Comprehensive Score For Financial Toxicity Research Articles

Patient reported outcomes affecting quality of life in socioeconomically disadvantaged cancer patients

Purpose The aim of this study was to identify correlates of quality of life (QOL) for socioeconomically disadvantaged cancer patients receiving care in the “safety net” health system. Design This cross-sectional study used linear regressions to determine the effect of patient reported outcome measures (PRO) on QOL. Sample/Methods: Cancer patients (n = 115) receiving drug therapy completed a series of PROs including: Functional Assessment of Cancer Therapy (FACT-G), PROMIS (Anxiety, Depression, Fatigue, Pain Interference, and Physical Function), and the Comprehensive Score for Financial Toxicity. Findings More than 60% of patients reported an annual income below $24,999. Forty-five percent of patients were either uninsured or county-funded. Depression, pain, and financial toxicity were found to be consistently significant correlates of QOL. Implications: Cancer patients with existing financial strain have unique psychosocial stressors. This study provides insight into the relationship between these stressors, and the need for targeted screening and intervention that address such aspects of care.

Assessing the reliability and validity of comprehensive score for financial toxicity (COST) among radiation oncology patients in India: a cross-sectional pilot study.

BackgroundBesides physical toxicity, cancer care imposes significant financial distress referred to as financial toxicity (FT). FT has become a growing concern among cancer patients. Researchers have associated FT among cancer patients with clinical outcomes like mortality, poor quality of life and non-adherence. Currently, no reliable tools are available for assessing FT among cancer patients in India. The aim of this pilot study was to test the reliability and validity of the Comprehensive Score for Financial Toxicity (COST) questionnaire among patients undergoing radiotherapy in India.Material and methodsThis cross-sectional pilot study was conducted among head and neck cancer patients on follow-up in radiation oncology department. The reliability of COST measure was assessed using Cronbach’s α. The underlying construct of COST was verified by Exploratory Factor Analysis (EFA). EFA was performed using parallel analysis technique.ResultsBased on inclusion and exclusion criteria, the COST questionnaire was administered to 29 patients using the interview method after written informed consent. The COST measure demonstrated excellent reliability with Cronbach’s α of 0.92. A Kaiser–Meyer–Olkin of 0.87 verified the sample adequacy and a p-value of ˂0.001on Bartlett’s sphericity test indicated that the strength of the correlation between 11 COST items was good to perform the EFA. Parallel analysis technique identified one factor on scree plot with eigenvalue of 6.21 explaining 56.5% of the variance by non-rotated solution. All the factor loadings in one factor model were ˃0.3 (range 0.35–0.97). The factor loadings indicated that the underlying construct can be considered as one factor domain as intended by the original COST development study. However, Chi-square goodness of fit test revealed the one factor model did not adequately depict the data. However, the results were consistent with the construct obtained in the original scale development study.ConclusionThis pilot study demonstrated excellent reliability of COST for measuring FT among radiation oncology patients. Further studies are warranted to study the clinical implications of FT in the Indian population for making better strategies and policies to ease the financial burden on cancer patients.

Identifying a cut-off score for the COST measure to indicate high financial toxicity and low quality of life among cancer patients.

To identify a cut-off score for the COmprehensive Score for financial Toxicity (COST) to predict a clinical implication of a high level of financial toxicity (FT). A total of 640 cancer patients were recruited from three regional hospitals in Hong Kong. They completed a questionnaire comprising the COST measure and the Functional Assessment of Cancer Therapy - General (FACT-G) instrument. The cut-off score for the COST that predicts the lowest quartile of the FACT-G total score was identified by receiver operating characteristic (ROC) analysis. The sample was then stratified by this cut-off score, and characteristics were compared using Fisher's exact, chi-squared or independent sample t-test. The mean scores were 20.1 ± 8.8 for the COST and 71.6 ± 15.5 for the FACT-G. The ROC analysis suggested that the cut-off of 17.5 yielded an acceptable sensitivity and specificity. Characteristics of patients with a higher level of FT included being younger, having a monthly household income of < 10,000 HKD (approximately 1290 USD), being more likely not employed, having stage IV cancer and receiving targeted and/or immunotherapy. In terms of financial support, a higher proportion of these patients had discussed financial issues with health care professionals and had received financial assistance. In addition, fewer of them were covered by private health insurance. Our findings suggest a cut-off for the COST that can be used to screen for FT in clinical settings. In addition, while a considerable proportion of high-FT patients received targeted therapy, they often received financial assistance. There is a gap between financial hardship and assistance that warrants attention.

