Oncology Patient Population Research Articles

Detection of Enteroviruses in a Pediatric Oncology Patient Population

Abstract Enteroviruses are responsible for around 10 to 15 million infections and tens of thousands of hospitalizations annually. Infants, children, and people with weakened immune systems are more likely to get hospitalized and can have serious complications from enterovirus infection. Non-polio enteroviruses like EV-D68 can cause mild to severe symptoms like wheezing, difficulty breathing and acute flaccid myelitis (AFM). Therefore, it is crucial to continue to monitor the prevalence of enteroviruses, especially those that can potentially cause severe symptoms like EV-D68. This study focused on determining the prevalence of enteroviruses in a pediatric oncology patient population. Residual Nasopharyngeal swabs (NPS) specimens, collected from pediatric patients (<18 years old) presenting to a cancer hospital in New York between September 2022 and December 2022, and September 2023 and December 2023 for cancer care were included in the study. Rhinovirus/Enterovirus (RV/EV) was detected using the BioFire FilmArray Respiratory Panel (bioMerieux, Inc.) or the ePlex Respiratory Pathogen Panel (GenMark/Roche Molecular). For Enterovirus identification, RNA was extracted from the RV/EV positive NPS using the KingFisher™ Flex Magnetic Particle Processors (Thermo Scientific, USA), followed by RT-PCR in the ABI 7500 Fast real-time PCR instrument (ThermoFisher, USA) for enteroviruses and EV-D68 using pan-Enterovirus and EV-D68 specific primers, respectively. A total of 880 and 694 NPS samples from patients <18 years old were tested during the study period in 2022 and 2023, respectively. Of these, 238 (238/880; 27%) and 225 (225/694; 32%) RV/EV positives NPS were detected in 2022 and 2023 respectively. A total of 370 (370/463; 80%) RV/EV positive samples (182 samples from 2022 and 188 samples from 2023) were selected for additional testing and 14 samples (14/370; 4%) were positive for Enteroviruses. Of note, EV-D68 was not detected. In this study, we report a high prevalence of RV/EV which is consistent with the higher detection rate in the fall seasons, when our samples were collected. The low prevalence of EV suggests a high prevalence of RV, although this was not tested. Despite a nationwide surge in the USA in 2022, there was no EV-D68 circulating in these patients. Further analysis, using Whole genome sequencing of the enteroviruses detected in this study will provide additional information on specific circulating Enterovirus genotypes.

Virtual addressing reality: Development of a virtual social work program to address health-related social needs.

405 Background: Assessment of Health-Related Social Needs (HRSNs) has become an integral part of understanding barriers to care and improving patients’ lives and experiences as they receive cancer care. Increased assessment, however, can result in a raised awareness of unmet needs in oncology patient populations. This tends to highlight gaps in services and necessitate additional staff to attend to these needs. Addressing HRSNs can be facilitated with lay navigators (non-licensed staff), licensed staff, clinical staff, and other members of a multi-disciplinary team. Actions can include, but are not limited to, identification of practical concerns, referrals to community-based organizations (CBOs), referral to the clinical team, or further escalation to a licensed clinical social worker (LCSW). Methods: The National Comprehensive Cancer Network (NCCN) Distress Thermometer screening tool was implemented in July 2023 where patients are screened every 3 months in a community oncology setting. A workflow was established where a clinic staff would administer the screening tool and enter the details of the screening into the EHR system. Based on established criteria, the patient would be referred to the social work team via electronic referral. Due to an increase in screening and subsequent referrals, a virtual team of (5) social workers called Patient Resource Coordinators (PRCs) was established in December 2023 to address the practical concerns and facilitate the coordination of resources based on identified needs. After the team was established, non-urgent referrals were then assigned to a PRC. The PRC could refer to an on-site LMSW/LCSW for higher level of acuity assessment, like crisis support or positive PHQ-9 scores. Results: See Table. Conclusions: The virtual PRC team is able to manage ~55% of referrals made to a social worker based on results from an HRSN screening tool. This has allowed the onsite LMSWs/LCSWs to work at the top of their license and enabled patients to receive support with care coordination and connection to resources. Over time, the referrals managed by the virtual team has increased and their connections to patients have grown. In the future, the PRC team aims to add additional LCSW services to assist patients with higher acuity needs. This will broaden the scope of services available to the patients to address their health-related social needs in a timely manner. PRC Activity Dec ’23 Jan ‘24 Feb ‘24 Mar ’24 Apr ‘24 May ’24 (*May to date at time of submission) # of Referrals Received via EHR 110 542 610 586 1216 570 # of Referrals Assigned to PRC 45 245 299 315 660 312 % of Referrals Assigned to PRC 41% 45% 49% 54% 54% 55% *Secondary Referral to SW 8 9 20 4 # of calls attempted 102 479 536 577 959 448 # of patients reached 38 180 217 270 413 277 % of patients reached 37% 38% 40% 47% 43% 62% # of practical concerns identified 31 131 426 430 742 349 Total Visit Duration (in hrs.) 36hrs 181hrs 348hrs 450hrs 836hrs 485hrs

Telehealth use and acceptability amongst a diverse oncology patient population.

