Higher Financial Toxicity Research Articles

Financial Toxicity in Complex Gastrointestinal Surgery and Correlation with Patient Reported Outcomes.

To describe financial toxicity (FT) in patients who have undergone gastrointestinal (GI) surgery and its correlation with patients' emotional (EWB) and social well-being (SWB). FT describes the financial burden associated with treatment and its impact on patient outcomes. Few prior studies have examined FT in gastrointestinal surgery and its impact on patient quality of life. Patients who underwent gastrointestinal surgery at our institution were assessed for FT with a validated instrument between Jan 2022 and Jan 2023. EWB and SWB were assessed with a validated instrument. Risk factors for FT were determined using a multivariable model. The correlation between FT and patient EWB and SWB was assessed using Pearson correlation. 188 patients were surveyed, the majority had pancreatic resections (n = 90, 47.9%), 59 (31.4%) patients experienced FT. On multivariable analysis, categories associated with increased likelihood of exhibiting financial toxicity included single marital status and not receiving chemotherapy and/or radiation therapy, with odds ratio (95% C.I) of [3.02 (1.07, 8.51), P=.037] and [3.86 (1.3, 11.44), P=.015) respectively. Higher EWB and SWB scores directly correlated with higher FT scores. Patients undergoing complex gastrointestinal surgery often experience financial toxicity that affects patient reported outcomes. Financial toxicity is associated with identifiable pre-operative factors that can be utilized to screen patients for interventions that may mitigate some of the harmful effects of FT.

Correlation of a single-item measure of financial toxicity with overall score.

351 Background: Financial toxicity (FT) refers to the financial burden experienced by patients due to direct and indirect costs associated with their medical care. It has been linked to higher symptom burden, poorer clinical outcomes, quality of life, and psychological well-being and has been shown to extend beyond diagnosis and treatment. Despite the availability of validated tools to measure FT, no single-item screening measure has been validated yet. In the context where time constraints are the most cited reason for patients declining FT surveys, it is crucial to develop efficient tools that allow us to routinely screen patients for FT at different stages of their care. We, therefore, sought to establish item 12 (“My illness has been a financial hardship to my family and me”) of the Comprehensive Score for Financial Toxicity (COST) measure as a well-functioning screening item for FT. Methods: In this secondary analysis of 579 patients who completed a survey on financial toxicity screening preferences, items 1-11 were scored (including reversing 7 items per the version 2 scoring guidelines), with lower scores indicating worse FT. Analyses focused on establishing a correlation with the total score as well as examining item properties. Item 12 was also reverse scored, so lower scores mean greater hardship. Results: Item 12 had an item-total correlation of r = 0.63 (adjusted item-total correlation = .531). Similarly, a linear model with item 12 score as a predictor and total score as the outcome showed that increases of 1 point on item 12 is associated with around 3 total points on the full scale (b = 3.35, p < .001, adjusted R 2 = 0.28. Finally, item analysis with the graded-response item response theory (IRT) model showed very good discrimination (a = 2.10) for item 12, indicating that it can reliably distinguish between low and high FT in patients. IRT results also showed that the item functions as a nearly binary item with responses of “quite a bit” and “very much” corresponding to a high probability of high FT, while responses of “somewhat,” “a little bit,” and “not at all” corresponding to a high probability of low FT. Conclusions: This is the first validation of a single-item screening measure for RT. Overall, these results illustrate that item 12 is a good candidate for a single-item screener, with “quite a bit” and “very much” responses indicating a high likelihood of high FT.

National survey of patient perspectives on medication costs among co-pay assistance recipients with cancer.

246 Background: Individuals with cancer may seek assistance from co-pay assistance programs (CAPs) to help with high medication costs. However, little is known about these individuals’ perspectives on medication costs and their associations with other patient-reported outcomes (PROs). Methods: From 10-11/2022, we conducted a national, cross-sectional survey of CAP recipients with cancer, which asked about patient perspectives on medication costs (knowing monthly spending on medications, belief that health insurance would prevent high medication costs, and inability to afford care even with help paying for medications). We fit logistic regression models to describe associations between patient characteristics, including patient demographics and PROs (depression/anxiety symptoms [PHQ-4], financial toxicity [COST tool, score <14 indicates high financial toxicity], and health literacy [Brief Health Literacy Screener]), with patient perspectives. Results: Among 1,108 survey participants (median age=72 [range 41-92], 60% male sex), the most common cancer types were multiple myeloma (54%) and prostate cancer (13%). The majority of participants reported knowing their monthly spending on medications (75%); most believed their health insurance would prevent them from high medication costs (67%); under half reported an inability to afford care even with help paying for medications (41%). Factors associated with lower odds of knowing monthly medication spending included Black race (OR=0.45, P=.005), having Medicare Advantage (OR=0.73, P=.036), lack of supplemental insurance (OR=0.68, P=.011), more comorbidities (OR=0.52, P=.002), depression symptoms (OR=0.61, P=.013), and lower health literacy (OR=0.43, P<.001). Factors associated with believing that health insurance would prevent high medication costs were depression symptoms (OR=1.54, P=.02), anxiety symptoms (OR=1.40, P=.045), and financial toxicity (OR=2.24, P<.001). Factors associated with reporting an inability to afford care even with help paying for medications included Hispanic ethnicity (OR=2.55, P=.024), more comorbidities (OR=1.84, P=.003), depression symptoms (OR=3.16, P<.001), anxiety symptoms (OR=3.60, P<.001), and financial toxicity (OR=7.83, P<.001). Conclusions: In this large sample of CAP recipients with cancer, most reported knowing their monthly medication spending, believing health insurance would prevent high medication costs, and feeling able to afford care with help paying for medications. We identified patient characteristics associated with these perspectives and found correlations between depression/anxiety symptoms, financial toxicity, and low health literacy with greater concerns with medication costs. Effort to mitigate financial toxicity by reducing adverse effects of medication costs in oncology should consider patients’ perspectives and their impact on PROs.

