Heat Resilence and Performance Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
BMJ Open. 2023 Oct 24;13(10):e077219. doi: 10.1136/bmjopen-2023-077219.
Conventional interventional modalities for preserving or improving cognitive function in patients with brain tumour undergoing radiotherapy usually involve pharmacological and/or cognitive rehabilitation therapy administered at fixed doses or intensities, often resulting in suboptimal or no response, due to the dynamically evolving patient state over the course of disease. The personalisation of interventions may result in more effective results for this population. We have developed the CURATE.AI COR-Tx platform, which combines a previously validated, artificial intelligence-derived personalised dosing technology with digital cognitive training.
This is a prospective, single-centre, single-arm, mixed-methods feasibility clinical trial with the primary objective of testing the feasibility of the CURATE.AI COR-Tx platform intervention as both a digital intervention and digital diagnostic for cognitive function. Fifteen patient participants diagnosed with a brain tumour requiring radiotherapy will be recruited. Participants will undergo a remote, home-based 10-week personalised digital intervention using the CURATE.AI COR-Tx platform three times a week. Cognitive function will be assessed via a combined non-digital cognitive evaluation and a digital diagnostic session at five time points: preradiotherapy, preintervention and postintervention and 16-weeks and 32-weeks postintervention. Feasibility outcomes relating to acceptability, demand, implementation, practicality and limited efficacy testing as well as usability and user experience will be assessed at the end of the intervention through semistructured patient interviews and a study team focus group discussion at study completion. All outcomes will be analysed quantitatively and qualitatively.
This study has been approved by the National Healthcare Group (NHG) DSRB (DSRB2020/00249). We will report our findings at scientific conferences and/or in peer-reviewed journals.
NCT04848935.
为了在接受放疗的脑肿瘤患者中保留或改善认知功能，传统的干预方式通常涉及药物治疗和/或认知康复治疗，这些治疗以固定剂量或强度进行，由于疾病过程中患者状态的动态变化，往往导致效果不理想或无效。针对干预措施进行个性化定制可能会为这一人群带来更有效的结果。我们开发了 CURATE.AI COR-Tx 平台，该平台结合了经过验证的人工智能衍生的个性化剂量技术和数字认知训练。
这是一项前瞻性、单中心、单臂、混合方法可行性临床试验，主要目的是测试 CURATE.AI COR-Tx 平台干预措施作为数字干预和数字认知功能诊断的可行性。将招募 15 名被诊断患有脑肿瘤需要放疗的患者参与者。参与者将在家中接受为期 10 周的远程个性化数字干预，每周使用 CURATE.AI COR-Tx 平台三次。认知功能将通过非数字认知评估和数字诊断会话在五个时间点进行评估：放疗前、干预前和干预后以及干预后 16 周和 32 周。在干预结束时，通过半结构化患者访谈和研究团队焦点小组讨论，评估与可接受性、需求、实施、实用性和有限疗效测试以及可用性和用户体验相关的可行性结果。所有结果将进行定量和定性分析。
这项研究已获得新加坡国家医疗保健集团（NHG） DSRB（DSRB2020/00249）的批准。我们将在科学会议上或同行评议期刊上报告我们的发现。
NCT04848935。