104 Background: Existing research describes numerous barriers to care for patients with cancer, including time constraints, cost, and additional health conditions. We sought to assess telehealth access and experience amongst a diverse patient population at an academic medical center. Methods: We administered a 60-question, cross-sectional, in-person survey to adult patients with a diagnosis of solid tumor or hematological malignancy on active treatment at Columbia University Irving Medical Center (CUIMC) in New York, NY between January 2023 and February 2024. The survey assessed access to and attitudes, beliefs and experience with telehealth as part of routine care and clinical trials. Demographics including age, gender, race/ethnicity, marital status, income, insurance type and education were self-reported. Results: The survey was administered to 100 patients with cancer (breast cancer, n=25; gastrointestinal cancer, n=25; genitourinary cancer n=25; and hematologic malignancy, n=25); 37% were actively enrolled or previously enrolled on a clinical trial. The mean age was 61 years; 51% were female; 45% non-White, and 23% Hispanic. The majority (63%) reported traveling >30 min to their treatment, with 48% reporting travel costs >$20 per visit. Six percent reported difficulty receiving treatment due to cost, and 23% reported difficulty getting to visits due to other conditions or disabilities. The majority (87%) reported having access to a computer or electronic device; 99% of those had internet access and 81% were comfortable using the internet. Of those who had prior video visits (59%), almost all (97%) reported that video visits addressed their issues/questions well. About a quarter of the patients who had not had a video visit reported that they would prefer to have video visits about a cancer-related issue rather than going into the office. For those who preferred a video visit (n=18), top reasons included elimination of travel, convenience, and not feeling rushed. Top barriers among those who expressed hesitance (n=23) included lack of access to necessary technology, not knowing how to use the technology, concern about getting the same level of care, or preference for in-person communication. Similar to video visits, 52% participants reported that they had a scheduled telephone visit with their oncologist instead of going to the office; 98% reported that their issues were either somewhat or very well addressed. Conclusions: In this cross-sectional study amongst a racially, ethnically and socioeconomically diverse population, we found that most patients with cancer on active treatment had access to telehealth and were satisfied with telehealth visits. Those who had not utilized telehealth were interested given convenience and elimination of travel. We found minimal barriers to telehealth access in this diverse urban population. Telehealth may offer an adjunct to reduce financial and logistic barriers to cancer care.

Patient interest in clinical trials and remote technology among a diverse oncology patient population.

389 Background: Existing research describes a number of barriers limiting cancer clinical trial enrollment, including time constraints and financial burden, particularly among under-represented populations. In this study, we sought to assess the relationship between the use of remote technology in clinical trials and patient interest in trial participation amongst oncology patients at an urban academic medical center. Methods: We administered a 60-question, cross-sectional, in-person survey to adult patients with a solid tumor or hematological malignancy diagnosis on active treatment at Columbia University Irving Medical Center between 1/2023 and 2/2024. The survey assessed patient demographics, telehealth access, and interest in using telehealth as part of routine care and clinical trials. Demographics including age, gender, race/ethnicity, marital status, income, insurance type, education level, and cancer type were self-reported. Results: The survey was administered to 100 oncology patients. The mean age was 61 years; 51% were female; 45% non-White and 23% identified as Hispanic. The majority (87%) reported having access to a computer or electronic device; 99% of those having internet access and 81% being somewhat or very comfortable using the internet. Forty seven percent of patients had been offered a cancer clinical trial by their oncology provider, and 19% had participated or were currently participating in a clinical trial. Of the 53% of patients who had not been offered a clinical trial or did not know, 64% reported they would consider participating in a trial recommended by their oncologist. Among all respondents, 52% of patients reported it would make no difference in their decision to participate in a trial if they learned about the risks and benefits remotely (phone or video), 28% were somewhat more or much more likely to participate learning about the risks and benefits remotely, and 20% were somewhat less or much less likely to participate under these conditions. Seventy five percent of respondents would be willing to sign consent for a trial remotely. Sixty four percent of respondents were not willing to spend over an hour traveling to a trial site, citing time, cost, family, and work obligations as reasons for limiting travel. The majority of respondents (>50%) indicated that they would be more likely to participate if the trial used remote technology to decrease the need to travel to a trial site. Conclusions: In this cross-sectional study amongst a diverse patient population, we found that the majority of oncology patients on active treatment have access to telehealth, express interest in clinical trials despite barriers to participation, and would be more likely to enroll in trials if remote communication reduced the amount of travel time for trial participation. Decreasing the logistical burden of cancer clinical trials may increase patient access and diversity in trial participation.

