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293 citation(s) found for "Haddad, TC".

Abstract PD8-06: Real-world Analysis on the Impact of GLP-1 Receptor Agonists on All-cause Mortality and Endocrine Therapy-Tolerability in Obese Breast Cancer Patients
Jones, C. F., Michalek, Joel , Obomanu, Elvis , Arya, Yajur , Syal, Arshi , Haddad, Stephanie Adel, Kaklamani, V., Shaikh, S.

Clinical Cancer Research | February 17, 2026 | Volume: 32 | Issue: 4_Supplement | Pages: PD8-06-PD8-06

10.1158/1557-3265.sabcs25-pd8-06 Get It

Abstract Introduction: Endocrine therapy (ET) improves survival in hormone receptor-positive breast cancer (BC) but has side effects that may affect compliance. GLP-1 receptor agonists (GLP-1 RA), used for diabetes and obesity, possess anti-inflammatory properties and may reduce cancer incidence. Their impact on all-cause mortality and ET tolerability remains underexplored. This real-world analysis is the first of its kind to examine the effects of GLP-1 RA on these outcomes. Methods: We used de-identified data across 130 million patients and 108 health systems from the TriNetX database to identify obese women (BMI ≥30) with BC receiving ET. Patients were grouped by GLP-1 RA exposure into age cohorts (≤50 and ≥51 years, as a surrogate for menopause). The primary endpoint was all-cause mortality; the secondary endpoint was ET tolerability. The index event was the first day meeting all criteria: BC and obesity diagnoses, and initiation of ET ± GLP-1 RA. Patients with outcomes before the study window were excluded. Propensity score matching performed by TriNetX adjusted for demographics, diabetes, comorbidities, cancer stage, and prior chemotherapy. Multivariate logistic regression assessed associations (risk ratios [RR], 95% CIs). Results: After matching, 2,574 patients were assigned to the age ≤50 group: Cohort A (GLP-1 RA exposure, n=1,287) and Cohort B (non-exposure, n=1,287). 13,012 patients were in the age ≥51 group: Cohort C (GLP-1 RA exposure, n=6,506) and Cohort D (non-exposure, n=6,506). In the ≤50 group, the mean age at index event was 42.3 ± 5.2, 99.5% female, 68.9% White, 16.9% Black, and a mean BMI of 37 in Cohort A, with similar demographics and BMI in Cohort B. In the ≥51 group, there was a mean age at index event of 61.8 ± 7.7, 99% female, 71.7% White, 17.4% Black, and a mean BMI of 37 in Cohort C with similar demographics and BMI in Cohort D. GLP-1 RA use significantly reduced all-cause mortality in all cohorts. In the age ≤50 group, there were 29/1,242 events in Cohort A and 71/1,258 in Cohort B [RR 0.414 (0.271-0.633)]. In the age ≥51 group, there were 240/6,287 events in Cohort C and 400/6,285 in Cohort D [RR 0.600 (0.513-0.701)]. GLP-1 RA use worsened ET side effects. In the age ≤50 group, GLP-1RA increased the risk of hot flashes [RR: 1.473 (1.235-1.756)], venous thromboembolism (VTE) [RR: 1.439 (1.090-1.902)], nausea/vomiting [RR: 1.460 (1.242-1.717)], abdominal pain [RR: 1.353 (1.184-1.545)], diarrhea [RR: 1.319 (1.096-1.589)], joint pain [RR: 1.382 (1.243-1.536)], and depression [RR:1.634 (1.382-1.932)]. No significant risk was found in endometrial cancer (EC) and osteoporosis. In the age ≥ 51 group, GLP-1 RA use increased hot flashes [RR: 0.1.239 (1.091-1.407)], [RR:0.591 (0.482-0.724)], nausea/vomiting [RR: 1.429 (1.324-1.542)], abdominal pain [RR: 1.310 (1.227—1.399)], diarrhea [RR: 1.446 (1.328-1.575)], joint pain [RR: 1.334 (1.270-1.400)], osteoporosis [RR: 1.110 (1.026-1.201)], and depression [RR: 1.536 (1.413-1.670)]. No significant differences were noted in VTE and EC risk. Conclusion: This real-world analysis demonstrates that GLP-1RA use is associated with a significant reduction in all-cause mortality among obese BC patients undergoing ET. However, GLP-1 RA exposure appears to exacerbate several ET-related adverse effects. Future prospective studies are needed to determine these associations as they may warrant clinical consideration. Citation Format: C. Jones, J. Michalek, E. Obomanu, Y. Arya, A. Syal, S. Haddad, V. Kaklamani, S. Shaikh. Real-world Analysis on the Impact of GLP-1 Receptor Agonists on All-cause Mortality and Endocrine Therapy-Tolerability in Obese Breast Cancer Patients [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PD8-06.
Impact of cannabidiol on myocardial recovery in patients with acute myocarditis: primary results of the ARCHER study
McNamara, Dennis M. , Cooper, Leslie, Arbel, Yaron, Bocchi, Edimar, Hamer, A. J. , Herdy, Artur Haddad , Kerneis, Mathieu, Liu, Peter P., Parker, Andrea B., Pocock, Stuart , Smith, Eldon R., Tang, W H Wilson, Torre-Amione, Guillermo, Tschöpe, Carsten , Group, ARCHER Study, Bocch, Edimar, Moreira, Maria da Consolação Vieira , Dytz, Eduardo, Neuenschwander, Fernando Carvalho , Silva, Luís Beck da, Pezel, Theo, Abtan, Jeremie, Puymirat, Étienne , Moravsky, Gil, Piltz, Xavier Alejandro, Orlev, Amir , Bhat, Pavan , Thomas, Georgia , Lin, David, Palmer, Brittany, Kerneis, Mathieu , Pocock, Stuart J , McNamara, Dennis M , Tschöpe, Carsten , Friedrich, Matthias G. , Arbel, Yaron , Bhimaraj, Arvind , Hamer, Andrew, Tang, W.H. Wilson , Torre‐Amione, Guillermo , Caramori, Paulo , Moura, Lídia Zytynski , Macedo, Ariane Vieira Scarlatelli , Albuquerque, Denílson Campos de , Beck-da-Silva, Luís , Lattuca, Benoît , Bouleti, Claire , Pezel, Théo , Abtan, Jérémie , Delmas, Clément , Huang, Florent , Roubille, François , Bochaton, Thomas , Piltz, Xavier, Zlotoff, Daniel A , Hofmeyer, Mark R. , Hamer, Andrew