An updated comparative analysis of needs and role of patient navigation among early phase cancer clinical trial participants and non-participants at a single cancer center.

237 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptom burdens. EPCTs may add to these burdens by requiring frequent, long visits and additional procedures. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters and SDoH barriers between the EPCT and non-EPCT pt groups. Results: From February 2023 to April 2024, 40 EPCT pts and 1290 non-EPCT pts completed the assessment. Median age was 60.5 and 63.1 years, respectively. Racial and ethnic self-identification included 17.5% vs. 19% Black pts and 10% vs. 17% Hispanic pts. EPCT pts had a mean 5.2 navigation encounters per pt compared to 3.05 in non-EPCT pts (p=0.002). Pts in the EPCT group were found to have an average of 2.8 SDoH barriers identified, in contrast to 2.0 in the non-EPCT group (p=0.002). The most common barriers identified in EPCT pts were institutional, knowledge, psychosocial and financial; in non-EPCT pts, transportation, institutional, knowledge and treatment adherence were most common. Interventions related to institutional barriers most frequently involved coordinating with the primary team and among departments. Interventions related to knowledge included providing education and teach back. Conclusions: EPCT pts had more SDoH barriers identified, higher acuity of barriers, and required more navigation encounters than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. EPCT pts Non-EPCT pts p value Navigation encounters, mean (SD) 5.20 (6.16) 3.05 (4.34) 0.002 SDoH barriers identified, mean (SD) 2.82 (1.83) 2.00 (1.66) 0.002

Association between food insecurity, financial toxicity, and healthcare utilization in adolescents and young adults with cancer.

305 Background: Adolescents and young adults with cancer experience high rates of financial toxicity (FT) and unmet health-related social needs (HRSN: food, housing, transportation insecurity). FT and unmet HRSN, specifically FI, are modifiable factors that impact health outcomes; however, the relationship between FI, FT, and healthcare utilization (emergency department (ED) visits or hospitalizations) remains unclear. Leveraging systematic screening for FT and HRSN using the electronic health record (EHR) patient portal among AYAs with cancer, we examined the association between FI, FT, and healthcare utilization measures among AYAs with cancer. Methods: AYAs (ages 15-39) who utilize the EHR patient portal were prompted to complete an 8-item standardized HRSN survey (i.e., food insecurity, housing instability, transportation difficulties) and a 2-item previously established FT survey during e-check in between November 2022 and April 2024. ED visits and hospitalizations were extracted from the EHR directly. Descriptive statistics and associations using chi-square tests were used to describe the patients and examine associations between FI or FT and ED visits or hospitalizations. Results: Of 691 AYAs who completed the HRSN survey, 16% (n=109) screened positive for FI. Among AYAs with FI, 42% (n=46) had at least one ED visit compared with 28% (n=163) among AYAs without FI (p<0.01). Among AYAs with FI, 39% (n=43) were hospitalized at least once compared to 31% (n=179) among AYAs without FI (p=0.07). Of 439 AYAs who responded to the FT survey, 66% (n=290) met criteria for high FT. Within this group, 26% (n=74) had at least one ED visit compared with 17% (n=26) who screened negative (p=0.06). Among AYAs with high FT, 22% (n=65) were hospitalized at least once, compared with 19% (n=28) among those with low or moderate FT (p=0.38). Among 384 AYAs who responded to both the HRSN and FT surveys, 19% (n=74) screened positive for FI, 92% (n=68) of whom also had high financial toxicity. The table describes characteristics of screened AYAs by language and race/ethnicity. Conclusions: FI may be a risk factor for increased ED visits during cancer treatment among AYAs. Systematic screening to identify FI, FT, and other HRSN is important to facilitate referral for resources, support services, or interventions. Sociodemographic characteristics of AYA participants in FI and FT screening. Characteristic +FI -FI +FT -FT N=109 (%) N=582 (5) p-value N=290 (%) N=149 (%) p-value Language <0.01 <0.01 English 82 (75) 496 (85) 241 (83) 134 (90) Spanish 24 (22) 45 (8) 29 (10) 1(1) Other 3 (3) 41 (7) 20 (7) 14 (9) Race/Ethnicity <0.01 <0.01 Hispanic, any race 67 (61) 175 (30) 125 (43) 16 (11) Non-Hispanic Black 12 (11) 62 (11) 30 (10) 10 (7) Non-Hispanic White 16 (15) 219 (38) 78 (27) 84 (56) Other 14 (13) 126 (22) 57 (20) 39 (26)

Longitudinal outcomes after financial toxicity and health-related social risks screening and referral.

