Citations

Abstract Rural and low-socioeconomic status women face social determinants of health barriers leading to disproportionately low rates of breast cancer screening and markedly reduced participation in clinical trials. To address this gap, we developed the WeCARE (Women’s Engagement for Cancer Awareness, Resources, and Education) intervention using a community-engaged approach. This paper describes how Community Advisory Board feedback informed the development of Mayo Clinic Health System’s WeCARE intervention components. Their input was systematically analyzed using the Consolidated Framework for Implementation Research (CFIR 2.0) to identify determinants of acceptability, appropriateness, and feasibility and to guide actionable refinements to intervention content and delivery.

Introduction Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers. Methods and analysis This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials. Ethics and dissemination Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

TPS6126 Background: Oral cavity cancers (OCC) are a rare subtype of head and neck cancer (HNC) with poor outcomes and limited second-line treatment options in the recurrent or metastatic (R/M) setting. Treatment-related morbidity and repeated local recurrences in OCC result in significant impairment of function and quality of life. Rural OCC patients comprise a sizable portion (50%) of our practice and are usually of lower socioeconomic status with lack of access to specialist care. They also have multiple barriers to treatment access and ancillary services, translating to poorer clinical outcomes. There is a critical need for effective and accessible therapies for R/M OCC in rural patients. Triple oral metronomic chemotherapy (TOMC) with Methotrexate, Erlotinib and Celecoxib (MEC) suppresses angiogenesis and activates antitumor microenvironment in HNC. Studies using TOMC in R/M OCC outside the US show reasonable efficacy (6-month OS 52.9%), better safety and lower cost compared to standard second line options. We hypothesize that a decentralized clinical trial with TOMC in R/M OCC is feasible, safe and effective in addition to being economical and accessible for rural patients. Methods: MC240701 is a single institution, open label, decentralized, single arm pilot study of MEC in patients with R/M OCC. Eligible pts must be ≥18 years old, have pathologically confirmed R/M OCC not amenable to curative-intent therapy, ECOG 0-2 and adequate organ function. At least 1 measurable lesion by RECIST 1.1 OR non-measurable disease (evident mucosal lesions, CNS/bone disease, lesions not meeting RECIST criteria) is permitted. Patients must have received standard first line immunotherapy with or without chemotherapy OR should be unable/unwilling to receive first line treatment. Key exclusion criteria include patients unable to take pills by mouth, serious medical co-morbidity or autoimmune disease, immunocompromised patients and other active malignancy. Primary endpoint is to demonstrate feasibility of decentralized clinical trials, secondary outcomes include overall response rate, progression free and overall survival and toxicity. Additional goals are to evaluate patient impact of decentralized treatment through surveys and interviews After initial screening and evaluation, patients are remotely consented and will receive study drugs by mail. All patients will receive the same treatment of Methotrexate 9mg/m 2 PO weekly, Erlotinib 150 mg PO daily, and Celecoxib 200 mg PO BID, each cycle will be 28 days. Treatment will continue until disease progression or treatment tolerance, study duration is for 2 years. All subsequent clinical and laboratory monitoring and response assessments (every 3 cycles) will be remotely performed or have an option for local testing. Enrollment began July 2025 and 4 out of planned 25 patients have been accrued. FDA IND:174540. Clinical trial information: NCT06997068 .