ESC Heart Failure | January 6, 2026 | Volume: 13 | Issue: 1 | Pages: No page available

10.1093/eschf/xvaf034 | PMID 41711722 Get It

Abstract Introduction Cannabidiol has been shown to exert significant anti-inflammatory effects and has demonstrated efficacy in murine models of autoimmune myocarditis, pericarditis, and heart failure. The ARCHER Study assessed whether a pharmaceutically produced cannabidiol formulation showed beneficial effects on cardiac magnetic resonance (CMR) endpoints known to predict prognosis in this patient population. Methods In a multicentre international double-blind placebo-controlled phase 2 study, we randomly assigned 109 patients within 10 days of CMR confirmed diagnosis of acute myocarditis to 12 weeks of pharmaceutically produced oral cannabidiol (active) or placebo. Dose was titrated up to 10 mg/kg of body weight twice daily. Primary endpoints were the difference in extracellular volume (ECV) and global longitudinal strain (GLS) measured by CMR at week 12. Other CMR endpoints included left-ventricular ejection fraction (LVEF), LV mass, intracellular volume (ICV), LV end-diastolic and end-systolic volumes (LVEDV, LVESV), and left-atrial end-systolic volume (LAESV). Results All randomized patients (56 active/53 placebo) completed the study with no loss to follow-up. Study drug appeared safe and well tolerated. Baseline mean ECV 38.9 ± 10.9 ml, GLS −15.3 ± 3.6%, and LVEF 60.6 ± 9.9% were consistent with mild to moderate myocarditis and predominantly intact LV function. Week 12 mean ECV was 33.6 ml in the active group and 37.3 ml in the placebo group, a difference of −3.7 ml, confidence interval (CI): −7.4 to 0.1; P = .0538; GLS was −16.0% in the active group and −15.9% in the placebo group, difference of −0.1, CI: −1.2 to 1.1; P = .90. Left ventricular mass was significantly reduced in the active group at 121.1 g compared to placebo 130.3 g, a difference of −9.2, CI: −16.4 to −2.1; P = .0117. In terms of remodelling, LAESV was significantly reduced in the active group (−8.1 ml; P = .0376) while the reduction in LVEDV failed to reach significance (−7.4 ml; P = .098). Conclusion In mild-to-moderate acute myocarditis, treatment with pharmaceutically manufactured cannabidiol was not associated with a statistically significant change in myocardial ECV or GLS, although a trend towards reduction in ECV was observed. In addition, improvement in other potential markers of myocardial recovery, including a significant reduction in LV mass, was seen in the active treatment group. Further investigation of the therapeutic potential of this therapy in inflammatory cardiac conditions is warranted.
Hematopoietic cell transplantation for Wiskott-Aldrich syndrome: a PIDTC report
Alexander, Jessie L. , Saldaña, Blachy J. Dávila , Brazauskas, Ruta , Dammalapati, Sravya Gethika, Griffith, Linda M. , Shah, Ami J. , Shimano, Kristin A. , Ochs, Hans D., Bleesing, Jack , Ebens, Christen L. , Kapadia, Malika, Bauchat, Andrea , Oved, Joseph H. , Eissa, Hesham, Lust, Hannah , Haines, Hilary , Rayes, Ahmad , Madden, Lisa, Shereck, Evan , Miller, Holly, Martinez, Caridad , Rozmus, Jacob, Yu, Lolie C. , Chellapandian, Deepak , Aquino, Victor M., Knutsen, Alan P. , Chong, Hey , Chopek, Ashley, Gillio, Alfred P. , Joshi, Avni Y. , Rangarajan, Hemalatha G. , Andolina, Jeffrey R. , Lugt, Mark T. Vander , Prockop, Susan E. , Shyr, David C. , Sullivan, Kathleen E. , Weinacht, Katja G. , Torgerson, Troy R. , Marsh, Rebecca , Dvorak, Christopher C. , Heimall, Jennifer , Leiding, Jennifer W. , Puck, Jennifer M. , Rawlings, David J. , Cowan, Morton J. , Petrović, Aleksandra , Pai, Sung‐Yun , Burroughs, Lauri M. , Dávila Saldaña, Blachy J , Oved, Joseph H , Lust, Hannah , Rayes, Ahmad , Forbes Satter, Lisa R , Bednarski, Jeffrey J , Chellapandian, Deepakbabu , Joshi, Avni, Rangarajan, Hemalatha G , Andolina, Jeffrey R , Prockop, Susan E , Parikh, Suhag , Torgerson, Troy R , Chan, Alice Y , Haddad, Elie , Pulsipher, Michael A. , Leiding, Jennifer W , Kohn, Donald B , Puck, Jennifer M , Notarangelo, Luigi D , Pai, Sung-Yun , Burroughs, Lauri M , Ebens, Christen L , Dvorak, Christopher C , Shimano, Kristin A , Shah, Ami J , Ochs, Hans D., Kapoor, Neena R. , Keller, Michael D. , Chandrakasan, Shanmuganathan , Talano, Julie‐An , Satter, Lisa Forbes , Moore, Theodore Bruce , DeSantes, Kenneth B , Parikh, Suhag , Haddad, Élie , Kohn, Donald B.

