Financial Toxicity In Patients Research Articles

Financial toxicity in lung cancer.

In the United States, lung cancer is the third most common cancer and the overall leading cause of cancer death. Due to advances in immunotherapy and targeted therapy, 5-year survival is increasing. The growing population of patients with lung cancer and cancer survivors highlights the importance of comprehensive cancer care, including recognizing and addressing financial toxicity. Financial toxicity is a term used to contextualize the negative effects of the costs of cancer treatment in terms of patient quality of life. The American Society of Clinical Oncology (ASCO) Value Framework places emphasis on high-value care as it evaluates cancer treatments "based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost". Prior studies have shown that risk factors for financial toxicity in patients with lung cancer include lower household income or savings, inability to afford basic necessities, higher than anticipated out of pocket expenses, and taking sick leave. Among lung cancer survivors, patients experience increased unemployment and lower wages compared to the general population underscoring the lasting effects of financial toxicity. Financial toxicity is associated with increased psychosocial distress and decreased quality of life, and bankruptcy is an independent predictor of mortality in patients with cancer. Despite the negative implications of financial toxicity on patients, standardized screening practices and evidence-based interventions are lacking. The "COmphrensive Score for financial Toxicity (COST)" tool has been validated for assessing financial toxicity with correlation with health-related quality of life. Further research is needed to understand the utility of incorporating routine screening for financial toxicity into clinical practice and the efficacy of interventions. Understanding the relationship between financial toxicity and quality of life and survival is critical to providing high-value cancer care and survivorship care.

Financial toxicity in patients with advanced solid malignancies participating in early-phase clinical trials.

267 Background: Financial toxicity (FT) adversely influences patient quality of life and is a barrier to clinical trial enrollment. Early phase clinical trials (EPTs) primarily recruit patients with advanced malignancies who have received all standard therapy regimens and may thus have high levels of FT. We sought to assess baseline FT and its association with clinicodemographic factors in patients participating in early phase clinical trials. Methods: We conducted a study to assess baseline FT in English-speaking patients (pts) with advanced metastatic solid tumors who were participating in EPTs at the Yale Cancer Center (Yale) and the Tisch Cancer Institute at Mount Sinai (Sinai). Pts were consented after EPT consent and prior to day 1 of study treatment. Pts completed a clinical and demographic questionnaire as well as the 11-item validated Comprehensive Score for Financial Toxicity (COST) FT instrument. Primary endpoints included baseline FT and association with clinicodemographic variables. Statistical analysis was performed using two-sided T-tests and Pearson correlations for numeric data and Fisher’s Exact Test for categorical data. Multivariate analysis was performed using a linear regression model. Results: 138 pts enrolled in this study, of whom 132 completed the COST instrument (Yale, N = 84; Sinai, N = 48). Median age was 62 and 49.2% were male. 71.2% patients self-identified as White and 15.2% as Black; 7.2% identified as Hispanic. 32.6% reported an annual income of < $50,000. Insurance providers included private insurers (50%), Medicare (31.8%), Medicaid (10.6%), and Medicaid with Medicare supplemental (3.8%). 56.8% reported monthly out of pocket medical expenses of $100 or more. Median FT score was 22.5 out of a maximum score of 44 (mean 21.5). FT scores ≥ 22.5 in pts were associated with age < 65 (OR = 2.229, P = 0.04), being the household money manager (OR = 2.98, P = 0.02), and being the primary wage earner (OR = 3.12, P = 0.004). FT scores < 22.5 in pts was associated with retirement (OR = 0.15, P = 3.67e-05). In multivariate analysis, retirement was associated with FT score < 22.5 (OR = 0.18, P = 0.02). There was no statistically significant difference in FT scores between Yale and Sinai pts. However, Sinai pts were more racially diverse (p = 3.05e-05), had lower household income (P = 0.01), out of pocket expenses (P = 0.01), ED visits (P = 0.0075), and dependents (P = 0.004) and were less likely to have private insurance (P = 0.004). Conclusions: Pts with advanced cancers consenting to EPTs report significant baseline FT. Our study encompasses a diverse population from two large urban academic centers. Baseline FT was higher among pts < 65 years of age, primary wage earners, and those who managed household finances independently. Retirement was a protective factor, which may be explained by the life savings often required to retire. Ongoing work will compare baseline and 2 month FT in this patient population.

Levine Cancer Institute Financial Toxicity Control Program: Expanding the program to reduce fiscal vulnerability of patients.

