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Purpose: There are multiple treatment options for patients with metastatic breast cancer (MBC); however, there is minimal data on the optimal sequencing. Furthermore, limited information is available to understand the influence of prior treatment duration and class on novel therapies in real-world settings, such as cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2- negative (HR+ HER2-) MBC. Our study sought to identify the effect of prior treatments on post-CDK 4/6i survival. Methods: This retrospective study used the nationwide, de-identified electronic health record-derived Flatiron Health database of women with HR+ HER2- MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between duration and class of all cancer treatments prior to receipt of CDK 4/6i and overall survival (OS) adjusting for age at diagnosis, race and ethnicity, site of metastasis, and metastatic diagnosis year. Time dependent HRs were used to compare the OS for patients receiving one versus multiple CDK 4/6i. Results: Of 5,363 patients, most were aged 55-64 (29%), White (69%), and had visceral metastasis (70%). The median survival from receipt of first CDK 4/6 inhibitor was 3.3 years. When compared to patients with no prior treatments, patients with up to one year of prior treatments had a 30% increased hazard of death ((HR, 1.30; 95% CI 1.15-1.46; Table 1). Similarly, patients with one to less than three years of prior treatment had a 68% increased hazard of death (HR 1.68; 95% CI 1.49-1.88) and those with three or more years had a 55% increased hazard of death (HR 1.55; 95% CI 1.36-1.76). Furthermore, patients who received prior endocrine therapy alone experienced a 29% increased hazard of death (HR, 1.29; 95% CI 1.16-1.44), while patients receiving prior chemotherapy experienced a 72% increased hazard of death (HR, 1.72; 95% CI 1.54-1.93) when compared with patients who did not receive a prior treatment. Finally, patients who received a different CDK 4/6i after their first had a 17% decreased hazard of death compared to patients who received subsequent endocrine or chemotherapy after their first CDK 4/6i (HR, 0.83; 95% CI 0.71-0.96). Conclusion: Prior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. However, patients receiving more than one CDK 4/6 inhibitor in their sequence saw survival benefits. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when reporting results of future studies. Table 1: The association between OS and treatment duration and class before CDK 4/6 Citation Format: Jeffrey Franks, Nicole E. Caston, Ahmed Elkhanany, Travis Gerke, Andres Azuero, Gabrielle B. Rocque. Effect of prior treatments on post-CDK 4/6 inhibitor overall survival in hormone receptor positive breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-20.

PURPOSE: Cancer clinical trials can benefit current and future patients; however, Black patients, rural residents, and patients living in disadvantaged areas are often underrepresented. Using an adapted version of Unger and colleagues' model of the process of clinical trial enrollment, we evaluated the relationship between underrepresented patient populations and trial end points. METHODS: This retrospective study included 512 patients with breast or ovarian cancer who were prescribed a therapeutic drug at the University of Alabama at Birmingham from January 2017 to February 2020. Patient eligibility was assessed using open clinical trials. We estimated odds ratios and 95% CIs using logistic regression models to examine the relationship between underrepresented patient populations and trial enrollment end points: eligibility, interest, offer, enrollment, and declining enrollment. RESULTS: Of the patients in our sample, 27% were Black, 18% were rural residents, and 19% lived in higher disadvantaged neighborhoods. In adjusted models, each comparison group had similar odds of being eligible for a clinical trial. Black versus White patients had 0.40 times the odds of interest in clinical trials and 0.56 times the odds of enrollment. Patients living in areas of higher versus lower disadvantage had 0.46 times the odds of enrolling and 3.40 times the odds of declining enrollment when offered. CONCLUSION: Eligibility did not drive clinical trial enrollment disparities in our sample; however, retention in the clinical trial enrollment process appears to vary by group. Additional work is needed to understand how interventions can be tailored to each population's specific needs.

Purpose Multiple treatment options exist for patients with metastatic breast cancer (MBC). However, limited information is available on the impact of prior treatment duration and class on survival outcome for novel therapies, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ HER2−) MBC. Methods This study used a nationwide, de-identified electronic health record-derived database to identify women with HR+ HER2− MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between prior duration and class of cancer treatment (both early-stage and metastatic) and prior CDK 4/6i survival as well as for those with multiple CDK 4/6i. Results Of 5363 patients, the median survival from first CDK 4/6 inhibitor administration was 3.3 years. When compared to patients with no prior treatments, patients with Conclusion Prior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when randomizing patients or reporting results of future studies.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188).This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks.Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants.The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising.To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.

Background Given the high risk of COVID‐19 mortality, patients with cancer may be vulnerable to fear of COVID‐19, adverse psychological outcomes, and health care delays. Methods This longitudinal study surveyed the pandemic's impact on patients with cancer (N= 1529) receiving Patient Advocate Foundation services during early and later pandemic. Generalized estimating equation with repeated measures was conducted to assess the effect of COVID‐19 on psychological distress. Logistic regression with repeated measures was used to assess the effect of COVID‐19 on any delays in accessing health care (e.g., specialty care doctors, laboratory, or diagnostic testing, etc.). Results Among 1199 respondents, 94% considered themselves high risk for COVID‐19. Respondents with more fear of COVID‐19 had a higher mean psychological distress score (10.21; 95% confidence intervals [CI] 9.38–11.03) compared to respondents with less fear (7.55; 95% CI 6.75–8.36). Additionally, 47% reported delaying care. Respondents with more fear of COVID‐19 had higher percentages of delayed care than those with less (56; 95% CI 39%–72% vs. 44%; 95% CI 28%–61%). These relationships persisted throughout the pandemic. For respondents with a COVID‐19 diagnosis in their household (n = 116), distress scores were similar despite higher delays in care (58% vs. 27%) than those without COVID‐19. Conclusions Fear of COVID‐19 is linked to psychological distress and delays in care among patients with cancer. Furthermore, those who are personally impacted see exacerbated cancer care delays. Timely psychosocial support and health care coordination are critical to meet increased care needs of patients with cancer during the COVID‐19 pandemic., Fear of COVID‐19 is associated with psychological distress and delay in cancer care. Timely psychosocial support and health care coordination are needed to meet increased care needs of patient with cancer during the pandemic.

PURPOSE: The extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. METHODS: This retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race/ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011–2020. Odds ratios (OR) from a logistic regression model was used to evaluate the association between receipt of high-intensity chemotherapy and clinical trial representation status characteristics adjusting for cancer stage and subtype. RESULTS: Of 970 patients with EBC, 41% were characterized as well represented, 45% as underrepresented, and 13% as unrepresented in clinical trials. In adjusted models, patients aged ≥ 70 versus 45–69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26–0.60), while those aged < 45 versus 45–69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10–3.01). In predicted estimates, the proportion of patients receiving a high-intensity treatment was 87% for patients aged < 45, 79% for patients aged 45–69, and 60% for patients aged ≥ 70. CONCLUSION: 59% of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity. Widening clinical trial eligibility criteria should be considered to better understand survival outcomes, toxicity effects, and ultimately make evidence-based treatment decisions using a more diverse sample.

Though lay navigation programs have proven beneficial for individuals during cancer treatment, little is known about the effects of lay navigation on health care utilization and Medicare spending among older adults during cancer survivorship. This retrospective cohort study used administrative claims data to evaluate a lay navigation program implemented from 2012 to 2015 at 12 academic and community cancer centers in the Southeast. Medicare beneficiaries age ≥65 years navigated during survivorship were compared to propensity score–matched, non-navigated cancer survivors. Quarterly trends in Medicare spending were estimated using repeated measures mixed models. Rate ratios (RRs) and 95% confidence intervals (CIs) were estimated using repeated measures generalized linear models for quarterly emergency room (ER) visits and hospitalizations. Medicare spending for navigated (n = 3255) versus non-navigated older cancer survivors (n = 3255) was initially higher but declined faster by $513 per patient per quarter (95% CI −$616, −$410). Per patient per quarter risk of ER visits decreased by 11% (RR 0.89, 95% CI 0.86, 0.92) and hospitalizations decreased by 16% (RR 0.84, 95% CI 0.81, 0.88) over time comparing navigated versus non-navigated patients. Similar results were seen for patients enrolled in navigation post-treatment (N = 1893). In older cancer survivors receiving care in the Deep South, patients receiving lay navigation compared to those non-navigated had significant reductions in Medicare spending, hospitalizations, and ER visits. Though much emphasis has been placed on lay navigation during initial cancer treatment, navigation is needed throughout survivorship due to the high costs and health care utilization that persist post-treatment.

