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385 Background: Since the onset of COVID-19, oncology practices across the U.S. have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. However, the extent of provider experience and comfort with TM/RPM in treatment trials is unknown. In this study, we surveyed oncology researchers to assess experience and comfort with TM/RPM. Methods: Between April 10 and June 1, 2022, we distributed email surveys to U.S.-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated an interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, and workplace characteristics, as well as frequency and impression of TM/RPM use across trial components in phase 1, phase 2/3, and post-treatment trials. TM/RPM was defined as clinical trial-related health care and monitoring for patients geographically separated from the site administering the clinical trial. Results: There were 141 respondents. 53% identified as female. 39% were under 45 years old, and 25% were over 60. 70% identified as White. 90% were site or study PIs. 98% practiced in a non-rural site. Most respondents had enrolled patients on industry-sponsored trials (97%), NCI-sponsored trials (84%), and investigator-initiated trials (83%), across Phase 1 (92%), Phase 2/3 (100%), and post-approval trials (75%). About 41% of respondents had >20 years of trial experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. For Phase 2/3 trials, while > 75% of respondents expressed comfort (C) using TM/RPM for some trial components, the corresponding experience (E) in these areas was lower. Specifically for Phase 2/3 trials, comfort levels exceeded experience for pre-screening (C = 91% vs. E = 47%), education and counseling (C = 95% vs. E = 52%), informed consent (C = 79% vs. E = 30%), routine lab testing (C = 81% vs. E = 37%), symptom monitoring for adverse events (C = 88% vs. E = 55%), PROs in real time (C = 87% vs. E = 20%), PROs as a study endpoint (C = 89% vs. E = 27%), and long-term outcome monitoring (C = 90% vs. E = 47%). Notably, 60% of respondents ranked patient access as the top advantage of providing TM/RPM in treatment trials. Top disadvantages included limited ability to monitor patients (34%) and disparities in patient technology access (23%). More than a quarter of respondents identified the top barrier to use of TM/TPM as trial regulations (29%) or cross-state licensure challenges (27%). Conclusions: COVID-19 spurred the rise of TM/RPM in cancer treatment trials. Among oncology researchers, higher levels of comfort compared to real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.

94 Background: During the COVID-19 pandemic, remote cancer care, and video communication in particular, has become increasingly common in the context of routine visits and clinical trials. Though this medium has the potential to augment patient-provider communication, telehealth also raises concerns about the digital divide promoting disparities in access to cancer care. In this study, we surveyed oncology patients who declined to participate in a pilot study looking at a one-time pharmacist-led video visit for patients initiating oral anti-cancer medications to evaluate their primary reason for declining the intervention. Methods: Between June 2021 and June 2022, we conducted a prospective survey among adult oncology patients at Columbia University Medical Center (CUMC) who declined a pilot study looking at a video visit intervention for patients initiating oral anti-cancer medications to assess the primary barriers to participation. The survey categorized specific reasons for decline into telehealth-related barriers (no access to electronic device, inability to navigate video visits specifically, patient preference for in person care) and trial-related barriers (patient too tired/unwell, no time to participate, not interested in this study specifically, not interested in clinical trial participation in general), and patients were asked to select the primary reason for declining among the list of options. Results: Twenty-three patients completed the survey (82% completion rate). Among 23 respondents, 9 patients (39%) described a technology-related barrier to participation, including 7 (30%) who owned a mobile device with video capacity, but did not know how to use video technology well enough for the visit, 1 (4%) who did not own a device with video capacity, and 1 (4%) who preferred in person visits. Fourteen respondents cited a reason unrelated to telehealth for declining participation, including 7 (30%) who did not feel the study would benefit them, 3 (13%) who did not have time, 2 (9%) who were too tired to participate in a study, and 2 (9%) who were not interested in participating in any kind of clinical trial. Conclusions: Video-based telehealth visits have become increasingly common in routine cancer care and clinical trials. Among oncology patients who declined participation in a pilot study looking at a pharmacist-led video consultation, over a third cited telehealth-related barriers to participation, the majority of whom had a mobile device, but did not know how to use video technology well enough to participate. Focusing efforts on training patients to use technology, particularly video communication, may help address the digital divide in cancer care.