17 Background: Financial toxicity (FT) is associated with delayed/omitted care, reduced quality of life, and worse mortality. Routine screening for FT and health-related social risks (HRSR) is recommended during clinical care, but there is limited longitudinal evidence on outcomes after patients screen positive and are referred for assistance. Methods: FT and HRSR screening for patients with breast, gynecologic, gastrointestinal, or thoracic cancers was implemented at an urban comprehensive cancer center. Screening included the Comprehensive Score for Financial Toxicity (COST) tool (0-44, lower scores=worse FT) and a HRSR checklist to identify food, housing, and transportation insecurity. COST score ≤16-20 or reported HRSR was a “positive” screen and counseling referral was offered: patients could accept the referral by identifying their current concerns. Analysis sample was limited to receiving chemotherapy, radiotherapy, or surgery 120 days prior to baseline survey and had a follow-up survey 4-12 months later. Data were collected 10/2022-12/2023. Results: 2196 patients met inclusion criteria, median time between surveys was 5.5 months (IQR 4.4, 6.9). 20% (n=438) screened positive and accepted referral; 11% (n=246) screened positive and declined referral; the remaining 69% (n=1512) screened negative. Sociodemographic factors of age (median 58 vs 62, p<.001), sex (82% vs 74% female, p =.015), and race (31% vs 17% racial/ethnic minority, p<.001) were associated with accepting vs declining referral. Those who accepted referral had lower COST scores (median 10 vs 19) and more HRSR (39% vs 20% housing; 32% vs 18% food; 37% vs 17% transportation) at baseline (all p≤.001). At follow-up, both cohorts had COST decrease, indicating worsened FT [mean difference (95% CI): accepted referral -2.0 (-2.8, -1.2) vs declined referral -2.8 (-4.0, 1.5)]. Across all collected HRSR, those who accepted referral had small benefits in previously reported HRSR, however were more likely to have newly designated HRSR (Table shows changes). Conclusions: Screening for FT and HRSR identified one-third of patients on recent cancer treatment with financial or social needs. Those who accepted financial assistance referral had significantly higher FT and more reported HRSR. Although referral did appear to have some benefit on initial needs, new HRSR were identified at follow-up. Future work will focus on optimizing available assistance to meet ongoing patient needs during and after cancer treatment. Accepted Referraln = 438 (%) Declined Referraln = 246 (%) Housing Resolved need 67 (15) 31 (13) New need 54 (12) 15 (6.1) Stable unmet need 102 (23) 18 (7.3) Stable no need 215 (49) 182 (74) Food Resolved need 64 (15) 31 (13) New need 69 (16) 16 (6.5) Stable unmet need 77 (18) 14 (5.7) Stable no need 228 (52) 185 (75) Transportation Resolved need 73 (17) 34 (14) New need 56 (13) 20 (8.1) Stable unmet need 87 (20) 8 (3.3) Stable no need 222 (51) 184 (75)

Abstract A100: Addressing financial toxicity and associated social determinants among Hispanic cancer patients in Puerto Rico

Abstract Introduction: Cancer is one of the most expensive medical conditions to treat due to the cost and duration of treatment. Financial toxicity (FT) describes the problems that a cancer patient has related to the cost of medical care, including subjective financial concerns. Despite the high burden of cancer, significant levels of poverty, and a fragile healthcare system in Puerto Rico (PR), no previous studies have evaluated FT among cancer patients in PR. Thus, we aimed to assess FT and associated social determinants among Hispanic cancer patients in PR. Methods: We are conducting a cross-sectional study through an online survey among cancer patients aged 21+ years who have received active cancer treatment over the last year. We use the COST-FACIT questionnaire, a validated survey composed of 12 questions; to measure low (score ≥ 21) and high (score < 21) FT. We also collect information on social determinants, including demographics, clinical characteristics, access to healthcare services, quality of life, social support, and patient navigation services, among others. Cronbach's alpha was used to assess the internal consistency of the FT score. Univariate (ULRM) and multivariate logistic regression models (MLRM) were used to determine the social determinants associated with FT. MLRM included significant variables in the ULRM (p < 0.10) and predictors supported by scientific literature. Results: As of April 8th, 2024, 387 people accessed the survey, with 294 (80.0%) completing it, including the FT section. The final sample size for this preliminary data analysis included 226 participants due to the exclusion of missing information on important covariates. Most of the participants were 51 to 64 years of age (46.9%), female (72.6%), had annual income < $25,000 (59.7%), and had a bachelor’s degree or higher (51.8%). COST-FACIT demonstrated good internal consistency (alpha=0.83). Approximately 46.0% of the participants had a high FT (overall FT mean score = 21.0±8.9). MLRM show that retired participants (OR: 0.22, 95%CI: 0.22-0.59) had less odds of high FT, while those who have public health insurance (OR: 2.38, 95%CI: 1.02-5.54), have comorbidities (OR: 2.27, 95%CI: 1.08-4.79), and have had a cancer diagnosis for more than 1 year (OR: 1.90, 95%CI: 1.02-3.53) have significantly higher odds of experiencing high FT. Conclusion: FT is higher among cancer patients with public health insurance, comorbidities, and more than one year since cancer diagnosis, but FT is lower in retired cancer patients. More research is needed to identify and evaluate interventions to address the FT of cancer treatment and the social determinants associated among Hispanic/Latino patients. IRB: This project was approved by the Institutional Review Board of the University of Puerto Rico Comprehensive Cancer Center (IRB # 2023-11-123). Citation Format: Marievelisse Soto-Salgado, Sofía Contreras-Fernández, Lorena González-Sepúlveda, Karina Torres-Mojica, Rocío Avilés-Mercado, Juan Paulo González-Mayoral, Nancy Cardona-Cordero. Addressing financial toxicity and associated social determinants among Hispanic cancer patients in Puerto Rico [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A100.