Blood Advances | December 5, 2025 | Volume: 10 | Issue: 5 | Pages: 1783-1798

10.1182/bloodadvances.2025017662 | PMID 41346295 Get It

Abstract Wiskott-Aldrich syndrome (WAS), an X-linked disorder characterized by immunodeficiency, thrombocytopenia, autoimmunity, and malignancy, can be effectively treated with allogeneic hematopoietic cell transplantation (HCT). Older age at HCT and mismatched donors are known to affect overall survival (OS). However, the influence of specific clinical manifestations or WAS variant class on OS and factors associated with event-free survival (EFS) remain incompletely defined. We analyzed outcomes of 308 patients with WAS who underwent HCT at 37 institutions of the Primary Immune Deficiency Treatment Consortium from 1990 to 2018. With a median follow-up of 5.3 years, the 5-year OS and EFS were 87.2% and 79.7%, respectively. Age ≥5 years, donor type, and a pre-HCT history of severe infection had a negative impact on OS and EFS, whereas pre-HCT autoimmunity had no impact. Reduced-intensity regimens were associated with lower T-cell and myeloid donor chimerism, particularly when non–busulfan-based regimens were used. Low myeloid donor chimerism was associated with lower platelet counts. Mixed chimerism was not consistently associated with post-HCT autoimmunity. Patients with class I (exon 1-2 missense and intron 5 hot spot variants) and class II variants (all others) had similar pre-HCT clinical symptom severity and no difference in OS, EFS, or platelet recovery post-HCT. In conclusion, our study showed excellent long-term OS and EFS after HCT for WAS, highlighting the importance of early HCT, before the development of severe infections. We confirmed that HCT using busulfan-based conditioning was associated with improved donor chimerism and platelet recovery. This trial was registered at www.clinicaltrials.gov as NCT02064933.
Machine learning–driven prognostication of overall survival at 6 months after CAR-T cell therapy
Shreve, Jacob , Khurana, Arushi , Kapoor, Prashant , Johnston, Patrick B. , Kumar, Shaji , Ansell, Stephen, Kharfan‐Dabaja, Mohamed A. , Haddad, Tufia C. , Lin, Yi, Paludo, Jonas , Guzman, Emmanuel Contreras , Gertz, Morie A. , Wang, Yucai , Binder, Moritz , Villasboas, José C. , Bennani, N. Nora , Hilal, Talal , Iqbal, Madiha , Moustafa, Muhamad Alhaj , Parrondo, Ricardo D , Chhabra, Saurabh , Rosenthal, Allison , Lin, Yi‐Sheng

Blood | December 4, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 2563-2563

10.1182/blood-2025-2563 Get It

Abstract Background Chimeric-antigen-receptor (CAR) T-cell therapy has transformed outcomes for relapsed or refractory hematologic malignancies, yet early identification of patients at highest risk for death remains elusive. A prognostic model that leverages only the information routinely available at the time of CAR-T evaluationcould guide pre-infusion counseling, intensity of follow-up, and resource allocation. Methods We analyzed a prospectively maintained cohort of CAR-T recipients treated at Mayo Clinic to develop and test our model. For each patient, data (vital signs, lab results, cardiac assessments [ECG and echocardiography], and PET/CT images) from initial CAR-T evaluation (up to 60 days prior to CAR-T infusion) was considered. Vital signs and labs were left un-imputed, while ECG, echocardiographic parameters, and PET/CT features were forward-filled from the preceding 60 days. Each patient-day was labeled as “outcome present” or “no outcome,” enabling supervised training of gradient-boosting models to predict overall survival (OS) at 6 months post CAR-T infusion. Model performance was evaluated using the area under the ROC curve (AUC) with 10,000-fold bootstrapping with data shuffling between each iteration to derive confidence intervals for stability. To enhance interpretability, we also developed a simplified model using the top 19 features (determined by Shapley value-based importance), aiming to preserve predictive accuracy with a smaller feature set. Results A total of 570 CAR-T cell treated patients were included in this study (476 patients in the training cohort and 94 patients in the validation cohort). The median age was 64 years and 61% males. The primary diagnoses were B-cell lymphoma (324 patients) and multiple myeloma (246 patients). A total of 4,851 individual vital-sign readings, 11,781 laboratory measurements were included. PET/CT images were available in 318 patients. The ML model demonstrated high discriminative ability for predicting OS at 6 months post CAR-T infusion. Vital signs alone produced a mean AUC of 0.63; radiomics features alone produced a mean AUC of 0.71, while laboratory tests alone produced a mean AUC of 0.84. The features most contributory to each single-modality model were then combined into a simplified multimodal model with a total of 19 features, which produced a mean AUC of 0.87, with a 95% CI of 0.73 - 0.97. The 19 features included in the simplified model were: LDH, ferritin, uric acid, eosinophils, fibrinogen, D-dimer, heart rate, mean arterial blood pressure, QTc, QT interval, and the radiomics features of sphericity, first-order Kurtosis, first-order mean, first-order energy, first-order total energy, shape maximum2D diameter (sagittal plane), SUV CoV, SUVp90, shape flatness. This multimodal predictive model was then applied to the validation cohort (uninvolved with model training or testing), which produced an AUC of 0.93, with a 95% CI of 0.84 - 0.98. Conclusions Our ML-driven approach successfully predicts overall survival 6 months post CAR-T infusion, highlighting those individuals at most risk of poor outcomes at the time of CAR-T evaluation. The strong performance of the multimodal version of the model suggests that each data domain contributes complementary resolving power, and by including novel data types, such as PET CT radiomics features, the most accurate predictions could be realized. By providing accurate, near-real-time risk stratification for poor outcomes within 6 months of CAR-T infusion, the model could facilitate proactive patient management. Prospective studies of the integration of this ML model into CAR-T treatment workflows will be crucial to confirm its clinical benefits and to facilitate its adoption in practice.
Serum erythropoietin level as a selective pressure in clonal hematopoiesis: Insights into the mutational landscape of myeloid neoplasias
Brady, Zachary, Zurowski, Charlotte, Sartori, F. , Hunyadi, Olivia, Mandala, Aashray, Haddad, Christopher, Ünlü, Serhan , Marumo, Atsushi , Lakhotiya, Kartik, Maciejewski, Jaroslaw P. , Sartori, Felipe de Almeida, Kewan, Tariq Zuheir , Orland, Mark D. , Mandala, Aashray, Carraway, Hetty E. , Singh, Abhay , Gurnari, Carmelo , Durmaz, Arda , Visconte, Valeria

