Abstract
BackgroundPatients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients’ knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.MethodsIn total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient’s knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2.DiscussionThis trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.Trial registrationClinicalTrials.gov NCT04240717. Registered on 27 January 2020
Highlights
Immunotherapy with immune checkpoint inhibitors is a promising new treatment option for various types of cancer
We aim to evaluate whether patients of the intervention group (IG), who have used the patient decision aid (PtDA), have a higher level of knowledge regarding their treatment options compared to the patients in the control group (CG), who have not had access to the PtDA
In this study, we want to investigate whether an interactive web-based PtDA developed by our research group can effectively support patients with metastatic melanoma in their treatment decision
Summary
Background Immunotherapy with immune checkpoint inhibitors is a promising new treatment option for various types of cancer. In a recent study on treatment choices, melanoma patients (stages I– IV) and their providers systematically accepted all levels of risk for adverse events in exchange for improved survival rates [12]. This finding suggests that patients make extreme, yet conscious, decisions. Risks and benefits vary considerably between various treatment options With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients’ knowledge of treatment options and promote shared decision-making (SDM) and patient decision satisfaction
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