Clinical trials offer novel treatments, which are essential to high quality cancer care. Patients living in rural areas are often underrepresented in clinical trials due to several factors. This study evaluated the association between rurality and interest in clinical trial participation, change in interest, and treatment decision-making style preference.This cohort study included patients with cancer receiving oncology care at the University of Alabama at Birmingham from 2017 to 2019. Associations between treatment decision-making preference and the interaction between rurality and area deprivation were analyzed using multinomial logistic regression. Initial interest in clinical trial participation and change in interest were analyzed using modified Poisson regressions with robust standard errors. Initial interest model was stratified by Area Deprivation Index (ADI; higher vs. lower disadvantaged).In adjusted models, patients in rural versus urban areas had similar initial interest in clinical trials, both those in higher (40% vs. 50%) and lower disadvantaged settings (54% vs. 62%). Additionally, rural versus urban patients had similar change of clinical trial interest for both those who changed from uninterested-to-interested (31% vs. 26%) and interested-to-uninterested (47% vs. 42%).This study compares the interest in clinical trial participation among patients living in rural and urban settings. Lack of interest may be secondary to barriers that patients in rural areas face (e.g., transportation, financial, access). Most rural patients prefer a shared treatment decision-making style, which should be considered when identifying interventions to increase enrollment of underserved rural patients in clinical trials.

Resilience has been proposed as a primary factor in how many family caregivers of patients with advanced cancer are able to resist psychological strain and perform effectively in the role while bearing a high load of caregiving tasks. To evaluate this hypothesis, we examined whether self-perceived resilience is associated with distress (anxiety and depressive symptoms), caregiver preparedness, and readiness for surrogate decision-making among a racially diverse sample of family caregivers of patients with newly diagnosed advanced cancer. Secondary analysis of baseline data from two small-scale, pilot clinical trials that both recruited family caregivers of patients with newly diagnosed advanced cancer. Using multivariable linear regression, we analyzed relationships of resilience as a predictor of mood, caregiving preparedness, and readiness for surrogate decision-making, controlling for sociodemographics. Caregiver participants (N = 112) were mean 56 years of age and mostly female (76%), the patient’s spouse/partner (52%), and White (56%) or African-American/Black (43%). After controlling for demographics, standardized results indicated that higher resilience was relevantly associated with higher caregiver preparedness (beta = .46, p

Introduction Oncologists have increasingly been proponents of shared decision making (SDM) to enhance patient outcomes and reduce unnecessary health care spending. However, its effect on patient out-of-pocket costs is unknown. This study investigated the relationship between patient preferences for SDM and financial toxicity (FT) in patients with metastatic breast cancer (MBC). Patients and Methods This cross-sectional study utilized surveys of women aged ≥ 18 with MBC who received care at two academic hospitals in Alabama from 2017 to 2019. Patients self-reported their SDM preference (Control Preferences Scale) and FT (Comprehensive Score for Financial Toxicity [COST] tool; 11-item scale, with lower scores indicating worse FT). Effect sizes were calculated using the proportion of variance explained (R2) or Cramer’s V. Differences in FT by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. Results In 95 women with MBC, 44% preferred SDM, 29% preferred provider-driven decision making, and 27% preferred patient-driven decision making. Patients preferring SDM were more often college educated (53% vs. 39%; V = 0.12) with an income greater than $40,000/y (55% vs. 43%; V = 0.18). Overall median COST was 22 (interquartile range, 16-29). After adjusting for patient demographic and clinical characteristics, patients preferring patient-driven decision making trended toward worse FT (COST 17: 95% confidence interval, 12-22) compared to those preferring SDM (COST 19: 95% confidence interval, 15-23) and those preferring provider-driven decision making (COST 22: 95% confidence interval, 17-27). Conclusion Patients preferring more patient-driven decision making reported worse FT, although differences did not reach statistical significance. Further research is needed to understand this relationship.

PURPOSE Sequential drug treatments in metastatic breast cancer (MBC) are disparate. Clinical trial data includes limited reporting of treatment context, primarily including the number of prior therapies. This study evaluates the relationship between prior treatment time, prior lines of treatment, and survival using a novel visualization technique coupled with statistical analyses. PATIENTS AND METHODS This retrospective cohort study used a nationwide, de-identified electronic health record–derived database to identify women with hormone receptor–positive, human epidermal growth factor receptor 2–negative MBC diagnosed in 2014 who subsequently received paclitaxel. Images were created, with individual patients represented on the y-axis and time, on the x-axis. Specific treatments were represented by colored bars, with Kaplan-Meier curves overlaying the image. Separate images assessed progression-free survival and overall survival (OS). Hazard ratios (HRs) and 95% CIs from Cox proportional hazards models evaluated the association between prior treatment time and OS. RESULTS Of 234 patients, median survival from first paclitaxel administration was 20 months (interquartile range, 8-53 months). An inverse relationship was observed between OS after paclitaxel and timing of administration. In adjusted models, each year on treatment prior to paclitaxel was associated with a 16% increased hazard of death after paclitaxel (HR, 1.16; 95% CI, 1.05 to 1.29). CONCLUSION OS after a specific treatment is dependent on when a drug is given in the disease context, highlighting the potential for an overall OS benefit to be observed on the basis of treatment timing. Prior time on treatment should be considered as a stratifying factor in randomized trials and a confounding factor when examining survival in observational data.

PURPOSE Treatment sequencing of metastatic breast cancer (MBC) is heterogeneous. The primary objective of this study was to develop a visualization technique to understand population-level treatment sequencing for MBC. Secondary outcomes were to describe the heterogeneity of MBC treatment sequencing, as measured by the proportion of patients with a rare sequence, and to generate hypotheses about the impact of sequencing on overall survival. METHODS This retrospective review evaluated treatment sequencing for patients with MBC in the SEER–Medicare database. Patients with either de novo MBC or International Classification of Diseases, Ninth Revision, diagnosis codes for secondary metastasis (197.XX-198.XX) on two separate dates, excluding breast (198.81, 198.82, 198.2) and lymph nodes (196.XX), were included. Complete Medicare Parts A, B, and D coverage was required. A treatment sequence that fewer than 11 patients received was considered rare. A graphic was created with each nonrare treatment-sequence grouping on the y-axis and time on the x-axis. Bars representing time on hormonal therapy, chemotherapy, human epidermal growth factor receptor 2–targeted therapy, and other targeted therapies were color coded. Kaplan-Meier–like curves were overlaid on treatment maps, using estimated median survival for each sequence. RESULTS Of 6,639 patients with MBC, 56% received a treatment sequence that fewer than 11 other patients received, with 2,985 other unique, rare sequences were identified. Sequence visualization demonstrated differential survival, with longer median survival for those initially receiving hormonal therapy. The median time receiving initial treatment was similar for patients receiving first-line chemotherapy. CONCLUSION Treatment-sequence visualization can enhance the capacity to effectively conceptualize treatment patterns and patient outcomes.

Background Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life‐limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment‐related decision‐making. Methods Estimates of time spent receiving cancer‐related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time‐in‐motion quality improvement evaluation (process mapping); (b) cross‐sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). Results Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. Conclusion Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method., In patients with metastatic breast cancer, time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on type of treatment received and its administration method. The greatest time contributions were time spent traveling for care and on inpatient services, and health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents.

PURPOSE: In patients with metastatic breast cancer (MBC), low health insurance literacy may be associated with adverse material conditions, psychological response, and coping behaviors because of financial hardship (FH). This study explored the relationship between health insurance literacy and FH in women with MBC. METHODS: This cross-sectional study used data collected from 84 women receiving MBC treatment at 2 southeastern cancer centers. Low health insurance literacy was defined as not knowing premium or deductible costs. FH was defined by lifestyle changes as a result of medical expenses, financial toxicity, and medical care modifications attributable to cost. Mean differences were calculated using Cramer’s V. Associations between health insurance literacy and FH were estimated with adjusted linear models. RESULTS: Half of the surveyed patients had low health insurance literacy, 26% were underinsured, 45% had private insurance, 39% had Medicare, and 15% had Medicaid. Patients with low health insurance literacy more often reported borrowing money (19% v 4%; V = 0.35); an inability to pay for basic necessities like food, heat, or rent (10% v 4%; V = 0.18); and skipping a procedure (8% v 1%; V = 0.21), medical test (7% v 0%; V = 0.30), or treatment (4% v 0%; V = 0.20) compared with patients with high health insurance literacy. Median Comprehensive Score for Financial Toxicity was 23 (interquartile range, 17-29). In adjusted models, health insurance literacy was not associated with financial toxicity. CONCLUSION: Low health insurance literacy was common in women receiving MBC treatment. Additional research to increase health insurance literacy could lessen undesirable material FH and unnecessary behavioral FH associated with cancer-related care.