Association of shared decision-making with financial toxicity and coping actions in adult patients with cancer: a nationwide study in China

Abstract Objective Evidence on the impact of shared decision-making (SDM) on the financial toxicity (FT) of patients with cancer in real clinical settings is lacking. Using a nationwide patient survey in China, we aimed to identify the prevalence of SDM, FT as well as its consequent coping actions, and investigate their associations in adult patients with cancer. Methods A cross-sectional survey was administered to patients with cancer near discharge at 33 tertiary public cancer hospitals across China between January and March 2021. The FT was measured using the COST (comprehensive score for financial toxicity) tool and was categorized into 3 groups: no (COST 26-44), mild (COST 14-25), and moderate or severe (COST 0-13) FT. SDM was measured using 2 items from patient’s perspective. The surveyed questionnaire also included patient’s coping actions, demographics, and clinical information. Multinomial logistic regression was used to investigate the association between SDM and FT, and for sensitivity analysis, linear regression was also used taking the COST score as a dependent variable. Pearson’s chi-square tests were used for association analyses of coping actions with FT and SDM. Results A total of 5008 adult patients with cancer were included, of which 26.18%, 54.13%, and 19.69% patients were categorized as no FT, mild FT, and moderate or severe FT with the average COST score of 21.0 for all patients. Besides, 3943 (78.73%) patients reported a better SDM. Better SDM had significantly lower odds of developing high FT than worse SDM (adjusted ORmild vs no 0.50, 95% CI 0.39-0.56; adjusted ORmoderate or severe vs no 0.63, 95% CI 0.50-0.80). In sensitivity analysis, better SDM was significantly associated with higher COST scores (β: 1.34, 95% CI 0.85-1.83), which indicated lower FT. Patients with higher FT were more likely to take adverse coping actions including treatment nonadherence, limiting basic health service expense, reducing leisure activity expense, and loan. Conclusions Adult patients with cancer reporting worse SDM tended to experience higher FT and those with higher FT tended to take adverse coping actions. Understanding the impact of SDM on FT is crucial to inform early interventions designed to mitigate FT and consequent coping actions in cancer care practice.

Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Mixed Methods Approach to Identify Effective Interventions.

Financial toxicity associated with treatments for metastatic prostate cancer remains poorly defined. We sought to understand aspects of financial toxicity not captured in a commonly employed financial toxicity questionnaire and identify potential interventions to help alleviate financial toxicity through a convergent mixed methods approach. Patients seen at our institution's advanced prostate cancer clinic were approached for completion of the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire (quantitative analysis). A maximal variation purposive sample was chosen to participate in focus group discussions (qualitative analysis). Conventional content analysis was performed using an inductive approach. COST-FACIT scores were compared between patients experiencing high and low financial toxicity using Wilcoxon rank sum test. Three themes were identified through qualitative analysis: (1) workload, (2) coping strategies, and (3) communication. We found alignment with the existing theory of financial capacity across our findings. Two unique aspects of financial toxicity emerged that were not assessed quantitatively and deemed to be significant. Specifically, cost transparency (including health care teams knowledgeable about and willing to discuss costs) and inclusion of informal caregivers in financial toxicity screening and decision-making may guide future interventions aimed at limiting financial toxicity in this population. Prolonged treatment courses involving multiple lines of treatment with varying costs result in distinct financial toxicity components for patients with metastatic prostate cancer that are not assessed with COST-FACIT. Improving cost transparency, health care team knowledge and engagement, and providing resources to support informal caregivers may have a significant impact on the financial toxicity experienced by these patients.

Financial toxicity, coping strategies, and quality of life among Chinese patients with hematologic malignancies: a cross-sectional study.