43 Background: It is well known that financial toxicity is becoming one of the most substantial problems encountered by patients receiving cancer care, and active solutions are required to address this (JCO Oncol. Pract., 2021, 17: e 1433-39). We have established a Financial Toxicity Tumor Board to address specific issues that cause out-of-pocket costs for patients and have saved more than $55 million per year in such costs to patients. A major contributor to patient-centric costs is denials from health insurance companies. We have developed an innovative, pharmacy technician program to assess and understand such denials and to avoid them proactively. Methods: Pharmacy technicians were inserted into an additional site’s treatment team to ensure appropriate prior authorizations were in place prior to patient infusion. Sequential and unselected data were collected over by the prior authorization technician. Medication denial reports generated by the financial clearance team were analyzed to identify issues that might be improved by changes in standard operating procedures in order to avoid recurrent concerns and these solutions were implemented. Results: The approach adopted by the LCI Financial Toxicity Tumor Board, with the use of additional pharmacy technicians to manage and preplan documentation, has resulted in a reduction of denials over a one-year period of from 16-18/month to 3-4/month with a concomitant additional saving to patients of $5,720,753. The expansion to an additional site over the evaluation period has preliminarily resulted in a 48% decrease in financial toxicity for patients as compared to the previous year. Conclusions: A reality of clinical practice is an ever-present fiscal tension between payers, patients and providers, with payers adopting increasingly complex rules and regulations to avoid payment of charges. When this occurs, patients inevitably sustain increased out-of-pocket charges and anxiety, contributing to the pattern of financial toxicity. The approach of using technical support staff to prospectively avoid insurance denials can be scaled universally to ensure that health insurance payers, while adhering to their defined rules and regulations, are held accountable for their contractual obligations.

Financial toxicity of patients with lung cancer in China: Results from a National Survey Study.

To develop a comprehensive understanding of financial toxicity (FT) among patients with lung cancer in China and the major factors affecting FT. Drawing from a national cross-sectional survey, which used the validated comprehensive score for financial toxicity (COST) questionnaire, we estimated the prevalence and degree of FT. Patient coping actions were investigated. Pearson's chi tests and multinomial logistic regression were used to evaluate the predictors of FT in patients with lung cancer. The median score of FT was 20 (scored on a range of 0-44, with lower scores indicating more severe toxicity). Altogether, 77% of the sample patients had FT (COST <26), 54.5% had mild FT (COST 14-25), and 22.5% had moderate and severe FT (COST 0-13). Living in the less-developed western region of China, being male, having a lower educational level, lower annual family income, and advanced stage or worse self-reported health status were significantly related to higher FT than their counterparts (p< 0.05). Patients with higher FT tended to have a lower level of medical compliance, a higher risk of incurring debts, and reduced living expenditures relative to those with lower FT. Despite China's remarkable progress in the past two decades with regard to Universal Healthcare Coverage, FT still presents a serious challenge for patients with lung cancer. Keen attention must be paid to reducing the disproportionate high financial risks of patients with low socioeconomic status.

Preferred cost communicator in BRCA mutation carriers (483)

<b>Objectives:</b> Prior research has established Financial Toxicity (FT), the cumulative financial burden experienced by patients due to medical care, as a significant adverse outcome of medical treatment. As a result, professional medical societies have encouraged physicians to discuss FT with their patients, but data on patient preference surrounding these conversations are limited. Assessment of FT in <i>BRCA</i> mutation carriers has been largely unstudied. This analysis represents nascent research on FT in this high-risk patient population and examines preferences of <i>BRCA</i> mutation carriers related to their costs of care, including preferred cost communicator (the person with whom they would most prefer to discuss the costs of their medical treatment). <b>Methods:</b> This abstract represents a subanalysis of our novel, crosssectional study of FT in patients with <i>BRCA1/2</i> mutations. <i>BRCA+</i> patients were recruited via phone and/or email; patients who agreed to participate completed consents and surveys on RedCap. The COST tool, a validated measure, was used for the assessment of FT. COST scores were divided into tertiles, with high FT defined as COST score < 24. Cost communication preferences, demographics, and medical history were also assessed. <b>Results:</b> A total of 76 <i>BRCA</i> positive female patients who met enrollment criteria had responded at the time of this analysis. Most patients (58.9%) responded that they would like to know the out- of-pocket (OOP) costs of their treatment before receiving it. When surveyed regarding preferred cost communicator, most patients (32.8%) preferred to speak with a financial counselor, with 27.6% preferring a physician. When dividing patients into high FT <i>(n</i> = 23) and low/medium FT groups (<i>n</i> = 39), no differences were seen in desire to know OOP costs beforehand (60.9% vs 59%, <i>p</i> = 0.61). Preferred cost-communicator did not differ statistically amongst high and low/medium FT groups (<i>p</i> = 0.16). However, a trend was seen where patients with high FT were more likely to want to speak with a physician about the cost of care (31.8% vs 30.8%). In contrast, patients with low FT were more likely than their high FT counterparts to want to speak to a financial counselor (35.9% vs 27.3%) or social worker (20.5% vs 9.1%) about their costs of care. <b>Conclusions:</b> This is the first study of <i>BRCA+</i> patients' cost communication preferences. As previously reported, financial toxicity exists in this high-risk patient population, and there is a strong patient desire to better understand their own OOP costs. Patients' preferences for discussing care with financial counselors, regardless of their FT severity, indicate that multidisciplinary teams may be beneficial for addressing questions about the costs of care. Additional research with larger patient populations is needed to better understand preferred cost communicator trends seen amongst FT groups, with low/ mid FT groups seeming to prefer discussion about costs with nonpractitioners and high FT patients preferring physician counseling.

