Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial

Pia Grabbe, Kathrin M Gschwendtner, Imad Maatouk, Sophia B Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C Hassel, Christiane Bieber, Pia Grabbe, Kathrin M Gschwendtner, Imad Maatouk, Sophia B Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C Hassel, Christiane Bieber

Abstract

Background: Patients 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.

Methods: In 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.

Discussion: This 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 registration: ClinicalTrials.gov NCT04240717 . Registered on 27 January 2020.

Keywords: Immunotherapy; Melanoma; Patient decision aid; Randomized controlled trial; Shared decision-making.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure). Note that the assessment of covariates is not depicted here

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