Blood | December 4, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 3174-3174

10.1182/blood-2025-3174 Get It

Abstract Outgrowth of a founder mutant clone is an initial event in leukemogenesis. The corresponding somatic hit likely conveys a fitness advantage over a polyclonal background. Several factors may modulate the competitiveness of hematopoietic stem or progenitor cells, including aging, genotoxic stress, repeated cycles of stress hematopoiesis, and inherited genetic fitness deficiency. The nature of these conditions provides a particularly fertile environment in which only certain mutant clones thrive. For instance, chemotherapy facilitates expansion of PPMD1MT or TP53MT clones, aging-related loss of fitness predisposes to outgrowth of TET2MT clones, while many inherited bone marrow failure (BMF) syndromes are associated with specific clonal acquisitions due to somatic gene rescue. Identification of factors enabling the expansion of clones with specific mutations may help to develop targeted preventive, screening, or therapeutic strategies. Recently, high levels of erythropoietin (EPO) induced by frequent blood donation were shown to favor the emergence of DNMT3AR882 clones due to their increased EPO sensitivity1. We theorized that this may be a more general phenomenon operating in other diseases characterized by high EPO levels. Thus, we selected 644 patients in whom endogenous serum EPO levels had been assessed and who underwent mutational NGS analysis. Given that this cohort consisted of patients with hematologic neoplasms, EPO levels were broad with the majority falling outside the normal clinical reference range. For this study we used EPO levels ≥100mU/mL as the threshold to define high and low EPO groups. This threshold laid above the 75th percentile for our cohort (M=31.1; IQR=109.7) to capture outliers more likely to reflect biologically significant erythropoietic stress. DNMT3AMT were present in 14% of high EPO and in 12% of low EPO groups (p=0.5). However, in the high EPO group, R882 constituted 32% of DNMT3AMT while in the low EPO group R882 was found in only 11% of DNMT3AMT cases (p=.02). In a reverse fashion, the mean level of EPO in DNMT3AR882 was 441.7mU/mL while it was 215.3mU/mL in other DNMT3AMT carriers (p=0.03) and 186.2mU/mL in DNMT3AWT cases (p<0.001). To assess whether the effect on DNMT3A was dependent on EPO levels rather than anemia, we determined mean hemoglobin levels in R882 (µ=10.2g/dL), other DNMT3AMT (µ=10.4g/dL), and wild type cases (µ=10.9g/dL) and found no significant differences (p=0.33). To assess whether R882-EPO sensitivity was related to EPO-R expression levels, we compared EPO-R expression in R882 (µ=2.7), non-R882 (µ=2.6) mutations, and WT cases (µ=2.8) and found no significant difference. To assess whether the impact of high EPO states was specific to DNMT3AMT we next analyzed the distribution of other mutations. We observed that frameshift mutations in BCOR (p = 0.013) and BCORL1 (p=0.036) were significantly more frequent in high EPO patients. BCORMT was also overall more prevalent in the high EPO group (p=.001), while BCORL1 frequency was similar across EPO strata (p=0.77) showing a similar trend to DNMT3AMT. Beyond these genes, other patterns emerged, particularly within CH-associated genes. Individuals with U2AF1MT had elevated EPO (p=.0087), with variant-specific enrichment: p.S34F was more common in high EPO (p=.038) whereas p.Q157P predominated in low EPO patients (p=0.038). No significant EPO associations were observed for other CH-related genes such as ASXL1, CBL, and TET2. The limitations of this study notwithstanding, these findings support a biologically meaningful relationship between elevated EPO levels and the acquisition or enrichment of specific CH-associated mutations in patients with hematologic malignancies. The association of high EPO with DNMT3AR882, frameshift mutations in BCOR/L1, and variant-specific enrichment in U2AF1 suggests that EPO-driven stress may contribute to clonal selection or expansion. Our study of high EPO levels and DNMT3AMT analysis illustrates that external conditions may influence selection pressure for specific mutations. However, selection pressure may be a complex combination of factors. Non-malignant conditions with high EPO, such as hypoxia or intrinsic BMF, may also create conditions facilitating the acquisition of specific somatic hits. Recognition of evolutionary pressures and their associations with specific mutations may improve our understanding of CH pathogenesis, and conceptualization of therapeutic or preventative measures.
Abdominal Arterial Calcification Score‐Association With Patient Survival Post Kidney Transplant
Idilbi, Amro , Ghanem, R, Hanouneh, Tareq, Hassoun, Ali, Nasrini, Tala , Haddad, Walid, Hallak, Mohamed Hussam, Sella, David M., Craver, Emily C. , Alasfar, Sami , Ghanem, Roaa, Alhassoun, Alia, Stegall, Mark D , Schinstock, Carrie , Jarmi, Tambi , Alhassoun, Alia, Alexander, Lauren F. , Stegall, Mark D. , Schinstock, Carrie A. , Jarmi, Tambi