Factors associated with increased financial toxicity after the completion of radiation treatment for gynecologic cancer (512)

<b>Objectives:</b> Financial toxicity (FT) impacts approximately 50% of patients with gynecologic malignancies. Still, little is known about factors that predispose patients receiving radiation therapy to financial distress or what impact the COVID-19 pandemic had on their financial well-being. We evaluated FT in patients with gynecologic cancer treated with radiation before and after the start of the COVID- 19 pandemic. <b>Methods:</b> Patients from an urban, academic gynecologic radiation oncology practice completed a survey one month after completing radiation from August 2019-March 2020 and November 2020-June 2021. The survey included demographic questions, the Comprehensive Score for Financial Toxicity (COST) tool, and the EQ-5D to measure the quality of life (QOL). Pandemic-related questions were added during the second survey period (pandemic cohort). As with our prior work, high FT was defined as a COST score of ≤23. We assessed the correlation of COST scores with QOL. We used logbinomial regression to examine associations between FT and costcoping strategies, adjusting for age and insurance. <b>Results:</b> Of 97 respondents (92% response rate), 49% completed the survey before, and 51% completed it after the pandemic started. Among the participants, 76% identified as White, 11% as Black, and 8% as Asian. Most patients had uterine (64%), followed by cervical (24%) and vaginal (6%) cancer. Two-thirds (60%) received external beam radiation with or without brachytherapy; the remaining 40% had brachytherapy alone. The median COST score was 15 (IQR: 7-19) in the high FT group (<i>n</i>=27) and 33 (IQR: 28-36) in the low FT group (<i>n</i>=70). High FT correlated with worse QOL (r=-0.37, p<0.01) and was associated with younger age and type of insurance (both p <0.03). Patients with high FT were more likely to move from full- to parttime employment (22% vs 1%, p<0.01), six (95% CI: 1.0-36) times more likely to delay/avoid medical care, 14 (95% CI: 3-64) times more likely to borrow money, and seven (95% CI: 2-27) times as likely to reduce spending on basic goods. Patients with high FT were more likely to report that decreased ability to work (48% vs 13%), medical bills (41% vs 13%), and transportation or parking (15% vs 3%) mostly contributed to their financial stress (p<0.05 for all). The pandemic cohort had fewer patients with high FT than the pre-pandemic cohort (20% vs 35%, p=0.10) and a higher median COST score (32 [IQR: 25-35] vs 27 [IQR: 19-34], p=0.07). The use of cost-coping strategies did not differ between cohorts. <b>Conclusions:</b> Privately insured, younger patients who received radiation for gynecologic cancer were at risk for FT. High FT correlated with worse QOL and was associated with delays or avoidance of medical care and other cost-coping strategies. The prevalence of high FT was not statistically different before and during the pandemic, though we observed less FT in the pandemic cohort. More work is needed regarding the impact of the COVID-19 pandemic on the financial well-being of patients with cancer.

Subjective Financial Hardship due to Medical Bills Among Patients With Heart Failure in the United States: The 2014–2018 Medical Expenditure Panel Survey

Heart failure (HF) poses a substantial economic burden on the United States (US) health care system. In contrast, little is known about the financial challenges faced by patients with HF. In this study, we examined the scope and sociodemographic predictors of subjective financial hardship due to medical bills incurred by patients with HF. In the Medical Expenditure Panel Survey (MEPS; years 2014--2018), a US nationally representative database, we identified all patients who reported having HF. Any subjective financial hardship due to medical bills was assessed based on patients' reporting either themselves or their families (1) having difficulties paying medical bills in the past 12 months, (2) paying bills late or (3) being unable to pay bills at all. Logistic regression was used to evaluate independent predictors of financial hardship among patients with HF. All analyses took into consideration the survey's complex design. A total of 116,563 MEPS participants were included in the analysis, of whom 858 (0.7%) had diagnoses of HF, representing 1.8 million (95% CI 1.6-2.0) patients annually. Overall, 33% (95% CI 29%-38%) reported any financial hardship due to medical bills, and 13.2% were not able to pay bills at all. Age ≤ 65 years and lower educational attainment were independently associated with higher odds of subjective financial hardship due to medical bills. Subjective financial hardship is a prevalent issue for patients with HF in the US, particularly those who are younger and have lower educational attainment. There is a need for policies that reduce out-of-pocket costs for the care of HF, an enhanced identification of this phenomenon in the clinical setting, and approaches to help minimize financial toxicity in patients with HF while ensuring optimal quality of care.