Risk of transfusion-related iron overload varies based on oncologic diagnosis and associated treatment: Retrospective analysis from a single pediatric cancer center.

Transfusion-related iron overload (TRIO) is a widely acknowledged late effect of antineoplastic therapy in pediatric cancer survivors, but firm guidelines as to screening protocols or at-risk populations are lacking in the literature. We performed retrospective analysis of all oncology patients diagnosed at our center from 2014 to 2019, who underwent TRIO screening as part of an internal quality improvement project. Correlations of MRI-confirmed TRIO with patient-, disease-, and treatment-specific features were evaluated. We show that a tiered screening algorithm for TRIO, when followed as intended, led to the identification of the highest proportion of patients with TRIO. We confirm that cardiac TRIO is quite rare in the oncology patient population. However, accepted surrogate markers including red blood cell transfused volume and ferritin only modestly correlated with TRIO in our patient cohort. Instead, we found that older age, leukemia diagnosis, anthracycline exposure, and receipt of stem cell transplant were most strongly associated with risk for TRIO. We describe associations between TRIO and patient, disease, and treatment characteristics in a multivariate risk model that could lead to an improved risk stratification of off-therapy patients, and which should be validated in a prospective manner.

Anxiety and depression are common in surgical oncology patients: Results of a prospective cohort study

BackgroundThe oncology patient population is vulnerable to elevated levels of anxiety and depression. These states of psychological distress have been associated with negative effects on treatment course and outcomes, but reported prevalence rates are varied. The General Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) questionnaires are screening tools that can be utilized to assess the levels of anxiety and depression, respectively. MethodsThis prospective, surgeon-blinded study assessed the preoperative prevalence of anxiety and depression in patients with abdominal malignancies who underwent curative-intent resection. Postoperative outcomes and survival were assessed. ResultsOverall, 218 patients were enrolled and included in the final analysis. Patients were stratified into groups by severity of anxiety and depression. 67 (31 %) patients reported at least mild anxiety as defined by GAD-7 score of 5 +, and 74 (34 %) patients reported at least mild depression, as defined by PHQ-9 score of 5 +. Functional status as defined by Eastern Cooperative Oncology Group scores was associated with anxiety (P = 0.003) and depression (P = 0.024). Depression was associated with race and ethnicity (P = 0.014) and marital status (P = 0.021), with Hispanic/Latino and unpartnered patients reporting higher rates of depression. ConclusionAnxiety and depression are common in the surgical oncology population, affecting a third of the patient population in this prospective study. In addition to a thorough social assessment, the GAD-7 and PHQ-9 questionnaires can be utilized preoperatively to identify patients with psychological distress. SynopsisAnxiety and depression were assessed preoperatively in patients with abdominal malignancies who underwent curative-intent resection. These states of psychological distress were highly prevalent, affecting a third of the population, and significantly associated with certain vulnerable groups.

Evaluation of safety outcomes between nivolumab regimens with differing dosing patterns.

Real-world safety outcomes between the two flat-dose nivolumab regimens demonstrated to be similar in a study of adjuvant nivolumab recipients for melanoma. However, this study was limited by a single oncology patient population, a small sample size, and insufficient study power. The primary objective of this study was to evaluate the incidence of immunotherapy-related adverse effects (irAEs) between nivolumab regimens with differing dosing patterns in various solid tumor patient populations. Single-center retrospective cohort study of adult patients with solid tumor malignancies who received nivolumab 240 mg Q2W or 480 mg Q4W, or who were transitioned from 240 mg Q2W to 480 mg Q4W from March 1, 2018 to March 31, 2022 were selected for analysis from an electronic health record generated report. The primary endpoint evaluated was the incidence of irAEs. Secondary endpoints included the incidence of significant irAEs and reasons for treatment discontinuation. These endpoints were compared by univariate analysis between all three cohorts. A multivariate analysis was then conducted for the primary endpoint. Nivolumab 240 mg Q2W was associated with a statistically significant increase in the incidence of colitis whereas the 480 mg Q4W regimen was associated with a statistically significant increase in the incidence of pruritis. The incidence of irAEs was not different between the three cohorts, while the incidence of significant irAEs was higher in the 240 mg Q2W and 240 mg Q2W to 480 mg Q4W cohorts. Clinicians ought to be aware of differences in the irAE profiles between nivolumab regimens with differing dosing patterns.