1633 Background: CAR-T cell therapy has transformed outcomes of hematologic malignancies and is poised to expand into solid malignancies. However, broader use of CAR-T remains constrained by the need for timely cytokine release syndrome (CRS) detection. Current episodic monitoring may miss early physiologic changes. Wearable digital health technologies (DHTs), offering continuous monitoring and real-time alerts, could enable earlier CRS detection, further support outpatient delivery, and expand access to CAR-T and potentially other immunotherapies associated with CRS. Methods: This single-center observational study (NCT05018208) enrolled patients receiving FDA-approved CAR-T products in the outpatient setting at Mayo Clinic, Rochester MN. Management of post-CAR-T complications (e.g. CRS) followed the institution’s standard of care. Patients were monitored from day -5 to day +30 post infusion with intermittent remote patient monitoring (SoC) and an arm-worn wearable device for continuous monitoring (DHT). Patients were included in this analysis if DHT data were available for ≥ 5h of data/day or ≥ 2h of data/night on ≥2 days or nights for baseline and ≥1 day or night within 72h prior to CRS, or at least 2h within 4h of CRS onset, or if DHT was available for ≥7 days/nights post infusion with no CRS event. CRS detection time by DHT was defined as the onset of pyrexia or threshold-based deviation from an individual’s baseline pulse distributions. Results: 32 patients were included in this report (median age 64 years, gender 12 F/20 M, diagnoses 18 MM/14 NHL). 25 patients experienced a CRS event, with maximum CRS grades ranging from 1-3 (16 G1, 8 G2, 1 G3). 24/25 patients with CRS required tocilizumab/steroid. Median CRS onset time was 3.4 days (range 0.4-18.4). 12/32 patients had sufficient DHT data (7 CRS, 5 no CRS) for analysis. 5 patients with CRS had a DHT detection time in advance of the SoC by a median of 13h (range 2.8 - 69.2). The DHT prediction of CRS by baseline HR change was earlier than the first episodic fever by a median of 14.5h (range 13-77.5). The remaining 2/7 patients who did not have CRS detected by the DHT had missing DHT data for more than 45h before a treated CRS event. DHT detected CRS in 2/5 patients without CRS according to SoC. One patient had fever caught with intermittent monitoring. The other was treated for neutropenia fever with suspicion of CRS and/or infection. Conclusions: These results offer evidence that continuous DHT can identify CRS events earlier than intermittent monitoring (SoC). Despite limitations related to compliance with wearable device use and data missingness, and variability in clinical management of CRS, we highlight the usability of DHT and its potential for future studies with optimized strategies to address these limitations. Clinical trial information: NCT05018208 .

1503 Background: CAR T-cell therapy has revolutionized treatment outcomes in hematological malignancies, but has traditionally required inpatient post-infusion monitoring, which is associated with significant cost and time toxicity. Outpatient CAR T infusion and monitoring has been the standard approach at Mayo Clinic site in Rochester, MN, with demonstrated feasibility and safety (Bansal et al., ASCO 2023). We present data comparing healthcare utilization between CAR T recipients who underwent outpatient remote monitoring and those with traditional inpatient monitoring. Methods: Electronic medical records were retrospectively analyzed for 293 patients who received CAR T-cell therapy for a hematological malignancy at any of the 3 Mayo Clinic sites (MN, AZ, FL) between 2020 and 2024 . Healthcare utilization was compared between patients who received outpatient CAR T with remote patient monitoring in Rochester, MN (N = 125) and those who received inpatient CAR T in the Arizona (n = 90) and Florida (n = 78) sites. Per protocol, patients in the inpatient group underwent mandatory inpatient monitoring for 7 days, with extension per provider discretion. Data was analyzed through Chi-Square and Wilcoxon tests. P values < 0.05 were considered statistically significant. Results: There was no significant difference in baseline sex, age, ethnicity, LDH, platelets, or neutrophils among the 293 patients. Diagnoses included lymphoma (n = 175), multiple myeloma (n = 106), and B-ALL (n = 12). The most common CAR T-cell products used were axicabtagene ciloleucel (n = 138) idecabtagene vicleucel (n = 56), and ciltacabtagene autoleucel (n = 50). Median hospital days were lower in the outpatient group vs the inpatient group at 30 days (4.4 vs 13.3, P < 0.001) and 90 days (4.6 vs 13.6, P < 0.001). ICU admission occurred in 1 outpatient patient ( < 1%) vs 18 inpatient patients (11%) in the first 30 days (P < 0.001). In the first 30 days, 22% of patients in the outpatient group did not require hospitalization, while 56%, 15%, and 6% required 1, 2, and 3 hospitalizations, respectively. Similarly, only 11 (8.8%) patients in the outpatient group had ≥1 ED visit in the first 30 days compared with 32 (20%) pts in the inpatient group (P = 0.009). At 30 days, there was no difference in patient portal use, with 58% of patients using the portal at least once and a median of 1 message in both groups. Within the first 30 days, 53% and 2% of patients in the outpatient group required 1 and 2 outpatient visits, respectively, vs 29% and 2% in the inpatient group (P < 0.001). There was no difference in 30-day mortality (1.6% outpatient vs 2.4% in inpatient) between the 2 groups (P = 1.00) Conclusions: Outpatient CAR T-cell therapy monitoring was associated with significantly fewer hospital days without increased ED visits, ICU stays, portal use, or 30-day mortality. This demonstrates lower healthcare utilization for outpatient CAR-T therapy.