1592 Background: The past decade has seen a dramatic increase in the number of oral anti-cancer drug (OACD) approvals in the United States. Though polypharmacy and drug-drug interactions (DDIs) likely contribute to OACD toxicity, the prevalence of these features in patients on OACDs remains largely unknown. We aimed to evaluate a one-time 30-minute pharmacist-led video consultation among metastatic cancer patients initiating OACDs to identify medication list inaccuracies as well as the prevalence, characteristics, and severity of OACD-related potential DDIs. Methods: We conducted a single-arm, prospective telehealth intervention study among 29 patients initiating OACDs to evaluate a one-time 30-minute pharmacist-led video consultation. The video visits focused on identifying and discussing polypharmacy and potential DDIs, and pharmacists then communicated recommendations to each patient's oncologist. We estimated the prevalence, characteristics (QTc prolongation, absorption interactions, etc.), and severity of OACD-related potential DDIs. Lexicomp and Micromedex were used to assess potential DDIs and measure severity on a standardized scale (A – D, X). In addition, we assessed the prevalence of medication list inaccuracies, polypharmacy, and patient satisfaction. Results: Twenty-five patients completed the intervention (86% completion rate) of whom 40% were 75 years of age or older and 60% were men. The majority were white (68%) and non-Hispanic (76%). Sixteen patients (68%) had a solid tumor diagnosis. Nearly half (48%) were insured by Medicare. The median number of medications per patient was 9 with a range of 4 – 21, and 96% of patients had at least 5 prescriptions listed. The median number of medication list errors was 2 with a range of 0 – 16, with at least 1 error for 76% and more than 1 error for 52% of patients. Pharmacists identified potential OACD-related interactions in 9 cases (40%). These included change in drug absorption or metabolism (7), QTc prolongation (1), hypotension (1), and bleeding (1). Interactions were classified as either category C (8) or D (2), requiring close monitoring or a change in treatment, respectively. All patients expressed a high level of satisfaction with the video visit. Conclusions: Polypharmacy, medication list errors, and potential DDIs are prevalent among patients initiating OACDs despite use of an electronic medical record requiring medication reconciliation. Our study suggests that a one-time remote 30-minute pharmacist-led video consultation can effectively identify and address OACD-related potential DDIs, which may decrease medication complexity and improve adherence in this population.

43 Background: Most oral anti-cancer drugs (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies are intended to facilitate communication between multiple entities to deliver OACDs with increased efficiency. In 2018, our cancer center partnered with Shields Health Solutions (SHS), a freestanding organization providing care coordination to implement a hospital-based specialty pharmacy. We evaluated the rate of failed drug receipt (FR) and time to drug receipt (TTR) before and after specialty pharmacy implementation. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban cancer center from 1/1/2018 to 12/31/2019. In fall 2018, a specialty pharmacy was opened to facilitate drug procurement for patients. We collected patient demographic, clinical, and insurance data, OACD name, date prescribed, delivery date, and interactions with payers and financial assistance groups. For prescriptions received, TTR was the number of days from OACD prescription to patient receipt of the drug. FR was defined as failure to receive a prescribed OACD. We excluded OACD prescriptions for a washout period of two months during pharmacy initiation. We used multivariable logistic regression to examine factors associated with TTR > 7 days and FR before and after specialty pharmacy implementation. Results: In total, 883 patients were prescribed 1145 new OACDs. The majority of prescribed drugs were targeted treatment (56%, N = 646) and 72% (N = 819) required prior authorization (PA). Of all prescriptions, 86% (N = 999) were successfully received with an overall median TTR of 7 days. Adjusted analyses showed that patients were more likely to receive their drugs in less than 7 days after specialty pharmacy implementation (OR: 1.4 95% CI 1.04 – 1.81), p = 0.03). In an unadjusted analysis, patients were more likely to receive their initial medications after specialty pharmacy implementation, compared to before specialty pharmacy implementation (89% vs. 84%, p = 0.04). Multivariable analysis showed a trend toward more patients receiving drugs after specialty pharmacy implementation (OR: 1.42, 95% CI 0.98 – 2.03, p = 0.06). Conclusions: The implementation of a hospital-based specialty pharmacy in partnership with SHS decreased TTR. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer clinical practice disruptions.

6 Background: The past decade has seen a dramatic increase in the number of Food and Drug Administration approvals of oral anti-cancer drugs (OACDs). Most OACD prescriptions require coordination between payers and providers, which can delay drug receipt. In May 2021, two bills were introduced in the US House of Representatives (HR 3173 and HR 3258) to streamline the prior authorization (PA) process. In this study, we examined clinical and process-related factors associated with PA and time to drug receipt (TTR) for patients who received a new OACD prescription. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients from 1/1/2018 to 12/31/2019. We collected patient demographic, medical, and insurance data, drug type (hormonal, chemotherapy, targeted), and specialty pharmacy interactions with payers and financial assistance groups, including PA information. TTR was defined as the number of days from OACD prescription to patient receipt of the drug. We used multivariable logistic regression to separately assess factors associated with TTR and factors associated with PA for patients who received a new OACD prescription. Results: The cohort for both models included 883 patients who were prescribed 1014 new OACDs. Of these prescriptions, 72.3% (N=733) required PA. The median age was 66 and 44% identified as White. The median TTR was 7 days (IQR 0 – 142; 25% ≥ 14 days; and 5% ≥ 30 days). In unadjusted analyses, PA was associated with insurance and drug type and delayed TTR was associated with PA and insurance type. In a multivariable analysis, patients with Medicaid insurance were more likely to require PA compared to patients with Medicare (OR 1.93 (1.14 – 3.32), p=0.03). In addition, patients prescribed targeted and hormone therapies were more likely to require PA than those prescribed oral chemotherapy (targeted: OR 3.33 [2.38 – 4.68], p