Financial Toxicity Intervention Improves Outcomes in Patients With Hematologic Malignancy.

Patients with hematologic malignancies are extremely vulnerable to financial toxicity (FT) because of the high costs of treatment and health care utilization. This pilot study identified patients at high risk because of FT and attempted to improve clinical outcomes with comprehensive intervention. All patients who presented to the Levine Cancer Institute's Leukemia Clinic between May 26, 2019, and March 10, 2020, were screened for inclusion by standardized two question previsit survey. Patients screening positive were enrolled in the comprehensive intervention that used nurse navigators, clinical pharmacists, and community pro bono financial planners. Primary outcomes were defined as improvement in mental and physical quality of life in all patients and improvement in overall survival in the high-risk disease group. One hundred seven patients completed comprehensive intervention. Patients experiencing FT had increased rates of noncompliance including to prescription (16.8%) and over-the-counter medications (15.9%). The intervention resulted in statistically significantly higher quality of life when measured by using Patient-Reported Outcomes Measurement Information System physical (12.5 ± 2.2 v 13.7 ± 1.8) and mental health scores (11.4 ± 2.2 v 12.4 ± 2.2; all P < .001). In patients with high-risk disease (as determined by using disease-specific scoring systems), risk of death in those receiving the intervention was 0.44 times the risk of death in those without the intervention after adjusting for race, and treatment with stem-cell transplant, oral chemotherapy, or immunotherapy (95% CI, 0.21 to 0.94; P = .034). Screening and intervention on FT for patients with hematologic malignancies is associated with increased quality of life and survival.

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach.

Approximately one-half of individuals with cancer face personal economic burdens associated with the disease and its treatment, a problem known as financial toxicity (FT). FT more frequently affects socioeconomically vulnerable individuals and leads to subsequent adverse economic and health outcomes. Whereas multilevel systemic factors at the policy, payer, and provider levels drive FT, there are also accompanying intervenable patient-level factors that exacerbate FT in the setting of clinical care delivery. The primary strategy to intervene on FT at the patient level is financial navigation. Financial navigation uses comprehensive assessment of patients' risk factors for FT, guidance toward support resources, and referrals to assist patient financial needs during cancer care. Social workers or nurse navigators most frequently lead financial navigation. Oncologists and clinical provider teams are multidisciplinary partners who can support optimal FT management in the context of their clinical roles. Oncologists and clinical provider teams can proactively assess patient concerns about the financial hardship and employment effects of disease and treatment. They can respond by streamlining clinical treatment and care delivery planning and incorporating FT concerns into comprehensive goals of care discussions and coordinated symptom and psychosocial care. By understanding how age and life stage, socioeconomic, and cultural factors modify FT trajectory, oncologists and multidisciplinary health care teams can be engaged and informative in patient-centered, tailored FT management. The case presentations in this report provide a practical context to summarize authors' recommendations for patient-level FT management, supported by a review of key supporting evidence and a discussion of challenges to mitigating FT in oncology care. CA Cancer J Clin. 2022;72:437-453.

Patient-reported financial toxicity within the Italian public healthcare system: a single center cross-sectional analysis in patients with cancer

PROFFIT (Patient Reported Outcome for Fighting FInancial Toxicity of cancer) questionnaire has been developed in Italy, within a universal healthcare system, for measuring financial toxicity (FT) in patients with cancer and understanding its determinants. Our aim was to describe the amount of FT in patients with cancer, by using the PROFFIT questionnaire in subjects … Continued

Financial toxicity in patients with lung cancer: a scoping review protocol

IntroductionLung cancer has the second-ranked morbidity rate and the first-ranked mortality rate worldwide. With the progression of the cancer condition and the advancement of new treatments, the corresponding medical expenses...