110 Background: In Sudan, healthcare access may limit diagnostic workup for breast cancer. This study evaluates the relationship between geography and ethnicity and completeness of documentation of diagnostic workup (staging and receptor testing) in Sudan. Methods: This retrospective study used data abstracted from patients with breast cancer receiving cancer care at Sudan’s largest cancer center (Radiation and Isotopes Center Khartoum [RICK]) in 2017. The patient’s age at diagnosis, sex, breast cancer stage, ethnic subgroup (further categorized as Arab and non-Arab), regions of origin and residence (Central, Northeastern, Western, and Khartoum [where RICK is located]), and receptor status from pathology reports were abstracted from paper medical records. Complete diagnostic workup was defined as having both receptor testing and staging. Descriptive statistics were calculated using frequencies and percentages for categorical variables and median and interquartile range (IQR) for continuous variables. Odds ratios (OR) and 95% confidence intervals (CI) were estimated to evaluate complete diagnostic workup on ethnic group, origin, and residence using binomial logistic regression models (excluding non-Sudanese patients and those with missing demographics). Results: Of 240 patients included, 237 were female, median age was 53 (IQR 43-62). Most often patients were Arab (68%), originated from Northeastern and Khartoum regions (both 28%) and lived in the Khartoum region (53%). Overall, 49% patients were missing receptor testing and/or staging, with modest differences by geographic region and ethnicity (Table). In adjusted analyses, non-Arab patients had similar odds of having complete diagnostic workup when compared to Arab patients (OR 1.22; 95% CI 0.70-2.10). Patients originating from and residing in regions outside the Khartoum region had similar odds of complete diagnostic workup when compared to patients originating from and residing in the Khartoum region. Conclusions: Almost half of breast cancer patients had incomplete diagnostic workup, regardless of region of origin, region of residence, and ethnic group. This highlights a substantial systems-based quality gap in care delivery, warranting efforts to improve completeness in diagnostic workup for all patients with breast cancer in Sudan.[Table: see text]

351 Background: One key challenge of practice transformation activities, such as remote symptom monitoring (RSM) using electronic patient reported outcomes (ePROs), is identification of patients starting treatment. In real-world settings, reliance on referrals is likely to miss patients. We describe the difficulties encountered in patient identification and the subsequent changes implemented in protocol to remediate this. Methods: We conducted two PDSA cycles focused on identification and engagement of patients for RSM at the Mitchel Cancer Institute (MCI). Target patient capture was > 75%. Modifications to the patient identification process were documented. Schedules of physicians participating in the RSM program were reviewed from 6/2021 – 5/2022 to identify eligible patients. Patients were considered eligible if they were starting chemotherapy, targeted therapy, or immunotherapy. Patients seeking a second opinion were excluded. Patient demographics, cancer type, cancer stage, and PROs were abstracted from electronic health records and the PRO platform (Carevive). Initial clinic roll-out was conducted in gynecologic oncology, with expansion to breast and thoracic oncology in 10/2021 and 3/2022, respectively. The proportion of eligible patients approached per month was reported.Results: In the first PDSA cycle, the eligibility criteria was defined. Although clinical trials included advanced disease, non-clinical staff screening expressed concern about determining advanced vs. early-stage disease. Thus, inclusion criteria was broadened to include all patients starting treatments. From 6/2021 –8/2021, navigators identified patients by screening patients who presented for chemo-education visits. The navigation team approached 23 patients during this period. However, this process didn’t identify all eligible patients as not all patients beginning treatment received chemo-education visits. In PDSA Cycle 2, the process for new patient contact from initial call for appointment through treatment was reviewed. The implementation team screened all patients in a physician’s schedule a week prior to the office visit as well as on the day of visit. This updated process identified all eligible patients starting either intravenous or oral chemotherapy. The recruitment process was modified to screen the physician schedules rather than chemo educator visits. From 9/2022-5/22, the proportion of eligible patients identified and approached remained high at 100%. This methodological screening process helped the navigation team identify all eligible patients in an efficient manner and they reported comfort in expanding to additional disease teams. Conclusions: Systematic screening of physician schedules can be successfully leveraged for patient identification and reduce time spent manually screening for eligible patients by non-clinical navigators. Clinical trial information: NCT04809740.

272 Background: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. Methods: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman’s Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (Phase I) and workflow (Phase II and III) using electronic health data; qualitative evaluation with semi-structured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. Results: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real-time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. Conclusions: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

421 Background: For successful remote symptom monitoring using patient-reported outcomes, nurses should respond to alerts in a timely fashion. Where clinical trials utilized research staff for alert management, the shift to standard-of-care delivery necessitates that this responsibility be added as a task to an already strained nursing workforce. Little is known about strategies to engage nurses to improve timeliness of alert management. Methods: In this quality improvement initiative, we aimed to improve timeliness of alert closures generated by moderate or severe symptoms within a remote symptom monitoring program. Optimal closure was defined as < 48 hours, which was consistent with institutional requirements for response to patient phone calls. A continuous quality improvement approach, with multiple Plan Do Study Act (PDSA) cycles was conducted. Data was captured from the electronic medical record and PRO platform (Carevive). Descriptive statistics included frequencies and percentages. The proportion of alerts closed each month < 48 hours, 48-72 hours, 3-7 days, and > 7 days were reported overall and by disease team (i.e., major cancer types). Surveys not closed were considered > 7 days. The timing of strategies to improve nursing engagement were documented and evaluated for impact on alert closure. Results: From June 1, 2021-May 31, 2022, 1121 moderate or severe alerts were generated from 234 patients. Disease teams had variable remote symptom monitoring start dates: breast, leukemia, and limited gynecologic (prior to 6/2021); myeloma and gastrointestinal (7/2021); genitourinary (10/2021); head and neck (12/2021); melanoma (2/2022); and Lymphoma (4/2022). In 6/2021, the overall alert closure at < 48 hours, 48-72 hours, 3-7 days, and > 7 days was 57%, 4%, 14%, and 25% respectively (n = 28). To improve alert closures, several key strategies were deployed to improve alert closure times including disease-specific reporting and meetings with nursing leadership (10/2021); identification of a nurse champion, creation of “cheat sheets” to remind nurses how to close alerts, and individualized calls with nurses with open alerts (1/2022), and inclusions of requirement to close alerts in nursing newsletters (2/2022). Overall, alert closure less than 48 hours improved to 61% by 12/2021 (n = 97) and to 69% by 5/2022 (n = 167). Disease group alert closure varied, with higher closure more commonly in teams with greater duration of use, such as breast cancer team with an alert closure of 85% < 48 hours in May 2022. Conclusions: Key nursing engagement strategies improve alert closure for remote symptom monitoring programs implemented in real-world settings.

268 Background: Remote symptom monitoring (RSM) using patient-reported outcomes has been shown to reduce symptom burden and hospitalizations in clinical trials. However, little is known about how willing patients are to participate in remote symptom monitoring in real-world settings, particularly for vulnerable patient populations. This study aims to compare characteristics of cancer patients enrolled vs. patients who declined enrollment into RSM. Methods: This prospective study used data that assessed the characteristics of patients who enrolled vs. patients who declined enrollment into RSM. Inclusion criteria included participants’ age ≥18 with cancer who received chemotherapy, targeted therapy, or immunotherapy at the University of Alabama at Birmingham. Race and ethnicity (Black or African American, White, Asian, other and unknown), sex, cancer type (breast, gastrointestinal [GI], genitourinary [GU], gynecological [GYNX], head and neck, leukemia, lymphoma, melanoma, myeloma and other), urban/rural residence, Area Deprivation Index (ADI), and insurance type (Medicaid, Medicare, none, other and private) were abstracted from electronic medical records (EMR) and PRO platform (Carevive). Descriptive statistics were calculated using frequencies and percentages for categorical variables and medians and interquartile ranges for continuous variables. Differences in enrollment status characteristics were calculated using measures of effect size such as Cramer’s V. Results: Of the 307 patients, two thirds of patients were female (71%); 25% were Black or African American and 66% were White patients; 15% lived in an area of higher disadvantage. For insurance, 46%, 26%, 10%, 8%, and 9% of patients had Private, Medicare, Medicaid, other insurance, and no insurance, respectively. The proportion of patients who declined enrollment was higher for males than females (22% vs. 10%), Black or African American than White (18% vs 13%); and having Medicare than private insurance (22% vs. 10%). Compared to those who enrolled, patients who declined enrollment were more often to be male (V:0.2), Black or African American (V:0.1); and have Medicare insurance (V:0.2). Patients enrolled vs. declined in RSM had similar ADI scores (V:0.01). Conclusions: This study demonstrates that potentially vulnerable patients, including Black patients and those with public insurance, have lower RSM engagement. Future analysis is needed to understand participation barriers and how to better engage diverse populations to ensure optimal healthcare delivery to all patients.

