Jönköping Academy For Improvement of Health and Welfare and IMPROVE, School of Health and Welfare, Jönköping University, Jönköping, Sweden.
Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.
BMC Med Inform Decis Mak. 2021 Feb 25;21(1):76. doi: 10.1186/s12911-021-01448-3.
Radiation Therapy (RT) is a common treatment after breast cancer surgery and a complex process using high energy X-rays to eradicate cancer cells, important in reducing the risk of local recurrence. The high-tech environment and unfamiliar nature of RT can affect the patient's experience of the treatment. Misconceptions or lack of knowledge about RT processes can increase levels of anxiety and enhance feelings of being unprepared at the beginning of treatment. Moreover, the waiting time is often quite long. The primary aim of this study will be to evaluate whether a digital information tool with VR-technology and preparatory information can decrease distress as well as enhance the self-efficacy and health literacy of patients affected by breast cancer before, during, and after RT. A secondary aim will be to explore whether the digital information tool increase patient flow while maintaining or increasing the quality of care.
The study is a prospective and longitudinal RCT study with an Action Research participatory design approach including mixed-methods data collection, i.e., standardised instruments, qualitative interviews (face-to-face and telephone) with a phenomenological hermeneutical approach, diaries, observations, and time measurements, and scheduled to take place from autumn 2020 to spring 2022. The intervention group (n = 80), will receive standard care and information (oral and written) and the digital information tool; and the control group (n = 80), will receive standard care and information (oral and written). Study recruitment and randomisation will be completed at two centres in the west of Sweden.
Research in this area is scarce and, to our knowledge, only few previous studies examine VR as a tool for increasing preparedness for patients with breast cancer about to undergo RT that also includes follow-ups six months after completed treatment. The participatory approach and design will safeguard the possibilities to capture the patient perspective throughout the development process, and the RCT design supports high research quality. Digitalisation brings new possibilities to provide safe, person-centred information that also displays a realistic picture of RT treatment and its contexts. The planned study will generate generalisable knowledge of relevance in similar health care contexts.
ClinicalTrials.gov Identifier: NCT04394325. Registered May 19, 2020. Prospectively registered.
放射治疗（RT）是乳腺癌手术后的常见治疗方法，是利用高能 X 射线消灭癌细胞的复杂过程，这对降低局部复发风险非常重要。高科技环境和 RT 的陌生性质会影响患者的治疗体验。对 RT 过程的误解或缺乏了解会增加焦虑水平，并在治疗开始时增强不准备的感觉。此外，等待时间通常相当长。本研究的主要目的是评估具有 VR 技术和预备信息的数字信息工具是否可以减轻乳腺癌患者在接受 RT 前后的痛苦，增强自我效能感和健康素养。次要目的是探讨数字信息工具是否可以在保持或提高护理质量的同时增加患者流量。
该研究是一项前瞻性和纵向 RCT 研究，采用行动研究参与式设计方法，包括混合方法数据收集，即标准化工具、现象学解释学方法的定性访谈（面对面和电话）、日记、观察和时间测量，并计划于 2020 年秋季至 2022 年春季进行。干预组（n=80）将接受标准护理和信息（口头和书面）以及数字信息工具；对照组（n=80）将接受标准护理和信息（口头和书面）。研究招募和随机分组将在瑞典西部的两个中心完成。
该领域的研究很少，据我们所知，只有少数先前的研究检查了 VR 作为一种工具，用于增加即将接受 RT 的乳腺癌患者的准备情况，并且还包括完成治疗后六个月的随访。参与式方法和设计将确保在整个开发过程中能够捕捉到患者的观点，而 RCT 设计支持高研究质量。数字化为提供安全、以患者为中心的信息提供了新的可能性，这些信息还可以展示 RT 治疗及其背景的现实画面。计划中的研究将产生在类似医疗保健环境中具有相关性的普遍适用知识。
ClinicalTrials.gov 标识符：NCT04394325。于 2020 年 5 月 19 日注册。前瞻性注册。