Databases for Gastrointestinal Clinical and Public Health Research: Have Database, Will Research

Databases for Gastrointestinal Clinical and Public Health Research: Have Database, Will Research

Abstract P5-14-07: Financial toxicity in BRCA1 and BRCA2 carriers: A pilot study

Abstract Objective: Financial toxicity (FT), the cumulative financial burden experienced by patients due to medical care, is a well-established phenomenon. BRCA mutation carriers have increased cancer risk, require frequent screening, and often undergo prophylactic surgery, all risk factors for FT. Our primary aim in this study was to describe rates of FT among BRCA carriers. Methods: We performed a novel, cross-sectional study of FT in patients with BRCA1/2 mutations. Patients were recruited via phone and/or email; patients who agreed to participate completed consents and surveys on RedCap. The COST tool, a validated measure, was used for assessment of FT; scores were divided into tertiles, with high FT defined as COST score ≤ 24. Results: 265 BRCA positive female patients met enrollment criteria; 76 (28.7%) had responded at time of this analysis. Respondents were primarily non-Hispanic White (97.4%), privately insured (82.9%), employed full time (67.1%) with an annual income of $50,000-$99,000 (40.8%) and a mean age of 46.4 years. Fifty-nine patients (77.6%) reported undergoing prophylactic surgery related to their BRCA status. On chart review, 26 patients (34.2% of all respondents) had a confirmed prophylactic mastectomy and 44 patients (57.9%) had a confirmed bilateral salpingo-oophorectomy, with some patients undergoing both procedures. Cost concerns were widespread among respondents; 22.7% of participants reported delaying or avoiding care secondary to finances. Fifty-eight percent of patients wanted to know about the out-of-pocket costs of treatments before receiving them, but only 7.7% reported that costs were discussed. No statistically significant association was seen amongst the high FT and low/medium FT groups re: annual income, insurance type, marital status, or race. Patients with high FT were more likely to engage in all cost-saving measures, with a striking 41.7% of patients reporting delays/avoidance of care due to cost (p=0.02). High FT patients also were more likely to borrow money (16.7%, p=0.01), use savings for care (54.2%, p=0.04), and reduce spending on both necessities (37.5%, p=0.03) and leisure activities (58.3%, p=0.01). Conclusion: This study of financial toxicity in BRCA carriers shows that many patients desire information about the costs of their care and that financial toxicity is an existing issue in this unique patient population. This work serves as the first description of FT in BRCA carriers and supports efforts to incorporate routine counseling on cost in the clinical care of these high-risk patients. Citation Format: Ellie M Proussaloglou, Alex Rosenthal, Christina Raker, Jennifer Scalia Wilbur, Katrin E Eurich, Ashley Stuckey, Katina Robison. Financial toxicity in BRCA1 and BRCA2 carriers: A pilot study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-14-07.

Risk factors for financial toxicity in patients with gynecologic cancer

The cost of cancer care is high and rising. Evidence of increased patient cost burden is prevalent in the medical literature and has been defined as "financial toxicity," the financial hardship and financial concerns experienced by patients because of a disease and its related treatments. With targeted therapies and growing out-of-pocket costs, patient financial toxicity is a growing concern among patients with gynecologic cancer. This study aimed to determine the prevalence of financial toxicity and identify its risk factors in patients with gynecologic cancer treated at a large cancer center using objective data. Using institutional databases, we identified patients with gynecologic cancer treated from January 2016 to December 2018. Patients with a preinvasive disease were excluded. Financial toxicity was defined according to institutionally derived metrics as the presence of ≥1 of the following: ≥2 bills sent to collections, application or granting of a payment plan, settlement, bankruptcy, financial assistance program enrollment, or a finance-related social work visit. Clinical characteristics were gathered using a 2-year look-back from the time of the first financial toxicity event or a randomly selected treatment date for those not experiencing toxicity. Risk factors were assessed using chi-squared tests. All significant variables on univariate analysis were included in the logistic regression model. Of the 4655 patients included in the analysis, 1155 (25%) experienced financial toxicity. In the univariate analysis, cervical cancer (35%), stage 3 or 4 disease (24% and 30%, respectively), younger age (35% for age <30 years), nonpartnered marital status (31%), Black (45%) or Hispanic (37%) race and ethnicity, self-pay (48%) or commercial insurance (30%), clinical trial participation (31%), more imaging studies (39% for ≥9), ≥1 emergency department visit (36%), longer inpatient stays (36% for ≥20 days), and more outpatient clinician visits (41% for ≥20 visits) were significantly associated with financial toxicity (P<.01). In multivariate analysis, younger age, nonpartnered marital status, Black and Hispanic race and ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits were significantly associated with financial toxicity. Financial toxicity is an increasing problem for patients with gynecologic cancer. Our analysis, using objective measures of financial toxicity, has suggested that demographic factors and healthcare utilization metrics may be used to proactively identify at-risk patients for financial toxicity.