Financial toxicity is used to describe the financial hardship experienced by cancer patients. Financial toxicity may cause negative consequences to patients, whereas little is known in Chinese context. This study aimed to explore the level of financial toxicity, coping strategies, and quality of life among Chinese patients with hematologic malignancies. We conducted a prospective, observational study among 274 Chinese patients with hematologic malignancies from November 2021 to August 2022 in Sun Yat-sen University Cancer Center. Clinical data were extracted from electronic clinical records. Data on financial toxicity, coping strategies, and quality of life were collected using PRO measures. Chi-square or independent t test and multivariate logistic regression were performed to explore the associated factors of financial toxicity and quality of life, respectively. Effects of financial toxicity on coping strategies were examined using Chi-square. The mean age of the participants was 50.2 (± 14.6) years. Male participants accounted for 57.3%. About half of the participants reported high financial toxicity. An average median of ¥200,000 on total medical expenditures since the diagnosis was reported. The average median monthly out-of-pocket health expenditure relating to cancer treatment was ¥20,000 (range ¥632-¥172,500) after reimbursement. Reduce daily living expenses (64.9%), borrowing money (55.7%), and choosing cheaper regimens (19.6%) were the commonly used strategies to cope with financial burden. Financial toxicity was negatively associated with quality of life (β = 0.071, P = 0.001). Financial toxicity was not uncommon in patients with hematological malignancies. Reducing daily living expenses, abandoning treatment sessions, and borrowing money were the strategies commonly adopted by participants to defray cancer costs. Additionally, participants with high level of financial toxicity tended to have worse quality of life. Therefore, actions from healthcare providers, policy-makers, and other stakeholders should be taken to help cancer patients mitigate their financial toxicity.

Implementing financial toxicity and health-related social risks screening and referral.

11006 Background: Financial toxicity (FT), or cancer-related economic hardship, is associated with delayed/skipped care, reduced quality of life, and worse mortality. Screening for FT and health-related social risks (HRSR) as part of assessment for social determinates of health is currently being integrated into clinical care, but there is limited research on outcomes after patients screen positive for FT or HRSR. Methods: We conducted FT and HRSR screening for patients receiving treatment for breast, gynecologic, gastrointestinal, or thoracic cancer at an urban comprehensive cancer center. Screening included the 11-item Comprehensive Score for Financial Toxicity (COST) tool (scored 0-44, lower scores = worse FT) and a HRSR checklist to identify food, housing, medicine, and transportation insecurity. A COST score ≤20 or any endorsed HRSR was considered a positive screen, and financial/assistance counseling referral was offered. Multivariable logistic regression assessed associations of accepting referral, after controlling for demographic and clinical characteristics. Data were collected 09/2022-08/2023. Results: 28,606 patients completed screening, of which 32% (n = 9106) screened positive. Median COST was 16.0. Identified HRSR were: 23% food, 25% housing, 21% medicine, and 24% transportation insecurity. Of positive screens, 51% (n = 4683) requested some form of financial counseling. Associations with accepted referral include: higher FT (β = 1.15, 95% CI: 1.13, 1.16), younger age (β = 1.01, 95% CI: 1.008, 1.02), more essential needs (β = 1.19, 95% CI: 1.13, 1.25), non-White race/ethnicity (β = 1.70, 95% CI: 1.49, 1.93), and stage 3 (β = 1.29, 95% CI: 1.08, 1.53) or stage 4 (β = 1.26, 95% CI: 1.07, 1.49) diagnoses (vs. stage 0/1). Needs of patients who requested counseling included concerns relating to out-of-pocket expenses (68%), non-medical expenses (39%), health insurance coverage (23%), and paying for prescription medication (18%; not mutually exclusive). Of financial counseling sessions with available dispositions (n = 2336/4683, 50%), outcomes (not mutually exclusive) included general counseling (29%), referral to specific assistance programs (e.g., copay assistance, reduced cost care program; 15%), and insurance navigation (15%). One-third of patients requesting counseling did not respond to contact attempts; 21% reported no longer being interested in counseling upon contact. Conclusions: Screening for FT and HRSR was feasible, and one-third of patients were identified as at risk for FT or having an unmet essential need. Patients known to have worse FT outcomes (those with later-stage disease, younger age, higher FT, minoritized groups) were more likely to accept financial counseling; however, only one-half of those at risk accepted help. Future work will focus on improving workflows to ensure assistance meets patient needs, including addressing patient stigma around requesting help.

National survey of patient perspectives on medication costs among co-pay assistance recipients with cancer.

11062 Background: Individuals with cancer may seek assistance from co-pay assistance programs (CAPs) to help with high medication costs. However, little is known about these individuals’ perspectives on medication costs and their associations with other patient-reported outcomes (PROs). Methods: From 10-11/2022, we conducted a national, cross-sectional survey of CAP recipients with cancer, which asked about patient perspectives on medication costs (knowing monthly spending on medications, belief that health insurance would prevent high medication costs, and inability to afford care even with help paying for medications). We fit logistic regression models to describe associations between patient characteristics, including patient demographics and PROs (depression/anxiety symptoms [PHQ-4], financial toxicity [COST tool, score <14 indicates high financial toxicity], and health literacy [Brief Health Literacy Screener]), with patient perspectives. Results: Among 1,108 survey participants (median age=72 [range 41-92], 60% male sex), the most common cancer types were multiple myeloma (54%) and prostate cancer (13%). The majority of participants reported knowing their monthly spending on medications (75%); most believed their health insurance would prevent them from high medication costs (67%); under half reported an inability to afford care even with help paying for medications (41%). Factors associated with lower odds of knowing monthly medication spending included Black race (OR=0.45, P=.005), having Medicare Advantage (OR=0.73, P=.036), lack of supplemental insurance (OR=0.68, P=.011), more comorbidities (OR=0.52, P=.002), depression symptoms (OR=0.61, P=.013), and low health literacy (OR=0.43, P<.001). Factors associated with believing that health insurance would prevent high medication costs were depression symptoms (OR=1.54, P=.02), anxiety symptoms (OR=1.40, P=.045), and financial toxicity (OR=2.24, P<.001). Factors associated with reporting an inability to afford care even with help paying for medications included Hispanic ethnicity (OR=2.55, P=.024), more comorbidities (OR=1.84, P=.003), depression symptoms (OR=3.16, P<.001), anxiety symptoms (OR=3.60, P<.001), and financial toxicity (OR=7.83, P<.001). Conclusions: In this large sample of CAP recipients with cancer, most reported knowing their monthly medication spending, believing health insurance would prevent high medication costs, and feeling able to afford care with help paying for medications. We identified patient characteristics associated with these perspectives and found correlations between depression/anxiety symptoms, financial toxicity, and low health literacy with greater concerns regarding medication costs. Efforts to mitigate financial toxicity by reducing adverse effects of medication costs in oncology should consider patients' perspectives and their impact on PROs.