Development of Machine Learning Algorithms for the Prediction of Financial Toxicity in Localized Breast Cancer Following Surgical Treatment.

PURPOSEFinancial burden caused by cancer treatment is associated with material loss, distress, and poorer outcomes. Financial resources exist to support patients but identification of need is difficult. We sought to develop and test a tool to accurately predict an individual's risk of financial toxicity based on clinical, demographic, and patient-reported data prior to initiation of breast cancer treatment.PATIENTS AND METHODSWe surveyed 611 patients undergoing breast cancer therapy at MD Anderson Cancer Center. We collected data using the validated COmprehensive Score for financial Toxicity (COST) patient-reported outcome measure alongside other financial indicators (credit score, income, and insurance status). We also collected clinical and perioperative data. We trained and tested an ensemble of machine learning (ML) algorithms (neural network, regularized linear model, support vector machines, and a classification tree) to predict financial toxicity. Data were randomly partitioned into training and test samples (2:1 ratio). Predictive performance was assessed using area-under-the-receiver-operating-characteristics-curve (AUROC), accuracy, sensitivity, and specificity.RESULTSIn our test sample (N = 203), 48 of 203 women (23.6%) reported significant financial burden. The algorithm ensemble performed well to predict financial burden with an AUROC of 0.85, accuracy of 0.82, sensitivity of 0.85, and specificity of 0.81. Key clinical predictors of financial burden from the linear model were neoadjuvant therapy (βregularized, .11) and autologous, rather than implant-based, reconstruction (βregularized, .06). Notably, radiation and clinical tumor stage had no effect on financial burden.CONCLUSIONML models accurately predicted financial toxicity related to breast cancer treatment. These predictions may inform decision making and care planning to avoid financial distress during cancer treatment or enable targeted financial support. Further research is warranted to validate this tool and assess applicability for other types of cancer.

Abstract S10-03: Adolescent and young adult cancer patient and survivor employment changes during COVID-19 are associated with financial toxicity

Abstract Purpose: Describe associations between changes in employment during the COVID-19 pandemic and financial toxicity among adolescent and young adult (AYA) cancer patients and survivors. Methods: Eligible individuals were diagnosed between 15-39 years of age, currently age ≥18, and recruited through the Huntsman-Intermountain Adolescent and Young Adult Cancer Care Program. We sent the survey to N=709. Survey questions included demographics, employment, and the 11-item COmprehensive Score for financial Toxicity (COST) which captures financial toxicity in the last four weeks. COST is scored from 0 to 44 with lower scores indicating greater financial toxicity. Scores were dichotomized as high (0-21) or low (22-44). Changes in employment since March 2020 were categorized as no change, increase in hours, and decrease in hours/lost job. We calculated descriptive statistics and fit a multivariable logistic regression to examine the association between employment change and financial toxicity controlling for current age, gender, and treatment status. Results: Of 280 respondents (39.5% participation), 198 (70.7%) were employed prior to the pandemic and were thus included in analyses. Employed individuals were a mean of 29.4 years of age (range 18-58), 64.3% were female, and 50.5% had received cancer treatment since March 2020. Nearly a third (31.3%) had lost their job or reported reduced hours; 50.3% reported high financial toxicity. Among those previously employed, participants who lost their job or had their hours reduced had nearly six times the odds of high financial toxicity than those who reported no change in hours (Odds Ratio [OR]=5.8, 95% Confidence Interval [CI]: 2.6-12.9). In the same model, the odds of reporting high financial toxicity was over twice as high among females than males (OR=2.3, 95% CI: 1.2-4.5). Treatment status and age were not significant. Conclusions: Employment changes during the COVID-19 pandemic resulted in increased financial toxicity among a population already susceptible to high financial hardship. Societal gender inequity appears to be mirrored in participants’ financial toxicity during the pandemic. Employment interventions for patients and survivors of AYA cancers who have experienced job loss or reduction in work hours during the pandemic are needed and may particularly benefit females. Citation Format: Austin Waters, Heydon Kaddas, Karely Mann, Perla L. Vaca Lopez, Echo L. Warner, Joemy Ramsay, Judy Ou, Nicole Ray, Tomoko Tsukamoto, Douglas B. Fair, Joseph M. Letourneau, Mark A. Lewis, David A. Gill, Lauri Linder, Anne C. Kirchhoff. Adolescent and young adult cancer patient and survivor employment changes during COVID-19 are associated with financial toxicity [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr S10-03.