Symptoms and prophylaxis of venous thromboembolism in the population of cancer and hospice patients-what is known?

In a group of palliative patients, venous thromboembolism (VTE) is a significant cause of death and reduction in quality of life. Current guidelines and scientific research on thromboprophylaxis most often refer to the population of oncology patients, who differ in many aspects from patients receiving palliative care. Thus, doctors working with patients undergoing palliative treatment have to face many problems related to safety and effectiveness of antithrombotic therapy in this type of care. In the case of chronically ill patients, diagnostic process may be somewhat difficult because the symptoms resulting from the underlying diseases can mask VTE symptoms. The aim of this article is to review the literature on symptoms and thromboprophylaxis in this group of patients. According to the latest guidelines of the American Society of Clinical Oncology (ASCO), it is not recommended to use VTE prophylaxis in outpatient oncology patients routinely, but it should be considered in high-risk patients who received a Khorana score of at least 2 before starting a new chemotherapy cycle. In patients diagnosed with VTE, in long-term prophylaxis lasting at least 6 months, due to greater effectiveness, it is recommended to use low-molecular-weight heparins, edoxaban, rivaroxaban or apixaban instead of vitamin K antagonists, which can be used if the previously mentioned drugs are unavailable. There are some studies which show that thromboprophylaxis may be beneficial for patients in palliative care. On the other hand, another studies’ results suggest that patients won’t gain any benefit from prevention. As our article shows it is very crucial to conduct scientific research on palliative patients and create clear guidelines for prophylaxis for this group of people.

A national survey of obstetrics and gynecology resident perspectives on their preparedness to provide care for racially and socioeconomically diverse gynecologic oncology populations.

9037 Background: Despite 83% female representation, Obstetrics and Gynecology (Ob/Gyn) lags behind other residencies in racial diversity, with 35.2% of trainees classified as Underrepresented in Medicine (URM). Fellowships are markedly less diverse, with Gynecologic Oncology representing 26.1% URM. While studies have examined Ob/Gyn residents’ self-perceived preparedness for surgical skills, little is known about their confidence in treating vulnerable patients with gynecologic malignancies. This survey assessed resident confidence in providing Gynecologic Oncology care to patient populations diverse in racial/ethnic background and insurance status, while accounting for residents’ own racial/ethnic backgrounds. Methods: An anonymous, novel Qualtrics survey was disseminated to current US Ob/Gyn residents, to elicit their self-reported preparedness to provide NCCN guideline-based care to diverse Gynecologic Oncology patient populations. Subjects were asked multiple-choice questions to record their own demographics followed by Likert scale questions which ranged from strongly disagree (1) to strongly agree (5) regarding their perceived readiness to care for patients diverse in insurance and racial background. Differences in responses between racial groups were analyzed using the Kruskal-Wallis Rank Sum test while differences in responses between ethnic groups were evaluated using the Wilcoxon Rank Sum test. Results: 207 residents complete the survey, mirroring sample sizes of national surveys of Ob/Gyn residents. There was no statistical difference in self-perceived preparedness between Hispanic and non-Hispanic Ob/Gyn residents regarding providing care for diverse racial minorities (mean Likert Non-Hispanic = 4.1 vs. Hispanic = 4.2; p = 0.222) or insurance types (mean Likert Non-Hispanic= 4.0 vs. Hispanic = 4.0; p=0.563). There was a significant difference in the number of Hispanic residents who felt that patients with Medicaid insurance experienced more difficulty obtaining non-operative gynecologic care compared to those with other insurance types (Hispanic = 3.7 vs. non-Hispanic = 3.2; p = 0.044). Further, there was a significant difference in the number of Hispanic residents who felt that patients with Medicaid insurance had to wait longer for outpatient appointments with a gynecologic oncologist (Hispanic = 3.6 vs. non-Hispanic = 3.0; p=0.016). Conclusions: All Ob/Gyn residents will encounter, screen for, and diagnose gynecologic malignancies, regardless of pursuit of Gynecologic Oncology fellowship. This study evaluated Ob/Gyn resident perceptions, finding that they feel overall prepared to provide Gynecologic Oncology care to socioeconomically diverse patient populations, though differences exist when residents are compared based on their backgrounds.