Cost of Pediatric Acute Lymphoblastic Leukemia Care in the Current Treatment Era

Introduction: Acute lymphoblastic leukemia (ALL) is the most common malignancy of childhood, with a current incidence of 3,000 cases annually. Incremental alterations in treatment over time have resulted in overall survival rates that now exceed 90%. Although minor differences exist between ALL treatment protocols from different cooperative groups, risk-stratified treatment for ALL is generally standard across the country. As more has been understood about ALL biology and outcomes, treatments have been further risk stratified to optimize outcomes for higher risk individuals while minimizing toxicities for those with more favorable disease characteristics. With the improvements in outcome for ALL, cost of care is a critical component and financial toxicity for patients and society requires evaluation.Methods: Using commercial insurance data from the OptumLabs ® Data Warehouse, a cohort of 1941 ALL patients was identified, aged 1-30 years and diagnosed between 2000 and 2017 in the United States. ALL diagnosis was confirmed based on ICD-9 and ICD-10 diagnostic codes, in combination with bone marrow and lumbar puncture procedure codes within 14 days of diagnosis. Individuals were followed up to 36 months from diagnosis. Mean monthly and cumulative costs were computed for the initial 8 months of therapy and for 36 months from diagnosis, as were mean number of inpatient and outpatient days. Costs were further broken down by the types of services provided. All results were stratified by age group (1-9 years, 10-12 years, ≥13 years) as a proxy for risk group, with the younger group most consistent with standard risk disease and the older groups indicating high risk and very high risk disease, respectively.Results: Among the 1941 identified ALL patients (1-9 years, 1233; 10-12 years, 162; ≥13 years, 546), 44% were female, 51% were white, median age at diagnosis was 6 years (interquartile range 3-14 years) and 941 of enrolled patients had continuous data through 36 months. Mean cost of care over the approximate 3 years of therapy was $537,000, with approximately 58% of costs incurred within the initial intensive 8 months of therapy. Mean cost was highest among the ≥13 year age group, both for the initial 8 months of therapy ($487,000, 95% CI $449,300-530,400)), as well as over the 36 months following diagnosis ($850,000, 95% CI $778,400-937,100) (Figure). This was reflective of the highest mean number of inpatient days among the ≥13 year age group (88.1 days over 36 months, 95% CI 82.1-94.9) compared to the 10-12 year group (73.2 days, 95% CI 64.3-85.1) and the 1-9 year group (47.5 days, 95% CI 45.2-50.9). Mean number of outpatient visits over 36 months was not significantly different between 1-9 and 10-12 year age groups but was significantly higher among the ≥13 year age group compared with the 1-9 year group. Thirty-six month survival varied by age group and was highest among the 1-9 year group (95.9%, 95% CI 94.6-97.2) compared with the 10-12 year group (90.5%, 95% CI 85-4-95.8) and the ≥13 year group (79.6%, 95% CI 75.8-83.6).Conclusions: This robust real-world cost analysis shows for the first time that the average cost of ALL care in the current treatment era, including inpatient and outpatient data, is more than $500,000. We showed that the cost of care is highest among the oldest pediatric age group, indicating increasing cost with increased therapeutic intensity. This study provides a valuable benchmark that can be used to analyze the financial toxicity of ALL therapy on patients and families and can be re-assessed over time as novel therapeutics are introduced into ALL therapy. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Predictors of Financial Toxicity in Patients Receiving Concurrent Radiation and Chemotherapy

<h3>Purpose/Objective(s)</h3> Financial toxicity (FT) is an increasingly recognized concern for cancer patients. We reviewed prospectively collected data to explore factors associated with FT among patients undergoing concurrent chemotherapy and radiation therapy (CRT) within an urban, academic radiation oncology department serving a diverse patient population. <h3>Materials/Methods</h3> The study population was drawn from three prospective trials at our institution of patients receiving concurrent curative-intent CRT. FT was evaluated using weekly EORTC QLQ-C30 questionnaire assessments during the concurrent CRT course. FT was rated on a 4-point Likert scale ranging from experiencing "no" FT to "very much". Patients were classified as having FT if they answered anything other than "no". Rate of change of FT per 30 days was calculated for each patient using linear regression. Those with a rate of increase ≥ 1 point per month were categorized as having treatment-related FT. Chi squared, t test, and logistic were used as appropriate to assess patient demographics, tumor characteristics, and hospitalization as predictors of FT. <h3>Results</h3> 235 patients were included: 32% had head & neck cancer, 29% gastrointestinal primary, 27% lung cancer, 9% cervix cancer, and 4% glioblastoma multiforme. 34% of the study population identified as Black or African American, and 38% identified as Hispanic. On average, patients completed QLQ-C30 5.4 times. Before starting CRT, 52% of patients reported experiencing at least some FT. Higher T stage (<i>P</i> = 0.003) was associated with FT before CRT on bivariate analyses. On multivariate analysis, younger age (OR = 1.06, <i>P</i> = 0.02) was associated with higher FT before CRT after adjusting for age, race, insurance, socioeconomic status, and stage. The mean rate of change in FT was 0.23 points per month. 26% of patients demonstrated treatment-related FT. Experiencing FT before CRT was not associated with treatment-related FT (<i>P</i> = 0.693). Hospitalization during RT (<i>P</i> = 0.015) and cervical cancer diagnosis (<i>P</i> = 0.032) were associated with treatment-related FT. On multivariate analyses, hospitalization (OR 2.92, <i>P</i> = 0.008) was associated with treatment-related FT after adjusting for age, race, insurance, and stage. <h3>Conclusion</h3> Over half of patients reported FT prior to starting CRT. Reassuringly, most patients did not experience a significant increase in FT over the course of concurrent CRT. However, around a quarter of patients did experience treatment-related FT, which was associated with hospitalization during treatment. The finding that patients experience FT prior to CRT start suggests that FT should be evaluated as soon as cancer is diagnosed to allow for early intervention. Further research will help define mechanisms of FT and design interventions to improve FT and avoid hospitalizations.