Clinical Transplantation | November 12, 2025 | Volume: 39 | Issue: 11 | Pages: No page available

10.1111/ctr.70387 | PMID 42578517 Get It

ABSTRACT Background Abdominal arterial calcification (AAC) is a common comorbidity in patients with end‐stage kidney disease (ESKD) and a predictor of cardiovascular events post‐kidney transplant. However, prior studies lacked a standardized approach to evaluate AAC and its impact on post‐transplant outcomes. This study aimed to correlate AAC score values with post‐kidney transplant outcomes using a modified scoring system traditionally applied to coronary artery calcification. Methods This retrospective study included 14 339 adult patients listed for kidney transplant between 2002 and 2023 at three transplant centers. Among them, 3683 patients met the criteria of undergoing a kidney transplant and an abdominal computed tomography (CT) scan pre‐transplant. We modified the coronary calcium score software by adjusting intake data points to quantify calcification in the abdominal aorta, common iliac, external iliac, and internal iliac arteries. Outcomes focused on post‐transplant mortality. Results In 3683 kidney transplant recipients, higher AAC scores were significantly associated with increased mortality. Each 1000‐unit increase in AAC score elevated hazard ratios (HRs) across arterial regions, including 1.116 for the aorta and 1.389 for the internal iliac (all p < 0.001). Adjusted analyses confirmed AAC as an independent risk factor for mortality. Kaplan–Meier curves demonstrated lower survival with increasing AAC quartiles. Conclusions AAC, measured by a standardized score, is a significant mortality risk factor in kidney transplant recipients. Integrating AAC scores into pre‐transplant evaluations could enhance risk stratification and improve outcomes. Prospective studies are needed to validate these findings and explore interventions to reduce AAC and improve survival.
NCOG-27. Neuro-oncology anywhere: A fully decentralized clinical trial evaluating cognitive assessments and interventions for patients who received intracranial radiation therapy
Neth, Bryan J. , Galloway, Taylor , Hughes, Heather , Caron, Samantha, Batty, N., Alden, Eva , Kizilbash, Sani H. , Breen, William G. , Lehrer, Eric J. , Campian, Jian , Uhm, Joon H. , Ruff, Michael W. , Burns, Stacy D’Andre Terry, Haddad, Tufia C. , Flickinger, Lynn M. , Chan, Katrina, Mead‐Harvey, Carolyn , Geyer, Susan, Chan, Katrina , Neth, Byran J. , Kizilbash, Sani H , Sener, Uğur , Stricker, Nikki H. , Burns, Stacy D’Andre Terry

Neuro-Oncology | November 11, 2025 | Volume: 27 | Issue: Supplement_5 | Pages: v327-v327

10.1093/neuonc/noaf201.1294 Get It

Abstract BACKGROUND Cognitive symptoms are common among cancer patients treated with intracranial radiation but inadequately assessed and suboptimally treated, owing in part to the time-consuming and resource-intensive nature of formal neuropsychological testing. Through remote administration of brief cognitive assessments and symptom-directed interventions, decentralization uniquely addresses this problem. METHODS In this single-site phase 2 fully decentralized clinical trial (NCT06377696), patients treated with radiation therapy (RT) for primary or metastatic brain tumors undergo cognitive evaluations with the application, Mayo Test Drive, and the Short Test of Mental Status (STMS; via telehealth or in person), at baseline and every three months for one year. Participants are provided wearable devices for health promotion. Half the participants are randomized to metformin to evaluate this agent’s efficacy in treating RT-related cognitive symptoms. Target enrollment is 100 participants. RESULTS Seventy-three patients (median age 45.5, 46% female) with brain tumors who received RT were enrolled May 2024 to May 2025. In this unplanned interim analysis, we evaluated the impact of decentralization on study participation. Thirty-six participants (49%) reported a primary residence greater than 150 miles from our institution. Seven patients were consented remotely, the remainder in person. Of 380 study-related visits (201 STMS, 179 treatment toxicity checks) 216 (57%) were completed by telehealth. Thirty-two of 336 (9.5%) study-related lab draws were completed at locations outside our institution. Wearable device data was continuously collected, with median 3022 steps tracked per patient per day on study. 190/250 (76%) quality-of-life surveys sent digitally were completed to date. CONCLUSION Decentralization implemented as part of this clinical trial enabled participation despite significant distance from our institution and facilitated study-related assessments through digital solutions, eliminating the need for travel. Our findings demonstrate the feasibility of conducting a fully decentralized supportive care trial in neuro-oncology, which can increase participation and accelerate evaluation of novel therapeutics.
INNV-26. Neuro-oncology anywhere (NOA) 242: Interim results from a pragmatic clinical trial evaluating telehealth versus in-person evaluations for individuals with glioma undergoing oral chemotherapy
Galloway, Taylor , Schultz, Sydney , Hughes, Heather, Steinmetz, Sue, Tauer, William, Mason, Charles W. , Huebert, Carey, Walt, Charles Van Der , Uhm, Joon H. , Campian, Jian , Kizilbash, Sani H. , Neth, Bryan J. , Ruff, Michael W. , Karbhari, Nishika , Breen, William G. , Lehrer, Eric J. , Kottschade, Becky, Mead‐Harvey, Carolyn , Geyer, Susan, Haddad, Tufia C. , Neth, Byran J. , Kizilbash, Sani H , Karbhari, Nishika , Sener, Uğur , Hughes, Heather, Mason, Charles, Walt, Charles Van Der , Burns, Terry C.