Developing a manual clinical trials screening process in a diverse southern gynecologic oncology practice in the Deep South.

e23209 Background: At this time, there is no standard clinical trial screening process or definition that has been adopted within Gynecologic Oncology. In our low resource, highly diverse Gynecologic Oncology patient population, we sought to create an equitable, adaptable, manual screening process that better reflected our patient population. Our objective is to describe our clinical trial screening process and our success in improving trial enrollment and a matched trial portfolio. Methods: An IRB-approved, QI project was implemented in July 2022 to evaluate trial access for Gyn Onc patients. First, screenable events were defined as: the start of one’s first scheduled visit, bi-monthly tumor boards, weekly pre-op meetings, and by keeping track of on a shared Epic list. Potential patients were those with a screenable event: new patients or diagnoses, regimen changes, progressions, and recurrences. Events were categorized into screen positive or screened no trial available. Screen positives were further categorized as screen fail, screen positive, enrollment failure, or enrolled. Data about patients was collected via weekly research team meetings. Monthly meetings occurred to review progress. This data was compared to trials available, number of patients with trail available, and those that enrolled. Reasons for enrollment fails were tracked to improve access and anticipate barriers. Results: Overall demographic data of patients was collected. The average age of participants was 60.67 years (SD = 13.45), and the average distance to a treatment center was 59.27 miles (SD = 137.43). Other demographics are presented in Table 1. For each month, the percentages of “screen no trial available (SNTA)” events and patients who screened positive and did enroll on trial were recorded. Over time, SNTA rates stayed stable, but enrollment increased. Patient preference accounted for 32.8% of enrollment fails (n = 42), pre-existing symptoms/conditions accounted for 23.4% (n = 30), and distance/location accounted for 21.1% (n = 27). During a time of high employee turnover in the summer months of 2023, there was a rise in enrollment fails due to staffing (n = 6, 4.7%). Conclusions: Through a collaborative quality initiative, we describe an effective process of clearly defining and tracking our patient population and ‘screenable events’ for which all patients are screened and offered trial participation if eligible. We show that we improved understanding of the patient population, built a clinical trial portfolio better matched to population served, exceeded national averages for enrolling patients on trials, and are moving toward improved number eligible over time. [Table: see text]

The Patient Activation Measure-13 (PAM-13) in an oncology patient population: psychometric properties and dimensionality evaluation

BackgroundAccurate assessment and enhancement of health-related skills among oncology patients are pivotal for optimizing cancer care. The Patient Activation Measure (PAM-13), a questionnaire designed to reflect an individual’s knowledge, skills, and confidence in self-healthcare management, has been validated across diverse countries and settings. Concerns have been raised regarding the cross-situational applicability, as patients with specific diseases and cultural backgrounds interpret questionnaire items differently. This study aimed to examine the structural validity and psychometric properties of the PAM-13 in an oncological patient cohort.MethodsBaseline data from a longitudinal non-randomized controlled study involving cancer out-patients (n = 1,125) from Comprehensive Cancer Centres in Southern Germany were analysed. The German version of the PAM-13 was employed. With classical test and item response theory methods data quality, reliability, convergent and structural validity, as well as psychometric properties were assessed. Exploratory (EFA) and confirmatory factor analyses (CFA) were employed to investigate the postulated unidimensionality of the underlying construct. With a partial credit model (PCM) we examined item fit, targeting, local independence and differential item functioning.ResultsParticipants were predominantly female (73.0%) with a breast cancer diagnosis (41.3%). While items were generally well-accepted, ceiling effects were observed and a high mean PAM-13 score (69.7, SD = 14.2) was noted, potentially compromising responsiveness to interventions. Reliability was adequate (Cronbach’s α = 0.81), person and item separation reliability were good to excellent (0.81 and 0.99, respectively). Explorations of the unidimensionality of the construct (EFA, CFA, PCM) yielded inconclusive results, hinting towards a two-factor solution. Item difficulty rankings deviated from the original. No differential item functioning was identified, and local independence was confirmed.ConclusionsWhile the PAM-13 serves as a valuable instrument for comprehending and promoting health-related skills in cancer patients, the identification of ceiling effects, disordered item-difficulty rankings, and inconclusive findings regarding unidimensionality contribute to the expanding body of evidence, emphasizing the dependency of PAM-13’s validity and reliability on distinctive characteristics within the population under investigation. Future research should prioritize refining or adding PAM-13 items to better capture the specific health-related challenges within diverse populations, paving the way for more effective patient engagement strategies in oncology.Trial registration numberDRKS00021779

Major Perioperative Cardiac Risk Assessment: A Review for Cardio-Oncologists and Perioperative Physicians.