PURPOSE Limited access to high-speed internet (broadband [BB]) may pose challenges to video telehealth visit (VTV) utilization. This study explored barriers, facilitators, and attitudes toward VTV adoption in patients with cancer residing in low-BB settings. METHODS We examined a cohort of patients with cancer receiving longitudinal care at Mayo Clinic Cancer Practice in the Upper Midwest. Eligible patients had ≥6 in-person visits during July 2020-October 2022, received oncology care at Mayo Clinic sites, were alive at sampling, and resided in low-BB areas defined by Federal Communications Commission data as 0 or 1 internet service provider offering <25 Mbps. We enrolled 24 participants stratified into two groups: (1) Transitioned users (TUs): adopted VTVs postpandemic (November 2022-December 2023); (2) persistent nonusers (PNUs): received exclusively in-person visits. Semistructured telephone interviews were conducted in June 2024 and thematically analyzed. RESULTS The average age of participants was 71.3 years (range, 42-88), 50% was female, and all identified as White. Three themes emerged: (1) Structural and clinical constraints—physical examinations, laboratory testing, and chemotherapy administration were viewed as requiring in-person care, whereas VTVs were perceived acceptable for routine follow-ups; (2) Skills and experience—digital literacy was generally adequate, but confidence and direct exposure to VTV distinguished TU from PNU; (3) Motivations—both groups preferred in-person care for cancer-related emotional reassurance. TU cited weather, travel burden, and proactive provider offering as adoption triggers, whereas PNU reported that VTV was rarely offered. TU focused on system-level solutions, whereas PNUs preferred individual-level resources. CONCLUSION Differential VTV adoption in low-BB settings reflected exposure, provider offering, and situational necessity rather than BB access alone. Oncology practices should consider normalizing the hybrid care model combining in-person and video appointment visits and provide tailored supports to advance equitable telemedicine. Expanding video care in oncology requires more than digital access and depends on patient experience, care context, and human connection inherent in oncology care.

TPS892 Background: Enfortumab Vedotin (EV) plus pembrolizumab (Pembro) is now first-line therapy for advanced urothelial carcinoma (UC), yielding ~30% complete response (CR) rates; nevertheless, most patients (pts) progress within 1 year and median overall survival (OS) remains < 3 years. In muscle invasive bladder cancer, local consolidation after systemic therapy improves outcomes, suggesting that residual, treatment-refractory intravesical disease drives relapse. We hypothesize that cytoreductive cystectomy/nephroureterectomy (CC/U)—with metastasis-directed therapy (MDT) as needed—can consolidate responses to EV/Pembro and extend benefit in regionally advanced or metastatic UC. CAST-AI prospectively evaluates this multimodal strategy and integrates correlative studies of exosomal Nectin-4 and circulating tumor DNA (ctDNA) from blood and urine as predictive/MRD biomarkers. Methods: CAST-AI is a phase II, decentralized single-arm trial enrolling pts with histologically confirmed UC of the bladder or upper urinary tract with ≥N1 and/or M1 disease and ECOG PS 0–2 who are potential surgical candidates (planned n = 75). Treatment: EV 1.25 mg/kg IV D1 & D8 + Pembro 200 mg IV D1 q21d, ≥4 cycles; MDT permitted any time pre-surgery. Response assessments occur q9 weeks (±4) to 18 months, then q12 weeks (±4). Surgical eligibility requires: (A) fitness for surgery; (B) complete or partial response (CR/PR) or, for select low-burden/unmeasurable disease, urologist-adjudicated candidacy; (C) all distant sites addressed; and (D) procedure in pt’s best interest. Post-CC/U maintenance EV/Pembro is encouraged per clinical discretion and guided by definitive surgical pathology results, which provide true pathologic staging often unattainable through imaging after systemic therapy. Primary endpoint: 12-month progression-free survival (PFS). Secondary endpoints: Objective response rate (ORR), CR rate, down-staging at CC/U, PFS, OS, and safety (using CTCAE). Exploratory endpoints: longitudinal exosomal Nectin-4 and ctDNA dynamics as MRD and early relapse indicators; tissue–blood–urine Nectin-4 concordance; pt-reported tolerability (using CIPN20). Key exclusions: > 20% variant histology or disallowed subtypes (e.g., micropapillary, plasmacytoid, sarcomatoid, neuroendocrine); prior chemotherapy for UC; contraindications to surgery/EV/ICI; or active uncontrolled comorbidities/infections. Status: Enrollment is open and ongoing, with 25 of 75 pts enrolled as of September 2025. The trial uses a decentralized model, allowing pts to receive EV/Pembro at their local facility, with central coordination, biospecimen shipping, and surgical evaluation at Mayo Clinic or affiliated sites. ClinicalTrials.gov: NCT06764095. Clinical trial information: NCT06764095 .