A comparative analysis of needs and role of patient navigation among early-phase cancer clinical trial participants and non-participants at a single cancer center.

e23127 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptoms related to their cancer and previous treatments. EPCTs often require frequent visits and additional procedures which may be burdensome. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters, SDoH barriers and navigator interventions between the EPCT and non-EPCT pt groups. Results: From February to December 2023, 31 EPCT pts and 3126 non-EPCT pts completed the assessment. Median age was 55.9 and 56.1 years, respectively. Racial and ethnic self-identification included 13% vs. 23% Black pts and 19% vs. 20% Hispanic pts. EPCT pts had a mean 4.87 navigation encounters per pt compared to 1.94 in non-EPCT pts (p < 0.001). Pts in the EPCT group were found to have an average of 24.97 SDoH barriers identified, in contrast to 2.68 in the non-EPCT group (p < 0.001). The most common barriers identified in EPCT pts were institutional, knowledge, and psychosocial; in non-EPCT pts, institutional, treatment adherence, and transportation barriers were most common. Furthermore, based on the identified barriers, EPCT pts required an average of 17.23 interventions, compared to 1.80 among those not in the EPCT group (p < 0.001). Interventions most frequently involved coordination with the primary team and education for pts in both groups. Conclusions: EPCT pts had more navigation encounters, SDoH barriers identified, and resultant interventions than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. [Table: see text]

Common Sense Oncology: Equity, Value, and Outcomes That Matter.

While some recent drug treatments have been transformative for patients with cancer, many treatments offer small benefits despite high clinical toxicity, time toxicity and financial toxicity. Moreover, treatments that do provide substantial clinical benefits are not available to many patients globally due to issues with availability and affordability. The Common Sense Oncology's vision is that patients will have access to treatments that provide meaningful improvements in outcomes that matter, regardless of where they live. In recognition of the growing challenges in the field of oncology, Common Sense Oncology seeks to achieve this vision by improving evidence generation, evidence interpretation and evidence communication.

Change in financial toxicity during early-phase cancer clinical trial (EP-CT) participation.

11119 Background: The high costs of care (financial toxicity) represent a pressing concern in oncology. Little is known about the financial toxicity experienced by EP-CT participants. We sought to describe changes in financial toxicity during EP-CTs and assess associations of change in toxicity with patient characteristics, additional patient-reported outcomes (PROs), and trial reimbursement structure. Methods: We prospectively enrolled adults participating in EP-CTs from 4/2021 – 1/2023. We administered surveys at baseline (between enrollment and Day 1 of trial) and monthly during trial participation. We assessed financial toxicity using the COST tool, graded as low (≥26) and high (0–25) toxicity. We also surveyed baseline hope (Hope Herth Index), quality of life (QOL; FACT-G) and symptom burden (psychological: PHQ-4; physical: ESAS). We calculated within-patient changes in COST score and conducted linear mixed models, controlling for baseline COST score, to determine associations of change in financial toxicity with patient characteristics, baseline PROs, and trial reimbursement structure (using a factor x time interaction term). Results: Of 221 eligible patients, we enrolled 205 (median age = 63.3 years [range 32.8-88.6], 57.1% female). Most common tumors were GI (34.6%) and breast (20.0%). At trial start, 35.0% of patients reported high financial toxicity, 40.5% at 1 month, 33.6% at 2 months, 25.5% at 6 months, and 40.0% at 1 year. Within-patient COST score worsened over time (B=-0.20, p=0.059), although this change did not reach significance. We found no patient characteristics that significantly correlated with change in COST score, including age (B=-0.005, p=0.602), sex (B=-0.097, p=0.667), GI cancer (B=-0.11, p=0.118), annual income >$60,000 (B=-0.10, p=0.306), and current employment (B=-0.34, p=0.121). Higher baseline QOL was associated with increased COST score (financial wellbeing, while on trial (B=0.012, p=0.011); there was no significant association with other baseline PROs. Most patients (64.4%) enrolled on trials that offered reimbursement for study costs. Of those offering reimbursement, 40.1% had all research-specific costs reimbursed. There was no significant association between change in COST score and presence of any reimbursement (B=0.12, p=0.614) or presence of full reimbursement (B=-0.072, p=0.784). Conclusions: In this cohort of EP-CT participants, over one-third reported high rates of financial toxicity, which appeared relatively stable over time on trial. We did not identify any demographic factors associated with risk of worsening toxicity but did find that high baseline QOL may be protective. Trial reimbursement did not lead to improvement in financial wellbeing. Findings demonstrate that EP-CT participation may not place excess financial burden on at-risk patients and highlight the need to monitor for financial toxicity across all trial participants.

