An evaluation of biobanking and therapeutic clinical trial representation among adult glioma patients from rural and urban Utah.

Background: Social determinants of health (SDOHs)-specifically those related to rurality, health care accessibility, and income-may play as-yet-unidentified roles in prognosis for glioma patients, and their impact on access to clinical trials is important to understand. We examined SDOHs of patients enrolled in glioma clinical trials and evaluate disparities in trial participation and outcomes between rural and urban patients. Methods: We retrospectively identified patients enrolled in glioma clinical trials at Huntsman Cancer Institute (HCI) from May 2012 to May 2022 to evaluate clinical trial participation. We used multivariable models to evaluate SDOHs and geographic information system mapping to assess representation across Utah's counties. We utilized the most recent 10-year datasets of patients treated for glioma at HCI and from the Utah Cancer Registry to analyze survival and incidence, respectively. Results: A total of 570 participants (68 trials) resided in Utah, 84.4% from urban counties, 13.5% from rural counties, and 2.1% from frontier (least-populous) counties. Nineteen counties (65.5%) were underrepresented in trials (enrolled participants vs. eligible), 1 (3.5%) was represented in a near-1:1 ratio, and 9 (31.0%) were overrepresented. Counties with greater enrollment had greater population densities, highest per-capita income, and proximity to HCI. Among patients treated at HCI, patients from rural/frontier counties had equivalent survival with urban patients across nearly all glioma types, including glioblastomas, despite underrepresentation in clinical trials. Conclusions: By highlighting disparities in clinical trial enrollment, our results can support efforts to improve recruitment in underrepresented regions, which can assist providers in delivering equitable care for all patients.

Consolidation regimens in primary central nervous system lymphoma: a single-center retrospective cohort evaluating survival outcomes and cost-benefit analysis.

ABSTRACT: PURPOSE: Optimal treatment for primary central nervous system lymphoma (PCNSL) comprises polychemotherapy induction with high-dose methotrexate followed by consolidation therapy, but there is no standard treatment regimen because of a lack of comparative trials examining efficacy or relative value. We performed a retrospective outcome and relative cost analysis on consolidation regimens to gain perspective on how cost and benefit can be weighed in medical decisions for patients with PCNSL. METHODS: Patients with newly diagnosed PCNSL who completed consolidation at our institution from July 1, 2012, to March 1, 2019, were included. Patients completed etoposide/cytarabine (EA), high-dose cytarabine (HIDAC), or high-dose chemotherapy with autologous stem-cell rescue (HDC-ASCR) as consolidation regimen. Data were collected from the electronic medical record and our institution's Value Driven Outcomes tool. Survival was analyzed as date of diagnosis to last known date of survival. RESULTS: Of the 22 patients included in the study, 12 completed the EA regimen, 4 completed HDC-ASCR, and 6 completed HIDAC. Facility and pharmacy costs contributed most to the cost of each treatment. HDC-ASCR treatment was 50× the cost of the cheapest treatment, HIDAC. Outcomes were numerically superior with HDC-ASCR and HIDAC compared with EA (2-year progression-free survival 100% vs. 100% vs. 63.6%, respectively, p = 0.1915). CONCLUSION: This small retrospective cost-benefit analysis provides evidence that HDC-ASCR may be a superior treatment for PCNSL but at a higher cost than other consolidation regimens. HIDAC may increase value for patients, including elderly patients, who are not appropriate candidates for HDC-ASCR when compared with EA.

Caregiver burden by treatment and clinical characteristics of patients with glioblastoma.

BACKGROUND: Glioblastoma is an incurable disease with a poor prognosis. For caregivers of people with glioblastoma, the burden of care can be high. Patients often present with different clinical characteristics, which may impact caregiver burden in different ways. This study aimed to evaluate associations between patient clinical characteristics and caregiver burden/quality of life (QoL). METHODS: Caregiver-patient dyads were enrolled at 7 academic cancer centers in the United States. Eligible caregiver participants were self-reported as the primary caregiver of an adult living with glioblastoma and completed a caregiver burden survey. Eligible patients were age ≥ 18 years at glioblastoma diagnosis and alive when their respective caregiver entered the study, with the presence of cognitive dysfunction confirmed by the caregiver. Data were analyzed with descriptive statistics and multivariable analyses. RESULTS: The final cohort included 167 dyads. Poor patient performance status resulted in patient difficulty with mental tasks, more caregiving tasks, and increased caregiving time. Language problems were reported in patients with left-sided lesions. Patient confusion was negatively associated with all caregiver domains: emotional health, social health, general health, ability to work, confidence in finances, and overall QoL. Better caregiver QoL was observed in patients with frontal lobe lesions versus non-frontal lobe lesions. CONCLUSION: This study reinforced that patient performance status is a critical clinical factor that significantly affects caregiver burden, caregiving tasks, and caregiver time. Additionally, patient confusion affects multiple facets of caregiver burden/QoL. These results could be used to support guided intervention for caregiver support, customized to the patient experience.