345 Background: Pediatric febrile neutropenia (PFN) requires emergent evaluation due to risk of invasive bacterial infection. In the management of PFN, there are varying, accepted definitions for fever requiring emergency evaluation and neutropenia requiring admission. Problem statement: From September 1, 2022 - May 31, 2023, 15.1% (n = 11/73) of emergency department (ED) visits and 17.1% (n = 6/35) of admissions for PFN at Mayo Clinic Rochester may be considered unnecessary due to patients not meeting updated clinical criteria. Aim: Decrease unnecessary ED visits and hospitalizations for PFN by 50% from 15.1% to 7.5% (for ED visits) and from 17.1% to 8.6% (for hospitalizations) by 02/29/2024 without adversely impacting mortality from invasive bacterial infection. Methods: We used the DMAIC framework for process improvement. Interventions included (1) adoption of a higher fever definition for PFN, (2) adoption of a risk-stratified neutropenia definition for hospital admission, (3) provided electronic fever plans with definitions to all families, (4) re-iterated that parents call on-call provider with any concern for fever, (5) educated pediatric oncology staff on definition and management of fevers in pediatric oncology patients, and (6) educated pediatric emergency department staff on definition and management of fevers in pediatric oncology patients. Interventions were tested with rapid tests of change. Relevant clinical characteristics, variables, and outcomes for all patients from pediatric oncology were tracked for all encounters of pediatric oncology patients presenting to the ED for acute illnesses. Results: At baseline,15.1% (n = 11/73) of ED visits for PFN were considered unnecessary due to patients not meeting clinical criteria for emergency evaluation. Post-interventions, unnecessary ED visits for PFN had decreased to 3.4% (n = 1/32). At baseline, 17.1% (n = 6/35) of hospitalizations were considered unnecessary due to patients not meeting clinical criteria for admission. Post-interventions, 7.7% (n = 2/26) of hospitalizations were considered unnecessary. There were no patient deaths from invasive bacterial infection among this cohort at baseline or after interventions. Conclusions: Multiple interventions including adoption of a higher, accepted fever threshold and risk stratified neutropenia definition for PFN was associated with a reduction of unnecessary ED visits and hospitalizations for PFN without an increase in mortality from invasive bacterial infection. The projected medical expense savings of approximately $144,000-$210,000 per year.

566 Background: Video telemedicine visits (VTVs) have the potential to overcome disparities in access to cancer care for many socially, geographically, and economically disadvantaged populations. Internet connectivity, digital literacy, and socioeconomic factors are traditionally cited as influencing VTV utilization. However, digital diffusion has occurred rapidly across several sectors, including healthcare, since the onset of the COVID-19 pandemic, and less is known about how these factors have evolved to influence VTV utilization behavior over this time. Through a qualitative approach, we aimed to: (1) explore the lived experiences of cancer patients who transitioned to VTV use as compared to those who persistently did not, and (2) identify similarities and differences between these two groups that could inform targeted interventions to support access and patient acceptance of VTVs in the setting of cancer care. Methods: During June 2024, we conducted semi-structured interviews with 24 patients (Mean age 71.3 years, range 42-88; female 50%) receiving ongoing, longitudinal cancer care at our academic medical center since July 2021 who had not used VTVs through at least October 2022. Using purposeful sampling, patients were equally divided according to VTV utilization behaviors defined as “transitioned users” (TU; i.e. those who transitioned to VTV utilization after October 2022) and “persistent non-users” (PNU). Transcripts were analyzed using a combined deductive–inductive thematic approach and categorized into themes of barriers and facilitators across three domains consistent with the COM-B model: capabilities (C), opportunities (O), and motivations (M). Results: TU patients frequently cited a reduction in travel and logistical considerations as a primary reason for uptake of VTVs. PNU patients frequently reported digital literacy barriers, particularly among older patients, as primary reasons for lack of VTV utilization. TU patients reported more experience and comfort in technical skills as compared to PNU participants. PNU patients also reported less frequent offering of VTV as an option by their care teams over time, implying they may have transitioned to VTV utilization if it had been offered with more regularity. Both study groups desired improved internet access and technical support to enhance (or, in the case of PNU patients, enable) VTV utilization. Conclusions: These findings suggest that multi-modal care delivery may best serve current patient populations, not requiring, yet offering VTV services as an adjunct to in-person care. Longer term, individual barriers to VTV use will also need to be addressed to further optimize access for patients who desire to incorporate this care modality.