Financial Toxicity in Cancer Care: The Next Metric of Cancer Disparity

Financial toxicity refers to the adverse effects of financial strain on the well-being of a patient faced with a cancer diagnosis and the subsequent cost of care. As cancer care cost escalates and the health-related out-of-pocket expenses grow, patients can incur considerable financial burden. In the current issue, Coroneos and colleagues 1 Coroneos C.J. Lin Y.-L. Sidey-Gibbons C. et al. Correlates between financial toxicity, quality-of-life and patient satisfaction in an insured population of breast cancer surgical patients: a single institution retrospective study. J Am Coll Surg. 2021; 232: 253-263 Google Scholar examine the impact of financial toxicity on quality of life outcomes in women undergoing operations for breast cancer. Financial toxicity was measured using the validated Comprehensive Score for Financial Toxicity and was correlated with patient outcomes, including condition-specific quality of life (measured by the BREAST-Q) and global quality of life (measured by the SF-12). In their cohort of 532 patients, greater cost-associated distress was associated with lower BREAST-Q and SF-12 scores. Importantly, the Comprehensive Score for Financial Toxicity had the largest impact on BREAST-Q psychosocial well-being. This is interesting, as psychosocial well-being is a primary factor supporting the benefit of breast reconstruction and is the only BREAST-Q domain that shows long-term improvement for patients undergoing both implant-based and autologous reconstruction. 2 Santosa K.B. Qi J. Kim H.M. et al. Long-term patient-reported outcomes in postmastectomy breast reconstruction. JAMA Surg. 2018; 153: 891-899 Crossref PubMed Scopus (102) Google Scholar The current study highlights the importance of understanding the impact that financial toxicity can have on this reported endpoint over time.

Measuring Financial Distress and Quality of Life Over Time in Patients With Gynecologic Cancer-Making the Case to Screen Early in the Treatment Course.

Our objective was to measure the trajectory of financial distress and to determine its relationship with quality of life (QOL) among patients with cancer. We conducted a longitudinal survey of patients with gynecologic cancer starting a new line of systemic therapy at baseline, 3 months, and 6 months. Financial distress was measured using a Comprehensive Score for Financial Toxicity (COST) < 26, and QOL was measured using Functional Assessment of Cancer Therapy-General (FACT-G) with lower scores indicating worse responses. One-way repeated analysis of variances, generalized estimating equation models, and correlation coefficients were used to evaluate financial distress and QOL over time. There were 90 of 121 (74%) baseline participants with a 6-month follow-up. The average age was 60 years, 29% were African-American, 57% had an annual income < $40,000 in US dollars, and 6% were uninsured. At baseline, 54% of patients screened positive for financial distress, which was unchanged at 3 months (50%, P = .27) but decreased at 6 months (46%, P = .04) compared with baseline. There was no change in average COST (23.6, 25.1, 25.6; P = .33) or FACT-G (70.8, 71.0, 72.8; P = .68) over time. Less financial distress was moderately correlated with better QOL (r = 0.63, 0.61, 0.60) at each time point. The presence of financial distress was associated with a 16-point decrease in FACT-G QOL score over time. Upfront screening with COST identified 90% of patients who experienced financial distress, and COST did not change significantly over time. More severe financial distress was moderately correlated with worse QOL, and its presence was associated with a clinically meaningful 16-point decrease in QOL.

Measuring financial toxicity in Australian cancer patients - Validation of the COmprehensive Score for financial Toxicity (FACT COST) measuring financial toxicity in Australian cancer patients.