85 Background: Most patients with cancer experience multi-leveled barriers to clinical trial participation, potentially including financial concerns due to the complexity surrounding trial-related insurance coverage. Our study sought to understand the association between insurance status and cancer clinical trial eligibility, offer, and enrollment. Methods: This retrospective cohort study included patients with breast or ovarian cancer receiving a therapeutic cancer drug at the University of Alabama at Birmingham between January 2017 and February 2020. Available clinical trials and eligibility criteria were abstracted from OnCore and ClinicalTrials.gov. Patient trial eligibility, offer from provider, demographics, and clinical characteristics were abstracted from electronic medical records. Patient trial enrollment was determined via OnCore. Odds of clinical trial eligibility, offer, and enrollment by insurance status (private, public [Medicaid, Medicare]) were estimated using logistic regression models. Models estimating odds of trial offer and enrollment contained only eligible patients. Models were adjusted for patient age at diagnosis, race and ethnicity, rural-urban residence, Area Deprivation Index, cancer type, and cancer stage (early, late). Results: A total of 513 patients with breast (71%) or ovarian (29%) cancer were included in our analyses. Median age at diagnosis was 60 (interquartile range: 49-67) years; the majority were White (69%) and had early stage cancer (65%). Half of patients had private insurance (54%), and 46% of patients had public insurance (38% Medicare, 8% Medicaid). Patients with private insurance more often had early stage cancer compared to patients with public insurance (73% vs 57%). Almost two-thirds of patients (65%) were eligible for clinical trial enrollment. Of eligible patients (n = 333), 68% were offered a trial and 47% enrolled onto a trial. In adjusted analyses, patients with public vs private insurance had similar odds of clinical trial eligibility (odds ratio [OR] 0.95, 95% confidence intervals [CI] 0.61-1.48), being offered to participate (OR 1.23, 95% CI 0.71-2.14), and clinical trial enrollment (OR 1.13, 95% CI 0.68-1.89). Conclusions: Our results suggest oncologists do not assess trial eligibility or offering a trial based on insurance status, and patients do not differentially participate based on their insurance coverage. Further research is needed to understand implications of trial participation (e.g., out-of-pocket and time costs) for patients covered by differing insurance.

Background Little is known about the prevalence of healthy lifestyle (HLS) discussions between providers and older cancer survivors. Methods We utilized cross‐sectional data from older cancer survivors (≥65 years) seen at 12 southeastern cancer centers during 2013‐2015. Data on demographics, time since diagnosis, weight, height, and healthy behaviors were collected. Respondents were asked if providers (oncologists, other physicians, and/or nurses) discussed exercise, healthy diet, weight management, and/or smoking cessation during clinical encounters. Descriptive statistics and bivariate associations between HLS topics and survivor characteristics were calculated. Results Among 1460 cancer survivors, mean age was 74 years (SD 6), most were white (81%), and >1 year postdiagnosis (84%). The majority (71%) reported discussing at least one of three HLS topics (exercise 49%, healthy diet 53%, vegetable consumption 28%); 17% received counseling on all three. Weight loss was recommended to 33% of overweight/obese survivors and smoking cessation to 85% of current smokers. Oncologists and nurses discussed HLS less frequently compared to other physicians. Younger survivors (65‐74 years) received recommendations for exercise, weight loss, and tobacco cessation more often than older survivors (≥75 years). Compared to white respondents, minorities reported discussions on all topics more often except for tobacco cessation. Excluding tobacco cessation, survivors with recent cancer diagnoses (1 year postdiagnosis. Conclusion Despite the American Cancer Society's recommendations, older survivors reported a low prevalence of HLS discussions with their providers, with some variation by demographic groups. Strategies are needed to promote these important discussions in this population., Provider's recommendations for weight management, healthy diet, physical activity, and smoking cessation are key in promoting healthy lifestyles (HLS) among older cancer survivors. However, we found that not all survivors discuss all relevant HLS with their providers, with some groups of survivors having these discussions less often than others. Additional studies and strategies are needed to promote HLS discussions and achieve the American Cancer Society's (ACS) recommended HLS goals especially for diet, weight, and physical activity among older cancer survivors in the Southeastern US healthcare system

PURPOSE: To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS) in which education was delivered early or after the support component. METHODS: Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S), and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study - Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods. RESULTS: Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (Mean (Standard deviation): SF-36 PCS: 44.88 (10.6) vs. 45.08 (10.6) ; MCS: 49.45 (11.1) vs. 48.1 (11.9); CES-D: 10.11 (9.8) vs. 10.86 (10.5) ; POMS-SF: 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS: 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen’s d −0.22, 95% CI: −0.38, −0.06) and POMS (Cohen’s d 0.23, 95% CI: 0.07, 0.39) for EE-S vs. S-DE. CONCLUSIONS: The implementation strategies were equivalent. IMPLICATIONS FOR SURVIVORS: Enhancing support may be considered before delivering not-in-person interventions to RBCS.

BACKGROUND The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

Background National Comprehensive Cancer Network (NCCN) guideline-based treatment is a marker of high-quality care. The impact of guideline discordance on cost and health care utilization is unclear. Materials and Methods This retrospective cohort study of Medicare claims data from 2012 to 2015 included women age ≥65 with stage I–III breast cancer receiving care within the University of Alabama at Birmingham Cancer Community Network. Concordance with NCCN guidelines was assessed for treatment regimens. Costs to Medicare and health care utilization were identified from start of cancer treatment until death or available follow-up. Adjusted monthly cost and utilization rates were estimated using linear mixed effect and generalized linear models. Results Of 1,177 patients, 16% received guideline-discordant treatment, which was associated with nonwhite race, estrogen receptor/progesterone receptor negative, human epidermal growth receptor 2 (HER2) positive, and later-stage cancer. Discordant therapy was primarily related to reduced-intensity treatments (single-agent chemotherapy, HER2-targeted therapy without chemotherapy, bevacizumab without chemotherapy, platinum combinations without anthracyclines). In adjusted models, average monthly costs for guideline-discordant patients were $936 higher compared with concordant (95% confidence limits $611, $1,260). For guideline-discordant patients, adjusted rates of emergency department visits and hospitalizations per thousand observations were 25% higher (49.9 vs. 39.9) and 19% higher (24.0 vs. 20.1) per month than concordant patients, respectively. Conclusion One in six patients with early-stage breast cancer received guideline-discordant care, predominantly related to undertreatment, which was associated with higher costs and rates of health care utilization. Additional randomized trials are needed to test lower-toxicity regimens and guide clinicians in treatment for older breast cancer patients. Implications for Practice Previous studies lack details about types of deviations from chemotherapy guidelines that occur in older early-stage breast cancer patients. Understanding the patterns of guideline discordance and its impact on patient outcomes will be particularly important for these patients. This study found 16% received guideline-discordant care, predominantly related to reduced intensity treatment and associated with higher costs and rates of health care utilization. Increasing older adult participation in clinical trials should be a priority in order to fill the knowledge gap about how to treat older, less fit patients with breast cancer.

Purpose: The Oncology Care Model (OCM) is a highly controversial specialty care model developed by the Centers for Medicare & Medicaid aimed to provide higher-quality care at lower cost. Because oncologists will be increasingly held accountable for spending as well as quality within new value-based health care models like the OCM, they need to understand the drivers of total spending for their patients. Methods: This retrospective cohort study included patients ≥ 65 years of age with primary fee-for-service Medicare insurance who received antineoplastic therapy at 12 cancer centers in the Southeast from 2012 to 2014. Medicare administrative claims data were used to identify health care spending during the prechemotherapy period (from cancer diagnosis to antineoplastic therapy initiation) and during the OCM episodes of care triggered by antineoplastic treatment. Total health care spending per episode includes all types of services received by a patient, including nononcology services. Spending was further characterized by type of service. Results: Average total health care spending in the three OCM episodes of care was $33,838 (n = 3,427), $23,811 (n = 1,207), and $19,241 (n = 678). Antineoplastic drugs accounted for 27%, 32%, and 36% of total health care spending in the first, second, and third episodes. Ten drugs, used by 31% of patients, contributed 61% to drug spending ($18.8 million) in the first episode. Inpatient spending also substantially contributed to total costs, representing 17% to 20% ($30.5 million) of total health care spending. Conclusion: Health care spending was heavily driven by both antineoplastic drugs and hospital use. Oncologists’ ability to affect these types of spending will determine their success under alternative payment models.

This abstract was withdrawn by the authors.