41 Background: Oral anti-cancer drugs (OACDs) have become increasingly prescribed over the last 10 years and require a significant amount of care coordination. Preliminary administrative database studies have shown that 10-15% of prescriptions are never received by the patient, but the reasons behind this are poorly understood. In this study, we prospectively identified failure to receive (FR) cases in which OACD prescriptions were never received by patients, examined underlying reasons for FR, and assessed clinical and process-related factors associated with FR. Methods: We prospectively collected data on new OACD prescriptions for adult oncology patients at a large, urban academic cancer center from 1/1/2018 to 12/31/2019. We collected patient demographic, clinical, and insurance data, OACD delivery date, and interactions with payers and financial assistance groups. FR was defined as failure to receive a prescribed OACD. Reasons for FR were confirmed by manual chart review and classified into seven categories: clinical deterioration, financial access, provider-driven clinical decision making, patient-directed change, transfer of care, lost to follow up, and other. We calculated the relative proportion of each FR category and used multivariable logistic regression to identify factors associated with FR, including initiation of a prior authorization and drug class. Results: The cohort included 1,080 patients who were prescribed 1,269 new OACDs. Of these prescriptions, 13% (N=163) were categorized as FR. Among the 158 patients with FR, average patient age was 66 years, 55% identified as non-Hispanic white, 61% had any Medicare plan, 11% had Medicaid only, and 25% had commercial insurance. Overall, 18% of FR cases were attributed to clinical deterioration, 13% to financial access, 29% to provider-driven clinical decision making, 17% to patient-directed change, 13% to transfer of care, and 5% were lost to follow up. Univariate analysis showed that FR was less likely in cases where prior authorization was initiated (p < 0.001) and multivariate analysis confirmed this result (OR 0.47 [CI 0.33-0.66], p < 0.001). Conclusions: Though the majority of oncology patients prescribed OACDs received the drug, 13% of patients in our study experienced FR. FR is associated with a lack of prior authorization initiation, which may reflect barriers to access, a change in clinical decision-making, or patient choice. Ultimately, FR is multifactorial and may be appropriate in some cases. More work is needed to determine whether improved access would increase uptake in some patients. [Table: see text]

49 Background: Immune checkpoint inhibitors (ICI) improve survival for adults with metastatic NSCLC. Despite limited data on ICI efficacy in adults with poor performance status (PS), oncologists often elect to treat this population with ICI given their relatively favorable toxicity profile and potential for durable response. We aimed to describe the timing of ICI and patients’ survival based on PS, and explore the effect of late ICI use on end-of-life (EOL) care. Methods: Retrospective study of 235 adults with metastatic NSCLC at a single academic center who initiated ICI from 2015-2017. We compared overall survival (OS) among adults with Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at ICI start to those with ECOG PS < 2, using the log-rank test and Cox regression, adjusted for age, sex, comorbidity, time from diagnosis and line of therapy. We used logistic regression to analyze the association between ICI in the last 30 days of life and EOL care. Results: The median age at ICI start was 67 (range 37-91), and 83/235 (35%) had ECOG PS ≥ 2. Patients received ICI as first- (19%), second-line (56%) or later (25%) therapy. Median OS was 4.0 months in adults with ECOG PS ≥ 2 and 14.3 months in ECOG PS < 2 (p < 0.0001; HR = 2.5 [95% CI 1.8–3.5]). Among adults who died (n = 165), 17% of those with ECOG PS ≥ 2 started ICI in last 30 days of life and 24% started or continued ICI in their last 30 days, compared to 4% and 7% of ECOG PS < 2 (p = 0.005, p = 0.001, respectively). Receipt of ICI in last 30 days of life was associated with decreased hospice referral (OR 0.29, p = 0.006), decreased odds of hospice stay > 7 days (OR 0.15, p < 0.001), and increased in-hospital death (OR 6.8, p = 0.001). Conclusions: Adults with metastatic NSCLC and ECOG PS ≥ 2 experience significantly shorter survival than those with ECOG PS < 2 and more often receive ICI near the end of life, and late ICI use is associated with decreased hospice use and increased in-hospital death. Clinicians should thus use caution in extrapolating data from clinical trials, which are limited to ECOG PS < 2, to inform the care of adults with ECOG PS ≥ 2. Further, these results highlight potential tradeoffs of ICI and underscore the need for efforts to improve communication about ICI risks and benefits.

10040Background: As the population ages, it has become increasingly important to understand the risks and benefits of novel agents among older adults with cancer. Immunotherapy (IO) has revolutioni...

6566Background: Cancer patients’ (pts) financial concerns (FCs) represent a barrier to clinical trial (CT) participation and interventions targeting pts’ FCs are needed. We sought to assess the imp...