The Revised Cardiac Risk Index (RCRI) and the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) preoperative risk assessment tools are the most widely used methods for quantifying the risk of major negative perioperative cardiac outcomes that a patient may face during and after noncardiac surgery. However, these tools were created to include as wide a range of surgical factors as possible; thus, some predictive accuracy is sacrificed when it comes to certain surgical subpopulations. In this review, we explore the various surgical oncology patient populations for whom these assessment tools can be reliably applied and for whom they demonstrate poor reliability.

The language of palliative surgery: A scoping review

BackgroundDespite an identified need for palliative surgery to have a clear definition and well-defined therapeutic goals, comprehensive assessment of utilization of the term palliative has not been performed in the surgical literature. The objective of this scoping review is to characterize use of the word palliative in reference to surgery performed for adult general surgery patients. MethodsFour electronic databases were searched for peer-reviewed articles published from January 2000 to April 2023. Two independent reviewers extracted data and conducted a qualitative thematic synthesis of included studies. Representative analytic themes were generated and agreed upon by all authors. Results6906 studies were identified and 222 met inclusion criteria. 96.4% of studies were performed in oncology patient populations. Thematic synthesis revealed two domains: the language of palliative surgery and the evaluation of palliative surgery, each with associated themes. There was wide variability in the use and meaning of the term palliative. Many researchers reported survival as the sole outcome measure and very few studies utilized a validated instrument to quantify post-operative outcomes related to palliation. There was often a misalignment between the patient population, study objectives, study design, and conclusions drawn. ConclusionsDisparate definitions of palliative surgery and poor study design compromise the validity of studies investigating palliative-intent surgery. Patient-reported and patient-centered outcomes are not routinely measured and lead to unwarranted conclusions. Consistent and accurate use of medical terminology, in addition to proper study design, is required to inform surgeons who counsel patients and families regarding the potential benefits of palliative-intent surgical interventions.

Standardized Reproductive Endocrinology and Infertility Consultation for Pediatric and Adolescent Oncology Patients.

Purpose: To investigate the role of formal reproductive endocrinology and infertility (REI) consultation in fertility preservation counseling in a pediatric/adolescent oncology patient population. Methods: Retrospective chart review was performed at an academic adult hospital from 2021 to 2022. Pre- and postpubertal patients admitted to the pediatric/adolescent oncology service with cancer diagnoses and imminent gonadotoxic chemotherapy plans were included. Baseline characteristics were collected, including patient age, sex, race, language, insurance, and cancer diagnosis. Primary outcomes were formal REI consultation and fertility preservation election. Results: Nineteen of 58 eligible patients received a formal REI consultation. Patients were more likely to elect fertility preservation if they received a consult. Females were more likely to receive a consult than males and more likely to elect fertility preservation. Patients of age ≥16 years were more likely to receive consultation than younger patients. However, all patients of age <16 years who received a consult elected fertility preservation. There was no difference in consultation based on race, language, or insurance. Thirteen of 19 patients who received an REI consultation elected fertility preservation. Ten of 11 female elections were ovarian suppression, an unproven method of fertility preservation. The two male elections were semen cryopreservation. Conclusion: Underutilization of formal REI consults and a relative lack of proven fertility preservation elections may shed light on a need for increased fertility preservation awareness among young oncology patients and the providers who care for them. A streamlined process that automates formal REI consultation for all eligible patients may maximize the potential for comprehensive counseling and improve patient participation in fertility preservation.