Background As the population of older adults with cancer continues to grow, the most important factors contributing to their health-related quality of life (HRQOL) remain unclear. Methods A total of 1457 older adults (aged ≥65 years) with cancer participated in a telephone survey. Outcomes were measured using the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the 12-Item Short Form Survey (SF-12) from the Medical Outcomes Study (version 2). Statistical techniques used to identify factors in 4 domains (physical, psychological, social, and spiritual) most strongly associated with HRQOL included linear models, recursive partitioning, and random forests. Models were developed in a training data set (920 respondents) and performance was assessed in a validation data set (537 respondents). Results Respondents were a median of 19 months from diagnosis, and 28.1% were receiving active treatment. The most relevant factors found to be associated with PCS were symptom severity, comorbidity scores, leisure-time physical activity, and having physical support needs. The most relevant factors for MCS were having emotional support needs, symptom severity score, and the number of financial hardship events. Results were consistent across modeling techniques. Symptoms found to be strongly associated with PCS included fatigue (adjusted proportion of summary score's variance [R2 ] = 0.34), pain (adjusted R2 = 0.32), disturbed sleep (adjusted R2 = 0.16), and drowsiness (adjusted R2 = 0.16). Symptoms found to be strongly associated with MCS included fatigue (adjusted R2 = 0.23), problems remembering things (adjusted R2 = 0.17), disturbed sleep (adjusted R2 = 0.16), and lack of appetite (adjusted R2 = 0.16). Conclusions The findings of the current study support the importance of addressing persistent symptoms, managing comorbidities, promoting leisure-time physical activity, and addressing financial challenges. A long-term comprehensive approach is needed to ensure the well-being of older adults with cancer. Cancer 2018;124:596-605. © 2017 American Cancer Society.

75 Background: Many patient population groups are not proportionally represented in clinical trials, including patients of color, at age extremes, or with comorbidities. It is unclear how treatment outcomes may differ for these patients compared to those well represented in trials. Methods: This retrospective cohort study included women diagnosed with early-stage (I-III) breast cancer (EBC) between 2005-2015 in the CancerLinQ Discovery electronic medical record-based dataset. Patients with comorbidities or concurrent cancer were considered unrepresented in clinical trials. Non-White patients and/or those aged

152 Background: Given the high risk of COVID-19 mortality, patients with cancer are not only vulnerable to physical consequences of COVID-19 infection, but also to adverse psychological outcomes, including fear of COVID-19. Without intervention, psychological distress in patients with cancer can lead to worsening symptoms, poor quality of life, and lower survival. We sought to evaluate the association between fear of COVID-19 and psychological distress for under-resourced patients with cancer during the pandemic. Methods: This observational, longitudinal survey study, fielded during early (May 20- July 11, 2020) and later pandemic (December 2-December 23, 2020), evaluated the pandemic’s impact on patients with cancer receiving Patient Advocate Foundation (PAF) services from July 2019 – April 2020. Questions focused on individual experiences with COVID-19 and psychological, emotional, physical, and material effects from the pandemic. The validated Fear of COVID-19 Scale was used to determine fear of COVID-19. Psychological distress was determined using a four-item questionnaire by Holingue et al. (score range 4 – 16). Means and 95% confidence intervals (CI) were estimated using generalized estimating equation modeling with repeated measures to assess the effect of fear of COVID-19 on psychological distress early and later in the pandemic. Models adjusted for age, sex, race/ethnicity, region, annual household income, household size, marital status, employment status, Area Deprivation Index category, Rural-Urban Commuting Code category, cases per 100,000 in county of residence, cancer type, and number of comorbidities. Results: Amongst 1199 survey respondents, 94% considered themselves high risk for COVID-19. 448 respondents completed both the first and second survey. The majority of respondents were female (72%) and age 56-75 (55%); 40% were Black, Indigenous, or Persons of Color. In adjusted models of respondents who completed the early pandemic survey, respondents with more fear of COVID-19 had a higher mean psychological distress score (10.21; 95% CI 9.38-11.03) compared to respondents with less fear (7.55; 95% CI 6.75-8.36). Among those who completed the later pandemic survey, median fear of COVID-19 decreased (20 vs 19)median distress scores remained the same (8); respondents with more fear of COVID-19 had a higher mean psychological distress score (9.98; 95%CI 9.04-10.92) compared to respondents with less fear (7.87; 95%CI 6.98-8.76). Conclusions: Fear of COVID-19 was linked to psychological distress and persisted throughout the pandemic among under-resourced patients with cancer. Timely psychosocial support is critical to meet increased care needs experienced by patients with cancer during the COVID-19 pandemic. Given these results, fear of COVID-19 could be considered as a trigger to integrate psychological interventions in patients with cancer to treat psychological distress.

148 Background: The World Health Organization cited vaccine hesitancy as one of 2019’s top ten threats to global health, a threat that has been further exacerbated by COVID-19 pandemic. Existing COVID-19 vaccine hesitancy research focuses on the general population, but less is known about the specific concerns of medically vulnerable populations, including individuals with cancer. Methods: This cross-sectional analysis used data that assessed likelihood of COVID-19 vaccination (likely vs unlikely/unsure) among past or current patients with cancer from a nationwide survey administered in December 2020 by the Patient Advocate Foundation (PAF), a non-profit organization that provides case management and financial aid to patients diagnosed with a chronic illness. Inclusion criteria included previous or current cancer treatment, aged ≥ 19, and a valid e-mail address. Age, sex, race/ethnicity, and urban/rural residence were abstracted from the PAF database. Respondents self-reported education level, employment status, trust in media regarding COVID-19 pandemic, and media viewership on COVID-19 vaccine development. The Group-Based Medical Mistrust Scale assessed respondents’ level of mistrust in medical providers based on ethnicity. Likelihood of COVID-19 vaccine acceptance was evaluated using risk ratios (RR) and 95% confidence intervals (CI) from modified Poisson regression models with robust error variance. All variables were included in our model. Results: Of 429 respondents, 48% were unlikely/unsure about accepting the COVID-19 vaccine, primarily due to concerns about vaccine safety (32%) and worry about health conditions (12%). When compared to those likely to accept COVID-19 vaccine, respondents who were unlikely/unsure were more often Black, Indigenous, or People of Color (40% vs. 23%), aged 36-55 (40% vs. 29%), and female (80% vs. 65%). In adjusted analysis, Black respondents were 55% less likely to accept a COVID-19 vaccine, when compared to White respondents (RR 0.55; 95% CI 0.4-0.8). When compared to those who did not follow the media regarding COVID-19 vaccine development, those who followed the media very closely were 4.5 times more likely to accept a COVID-19 vaccine (RR 4.5; 95% CI 1.6-13.2). Respondents who reported below average trust in the media were 60% less likely to accept a COVID-19 vaccine (RR 0.6; 95% CI 0.5-0.8), compared to those who reported above average trust in the media. Conclusions: Despite being at high risk of COVID-19 morbidity and mortality, a substantial proportion of under-resourced individuals with cancer were unlikely/unsure about vaccination, exposing a significant disconnect between risk of severe disease and vaccine acceptance. Our analysis also reveals a need to assess for and debunk misinformation to increase vaccine enthusiasm among medically vulnerable populations.

98 Background: Patients with cancer are at risk for severe COVID-19 and may be vulnerable to health care delays. Delays or interruptions in care may lead to adverse cancer outcomes. Little is known about the relationship between fear of COVID-19 and disruptions in cancer care delivery. Methods: This longitudinal survey was distributed to individuals with cancer who received services July 2019-April 2020 from Patient Advocate Foundation, a non-profit organization that provides case management and financial aid to patients with chronic illness. Data was collected twice - early pandemic (5/20/20-7/11/20) and later pandemic (12/3/20-12/23/20). Fear of COVID-19 was assessed with the Fear of COVID-19 Scale and dichotomized as more (≥22) vs less (< 22) fearful. Respondents reported delays in care or treatment interruptions due to the pandemic and reasons for delays or interruptions. Respondents rated concern about potential long-term health issues due to delays on a 5-point Likert-like scale. We estimated predicted percentages and 95% confidence intervals (CI) using logistic regression models to assess the association of fear of COVID-19 (more vs less fearful) with delay in care or treatment interruption (any vs none) at each time point. We adjusted models for age, sex, race/ethnicity, region, annual household income, marital status, employment status, household size, Area Deprivation Index category, Rural-Urban Commuting Code category, county-level COVID-cases per 100,000, cancer type and number of comorbidities. Results: Amongst the 1,199 early pandemic survey respondents, the majority were female (72%), had household income < $48,000 (73%), and had ≥1 comorbidity (60%). 448 of the early pandemic survey respondents also completed the later survey. 464 (39%) and 166 (37%) respondents were categorized as more fearful at the early and later time points respectively. 567 (47%) and 191 (43%) reported delays or interruptions at the early and later time points respectively. The most common reported reasons for delays or interruptions were hospital/provider restrictions (early: 27%, later: 19%) and patient choice (early: 13%, later: 15%). Among respondents with delays or interruptions at each time point, > 70% were at least moderately concerned about potential long-term health issues due to delays. In adjusted models, more fearful respondents had higher predicted percentages of delayed care or treatment interruptions compared to less fearful respondents early (more fearful: 56%, 95% CI 39%-72%; less fearful: 44%; 95% CI 28%-61%) and later (more fearful: 55%, 95% CI 35%-73%; less fearful: 38%; 95% CI 22%-57%) in the pandemic. Conclusions: Fear of COVID-19 is common among patients with cancer and is linked with delays in care and treatment interruptions. System-wide strategies are needed to address fear of COVID-19 and to ensure equitable, timely, and safe access to cancer care throughout the pandemic.

