stereotactic body radiation therapy (SBRT) for a lung tumour located close to the thoracic wall, there are conflicting interests between (1) delivering the highest possible dose to obtain local tumour control and (2) reducing the dose to the thoracic wall to decrease the risk of chest wall pain and rib fractures following treatment. The radiation oncologist often makes the choice of dose without any engagement of the patient. We believe that the patients should be engaged in such a decision.To explore this matter, we have designed a randomised trial, 'SDM Lung SBRT', for which we present our study protocol with a special focus on a patient decision aid (PtDA), which is being tested in this trial.
Methods And Analysis: This study includes patients with a lung tumour located ≤1 cm from the thoracic wall. Patients are randomised to have the primary consultation with or without use of the PtDA. Treatment options are a radiation dose of either 66 Gray (Gy) in three fractions, 45 Gy in three fractions or no treatment. The primary outcome is patient engagement in decision-making measured by the validated observer-rated OPTION-12 score. Secondary outcomes are patient-reported outcomes, quality of life and side effects following treatment.
Ethics And Dissemination: All patients give informed consent to participate. According to Danish legislation, ethical approval is not required for this study as studies using questionnaires, observations or other non-biological studies are not considered interventions according to the Committee Act. Results from this study will be presented at scientific meetings and published in English peer-reviewed journals.
Trial Registration Number: ClinicalTrials.gov (NCT04940936).
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