Laryionava Katsiaryna, Schildmann Jan, Wensing Michael, Wedding Ullrich, Surmann Bastian, Woydack Lena, Krug Katja, Winkler Eva
Institute for History and Ethics of Medicine, Centre for Health Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.
JMIR Res Protoc. 2021 Sep 17;10(9):e24954. doi: 10.2196/24954.
To support advanced cancer patients and their oncologists in therapeutic decisions, we aim to develop a decision aid (DA) in a multiphased, bicentric study. The DA aims to help patients to better understand risks and benefits of the available treatment options including the options of standard palliative care or cancer-specific treatment (ie, off-label drug use within an individual treatment plan).
This study protocol outlines the development and testing of the DA in a pre-post study targeting a heterogeneous population of advanced cancer patients.
In the first step, we will assess patients' information and decisional needs as well as the views of the health care providers regarding the content and implementation of the DA. Through a scoping review, we aim to analyze specific characteristics of the decision-making process and to specify the treatment options, outcomes, and probabilities. An interdisciplinary research group of experts will develop and review the DA. In the second step, testing of the DA (design and field testing) with patients and oncologists will be conducted. As a last step, we will run a pre-post design study with 70 doctor-patient encounters to assess improvements on the primary study outcome: patients' level of decisional conflict. In addition, the user acceptance of all involved parties will be tested.
Interviews with cancer patients, oncologists, and health care providers (ie, nurses, nutritionists) as well as a literature review from phase I have been completed. The field testing is scheduled for April 2021 to August 2021, with the final revision scheduled for September 2021. The pre-post study of the DA and acceptance testing are scheduled to start in October 2021 and shall be finished in September 2022.
A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and switching to best supportive care.
ClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24954.
为了在治疗决策方面为晚期癌症患者及其肿瘤学家提供支持，我们旨在通过一项多阶段、双中心研究开发一种决策辅助工具（DA）。该决策辅助工具旨在帮助患者更好地理解现有治疗方案的风险和益处，包括标准姑息治疗或癌症特异性治疗方案（即在个体治疗计划中使用未获批准的药物）。
本研究方案概述了在一项针对晚期癌症患者异质性群体的前后对照研究中对该决策辅助工具的开发和测试。
第一步，我们将评估患者的信息和决策需求，以及医疗保健提供者对决策辅助工具的内容和实施的看法。通过范围综述，我们旨在分析决策过程的具体特征，并明确治疗方案、结果和概率。一个跨学科专家研究小组将开发和审查该决策辅助工具。第二步，将对患者和肿瘤学家进行决策辅助工具的测试（设计和现场测试）。最后一步，我们将进行一项前后对照设计研究，涉及70次医患会诊，以评估主要研究结果的改善情况：患者的决策冲突水平。此外，还将测试所有参与方对该工具的接受程度。
已完成对癌症患者、肿瘤学家和医疗保健提供者（即护士、营养师）的访谈以及第一阶段的文献综述。现场测试计划于2021年4月至2021年8月进行，最终修订计划于2021年9月进行。决策辅助工具的前后对照研究和接受度测试计划于2021年10月开始，2022年9月完成。
本研究的一个独特之处在于为不同类型的晚期癌症患者开发了一种决策辅助工具，该工具涵盖了与临终患者相关的广泛主题，如放弃癌症特异性治疗并转向最佳支持性护理。
ClinicalTrials.gov NCT04606238；https://clinicaltrials.gov/ct2/show/NCT04606238。
国际注册报告识别码（IRRID）：DERR1-10.2196/24954。