The FACT COST is a patient-rated measure of financial toxicity, developed and validated in a North American population. We aimed to confirm the validity and reliability of the FACT COST in Australian cancer patients, because the Australian healthcare funding structure is different to that in North America. A single center, cross-sectional study design investigated financial toxicity in oncology outpatients. Eligible adults had current malignancy, with or without active cancer treatment. The primary endpoint was the degree of financial toxicity experienced via the COST questionnaire; secondary endpoints included health-related quality of life (Functional Assessment of Cancer Therapy-General), anxiety, and depression (Hospital Anxiety and Depression Scale). Clinical and demographic data were recorded. Statistical analysis determined the internal consistency, test-retest reliability and validity of COST, and correlations between COST score and secondary endpoints. A total of 257 patients participated (79% response rate). Fifty-three percent were female; median age 63 years (range 19-88). COST scores were skewed toward less financial toxicity, median 26 (SD 10.3, range 1-43), lower scores indicating higher toxicity. High internal consistency (Cronbach's α=0.884), test-retest reliability (ICC=0.801), and convergent validity were demonstrated. Financial toxicity was greatest in younger participants, those with more inpatient admissions, those with a change in employment status following diagnosis, and those in the lowest income quintile. Financial toxicity was associated with worse health-related quality of life, and greater depression and anxiety. The COST measure of financial toxicity demonstrated acceptable validity parameters in an Australian outpatient population. Greater financial toxicity was associated with worse psychological well-being and with certain patient demographics.

Longitudinal Trends of Financial Toxicity in Patients With Lung Cancer: A Prospective Cohort Study.

Cancer therapy is associated with severe financial burden. However, the magnitude and longitudinal patient relationship with financial toxicity (FT) in the initial course of therapy is unclear. Patients with stage II-IV lung cancer were recruited in a prospective longitudinal study between July 2018 and March 2020. FT was measured via the validated COmprehensive Score for financial Toxicity (COST) at the time of cancer diagnosis and at 6-month follow-up (6MFU). 6MFU data were compared with corresponding baseline data. A lower COST score indicates increased financial hardship. At the time of analysis, 215 agreed to participate. Subsequently, 112 patients completed 6MFU. On average, slightly more FT was observed at diagnosis compared with 6MFU (median COSTbase 25 v COST6M 27; P < .001); however, individual patients experienced large changes in FT. At 6MFU, 27.7% of patients had made financial sacrifices to pay for treatment but only 4.5% refused medical care based on cost. Median reported out-of-pocket (OOP) costs for the initial 6 months of cancer treatment was $2,496 (range, $0-25,900). Risk factors for FT at diagnosis were unique from risk factors at 6MFU. Actual OOP expenses were not correlated with FT; however, inability to predict upcoming treatment expenses resulted in higher FT at 6MFU. FT is a pervasive challenge during the initiation of lung cancer treatment. Few patients are willing to sacrifice medical care regardless of the cost. Risk factors for FT evolve, resulting in unique interventional targets throughout therapy.

Crowdsourcing to measure financial toxicity in gynecologic oncology

ObjectiveTo utilize a novel crowdsourcing method to measure financial toxicity and its effects among a national cohort of gynecologic cancer patients. MethodsCrowdsourcing methods were used to administer an online survey to women in the United States with gynecologic cancers. We used the Comprehensive Score for Financial Toxicity (COST) tool to measure financial toxicity and the EQ-5D-3L to measure quality of life (QOL). Based on prior work, we defined high financial toxicity as a COST score ≤ 23. We assessed correlation of COST scores with QOL. We used log-binomial regression to examine associations between high financial toxicity and cost-coping strategies. ResultsAmong the final study sample of 334 respondents, 87% were white, median age at diagnosis was 55 (interquartile range 47–63), 52% had stage III or IV disease and 90% had private insurance or Medicare. Median COST score was 24 (interquartile range 15–32) and 49% of respondents reported high financial toxicity. Greater financial toxicity was correlated with worse QOL (p < 0.001). Participants reporting high financial toxicity were more likely to use cost-coping strategies, including spending less on basic goods (RR: 3.3; 95% CI: 2.1–5.1), borrowing money or applying for financial assistance (RR: 4.0; 95% CI: 2.4–6.9), and delaying or avoiding care (RR: 5.6; 95% CI: 2.6–12.1). ConclusionsCrowdsourcing is an effective tool to measure financial toxicity. Nearly half of respondents reported high financial toxicity, which was significantly associated with worse QOL, utilization of cost-coping strategies and delays or avoidance of care.

Unmet Care Needs and Financial Hardship in Patients With Metastatic Non-Small-Cell Lung Cancer on Immunotherapy or Chemoimmunotherapy in Clinical Practice.