Little is known about out‐of‐pocket (OOP) costs incurred for medical and health needs by rural breast cancer survivors and what factors may be associated with higher OOP costs and the associated economic burden. Data were examined for 432 survivors participating in the Rural Breast Cancer Survivor Intervention trial. OOP costs were collected using the Work and Finances Inventory survey at baseline and four assessments every 3 months. Mean and median OOP costs and burden (percent of monthly income spent on OOP costs) were reported and factors associated with OOP costs and burden identified with generalized linear models fitted with over‐dispersed gamma distributions and logarithmic links (OOP costs) and with beta distributions with logit link (OOP burden). OOP costs per month since the end of treatment were on average $232.7 (median $95.6), declined at the next assessment point to $186.5 (median $89.1), and thereafter remained at that level. Mean OOP burden was 9% at baseline and between 7% and 8% at the next assessments. Factors suggestive of contributing to higher OOP costs and OOP burden were the following: younger age, lower income, time in survivorship from diagnosis, and use of supportive services. OOP costs burden rural breast cancer survivors, particularly those who are younger and low income. Research should investigate the impact of OOP costs and interventions to reduce economic burden.

PURPOSE Many community cancer clinics closed between 2008 and 2016, with additional closings potentially expected. Limited data exist on the impact of travel time on health care costs and resource use. METHODS This retrospective cohort study (2012 to 2015) evaluated travel time to cancer care site for Medicare beneficiaries age 65 years or older in the southeastern United States. The primary outcome was Medicare spending by phase of care (ie, initial, survivorship, end of life). Secondary outcomes included patient cost responsibility and resource use measured by hospitalization rates, intensive care unit admissions, and chemotherapy-related hospitalization rates. Hierarchical linear models with patients clustered within cancer care site (CCS) were used to determine the effects of travel time on average monthly phase-specific Medicare spending and patient cost responsibility. RESULTS Median travel time was 32 (interquartile range, 18-59) minutes for the 23,382 included Medicare beneficiaries, with 24% of patients traveling longer than 1 hour to their CCS. During the initial phase of care, Medicare spending was 14% higher and patient cost responsibility was 10% higher for patients traveling longer than 1 hour than those traveling 30 minutes or less. Hospitalization rates were 4% to 13% higher for patients traveling longer than 1 hour versus 30 minutes or less in the initial (61 v 54), survivorship (27 v 26), and end-of-life (310 v 286) phases of care (all P < .05). Most patients traveling longer than 1 hour were hospitalized at a local hospital rather than at their CCS, whereas the converse was true for patients traveling 30 minutes or less. CONCLUSION As health care locations close, patients living farther from treatment sites may experience more limited access to care, and health care spending could increase for patients and Medicare.

Background: Treatment for metastatic breast cancer (MBC) that is not concordant with the NCCN Guidelines for Breast Cancer has been associated with higher healthcare utilization and payer costs. However, a significant knowledge gap exists regarding the impact of guideline-discordant care on patient cost responsibility. This study examined this question among patients with MBC in the year postdiagnosis. Methods: This retrospective cohort study used data from the SEER-Medicare linked database from 2000 through 2013. Guideline discordance, defined by year-specific NCCN Guidelines, was assessed for first-line antineoplastic treatment and grouped into discrete categories. Patient cost responsibility (deductibles, coinsurance, copayments) in women with MBC were summed for all medical care received in the year postdiagnosis. The difference in patient cost responsibility by guideline discordance status was estimated using linear mixed-effect models. Results: Of 3,709 patients with MBC surviving at least 1 year postdiagnosis, 17.6% (n=651) received guideline-discordant treatment. Median cost responsibility in the year postdiagnosis for patients receiving guideline-discordant treatment was $7,421 (interquartile range [IQR], $4,359–$12,983) versus $5,171 (IQR, $3,006–$8,483) for those receiving guideline-concordant care. In adjusted models, guideline-discordant treatment was significantly associated with $1,841 higher patient costs in the first year from index diagnosis date (95% CI, $1,280–$2,401) compared with guideline-concordant care. Patient cost responsibility differed by category of guideline discordance, with those receiving nonapproved bevacizumab having the highest cost responsibility (β=$3,330; 95% CI, $1,711–$4,948). Conclusions: Deviations from current treatment guidelines may have implications on patient healthcare cost responsibility. Additional research is needed to fully understand the mechanisms underlying how guideline deviation leads to greater costs for patients with MBC.

6584 Background: Early stage breast cancer (EBC) treatment is used in women of all ages, races, and health states. However, as clinical trials often do not represent real-world populations, the extent to which evidence-based treatments are prescribed to populations not well represented in these trials is not known. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. Methods: This retrospective cohort study used the nationwide de-identified electronic health record derived Flatiron Health database for patients diagnosed with EBC between 2011-2020. We categorized treatments as either high- (AC-TH [doxorubicin, cyclophosphamide followed by paclitaxel or docetaxel, trastuzumab]; ACT [paclitaxel or docetaxel, doxorubicin, cyclophosphamide]; TCH [paclitaxel or docetaxel, carboplatin, trastuzumab]; TCHP [paclitaxel or docetaxel, carboplatin, trastuzumab, pertuzumab]) or low-intensity (AC [doxorubicin, cyclophosphamide]; TC [paclitaxel or docetaxel, cyclophosphamide]; TH [paclitaxel or docetaxel, trastuzumab]). Unrepresented patients often have one or more comorbidities and/or prior cancer; underrepresented patients are typically Black, Indigenous, people of color, or of age extremes ( < 45, 70+); well represented patients are White and between the ages of 45-69. Odds ratios (OR), predicted proportions, and 95% confidence intervals (CI) from a two-level (patients nested in practice) hierarchical logistic regression model evaluated associations between receipt of high-intensity chemotherapy and patient characteristics of clinical trial representation (age, race/ethnicity, presence of comorbidity). Results: Our study included 970 patients with EBC with 13%, 45%, and 41% characterized as unrepresented, underrepresented, and well represented in clinical trials, respectively. In the adjusted model, those aged ≥ 70 vs 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 vs 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). The predicted proportion of patients receiving a high-intensity treatment was 87% (95% CI: 80%-92%) for patients aged < 45, 79% (95% CI: 74%-84%) for patients aged 45-69, and 60% (95% CI: 50%-70%) for patients aged ≥ 70. Neither race/ethnicity nor comorbidity status were associated with odds of receiving high-intensity chemotherapy. Conclusions: Over half of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity, despite a lack of evidence that these differences are appropriate. Widening clinical trial eligibility criteria is one way to better understand survival outcomes, identify potential toxicities, and ultimately make evidence-based treatment decisions using a more diverse sample.