Assessing financial toxicity in patients with metastatic breast cancer: A single institution experience during the COVID-19 pandemic.

176 Background: Assessment of financial toxicity (FTox) is recommended as a component of comprehensive supportive care for patients with metastatic cancer. FTox is common in patients with metastatic breast cancer (MBC) and is associated with poor quality of life. Available data suggest many patients with cancer have faced financial hardship during the COVID-19 pandemic. Methods: We evaluated FTox using the COmprehensive Score for Financial Toxicity (COST) measure in patients with MBC at Johns Hopkins clinical sites. Respondents were patients with MBC who completed the COST measure as part of the baseline assessment for one of two IRB-approved quality improvement projects initiated during the COVID-19 pandemic: 1) a pilot project evaluating incorporation of patient-reported outcome (PRO) measures into routine care (RC), and 2) a needs assessment prior to attending a multi-disciplinary clinic (MultiD-C) focusing on supportive care. COST scores range from 0-44 with higher scores indicating better financial well-being. FTox was graded as: Grade 0 (G0): &gt;26, Grade 1 (G1): &gt;14-26, Grade 2 (G2): &gt;0-14 and Grade 3 (G3): 0. Results: 40 patients with MBC completed the COST measure May 2020 through April 2021 as a component of RC and 17 patients with MBC completed the COST measure September 2020 through May 2021 in advance of anticipated attendance at the MultiD-C. Median age (range) for RC and MultiD-C respondents was 64 (36-85) and 55 (37-75) years, respectively. 4 (10%) and 4 (24%) of RC and MultiD-C respondents respectively reported household income &lt; $50,000. The majority of respondents in both groups were White [RC: 28 (70%), MultiD-C: 14 (82%)], non-Hispanic [RC: 36 (90%), MultiD-C: 16 (94%)], had more than high school education [RC: 37 (93%), MultiD-C: 17 (100%)] and all were insured. 27 (68%) of RC respondents and 11 (65%) of MultiD-C respondents were receiving oral cancer therapies. COST scores and grading are shown in the Table. Approximately half of the respondents in each group reported their illness has been at least “a little bit” of a financial hardship [RC: 22 (55%), Multi-D: 8 (47%)]. Conclusions: Patients with MBC receiving care during the COVID-19 pandemic frequently report FTox. Implementation of routine assessment for FTox via PRO measures and identification of strategies to support patients with MBC experiencing FTox are priorities both during the pandemic and beyond.[Table: see text]