Neuro-Oncology | November 11, 2025 | Volume: 27 | Issue: Supplement_5 | Pages: v230-v230

10.1093/neuonc/noaf201.0915 Get It

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.
Evaluation of Interventions for Cognitive Symptoms in Long COVID
Koltai, Deborah, Laskowitz, Daniel T. , Wisnivesky, Juan P., Federman, Alex D. , Silverstein, Adam M. , Lokhnygina, Yuliya, Haddad, Michelle M., Mahncke, Henry W. , Vleet, Tom Van, Huang, Rong , Cox, Wendy C., Terry, Diana, Karwowski, Jeannie, McCray, Netia, Lin, Jenny , Singh, Upinder , Geng, Linda N. , Reece, Rebecca , Moy, James N., Arvanitakis, Zoe , Parthasarathy, Sairam , Patterson, Thomas F., Gupta, Aditi , Parsonnet, Jeffrey, Kiriakopoulos, Elaine T. , Mullington, Janet , Jolley, Sarah E. , Shah, Nirav S. , Morimoto, Sarah Shizuko , Lee‐Iannotti, Joyce , Isache, Carmen, Frontera, Jennifer , O’Steen, Ashley, James, Melissa, Harper, Barrie, Zimmerman, Kanecia O. , Lawler, Andrew , Johnson, Brandon M. , Pitsch, Chloe E. , Feuerriegel, Elen , McKeehan, Jeffrey, Molden, Joie, Reid, Kayleigh M., Dowling, Sarah , Wodushek, Thomas, Canton, Diara, Turut, Dilara, Sheppard, Ethan , Scott‐Sutherland, Jennifer, Shaughnessy, Lynn, Beck, Michelle L. , Heisey, Sabrina, Katragadda, Vaishanvi, Yusuff, Amidat, Perlack, Amy, Merisme, Christie, Krause, David, Schulte, Duncan, Dupre, Fabiola, Sanchez, Gina A. Montealegre , Asupoto, Olanike, Simmons, Quinneil, Schroeder, Ryan W. , Timlin, Shannon, Devis, Ycar, Carter, Della, Caceres, Leomaris Caba, Rodríguez, Miguel Grande, Alvarez, Zariya , Yakubov, Amin , Engelson, Celia, Reyes, Michael, Youkhana, Alvin, Jennings, Cheryl , Naquiallah, Dina, Behun, Dylan , Stephen, Ellen, Timm, Emily , Bilimoria, Farrah, Li, Grace , Stricker, Thomas, Michelle, Kang, Minnie, Suarez, Rebeca Tojo, Carmona, Tania, Ramírez, Ana, Kadubek, Grace, Baker, Aileen, Romo-Serna, Andrea, Predki, Barbara, Leman, Cindy, Panhans, Cristina, Roth, Genevieve E., Rudraraju, Gowrisree , Miller, Hannah , DeLisa, Julie A., Williams, Kat, Woodson, Kimberly S., Jennette, Kyle J. , Villanueva, Laura, Norwick, Maria, Martínez, M. T., Rowley, Matt, Carrithers, Michael D. , Pliskin, Neil H. , Pérez, Nicolás , Durkin, Nicole M., Maniar, Nikita, Beety, Rachel, Daspgupta, Raktima, Ramchandran, Ramaswamy, Jaramillo, R., Hasek, Sharon, Macías, S Aguirre, Schuh, Tina , Ialacci, Sarah, Bailey, Christopher , Labbato, Danielle, Hautmann, Amanda , Smith, Beth, Nath, Dia, Meyer, Jessica , DiFrancesco, Kathryn, Pettinato, Kimberly, Curtis, Lynette, Daher, Joviane , Koberssy, Ziad , Mavar, Caleb, Andrefsky, John, Merheb, Alexander, Hernandez, Carla, Baissary, Jhony , Atieh, Ornina , Pereira, Carol, Carpenter, Deborah, Raynor, Jennifer , Brunton, Kristine, Podgoreanu, Andreea, Bunch, P. C., O’Brien, Sean M. , Dickey, Sheila, McNulty, Steven E., Gajjar, Varsha, Neale, Alec C. , Cohen, Cari, Geary, Elizabeth, Campanella, Franco, Anderson, Kirsten, Prestige, Laura, Guidotti-Breting, Leslie, Biewer, Megan, Morton, Melissa , Mathenia, Nicholas, Adeyemi, Oluwadamilola A. , Hengst, Samanike, Ning, Wei , Vanderloo, Adam, Caplan, Amanda, Chen, July, Acree, Mary Ellen , Nakhate, Mukund, Dan, Zaw Nu, Pk, Switzer, Aryal, Shambhu , Sanchez, Jessica, Sims, Luke, Ferdinand, Rebecca , Mammadova, Mehriban, Grimes, Carolyn Z. , Vidales, Elizabeth, Pham, Hau , Nielsen, Laura, Keller, Maryjane, Uruba, Syeda, Hernandez, Maria, Patel, Bela , Umana-Sanchez, Virginia, Pak, Chong, Gainer, Jeffery, BURR, R, Trapuzzano, Ashleigh, Celso, Brian G. , Bienkowski, Grace, Bowman, Jennifer, Verdecia, Jorge , Zerwekh, Kathryn, Serrano, Liliana , Marotz, Meghan, Propp, Piper, Sarig, Yonatan , Murphy, Annie, Comfort, Brandon, Torres, Iri, Klein, Jeffrey A. , Walker, John, Moore, John J., Tempest-Browning, Lisa, Arain, Mudassar, Kemp, Pamela, Sullivan, Samantha, Way, Sonja, Chevalier, Jessica, Sykes, Carly, Kruck, Carrie L., Sackett, L. W., Bang, Claire, Hynes, Mary, Gallagher, Torrey L., Childers-Kakos, Margaret, Zia, Ahmad, South, AP, Oravets, Anne, Ferreyra, Carolyn, Glaze, Chad, Villanueva, Daphne-Dominique , Blystone, Erica, Pritchard, Jane, Alyward, Laura, Cooper, Melissa, Chidester, Michelle, Alderson, R. Matt , Clark, Renee D., Hodder, Sally , Sarwari, Arif R, Juskowich, Joy, Welch, Shelly, Civil, Alyssa, Bendl, Ashley, Dicker, Elisa, Hanson, Hannah, Viola, Heather, Morinigo, Janice, Pantaleon, Karisma, Marcon, Kathryn, Stone, Kimberly, Stewart, Kiwan, Evo-Ortega, Lorraine, McVeety, Megan, Guliyeva, Sabina , Watson, Eric , Pehel, Shayna, Ko, Tim, Caropolo, Leah, Kocas, H. Deniz , O’Donnell, Andrew, Saperia, Corey , Thai, Daniel, Pathak, Divya , Keller, Jennifer M. , Olszewski, Kelly, Clinton, Kimberly, Cherian, Kirsten , Dutton, L M, Elepano, Ma, Mohapatra, Sukanya , Chen, Ting , Wroolie, Tonita, Leang, Zenita, Shashidhar, Sumana, Nguyen, T L, Ravisankar, Ashwath, Weiden, Brycie, Bolliger, Dawn, Glesne, Heather, Dixon, Jennifer , Chebrolu, Praneeth, Gazali, Zarine, Hurst, Whitney, Fry, Avery, Murthy, Ganesh, Grischo, Garrett, Erickson, Heidi L. , Gomez, Isaias, Copeland, Jacquelynn, Galaz, Judy, Autry, Lynn, DiLise-Russo, Marjorie, Marshell, Nikki, Borwege, Sabine, Vadovicky, Sheila, Marsh, Stephanie, Hartley, William, Murtagh, Linda, Kennedy, Anna, Meltzer-Christensen, Annie, Stringham, Caitlyn, Gaskin, Ella, Judd, Melissa, Côté, Sarah , Mahasenan, Shreya, Bjorklund, Todd, Farner, Cheryl E., Taylor, Barbara S. , Soileau, Bridgette, Cote, Cyrena , Hromas, Gabrielle A., Scholler, Irma, Longoria, Lisa, Heard, Patricia, Jones, Johnnie, Tragus, Robin , Harris, Maya, Pinones, Alexis, Anderson, Alyssa , Hastings, Gabrielyd, Courtright, jessica, Jayakumar, Madhumita, Fischer, M, Solis, Pamela, Harteloo, Alex, Elias-Warren, Anna, Nguyen, Daniel , McDonald, Dylan , Rau, Holly , Mernaugh, Jean, Pagulayan, Kathleen F. , Watanabe, Kino, Huden, Kristen, Peabody, Laurel, Mei, Tiffany, Ogunwuyi, Catherine, Cobbina, Esther, Sankar, Ian, Nguyen, Lisa , Fromm, N., Arnold, R. Douglas, Ogu, Stephanie, Yuan, Ying , Ibrahim, Homam , Szum, Izabella, Patel, Jignesh, Sultan, Sonia, Jazayeri, Yasmin, Anderson, Betty Lise, Muñoz, Isabel , Rhys, Logan, Vane, Ryan, Kim, Jessica , Diaz, Leticia M., Yee, Nathan, Gruhn, Robert, Browngoetz, Sarah, Johnson, Elisha, Chand, Arista , Bottrill, Kenneth , Henderson, Kymberly, Johnson, DeArmond, Richard C., Hughes, Trina, Silverstein, A , Silverstein, Adam P , Frontera, Jennifer , Geng, Linda N. , Knopman, David S. , Becker, Jacqueline , Charvet, Leigh , Pilloni, Giuseppina , Huang, Rong, Cox, Wendy, Karwowski, Jeannie, McComsey, Grace A. , Chu, Helen Y. , Ostrosky‐Zeichner, Luis , Fong, Tamara G. , Killgore, William D. S. , Dwyer, Brigid C. , Stringer, William W. , Krishnan, Jerry A , James, Melissa, Johnson, Brandon, Erlandson, Kristine M. , Dowling, Sarah, Hauser, Kristine , Doyle, Michael, Beck, Michelle, Tran, Anh, Altaras, Caroline , Sanchez, Gina, Krengel, Maxine , Ly, Monica T. , Asupoto, Olanike, Schroeder, Ryan, Rodriguez, Miguel, González, David Andrés , Torres, Jimena, García, Maria Luisa , Carrera, Laura, Rutherford, Melissa, Perez, Nicolas, Jaramillo, Ruthie, Smith, Beth, Walkup, Kevin, Scott, Sarah , Mavar, Caleb B., Carpenter, Deborah, Bunch, Pyper, Brown, Richard, Escobar, Carolina, Campanella, Franco, Mathenia, Nicholas, Glickman, Michael S. , Sims, Luke A., Pham, Hoai Phuang, Lopez, John, Hernandez, Maria, Lin, Matthew Junda , Gainer, Jeffery, Brown, Gina , Klein, Jeffrey, Reed, Jessica, Walker, John, Sackett, Lisa, Kaden, Sarah J. , Childers-Kakos, Margaret G, South, Amy, Blystone, Erica, Cooper, Melissa, Alderson, Rachael, Clark, Renee, Bardes, James M. , Hanson, Hannah, Loizos, Maria , Caropolo, Leah J., Fernandez, Luis, Keller, Jennifer, Lin, Rebecca, Brown, Daniel, Dixon, Jennifer, James, Michelle, Kala, Mrinalini , Smith, Ryan S. , Mahasenan, Shreya, Johnson, Hillary, Anderson, Alyssa, Hernandez, Jessica, Sullivan, Michael, Nguyen, Helen , Logue, Jennifer, Mei, Tiffany, Arnold, Rowan, Szum, Izabella , Hatlen, Timothy J. , Anderson, Betty, Munoz, Isabel, Wright, Matthew, Diaz, Leticia, DeCato, Thomas W. , Ortiz, Ernesto, Hildebrand, Lindsey L. , DeArmond, Richard

