Universität zu Köln

Grabbe, Pia, Gschwendtner, Kathrin M., Maatouk, Imad, Strobel, Sophia B., Salzmann, Martin, Bossert, Julia, Eich, Wolfgang, Wild, Beate, Meier, Friedegund, Hassel, Jessica C. and Bieber, Christiane (2021). Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial. Trials, 22 (1). LONDON: BMC. ISSN 1745-6215

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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, T-0; after intervention, T-1; and 3 months after intervention, T-2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T-1. 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 T-1 and T-2.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

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Grabbe, Pia UNSPECIFIED UNSPECIFIED UNSPECIFIED Gschwendtner, Kathrin M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Maatouk, Imad UNSPECIFIED UNSPECIFIED UNSPECIFIED Strobel, Sophia B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salzmann, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Bossert, Julia UNSPECIFIED UNSPECIFIED UNSPECIFIED Eich, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Wild, Beate UNSPECIFIED UNSPECIFIED UNSPECIFIED Meier, Friedegund UNSPECIFIED UNSPECIFIED UNSPECIFIED Hassel, Jessica C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bieber, Christiane UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-593037
DOI:	10.1186/s13063-021-05234-4
Journal or Publication Title:	Trials
Volume:	22
Number:	1
Date:	2021
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NIVOLUMAB; IPILIMUMAB; EFFICACY Multiple languages Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59303