Development of the Electronic Social Network Assessment Program Using the Center for eHealth and Wellbeing Research Roadmap.

BACKGROUND: The number of Web-based psychological and behavioral interventions is growing. Beyond their theoretical underpinnings, a key factor to the success of these interventions is how they are designed and developed to ensure usability over a new method of delivery. Our team has adapted ecomapping, a tool for visualizing family caregiver social network resources, for the Web. Here, we describe how we designed and developed the electronic Social Network Assessment Program (eSNAP) Web-based tool using a framework of the Center for eHealth and Wellbeing Research (CeHRes) Roadmap for Web-based intervention development. The CeHRes Roadmap is still new in terms of tool development and we showcase an example of its application. OBJECTIVE: The aim of our study was to provide an example of the application of the Web-based intervention development process using the CeHRes Roadmap for other research teams to follow. In doing so, we are also sharing our pilot work to enhance eSNAP's acceptance and usability for users and the feasibility of its implementation. METHODS: We describe the development of the eSNAP app to support family caregivers of neuro-oncology patients. This development is based on the 5 iterative stages of the CeHRes Roadmap: contextual inquiry, value specification, design, operationalization, and summative evaluation. Research activities to support eSNAP development prior to implementation included literature review, focus groups, and iterative rounds of interviews. RESULTS: Key lessons learned in developing the eSNAP app broadly fell under a theme of translating theoretical needs and ideas to the real world. This included how to prioritize needs to be addressed at one time, how the modality of delivery may change design requirements, and how to develop a tool to fit within the context it will be used. CONCLUSIONS: Using the CeHRes Roadmap to develop Web-based interventions such as eSNAP helps to address potential issues by outlining important intervention development milestones. In addition, by encouraging inclusion of users and other stakeholders in the process, Web-based intervention developers using the Roadmap can identify what will work in the real world and increase feasibility and effectiveness.

Incorporation of biomarker assessment in novel clinical trial designs: personalizing brain tumor treatments.

Advances in molecular genetics have aided the identification of potential biomarkers with significant clinical promise in neurooncology. These advances and the evolution of targeted therapeutics necessitate the development and incorporation of innovative clinical trial designs that can effectively validate and assess the clinical utility of biomarkers. In this article, we review the use and potential of several such designs in neurooncology trials in order to support the development of personalized treatment approaches for brain tumor patients.

Assessment and prognostic significance of mitotic index using the mitosis marker phospho-histone H3 in low and intermediate-grade infiltrating astrocytomas.

Distinguishing between grade II and grade III diffuse astrocytomas is important both for prognosis and for treatment decision-making. However, current methods for distinguishing between grades based on proliferative potential are suboptimal, making identification of clear cutoffs difficult. In this study, we compared the results from immunohistochemical staining for phospho-histone H3 (pHH3), a specific marker of cells undergoing mitosis, with standard mitotic counts (number of mitoses/10 high-power fields) and MIB-1 labeling index values for assessing proliferative activity. We tested the relationship between pHH3 staining and tumor grade and prognosis in a retrospective series of grade II and III infiltrating astrocytomas from a single institution. The pHH3 index (per 1000 cells), MIB-1 index (per 1000 cells), and number of mitoses per 10 high-power fields were determined for each of 103 cases of grade II and III diffuse astrocytomas from patients with clinical follow-up. pHH3 staining was found to be a simple and reliable method for identifying mitotic figures, allowing a true mitotic index to be determined. The pHH3 mitotic index was significantly associated both with the standard mitotic count and with the MIB-1 index. Univariate analyses revealed that all 3 measurements of proliferation were significantly associated with survival. However, the pHH3 mitotic index accounted for a larger proportion of variability in survival than standard mitotic count or MIB-1/Ki-67 labeling index. After adjusting for age, extent of resection, and performance score, the pHH3 mitotic index remained an independent predictor of survival. Thus, pHH3 staining provides a simple and reliable method for quantifying proliferative potential and for the stratification of patients with diffuse astrocytomas into typical grade II and III groups. These results also suggest that pHH3 staining may be a useful method in other neoplasms in which accurate determination of proliferation potential is relevant to tumor grading or clinical treatment decision-making.