Abstract 815: Leveraging clinical workflow for rapid integration of social needs assessment in a urologic oncology clinical practice

Abstract Introduction: Social determinants of health and resulting social needs are known to impact cancer care, yet characterization of social needs within a specific clinic’s population remains in its infancy. We aim to characterize early findings from social needs screening in patients seen in a tertiary urologic oncology clinic. Methods: Screening was conducted using survey questions about specific domains of social needs (e.g., financial strain, unmet transportation needs, and food insecurity) that were integrated into new patient and annual follow-up questionnaires for all patients seen within a urologic oncology faculty clinic, starting in January 2023. Screening items were rapidly implemented into workflow by taking advantage of existing processes. Clinical and demographic data and screening responses were abstracted from the electronic medical record. Summary statistics were calculated. P value&amp;lt;0.05 was deemed statistically significant. Results: A total of 2305 patients were included (4% Non-Hispanic Black, 11% Asian American, 8% Latinx, and 63% Non-Hispanic White). Responses increased from 30 in January to 399 in October. Respondent mean age was 67 years [standard deviation (SD) 12.3] with 87.8% identifying as male. Roughly 13% screened positive for at least one social need (one positive 8.1%, two positive 3.4%, three positive 1.2%) with variations by domain [transportation 3.6%, food insecurity 5.4%, 10.2%] and race and ethnicity (Figure 1, p&amp;lt;0.001 for all). Conclusions: By leveraging the existing clinical workflow, rapid uptake of social needs screening demonstrates variations by social needs domains and race and ethnicity within a urologic oncology patient population. These efforts represent institutional action towards characterizing the burdens faced by our patient population and inform the design of interventions to address social needs within the catchment area, to improve clinical care and clinical trial participation. Citation Format: Samuel L. Washington, Kim F. Rhoads, Peter R. Carroll, Salma Shariff-Marco, June M. Chan. Leveraging clinical workflow for rapid integration of social needs assessment in a urologic oncology clinical practice [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 815.

SARS-CoV-2 vaccination willingness and humoral vaccination response in radiation oncology patients

BackgroundSARS-CoV-2 infection has been and, in some parts, still is a threat to oncologic patients, making it crucial to understand perception of vaccination and immunologic responses in this vulnerable patient segment. SARS-CoV-2 vaccines in relation to malignant disease characteristics and therapies have so far not been studied consecutively in larger oncologic patient populations. This study captures SARS-CoV-2 vaccination willingness and humoral immune response in a large consecutive oncologic patient collective at the beginning of 2021. Methods1142 patients were consecutively recruited over 5.5 months at a tertiary department for radiation oncology and were assessed for vaccination willingness via a standardized interview. In already vaccinated patients total SARS-CoV-2 S antibody titres against the spike protein (Anti-SARS-CoV-2 S) and were evaluated 35 days or later after the first dose of SARS-CoV-2 vaccine. ResultsVaccination willingness was high with a rate of 90 %. The most frequent reasons for rejection were: undecided/potential vaccination after therapy, distrust in the vaccine and fear of interaction with comorbidities. Factors associated with lower vaccination willingness were: worse general condition, lower age and female sex. 80 % of the participants had been previously vaccinated, 8 % reported previous infection and 16 % received vaccination during antineoplastic therapy. In 97.5 % of the vaccinated patients Anti-SARS-CoV-2 S was detected. In a univariable analysis parameters associated with non-conversion were: lower performance status, spread to the local lymphatics (N + ), hematologic disease and diffuse metastases. All patients with oligometastatic disease achieved positive Anti-SARS-CoV-2 S titres. For patients with two vaccinations several risk factors were identified, that were associated with low antibody concentrations. ConclusionsSARS-CoV-2 vaccination willingness among oncologic patients was high in the first months after its availability, and most patients had already received one or two doses. Over 97 % of vaccinated patients had measurable anti-SARS-CoV-2 S titres. Our data supports early identification of low humoral responders after vaccination and could facilitate the design of future oncologic vaccine trials (clinicaltrials.gov Identifier: NCT04918888).

Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.

Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world data are increasingly used to supplement clinical trial evidence where no or little control arm data exists. The construction of an external control arm should always aim to match the population, treatment settings and outcome measurements of the corresponding treatment arm. Yet, external real-world data is typically fraught with limitations including missing data, measurement error and the potential for unmeasured confounding given a nonrandomized comparison. Quantitative bias analysis (QBA) comprises a collection of approaches for modelling the magnitude of systematic errors in data which cannot be addressed with conventional statistical adjustment. Their applications can range from simple deterministic equations to complex hierarchical models. QBA applied to external control arm represent an opportunity for evaluating the validity of the corresponding comparative efficacy estimates. We provide a brief overview of available QBA approaches and explore their application in practice. Using a motivating example of a comparison between pralsetinib single-arm trial data versus pembrolizumab alone or combined with chemotherapy real-world data for RET fusion-positive advanced non-small cell lung cancer (aNSCLC) patients (1-2% among all NSCLC), we illustrate how QBA can be applied to external control arms. We illustrate how QBA is used to ascertain robustness of results despite a large proportion of missing data on baseline ECOG performance status and suspicion of unknown confounding. The robustness of findings is illustrated by showing that no meaningful change to the comparative effect was observed across several 'tipping-point' scenario analyses, and by showing that suspicion of unknown confounding was ruled out by use of E-values. Full R code is also provided.

