Steinmetz, Sue

Abstract BACKGROUND Access to in-person evaluations is challenging for patients with glioma due to disease-related disability and distance from specialized neuro-oncology centers. Telehealth is an alternative to in-person evaluations, but acceptability of and therapy compliance with this model has not been prospectively evaluated. METHODS In this single-arm non-randomized pragmatic clinical trial, we compared patient satisfaction with telehealth and in-person assessments among patients with glioma undergoing chemotherapy with temozolomide. Participants acted as their own controls, alternating between telehealth and in-person visits. Patient satisfaction with care delivered was evaluated by Press-Ganey surveys with Likert response scales (1-5, 1=very poor, 5=very good). A digital pill diary (DPD) was implemented to track chemotherapy compliance. RESULTS We accrued 30 patients (median age 59, 38% female) between October 2024 and May 2025. Half of the patients (n=15) reported a primary residence greater than 150 miles from our institution. Surveys from 25 participants were reviewed, with 17/25 completing one or more surveys following an in-person visit, and 21/25 completing one or more surveys following a telehealth visit. Overall average Press-Ganey scores were similar between the two visit modalities with high scores (telehealth=4.8; in-person=4.7). Median scores for specific modalities were similarly highly rated: likelihood of recommending practice to others (telehealth=5.0; in-person=5.0), concern the care provider showed (telehealth=5.0, in-person=4.7), provider’s discussion of treatment options (telehealth=5.0, in-person=5.0), provider effort to include patients in decision-making (telehealth=5.0, in-person=5.0). DPDs used to monitor treatment compliance indicated adherence to all prescribed doses of temozolomide in 75/79 cycles; the other 4 (of 79) treatment cycles were halted per provider instructions. CONCLUSION This interim assessment demonstrates feasibility of treating patients with similar patient satisfaction of care delivered between telehealth and in-person visits. The DPD was effective in tracking chemotherapy administration. Additional results including visit type preference and acute care utilization data are maturing.

TPS2099 Background: Gliomas are the most common primary central nervous system (CNS) malignancy in adults, accounting for 26.3% of all brain tumors. Care at high volume centers is associated with an overall survival benefit, but access to in-person evaluations can be challenging due to disease-related neurological disability and loss of income. Telehealth represents a convenient and efficient alternative to in-person evaluations, but acceptability and comparative safety of this care delivery modality has not been prospectively evaluated among glioma patients undergoing chemotherapy. Methods: This single-arm non-randomized pragmatic clinical trial evaluates patient satisfaction with, and safety of video-enabled telehealth assessments compared to in-person evaluations for patients with glioma undergoing temozolomide chemotherapy. The study includes adult patients with a diagnosis of glioma requiring adjuvant temozolomide chemotherapy. Participants act as their own controls, alternating between in-person and telehealth assessments while undergoing chemotherapy dosed per standard of care. Monitoring labs are completed locally and transmitted electronically. For participants without access to Wi-Fi or a device (e.g. mobile phone or computer), cellular-enabled tablet devices are provided to facilitate appointments and completion of electronic study components. All participants who travel to in-person appointments are reimbursed for travel expenses. The primary outcome measure is patient satisfaction with care delivered, as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments. A key secondary outcome measure is completion rate of planned oral chemotherapy, tracked using a digital pill diary incorporated into our institutional electronic health record. The digital diary allows real-time tracking of chemotherapy adherence and adverse events experienced by participants. Other secondary outcomes include acute care utilization days following telehealth and in-person visits (defined as emergency department evaluations and days of inpatient stay), neurologic disability as measured by the Neurologic Assessment in Neuro-Oncology (NANO) scale, and disease related quality of life measured by the EORTC QLQ-C30. All participant surveys are self-reported and completed electronically. This decentralized pragmatic clinical trial provides unprecedented, prospective real-world data on utilization of telehealth services compared to in-person visits for patients undergoing chemotherapy for glioma. We expect the data generated to inform the design and conduct of future decentralized interventional neuro-oncology trials. NCT06625047 opened for enrollment in October 2024, 16 of 30 intended participants were accrued as of January 2025. Clinical trial information: NCT06625047 .

TPS1647 Background: The majority of patients with primary and secondary central nervous system (CNS) malignancy develop cognitive impairment, fatigue, and mood-related symptoms. Radiotherapy has been shown to contribute to symptom burden often limiting quality of life and functional status. The development of interventions mitigating neurocognitive toxicity requires an accurate assessment of function and symptom burden. Formal neuropsychological evaluation is resource and time intensive, and often challenging to incorporate in routine clinical practice. There is a critical need to accurately assess cognition without causing undue burden to cancer patients while evaluating the efficacy of interventions that can be scaled and implemented at a population level. Methods: To adequately assess the neurocognitive function and related symptoms in patients with CNS malignancy we have designed an open-label decentralized clinical trial that will randomize patients who received intracranial radiation for primary or metastatic brain tumors in a 1:1 allocation to a therapy targeting radiation-related toxicity (metformin shipped to patient home) plus health promotion with a wearable device vs. health promotion with a wearable device alone. Participants will be stratified based on tumor type (glioblastoma vs. other glioma vs. brain metastases vs. meningioma) and age (<70 vs. 70+ years). Participants will be provided a wearable device for monitoring health status. Participants will undergo serial remote cognitive assessments with the Mayo Test Development Through Rapid Iteration, Validation and Expansion platform (Mayo Test Drive). Remote reported symptom collection via patient surveys and remote neurologic examination by telehealth will also be incorporated. Cognitive assessments and symptom surveys will be designed for completion on a smartphone, tablet, or computer device. Health data will be collected from the wearable device, including the number of steps per day and sleep quality/duration. Participants receiving metformin will utilize device apps to report medication adherence and adverse events. Study-related laboratory assessments will be completed remotely and transmitted electronically. This decentralized clinical trial will provide real-world cognitive and quality-of-life data for patients with primary and metastatic brain tumors while providing preliminary data on the effectiveness of device-based health promotion with or without metformin for treating radiation-related cognitive decline. Results gained from this study will guide future trials in neuro-oncology and other fields. This study is expected to open in March 2024.