Mixed-methods clinical trial to evaluate the feasibility of the CURATE.AI optimised digital cognitive rehabilitation therapeutic (COR-Tx) in patients post brain radiotherapy.

Cognitive Training Cognitive rehabilitation therapy Human multitasking
DOI: 10.1200/jco.2023.41.16_suppl.tps1615 Publication Date: 2023-06-04T14:58:30Z
ABSTRACT
TPS1615 Background: Cognitive decline may be exacerbated, in brain tumour patients, by prior radiotherapy (RT). Traditional interventions to mitigate this typically involve fixed dose or intensity pharmacological and/or cognitive rehabilitation therapies that often elicit sub-optimal no response, due the dynamically evolving patient state and low adherence. Personalised digital therapeutics (DTx) more effective for population. Further, gamification has previously shown induce positive health behavioural change improve intervention To end, we have developed CURATE.AI COR-Tx platform, a gamified DTx, combines validated, small-data artificial intelligence-derived optimisation technology with multitasking training. This novel DTx personalises treatment using patient’s own longitudinal performance data generate an avatar guides training throughout intervention. Herein, aim evaluate feasibility, user experience usability of platform patients post-RT. Methods: is prospective, mixed-methods, interventional, single-arm, decentralised feasibility clinical trial. The primary objective as both (DI) diagnostic (DD) function 15 personalised home-based DI involves completing three 12-min sessions per week 10 weeks, starting 1 month will assessed via combined non-digital evaluation DD session at five time points: RT, pre- & post-DI 16- 32-weeks post-DI. Feasibility outcomes relating acceptability, demand, implementation, practicality limited efficacy testing additional secondary exploratory collected team through semi-structured interviews study focus group discussion completion. We adopt mixed-methods approach analysis. evaluated thematic analysis qualitative (acceptability practicality), descriptive correlational quantitative (demand implementation). CONSORT traffic light system decide on future expansion into large-scale randomised control trial began April 2021 enrolled 14 planned submission. Clinical information: NCT04848935 .
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