Financial toxicity in patients with gynecologic malignancies

<h3>Objectives:</h3> Financial toxicity is a growing burden in cancer survivors caused by the cost of treatment. This study aims to evaluate financial toxicity among gynecologic oncology patients and to assess patient related risk factors. <h3>Methods:</h3> This is a single institution cross sectional survey study that included two survey tools, as well as patient demographics and disease characteristics. Financial toxicity is measured by validated Comprehensive Score for Financial Toxicity (COST) tool, which uses responses to eleven items to generate a composite measure of financial burden ranging from 0 to 44, with lower scores indicating higher financial toxicity. Participants were also asked to complete a 55-question-survey on attitudes and perspectives surrounding cost of care. Descriptive statistics was used to report patient demographics. Correlation matrix was calculated to assess the relation between financial toxicity and patient/disease related variables. Graphpad Prism Software Version 8.0 was used for analyses. <h3>Results:</h3> A total of 50 patients with various gynecologic malignancies were enrolled. Overall, 48% had ovarian (24/50), 40% had endometrial (20/50), 8% had cervix (4/50), 2% had vulva (1/50) and 2% (1/50) had vaginal cancers. Mean age at cancer diagnosis was 60.6 years. Eighty percent (40/50) of the patients were receiving treatment at the time of enrollment, while 20% were under surveillance. Twenty two percent (9/41) were actively treated in a clinical trial at the time of survey completion, although overall enrollment was 40% (20/50) since diagnoses. Eighty percent (40/50) of the patients had private insurance, 4% (2/50) had Medicare, 10% (5/50) had Medicare with supplement, 4% (2/50) had Medicaid and 2% (1/50) had Medicaid with supplement. Overall median COST score was 20.5 (range 1 - 33). Correlation matrix analysis showed that COST score is correlated with age (r= -0.3, p=0.02) and malignancy type (r= -0.3, p=0.03). Ovarian cancer patients had significantly less financial toxicity (median COST score=23) when compared to patients with other gynecologic malignancies (median COST score=17, p=0.04). Ovarian cancer patients reported higher annual income when compared to non-ovarian (Table). When scores were dichotomized into low (score ≥ 22) and high toxicity (score < 22), 58% (29/50) of the patients were noted to have high financial toxicity. Enrollment to a clinical trial did not significantly alleviate financial burden. Patients, who were enrolled in clinical trials, had a median COST score of 23, while the median score was 18 in patients, who were not in clinical trials (p=0.2). <h3>Conclusions:</h3> Financial toxicity is a significant burden even among highly insured gynecologic oncology patients. Increased awareness of physicians and cost coping strategies are needed to optimize quality of care.

Correlates of financial toxicity in adult cancer patients and their informal caregivers.

Financial toxicity is commonly reported by cancer patients, but few studies have assessed caregiver perceptions. We aimed to validate the modified Comprehensive Score for Financial Toxicity (COST) in cancer caregivers, identify factors associated with financial toxicity in both patients and caregivers, and assess the association of caregiver financial toxicity with patient and caregiver outcomes. Using a convenience sampling method, 100 dyads of adult cancer patients and a primary caregiver visiting outpatient oncology clinics (Jan-Sep 2019) were recruited. We assessed the internal consistency and convergent and divergent validity of the modified COST. Multivariable analyses identified correlates of financial toxicity. Association of financial toxicity with care non-adherence, lifestyle-altering behaviors (e.g., home refinance/sale, retirement/saving account withdrawal), and quality of life (QOL) was investigated. Recruited patient vs. caregiver characteristics were as follows: mean age: 60.6 vs. 56.5; 34% vs. 46.4% female; 79% vs. 81.4% white. The caregiver COST measure demonstrated high internal consistency (Cronbach α = 0.91). In patients, older age (B, 0.3 [95% CI, 0.1-0.4]) and higher annual household income (B, 14.3 [95% CI, 9.3-19.4]) correlated with lower financial toxicity (P < 0.05). In caregivers, lower patient financial toxicity (B, 0.4 [95% CI, 0.2-0.6]) and cancer stages 1-3 (compared to stage 4) (B, 4.6 [95% CI, 0.4-8.8]) correlated with lower financial toxicity (P < 0.05). Increased caregiver financial toxicity correlated with higher care non-adherence in patients, increased lifestyle-altering behaviors, and lower QOL in patients and caregivers (P < 0.05). The COST measure can also be used to assess caregiver financial toxicity. Caregivers' financial toxicity was associated with negative outcomes for both dyad members.

Financial Toxicity in Head and Neck Cancer Patients Treated With Proton Therapy.

Cancer-related financial toxicity impacts head and neck cancer patients and survivors. With increasing use of proton therapy as a curative treatment for head and neck cancer, the multifaceted financial and economic implications of proton therapy—dimensions of “financial toxicity”—need to be addressed. Herein, we identify knowledge gaps and potential solutions related to the problem of financial toxicity. To date, while cost-effectiveness analysis has been used to assess the value of proton therapy for head and neck cancer, it may not fully incorporate empiric comparisons of patients' and survivors' lost productivity and disability after treatment. A cost-of-illness framework for evaluation could address this gap, thereby more comprehensively identifying the value of proton therapy and distinctly incorporating a measurable aspect of financial toxicity in evaluation. Overall, financial toxicity burdens remain understudied in head and neck cancer patients from a patient-centered perspective. Systematic, validated, and accurate measurement of financial toxicity in patients receiving proton therapy is needed, especially relative to conventional photon-based strategies. This will enrich the evidence base for optimal selection and rationale for payer coverage of available treatment options for head and neck cancer patients. In the setting of cancer care delivery, a combination of conducting proactive screening for financial toxicity in patients selected for proton therapy, initiating early financial navigation in vulnerable patients, engaging stakeholders, improving oncology provider team cost communication, expanding policies to promote price transparency, and expanding insurance coverage for proton therapy are critical practices to mitigate financial toxicity in head and neck cancer patients.