Financial toxicity in the background of free health care: A cross-sectional survey in a tertiary care hospital in India.

e13685 Background: The financial toxicity of cancer treatment is a known fact in low to middle-income countries due to poverty, lack of health insurance and illiteracy. We tried to estimate the financial strain and its contributing factors in an Indian population with access to free cancer treatment. Methods: All government employees and their dependents are eligible to receive free treatment including inpatient management, investigations and medicines at our institute. All cancer patients ≥18 years were invited to participate in a survey. The survey included their demographic, cancer and therapy details, the COST-FACIT questionnaire, and information about increase in expenses since cancer diagnosis and source of additional finances. Results: 300 cancer patients completed the survey. 61.3% of the respondents were females and the mean patient age was 43.14 years. Breast cancer was the most common malignancy and stage IV was the most common stage. 44% were residents of a rural area. The average duration of treatment was 8.03 months. Prior to cancer diagnosis, 37.2% of the patients had average monthly expenses between INR 10-25,000 (USD 120 to 300). The approximate increase in monthly expenditures after cancer diagnosis was between INR 5-10,000 (USD 60 to 120) for 33.4% and between INR 10-25,000 (USD 120 to 300) for 31.4% of the population. The primary income source for 65.7% respondents was the salary of the government employee while 48% had two or more earning members in the family. Cancer treatment negatively affected the earning capacity of the patient alone in 40% of the population, while in 28% it affected the earning capacity of the patient and caregiver. 51% had to utilise their savings, 39% sold fixed assets, and 31% borrowed or took a loan to cope with the additional financial strain. Commonest expenses were travel, accommodation, and food (75.7%). 34.5% spent money on other therapy-related costs (second opinion or alternative therapy). The mean COST-FACIT score was 21.38,(20-24) demonstrating mild financial toxicity. Predictors of high financial toxicity were a single-earning member, familial discord and long duration of treatment (> 6 months). Conclusions: Though all participants had access to free cancer treatment, all experienced mild financial toxicity due to non-therapeutic expenses. Despite desperate financial measures to complete treatment, most participants did not express severe financial toxicity. This may be attributed to the stigma of expected high expenditure associated with cancer treatment in India. COST-FACIT scoring may not have suitably assessed the financial strain experienced by patients with free healthcare. Additional financial information collected by the survey, (monthly expenses, earning members, source of additional funds), helped us to better understand financial impact of cancer treatment and identify gaps in our healthcare.

The Value of Patient-Reported Outcomes to Predict Symptom Burden and Health-Related Quality of Life After Chemoradiation for Cervical Cancer: A Prospective Study

Patients with cervical cancer undergoing chemoradiation have high symptom burden. We performed an analysis of prospectively collected data on patient-reported outcomes to determine characteristics predictive of poor treatment experience. Between 2021 and 2023, we prospectively collected data on patient-reported outcomes from patients with cervical cancer undergoing definitive chemoradiation. The European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Question-Core 30 and the EORTC-Quality of Life Question-Cervical Cancer module were completed at baseline (BL) and at the end of treatment (EOT). Poor treatment experience was defined as EOT poor health-related quality of life (HRQOL), low physical function, or significant overall symptom burden. Predictive factors analyzed included demographic, clinical, and disease-specific factors and BL financial toxicity, depression, social function, and emotional function. Receiver operating characteristic analysis provided appropriate predictive cutoff values. Univariable and multivariable (MVA) linear regression analyses were performed. Forty-nine patients completed BL and EOT questionnaires. Median age was 43 years (range, 18-85 years). Most patients (59%) had stage III disease. BL financial toxicity ≥66.7, depression ≥66.7, social function ≤50, and emotional function ≤58 on the EORTC linear transformed scale of 0 to 100 were significant predictors for poor treatment experience (p ≤ .04) based on receiver operating characteristic analysis. On MVA, poor BL social function was associated with reduced EOT HRQOL (β, -9.3; 95% CI, -16.1 to -2.6; p < .008), decreased physical function (β, -24.4; 95% CI, -36.3 to -12.6; p < .001), and high symptom burden (β, 26.9; 95% CI, 17.5-36.3; p < .001). Earlier disease stage predicted decreased symptom burden (β, -6.7; 95% CI, -13.1 to -0.3; p = .039). BL financial toxicity was a significant predictor in univariable analysis (p = .001-.044) and showed a significant interaction term on MVA (p = .024-.041) for all 3 domains of poor treatment experience. Demographic and treatment-related factors were not predictive. Patients with cervical cancer with poor BL social function or high financial toxicity were at risk for increased symptom burden and poor HRQOL. Screening for these factors provides an opportunity for early intervention to improve treatment experience.