JAMA Neurology | November 10, 2025 | Volume: 83 | Issue: 1 | Pages: 49

10.1001/jamaneurol.2025.4415 | PMID 41212544 Get It

Importance Treatment for cognitive dysfunction due to postacute sequelae of long COVID (ie, symptoms of fatigue, malaise, weakness, confusion that persist beyond 12 weeks after an initial COVID infection) remains a significant unmet need. Objective To test evidence-based rehabilitation strategies for improving cognitive symptoms in persons with long COVID. Design, Setting, and Participants This was a 5-arm, multicenter, randomized clinical trial of 3 remotely delivered interventions conducted between August 17, 2023, and June 10, 2024. The study took place at 22 trial sites and included the screening of individuals with cognitive long COVID. Interventions Participants were randomized to 1 of 5 arms: adaptive computerized cognitive training (BrainHQ [Posit Science]), cognitive-behavioral rehabilitation involving both group and individual counseling sessions (PASC-Cognitive Recovery [PASC-CoRE]) paired with BrainHQ, and transcranial direct current stimulation (tDCS) paired with BrainHQ. Two comparator arms were included as follows: unstructured computer puzzles and games (active comparator) and sham tDCS paired with BrainHQ. The interventions occurred 5 times per week over 10 weeks. Main Outcomes and Measures Cognitive and behavioral in-person assessments were performed at baseline, midintervention, at the end of intervention, and 3 months after the end of the intervention. The primary outcome measure was the modified Everyday Cognition Scale 2 (ECog2) completed at the end of the intervention compared to the baseline visit based on participant self-report looking back over the prior 7 days. Results A total of 378 individuals were screened, from which there were 328 participants (median [IQR] age, 48.0 [37.0-58.0] years; 241 female [73.5%]; race: 15 Asian [4.6%], 47 Black [14.3%], and 235 White [71.6%]; ethnicity: 52 Hispanic [15.9%]). None of the 3 active interventions demonstrated benefits on the modified ECog2 in the intention-to-treat population by the end of the intervention period. The adjusted differences in mean change were 0.0 (95% CI, −0.2 to 0.2) for BrainHQ vs active comparator, 0.1 (95% CI, −0.1 to 0.3) for PASC-CoRE + BrainHQ vs active comparator, 0.0 (95% CI, −0.2 to 0.2) for tDCS-active + BrainHQ vs tDCS-sham + BrainHQ, and 0.1 (95% CI, −0.1 to 0.3) for PASC-CoRE + BrainHQ vs BrainHQ alone. Secondary participant-reported outcomes and neuropsychological tests showed no differential benefits for any treatment arm. All 5 arms demonstrated some improvements over time on the modified ECog2 and on secondary outcomes. There were no serious adverse events attributable to the interventions. Conclusions and Relevance This phase 2 randomized clinical trial failed to demonstrate differential benefits for online cognitive training, a structured cognitive rehabilitation program, and tDCS for cognitive long COVID. Trial Registration ClinicalTrials.gov Identifier: NCT05965739 .
Perceptions of barriers and facilitators of video telemedicine visits among cancer patients since onset of the COVID-19 pandemic: A qualitative study.
Dholakia, Ruchita, Decker, Paul A. , Khera, Nandita , Tilburt, Jon C. , Haddad, Tufia C. , Pritchett, Joshua C. , Kamath, Celia , Brockman, Tabetha A. , Huang, Ming , Moriarty, James P. , Decker, Paul A. , Brewer, LaPrincess C. , Borah, Bijan J. , Patten, Christi A. , Sharma, Pravesh

JCO Oncology Practice | October 7, 2025 | Volume: 21 | Issue: 10_suppl | Pages: 566-566

10.1200/op.2025.21.10_suppl.566 Get It

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.