Protocol for Neuro-Oncology Anywhere: Deploying Mayo Clinic's remote cognitive assessment battery and wearable device monitoring platform while assessing the impact of metformin on cognition and quality of life in patients with history of cranial radiation

Contemp Clin Trials Commun. 2026 May 18:51:101648. doi: 10.1016/j.conctc.2026.101648. eCollection 2026 Jun.

Abstract

Cognitive symptoms are among the most frequently reported issues in cancer patients treated with cranial radiation, yet they remain inadequately assessed in clinical practice and are suboptimally treated. Cranial radiation is an integral part of treatment for primary and metastatic brain tumors that contributes to progressive and irreversible cognitive decline with currently limited therapeutic options. Development of effective interventions that can prevent or delay this neurocognitive toxicity requires accurate assessment of symptom burden. However, formal neuropsychological testing is resource intensive and time consuming. Repeated in-person assessments are often not feasible for cancer patients who must travel great distances to specialized cancer centers. The Neuro-Oncology Anywhere (NOA) study is a fully decentralized clinical trial with an overarching goal to evaluate remote cognitive assessments while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline. The primary objective of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and self-reported assessments among patients who have previously received cranial radiation. Key secondary objectives are to assess satisfaction of patients with remote monitoring, evaluate adherence to study drug, and compare neurocognitive function scores and the impact of receiving metformin and health promotion with a wearable device compared to wearable device alone. Determination of the remote platform's feasibility among patients with brain tumors will provide a strong scientific foundation for routinely integrating scalable remote cognitive assessment strategies into future clinical trials, enabling accelerated evaluation of potentially effective interventions unconstrained by geographic limitations.

Trial registration id: NCT06377696.

Keywords: Brain tumor; Cancer cognition; Decentralized trial; Radiation therapy; Telehealth.

Associated data

  • ClinicalTrials.gov/NCT06377696