141 Background: This study sought to understand treatment preferences and their association with financial toxicity in breast cancer patients served by Patient Advocate Foundation (PAF). Methods: This cross-sectional study used survey data from a nationwide sample of women with breast cancer who received assistance from PAF. Choice-based conjoint analysis elicited patient preferences and trade-offs. Latent class analysis segmented respondents into distinct preference groups. The Comprehensive Score for Financial Toxicity (COST) tool captured financial toxicity (range 0-44, lower scores indicate worse financial toxicity). Cramer’s V determined magnitude of relationships in bivariate associations. COST score differences by preference archetype was estimated by least square means and naïve 95% confidence intervals (CI) from adjusted generalized linear models. Results: Of 220 respondents (65% response rate), median age was 58 years (interquartile range [IQR] 49-66) and 60% had household incomes < $40,000. Most respondents were diagnosed with early stage cancer (91%), with 41% diagnosed within the past 2 years; 38% had recurred. Almost two-thirds (61%) were on active treatment. Treatment choice was most affected by preferences related to affordability and impact on activities of daily living (ADLs). Two distinct treatment preference archetypes emerged. The “Cost-Prioritizing Group” (75% of respondents) was most concerned about affordability, impact on ADLs, and burdening care partners. The “Functional Independence-Prioritizing Group” (25% of respondents) was most concerned about ability to work, physical side effects, and interference with important life events. Cost- vs. functional independence-prioritizing respondents were more often diagnosed with an early stage cancer (88% vs. 78%; V = .22), white (78% vs. 56%; V = .21), or privately insured (45% vs. 36%; V = .12). Functional independence- vs. cost-prioritizing respondents more often had household incomes < $40,000 (76% vs. 54%; V = .20), identified as Hispanic/Latino (20% vs. 9%; V = .15), or had Medicaid (15% vs. 7%; V = .12). COST scores were similar between archetypes in adjusted models (Cost-Prioritizing COST = 12, 95% CI 9-14; Functional Independence-Prioritizing COST = 11, 95% CI 9-13). Conclusions: Patients with breast cancer prioritized affordability or maintaining functional independence when making treatment decisions. Because of this variability, preference evaluation during treatment decision-making could optimize patients’ treatment experiences.

110 Background: Patients living in rural or disadvantaged settings are historically underrepresented in clinical trials. This study sought to understand associations between neighborhood characteristics and both interest in clinical trial participation and decision-making style preference. Methods: This cross-sectional study used patient-reported outcome data from patients with cancer treated at the University of Alabama at Birmingham from January 2017 to May 2019. Rural-Urban Commuting Area Codes (RUCA) scores were used to determine rurality of patient residence. Area Deprivation Index (ADI) values (range 0-100) were used to identify patients living in the most disadvantaged (top 15%) census block groups. The Control Preferences Scale captured decision-making preference. Likelihood of interest in clinical trial participation by rurality and neighborhood disadvantage was estimated using risk ratios (RR) and 95% confidence intervals (CI) from modified Poisson regression models. Multinomial regression was used to calculate RRs and 95% CIs estimating likelihood of preferred decision-making style by rurality and neighborhood disadvantage. Models were adjusted for age, sex, race, cancer type, cancer stage, ECOG performance status, and phase of care. Results: Of 1005 patients with cancer, mean age was 67 (SD 11), 68% were female, and 74% white. Gynecologic cancer (32%) was the most prevalent diagnosis, followed by hematologic (20%) and breast (15%) cancer. Of this sample, 16% of patients lived in a rural setting and 18% lived in a disadvantaged neighborhood. Interest in clinical trial participation was no different for patients living in rural vs. urban (RR 0.93, 95% CI 0.73-1.17) or disadvantaged vs. non-disadvantaged neighborhoods (RR 0.88, 95% CI 0.69-1.13). Patients living in rural vs. urban settings trended toward increased likelihood of preferring physician- to patient-driven decision-making (RR 1.67, 95% CI 0.95-2.94). Patients living in disadvantaged vs. non-disadvantaged neighborhoods trended toward increased likelihood of preferring physician- to patient-driven decision-making (RR 1.39, 95% CI 0.82-2.35). Conclusions: Though clinical trial participation interest was similar, patients with cancer living in rural vs. urban settings trended toward increased likelihood of preferring physician- vs. patient-driven decision-making. Opportunities exist for providers to engage historically underrepresented patients for trial participation.

Background Understanding factors that impact patient satisfaction with cancer care within the growing population of older adults living with cancer will contribute to tailoring programs that address patient needs and expectations. Further, patient satisfaction is a determinant of healthcare organizations' institutional performance. The purpose of this study was to investigate the relationship between patient satisfaction with care and health-related quality of life (HRQoL) among Medicare recipients with common cancers types (breast, prostate, or lung cancer). Methods Cross-sectional analysis of survey data from 637 Medicare beneficiaries (≥65 years) with breast (n = 304), lung (n = 158), or prostate cancer (n = 175) in twelve hospitals in the Southeastern United States. Participants responded eighteen satisfaction questions across five domains. HRQoL was measured with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the SF-12.v2 instrument. Results SF-12 scores were positively associated with satisfaction domain scores. The magnitude of these associations was small with covariate-adjusted effect sizes r ranging from 0.05 to 0.12. Satisfaction scores were highest within the Quality of Care domain and lowest within the Patient Engagement domain. Conclusions Patient satisfaction domains had only modest association with HRQoL, indicating that these constructs should not be assumed to correlate. Satisfaction domains, including how patients access care, coordinate care, and engage within the healthcare system, were identified as potential areas for improvement. Patient satisfaction assessment across age groups may inform oncology care providers on ways in which their patients perceive the quality of care received, which ultimately affect healthcare organizations' accreditation, ranking, and reimbursement.

OBJECTIVES The Patient Care Connect Program (PCCP), through lay navigators' distress assessments and assistance, was shown to lower healthcare utilization and costs in older cancer survivors. PCCP benefits and assistance needs for disadvantaged minorities (e.g., Black) vs. Whites are unknown. MATERIALS AND METHODS We examined the PCCP impact with retrospective analyses of Medicare claims (2012-2015). Outcomes were quarterly costs and utilization (emergency room (ER), hospitalizations) for navigated and matched survivors. Repeated measures generalized linear models with normal (costs), and Poisson (utilization) distributions assessed differences in trends overall and separately for Blacks and Whites. With distress data for navigated survivors, we assessed high distress (score > 3), ≥1 distress cause (overall, by domain), and ≥ 1 assistance request by minority group. RESULTS Beneficiaries were: 772 Black and 5350 White navigated, and 770 Black and 5348 White matched survivors. Impact was: i) costs: -$557.5 Blacks (p

Objective The purpose of this study was to describe distressed and underprepared family caregiver's use of and interest in formal support services (eg, professional counseling, education, organizational assistance). Method Cross-sectional mail survey conducted in communities of 8 cancer centers in Tennessee, Alabama, and Florida (response rate: 42%). Family caregivers of Medicare beneficiaries with pancreatic, lung, brain, ovarian, head and neck, hematologic, and stage IV cancers reported support service use and completed validated measures of depression, anxiety, burden, preparedness, and health. Results Caregivers (n = 294) were on average age 65 years and mostly female (73%), White (91%), and care recipients' spouse/partner (60%); patients averaged 75 years were majority male (54%) with lung cancer (39%). Thirty-two percent of caregivers reported accessing services while 28% were "mostly" or "extremely" interested. Thirty-five percent of caregivers with high depressive symptoms (n = 122), 33% with high anxiety symptoms (n = 100), and 25% of those in the lowest quartile of preparedness (n = 77) accessed services. Thirty-eight percent of those with high depressive symptoms, 47% with high anxiety symptoms, and 36% in the lowest quartile of preparedness were "mostly" or "extremely" interested in receiving services. Being interested in support services was significantly associated with being a minority, shorter durations of caregiving, and with higher stress burden. Conclusions A large proportion of family caregivers, including those experiencing depression and anxiety symptoms and who were underprepared, are not using formal support services but have a strong interest in services. Strategies to increase service use may include targeting distressed caregivers early in their caregiving experience.

Understanding how resources are used provides guidance to disseminating effective interventions. Here, we report data on implementation resources needed for the Rural Breast Cancer Survivors (RBCS) study that tested a telephone-delivered psychoeducational education and support intervention to survivors in rural Florida. Intervention resources included interventionists’ time on one intake assessment (IA) call, three education calls (ED), one follow-up education call (FUE), six support (SUP) calls, and documentation time per survivor. Interventionists logged start and end times of each type of call. Average interventionist time in minutes was calculated by call type. Associations between interventionists’ time and participants’ characteristics including age, race/ethnicity, time since treatment, cancer treatment, depressive symptoms, education, income, employment, and support, was assessed using linear mixed models with repeated measures. Among 328 survivors, IA calls lasted 66.9 min (SD 21.7); ED lasted 50.6 (SD 16.7), 48.1 (SD 15.9), and 39.6 (SD 14.8); FUE lasted 24.7 (SD 14.8); and SUP 42.8 (SD 29.6) min. Documentation time was 18.4 min for IA, 23–27 for ED, 12.3 for FUE, and 23.0 for SUP. Interventionists spent significantly more time with participants with depressive symptoms, who already used other support, and who received SUP calls before the ED vs. after. There were no significant differences by time since or type of cancer treatment, or other personal characteristics. Resources vary by survivor characteristics. Careful consideration of mental health status or support available is warranted for planning implementation and dissemination of effective survivorship interventions on a broad scale.

Purpose Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Patients and Methods Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Results Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). Conclusion Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.

