CURATE.AI COR-Tx platform as a digital therapy and digital diagnostic for cognitive function in brain tumour patients post-radiotherapy treatment: Protocol for a prospective mixed-methods feasibility clinical trial

Abstract

Abstract Background Brain tumour patients undergoing radiotherapy often experience cognitive impairment. Conventional interventional modalities for preserving or improving cognitive function usually involve pharmacological and/or cognitive rehabilitation therapy. These interventions are typically administered at fixed doses or intensities, often resulting in sub-optimal or no response, due to the dynamically evolving patient state over the course of disease. The personalisation of such 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 platform has the potential to be used as a digital intervention and digital diagnostic for cognitive function in brain tumour patients treated with radiotherapy. Methods 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 for this trial. 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: prior to radiotherapy commencement, pre- & post-intervention and 16- and 32-weeks post-intervention. 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 semi-structured patient interviews and through a study team focus group discussion at study completion. All outcomes will be analysed quantitatively and qualitatively. Discussion The immediate goal of this research is to assess the feasibility of the CURATE.AI COR-Tx platform as an appropriate digital intervention and diagnostic in this population and to inform the potential of a definitive, future, multi-site, randomised clinical trial within this setting. Additionally, if this trial proves feasible and the limited-efficacy testing is positive, this study may to lead to the advancement of post-radiotherapy care for brain tumour survivors with likely improvements in the daily lives of these individuals and their caregivers. Trial registration NCT04848935