Moens Katrien, Peeters Marc, Van den Bulcke Marc, Leys Mark, Horlait Melissa
Cancer Centre, Sciensano, Brussels, Belgium.
University Hospital Antwerp (UZA), Antwerp, Belgium.
JMIR Res Protoc. 2022 Jun 6;11(6):e29004. doi: 10.2196/29004.
Patients with pancreatic cancer do not feel involved in the development of their treatment and care plans. In Belgium, these plans are decided on during multidisciplinary team meetings. However, limited time is spent on the discussion of the preferences of the patient during these meetings. This research project aims to develop a patient-reported experience measure (PREM) for pancreatic cancer and assess if its use can support collaborative treatment decision-making.
This paper aims to outline the protocol for a multi-method research project to improve person-centered pancreatic cancer care in Belgium. Three subobjectives are pursued: (1) to develop a PREM to assess the experiences of care-related aspects in pancreatic cancer care, (2) to validate the PREM, and (3) to develop and evaluate an educational intervention to support the use of the PREM's results.
For the development of the PREM, an exploratory mixed methods study design will be used. The study will start with a survey followed by a telephone interview involving patients with pancreatic cancer and digestive oncology health care professionals. Study two is the testing of the content and construct validity of the PREM. Study three involves the implementation study according to the Medical Research Council framework of a complex intervention introducing the PREM in practice. The effectiveness of the intervention will be investigated using a pragmatic randomized controlled trial study design.
The protocol presents the entire structure of the research project. Ethics approval to conduct the exploratory mixed methods study (objective 1) has been obtained, and recruitment has started since January 2022.
The poor prognosis of patients with pancreatic cancer should not be considered a hurdle to not study this patient population group. Involving patients in the research and decision-making processes early on is key. This project aims to realize a scientifically sound research process providing research outputs that can easily and timely be implemented in the care trajectory of patients with pancreatic cancer. This research project will also lead to recommendations on how to involve patients with pancreatic cancer and how the methodology of this research project can be translated to other patient groups.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29004.
胰腺癌患者感觉自己没有参与到其治疗和护理计划的制定过程中。在比利时，这些计划是在多学科团队会议上决定的。然而，在这些会议上用于讨论患者偏好的时间有限。本研究项目旨在开发一种针对胰腺癌的患者报告体验测量工具（PREM），并评估其使用是否有助于支持协作性治疗决策。
本文旨在概述一项多方法研究项目的方案，以改善比利时以患者为中心的胰腺癌护理。该项目追求三个子目标：（1）开发一种PREM，以评估胰腺癌护理中与护理相关方面的体验；（2）验证该PREM；（3）开发并评估一项教育干预措施，以支持PREM结果的使用。
为了开发PREM，将采用探索性混合方法研究设计。该研究将首先进行一项调查，随后对胰腺癌患者和消化肿瘤医疗保健专业人员进行电话访谈。研究二是对PREM的内容和结构效度进行测试。研究三涉及根据医学研究理事会的复杂干预框架进行实施研究，即在实践中引入PREM。将使用务实的随机对照试验研究设计来调查干预措施的有效性。
该方案展示了研究项目的整体结构。已获得开展探索性混合方法研究（目标1）的伦理批准，自2022年1月起已开始招募参与者。
不应将胰腺癌患者的不良预后视为不研究该患者群体的障碍。尽早让患者参与研究和决策过程是关键。本项目旨在实现一个科学合理的研究过程，提供能够轻松、及时地在胰腺癌患者护理轨迹中实施的研究成果。该研究项目还将就如何让胰腺癌患者参与以及如何将本研究项目的方法应用于其他患者群体提出建议。
国际注册报告识别号（IRRID）：PRR1-10.2196/29004
