Internal Medicine, Vita Salute San Raffaele University, Milan, Italy.
Strategic Research Program on CLL, IRCCS San Raffaele Hospital, Milan, Italy.
BMJ Open. 2021 Nov 2;11(11):e050256. doi: 10.1136/bmjopen-2021-050256.
The systematic collection of electronic patient-reported outcome (ePRO) in the routine care of patients with chronic haematological malignancies such as chronic lymphocytic leukaemia (CLL) and myelodysplasia syndromes (MDS) can constitute a very ambitious but worthwhile challenge. MyPal is a Horizon 2020 Research & Innovation Action aiming to meet this challenge and foster palliative care for patients with CLL or MDS by leveraging ePRO systems to adapt to the personal needs of patients and caregiver(s).
In this interventional randomised trial, 300 patients with CLL or MDS will be recruited across Europe. Patients will be randomly allocated to early palliative care using the MyPal system (n=150) versus standard care including general palliative care if needed (n=150). Patients in the experimental arm will be given access to the MyPal digital health platform which consists of purposely designed software available on smartphones and/or tablets. The platform entails different functionalities including physical and psychoemotional symptom reporting via regular questionnaire completion, spontaneous self-reporting, motivational messages, medication management and a personalised search engine for health information. Data on patients' activity (daily steps and sleep quality) will be automatically collected via wearable devices.
The integration of ePROs via mobile applications has raised ethical concerns regarding inclusion criteria, information provided to participants, free and voluntary consent, and respect for their autonomy. These have been carefully addressed by a multidisciplinary team. Data processing, dissemination and exploitation of the study findings will take place in full compliance with European Union data protection law. A participatory design was adopted in the development of the digital platform involving focus groups and discussions with patients to identify needs and preferences. The protocol was approved by the ethics committees of San Raffaele (8/2020), Thessaloniki 'George Papanikolaou' Hospital (849), Karolinska Institutet (20.10.2020), University General Hospital of Heraklion (07/15.4.2020) and University of Brno (01-120220/EK).
NCT04370457.
在慢性血液恶性肿瘤（如慢性淋巴细胞白血病 [CLL] 和骨髓增生异常综合征 [MDS]）患者的常规护理中系统地收集电子患者报告结局（ePRO）可能是一项极具挑战性但非常有价值的任务。MyPal 是一项由欧盟地平线 2020 研究与创新行动计划资助的项目，旨在通过利用电子健康应用程序（ePRO）系统来适应患者及其照护者的个人需求，为 CLL 或 MDS 患者提供姑息治疗。
在这项干预性随机试验中，将在欧洲招募 300 名 CLL 或 MDS 患者。患者将被随机分配到早期姑息治疗组（使用 MyPal 系统，n=150）和标准治疗组（包括需要时的一般姑息治疗，n=150）。实验组患者将获得 MyPal 数字健康平台的使用权，该平台由智能手机和/或平板电脑上专门设计的软件组成。该平台具有不同的功能，包括通过定期完成问卷进行身体和心理情绪症状报告、自发自我报告、激励信息、药物管理和个性化的健康信息搜索引擎。患者的活动（每日步数和睡眠质量）数据将通过可穿戴设备自动收集。
通过移动应用程序整合电子健康应用程序引发了关于纳入标准、向参与者提供的信息、自由和自愿同意以及尊重其自主权的伦理问题。这些问题已由一个多学科团队认真解决。数据处理、传播和利用研究结果将完全符合欧盟数据保护法的规定。在开发数字平台时采用了参与式设计，涉及焦点小组和与患者的讨论，以确定需求和偏好。该方案已获得圣拉斐尔医院（2020 年 8 月）、塞萨洛尼基乔治·帕潘德里欧医院（2020 年 849 号）、卡罗林斯卡研究所（2020 年 10 月 20 日）、伊拉克利翁大学综合医院（2020 年 4 月 15 日）和布尔诺大学（2020 年 12 月 22 日）伦理委员会的批准。
NCT04370457。