Unmet Needs, Quality of Life, and Financial Toxicity Among Survivors of Lung Cancer

Despite a growing population of survivors of lung cancer, there is limited understanding of the survivorship journey. Survivors of lung cancer experience unmet physical, social, emotional, and medical needs regardless of stage at diagnosis or treatment modalities. To investigate the association of unmet needs with quality of life (QOL) and financial toxicity (FT) among survivors of lung cancer. This survey study was conducted at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center thoracic oncology clinics between December 1, 2020, and September 30, 2021, to assess needs (physical, social, emotional, and medical), QOL, and FT among survivors of lung cancer. Patients had non-small cell lung cancer of any stage and were alive longer than 1 year from diagnosis. A cross-sectional survey was administered, which consisted of an adapted needs survey developed by the Mayo Survey Research Center, the Comprehensive Score for Financial Toxicity measure, and the European Organization for Research and Treatment of Cancer QLQ-C30 QOL scale. Demographic and clinical information was obtained through retrospective medical record review. Data analysis was performed between May 9 and December 8, 2022. Separate multiple linear regression models, treating QOL and FT as dependent variables, were performed to assess the adjusted association of total number of unmet needs and type of unmet need (physical, emotional, social, or medical) with QOL and FT. Of the 360 survivors of lung cancer approached, 232 completed the survey and were included in this study. These 232 respondents had a median age of 69 (IQR, 60.5-75.0) years. Most respondents were women (144 [62.1%]), were married (165 [71.1%]), and had stage III or IV lung cancer (140 [60.3%]). Race and ethnicity was reported as Black (33 [14.2%]), White (172 [74.1%]), or other race or ethnicity (27 [11.6%]). A higher number of total unmet needs was associated with lower QOL (β [SE], -1.37 [0.18]; P < .001) and higher FT (β [SE], -0.33 [0.45]; P < .001). In the context of needs domains, greater unmet physical needs (β [SE], -1.24 [0.54]; P = .02), social needs (β [SE], -3.60 [1.34]; P = .01), and medical needs (β [SE], -2.66 [0.98]; P = .01) were associated with lower QOL, whereas only greater social needs was associated with higher FT (β [SE], -3.40 [0.53]; P < .001). The findings of this survey study suggest that among survivors of lung cancer, unmet needs were associated with lower QOL and higher FT. Future studies evaluating targeted interventions to address these unmet needs may improve QOL and FT among survivors of lung cancer.

High Financial Hardship among Patients with Advanced Ovarian Cancer

Ovarian cancer is considered the most fatal and costly gynecologic cancer. Although personalized therapies have improved ovarian cancer prognosis, they have resulted in increased financial toxicity concerns among this population. This study evaluated financial toxicity in patients with advanced ovarian cancer. Using secondary data from a study of barriers to palliative care, financial toxicity (FT) was measured through the Comprehensive Score for Financial Toxicity scale. Univariate and bivariate analyses were used to assess the relationship between selected demographic (i.e., age, race, ethnicity, education, place of birth, insurance type, yearly household income, employment status) and treatment-specific variables (i.e., years since diagnosis, surgery, chemotherapy, radiation, hormonal and targeted therapy) with clinically relevant financial toxicity. Characteristics were compared using Fisher’s exact or chi squared tests. A total of 38 participants with advanced ovarian cancer were included in this study; 24% (n = 9) reported clinically significant FT. Income (p = .001), place of birth (p = .048) and employment status (p = .001) were related to FT. Study findings highlight that advanced ovarian cancer patients experience high FT, particularly those with low income, who are not able to work and were born outside the US. Further research using larger datasets and more representative samples is needed to inform intervention development and implementation.

Prevalence of and Factors Associated with Financial Toxicity After Pancreatectomy and Gastrectomy.

Financial toxicity (FT) refers to the adverse impact of cancer treatment costs on patients' experiences, potentially leading to poor adherence to treatment and outcomes. However, the prevalence of FT among patients undergoing major upper gastrointestinal cancer operations, as well as factors associated with FT, remain unclear. We conducted a cross-sectional study by sending the Comprehensive Score for financial Toxicity (COST) survey and Surgery-Q (a survey specifically developed for this study) to patients who underwent gastrectomy or pancreatectomy for malignant disease at our institution in 2019-2021. We sent the surveys to 627 patients and received responses from 101 (16%) patients. The FT prevalence (COST score <26) was 48 (48%). Patients likely to experience FT were younger than 50years of age, of non-White race, earned an annual income <$75,000, and had credit scores <740 (all p<0.05). Additionally, longer hospital stay (p=0.041), extended time off work for surgery (p=0.011), and extended time off work for caregivers (p=0.005) were associated with FT. Procedure type was not associated with FT; however, patients who underwent minimally invasive surgery (MIS) had a lower FT probability (p=0.042). In a multivariable analysis, age <50years (p=0.031) and credit score <740 (p<0.001) were associated with high FT risk, while MIS was associated with low FT risk (p=0.024). Patients with upper gastrointestinal cancer have a major risk of FT. In addition to predicting the FT risk before surgery, facilitating quicker functional recovery with the appropriate use of MIS is considered important to reducing the FT risk.