Despite benefits for patients, sustainability of breast cancer navigation programs is challenging due to the lack of reimbursement for navigators. This analysis describes distress reported by breast cancer patients to navigators and the impact of navigation on healthcare utilization for older adults with breast cancer. We conducted a retrospective cohort study of Medicare administrative claims data and patient-reported distress assessments. The primary outcome was Medicare spending per beneficiary per quarter. Secondary outcomes included (1) the number of hospitalizations or ER visits in each quarter; (2) distress levels; and (3) causes of distress reported by patients to their navigators. A subset analysis was conducted for stage I/II/III versus stage IV patients. 776 navigated and 776 control patients were included in the analysis. The average age at diagnosis was 74 years; 13% of the subjects were African American; 95% of patients had stage I–III. Medicare spending declined faster for the navigated group than the matched comparison group by $528 per quarter per patient (95% CL −$667, −$388). Stage I/II/III navigated patients showed a statistically significant decline in Medicare spending, ER visits, and hospitalizations over time compared to the matched comparison group. No differences were observed for stage IV patients. Eighteen percent of patients reported moderate distress. Informational and physical distress were more common in late stage than in early-stage breast cancer. Lay navigation reduced healthcare utilization in older adults with breast cancer, with the greatest impact observed in early-stage breast cancer patients.

96 Background: Though uninsurance rates declined after the Affordable Care Act, the number of underinsured, or individuals who spend > 10% of their income on out-of-pocket (OOP) medical costs, continues to rise. In patients with metastatic breast cancer (MBC), underinsurance may lead to financial toxicity (FT), or patient-level financial burden and distress, since diagnosis and treatment is extremely costly. This study explores health insurance literacy and the association between FT and health insurance status in women receiving treatment for MBC. Methods: This cross-sectional study utilized survey data collected from 2017-2019 in women age ≥18 receiving treatment for MBC at two academic medical centers in Alabama. FT was measured by the Comprehensive Score for Financial Toxicity (COST) tool (11-item scale from 0-44, with lower scores indicating worse FT). Health insurance status and OOP costs were self-reported. Effect sizes were calculated using Cohen’s d or Cramer’s V. Mixed and generalized linear models clustered by site and treating medical oncologist estimated the association between FT and health insurance status. Results: In 81 women with MBC, median COST score was 24 (interquartile range [IQR] 17-30), 44% had private insurance, 40% Medicare, and 16% Medicaid. Though 25% and 33% of surveyed patients did not know their health insurance premium or deductible cost, respectively, privately insured patients more often knew the cost of their premiums (97%; V = 0.58) and deductibles (81%; V = 0.33) compared to publicly insured patients. In adjusted models, FT levels did not differ significantly based on health insurance type (private insurance COST 21, 95% confidence interval [CI] 18-25; Medicaid COST 23, 95% CI 17-29; Medicare COST 24, 95% CI 20-27). However, risk of severe FT (COST ≤13) was 147% higher for privately insured patients versus Medicare beneficiaries (risk ratio 2.47, 95% CI 1.44-4.21). Conclusions: Despite higher levels of health insurance literacy, privately insured patients receiving treatment for MBC may be at increased risk of severe FT. Further research is needed to understand causes of underinsurance in patients with MBC, which could lead to cancer-related FT.

316 Background: Optimal treatment sequencing (i.e., the order in which drugs are given) for metastatic breast cancer (MBC) is unknown. We aimed to develop an approach to visualize treatment patterns and survival in MBC. Methods: This retrospective study utilized ASCO’s CancerLinQ Discovery® database generated from electronic health records. Subjects included 3,312 women aged ≥18 years who were diagnosed with and received treatment for MBC after 1980. Hormone receptor (HR) status was determined by concordant diagnosis and treatment records. Human epidermal growth factor (HER2) status was determined by delivery of HER2-targeted therapy. Ordered and administered treatments were included. We created spatiotemporal plots of treatment patterns for HR+/HER2-, HER2+, and triple negative (TN) MBC. Individuals were represented on the Y-axis, and time on the X-axis with development of MBC aligned at time 0. Treatment classes were identified by colors: hormone therapies in shades of red, chemotherapies in shades of blue, HER2-targeted therapies in shades of green, and novel therapies in shades of orange. Concurrent treatments were represented by split bars. An overlaid Kaplan-Meier curve allowed for observations about the relationship between survival and treatment. Results: We developed a novel visualization approach to simultaneously display heterogeneous, longitudinal treatments and survival. Median survival after first documentation of MBC was 3.1 (IQR 1.4-7.2), 1.3 (IQR 0.6-2.8), and 2.6 (IQR 1.0-5.2) years for HR+/HER2-, TN, and HER2+ MBC, respectively. Patients with longer survival often had long duration of initial therapy, suggesting a more indolent or responsive disease. Substantial heterogeneity in treatment sequencing was observed for HR+HER2- and TN cohorts. In the HER2+ cohort, HER2-targeted therapy was commonly administered for the duration of treatment with more homogeneous sequencing. Conclusions: This novel visualization approach allows for observing the relationship between treatment patterns and survival, which is challenging to demonstrate with traditional quantitative methods. This approach can generate hypotheses regarding impact of treatment patterns on survival.

317 Background: Electronic health record (EHR) databases are a promising platform for clinical research using real-world data. However, information on potential limitations of these data sources is lacking. We sought to understand how data visualization might be used to identify data inconsistencies and the applicability of previously validated claims-based algorithms used to identify patients with metastatic breast cancer (MBC). Methods: This retrospective study utilized ASCO’s CancerLinQ Discovery database derived from EHR data. Subjects included women ≥18 years treated for MBC diagnosed ≥1980. Subjects with MBC were identified using two billing codes for metastasis on separate dates following primary breast cancer diagnosis. Treatment course sequences were visualized. Patients were represented by a horizontal bar on the Y-axis. Treatments were displayed using colored bars (blue: chemotherapy, red: endocrine therapy, green: HER2 targeted, orange: novel therapy) with time of treatment on the X-axis. Visualizations were qualitatively evaluated, and treatment patterns inconsistent with clinical practice were identified. Results: We identified 4,760 women treated for MBC using billing codes for primary breast cancer diagnosis and distant metastasis. Most patients (96%) had a primary breast cancer diagnosed in 2000 later. Treatment patterns inconsistent with clinical practice identified using the visualization technique included: 1% of patients received adjuvant chemotherapy continuously for ≥1.5 years, suggesting missed coding for metastatic disease; 5% of patients did not receive any treatment in the year following metastasis, suggesting the billing code may have been used in workup and not for confirmed metastatic disease. Among patients with MBC, 50% identified as HR+ across all records had not received hormone therapy, while 39% identified as HR- across all records received hormone therapy. Conclusions: Because previously validated algorithms may not translate well to EHR databases, quality auditing should always be performed. The proposed data visualization can be used for improving algorithms, qualitatively identifying errors, and avoiding biased or inaccurate results.

97 Background: Shared decision-making (SDM), a process where patients partner with their physician to incorporate personal preferences into treatment decisions, is a tenet of high-value healthcare. It is unknown if high-value care associated with SDM manifests in the form of decreased out-of-pocket costs. Therefore, this study analyzes the relationship between patient preference for SDM and financial toxicity in metastatic breast cancer (MBC). Methods: This cross-sectional study utilized surveys of women age ≥ 18 with MBC who received care at two academic hospitals in Alabama between 2017 and 2019. SDM preference and financial toxicity were measured using the Control Preferences Scale and the Comprehensive Score for Financial Toxicity (COST) tool (11-item scale from 0-44, with lower scores indicating worse FT), respectively. Patient demographic and clinical data were abstracted from the electronic medical record. Effect sizes were calculated using Cohen’s d or Cramer’s V. Differences in financial toxicity by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. Results: In 79 women with MBC, 41% preferred SDM, 33% preferred provider-driven decision making, and 22% preferred patient-driven decision making. Patients preferring SDM were more often college educated (48% vs. 40%; V = .15), higher income (52% vs. 44%; V = .09), and privately insured (47% vs. 41%; V = .11). Overall median COST score was 23 (interquartile range 16-30), which varied modestly by SDM preference. After adjusting for patient demographic and clinical characteristics, similar financial toxicity levels were found in patients who preferred SDM (COST 22, 95% confidence interval [CI] 19-25), patient-driven decision making (COST 22, 95% CI 18-26), and provider-driven decision making (COST 24, 95% CI 20-27). Conclusions: Similar levels of financial toxicity were found in patients with differing decision–making preferences regarding their MBC treatment, which may be secondary to lack of discussions about cost. Further research is needed to determine if and how financial toxicity is being identified or included within decision-making.