SIOG2023-5-P-339 - Association between gait speed and falls in Veteran Geriatric Oncology patient population

SIOG2023-5-P-339 - Association between gait speed and falls in Veteran Geriatric Oncology patient population

Machine Learning Algorithm to Perform the American Society of Anesthesiologists Physical Status Classification.

The American Society of Anesthesiologists (ASA) Physical Status (PS) Classification System defines perioperative patient scores ranging from 1 to 6 (healthy to brain dead, respectively).The scoring is performed and used by physician anesthesiologists and providers to classify surgical patients based on co-morbidities and various clinical characteristics. There is potentially a variability in scoring stemming from individual biases.The biases impact the prediction of operating times, length of stay in the hospital, anesthetic management, and billing.This study's purpose was to develop an automated system to achieve reproducible scoring. A machine learning (ML) model was trained on already assigned ASA PS scores of 12,064 patients. The ML algorithm was automatically selected by Wolfram Mathematica (Wolfram Research, Champaign, IL) and tested with retrospective records not used in training. Manual scoring was performed by the anesthesiologist as part of the standard preoperative evaluation.Intraclass correlation coefficient (ICC) in R (version 4.2.2; R Development Core Team, Vienna, Austria) was calculated to assess the consistency of scoring. An ML model was trained on the data corresponding to 12,064 patients. Logistic regression was chosen automatically, with an accuracy of 70.3±1.0% against the training dataset. The accuracy against 1,999 patients (the test dataset) was 69.6±1.0%. The ICC for the comparison between ML and the anesthesiologists' ASA PS scores was greater than 0.4 ("fair to good"). We have shown the feasibility of applying ML to assess the ASA PS score within an oncology patient population. Though our accuracy was not very good, we feel that, as more data are mined, a valid foundation for refinement to ML will emerge.

Are Psychiatric Comorbidities in the Radiation Oncology Patient Population Under-Recognized by Providers?

Under-recognition of psychiatric comorbidities may be directly tied to potential for poorer patient outcomes. However, there is a paucity of data in radiation oncology settings. This study hypothesized that a disparity exists between the perceived prevalence of psychiatric comorbidities in patients receiving radiotherapy and the rate at which radiation oncologists screen patients for anxiety and depression. From April-July 2021 an online survey was conducted of radiation oncologist members of ASTRO with self-identified practice specializations. Randomly selected invitations were electronically sent to providers from diverse practice backgrounds and geographic locations within the United States and Canada and was conducted using an IRB-reviewed, institutionally approved Microsoft Forms platform. The questionnaire consisted of 20 items examining a broad range of factors that involved general practice demographics, patient screening practice patterns, treatment details and preferred options, and availability and referral data for specialist care for possible psychiatric comorbidities. Statistical analysis was performed using Fisher's exact test. For questions with Yes/No responses, exact binomial test was used. A total of 500online invitations were emailed with 55 responses. Of the responders, 3 did not provide consent. Therefore, 52 (10.4%) responses were included in the analysis and are the subject of this report. This response rate is consistent with other published studies of this type. 85% (p<0.001) of respondents identified the need to screen for psychiatric comorbidities in radiation oncology settings. However, 71% (p = 0.003) did not perform formal screening for psychiatric comorbidities, and of those who did screen, there was no uniformity in the screening tool utilized. Likewise, 79% (p<0.001) did not initiate treatment for psychiatric condition(s). Of providers that did initiate treatment, 91% (p = 0.012) felt that psychiatric comorbidities were under-diagnosed in their patient population. No association was made between providers who specialize in CNS malignancies as being more likely to recognize psychiatric comorbidities in their patient population versus those who do not. Importantly, 75% self-reported that they would benefit from additional training to assess psychiatric comorbidities (p<0.001). A need to screen for psychiatric comorbidities in radiation oncology settings was identified despite very little formal screening performed. Responses revealed adequate community resources exist for referral in most instances. However, providers did not routinely refer patients for treatment of psychiatric comorbidities, even when recognized. This survey identified an unmet need for improved education among providers to engage in screening and referral for psychiatric comorbidities, and to develop a care system that supports standardization of screening practices and tools in this patient population.