Immunotherapy or chemoimmunotherapy is now standard treatment for most patients with metastatic non-small-cell lung cancer (mNSCLC), yet patient supportive care needs (SCNs) on immunotherapy are not well defined. This study characterized the SCNs and financial hardship of patients with mNSCLC treated with immunotherapy or chemoimmunotherapy and examined the relationship between patient and caregiver cancer-related employment reductions and patient financial hardship. Patients with mNSCLC on immunotherapy or chemoimmunotherapy from a single academic medical center completed the SCNs Survey-34, items indexing material, psychological, and behavioral financial hardship, and the Comprehensive Score for Financial Toxicity. Univariate and bivariate analyses examined care needs, financial hardship, and impact of cancer-related employment reductions on patient financial hardship. Sixty patients (40% male; 75% White, mean age = 62.5 years, 57% on immunotherapy alone) participated. Fifty-five percent reported unmet needs in physical or daily living and psychological domains. Financial hardship was common (33% material, 63% psychological, and 57% behavioral). Fifty-two percent reported hardship in at least two domains. Forty percent reported a caregiver cancer-related employment reduction. Caregiver employment reduction was related to patient financial hardship (68% of those reporting caregiver employment reduction reported at least two domains of hardship v 40% of those without reduction, P = .03) and patient financial distress (mean Comprehensive Score for Financial Toxicity = 19.6 among those with caregiver employment reduction v 26.8 without, P = .01). Patients with mNSCLC treated with immunotherapy or chemoimmunotherapy report multiple unmet care needs and financial hardship. Psychological, functional, financial, and caregiver concerns merit assessment and intervention in this population.

Persistent Obstructive Sleep Apnea Burden on Family Finances and Quality of Life.

We previously found that financial concerns negatively affect the quality of life of families of children with persistent obstructive sleep apnea (OSA) after tonsillectomy. The goal is to quantify the financial impact on families of children with persistent OSA and assess contributing factors. Cross-sectional survey study with comparison group. Upper airway center at a tertiary pediatric hospital. Participants included consecutive children with persistent OSA from September to October 2017. Healthy children seen in a general otolaryngology clinic served as controls. Families of both groups completed the Family Impact Questionnaire and the modified Comprehensive Score for Financial Toxicity (COST). Families of the 50 patients (25 study and 25 control) completed the surveys: the mean age was 6.4 years (95% CI, 5.0-7.8), and 19 (38%) were female. There were no differences in age, sex, race, or insurance status between groups (P > .05). The mean apnea-hypopnea index for the study group was 7.9 events/h (range, 5.5-10.3), and 40% (10/25) had Down syndrome. Positive airway pressure and/or oxygen were used by 72% (18/25). The Comprehensive Score for Financial Toxicity for study patients (21.9; 95% CI, 14.8-26.0) was significantly lower than for controls (30.2; 95% CI, 26.6-30.8; P = .003), reflecting elevated financial toxicity. Study families reported greater financial impact on the Family Impact Questionnaire (8.4; 95% CI, 6.1-10.7) versus controls (3.6; 95% CI, 1.8-5.4; P = .002); concerns regarding missed days of work and school were common (30.7%). Families of children with persistent OSA reported a high financial burden related to their children's disease and were more likely to report financial toxicity than families of controls. Concern regarding missed work and school associated with appointments and treatment was a significant factor.

Assessing the financial toxicity in Tunisian cancer patients using the Comprehensive Score for Financial Toxicity (COST).

Cancer care-related out-of-pocket expenses and financial toxicity (FT) are a rising burden for patients. We aimed to evaluate patient-reported FT and to identify relevant correlates within a Tunisian population. We conducted a survey using the 11-item Comprehensive Score for Financial Toxicity (COST) that could range from 0 = high to 44 = low. FT was grade 0 if ≥ 26, grade 1 = (14-25), grade 2 = (1-13), and grade 3 = 0. Scores were collected along with data regarding patient medical/social features and out-of-pocket expenses. Univariate and multivariate analyses were performed to identify factors associated with higher financial burden. Among the 179 participants, median COST score was 20.8 (Q1 17-Q3 24), with 80.4% of patients experiencing financial toxicity: grade 0 = 20%, grade 1 = 68.4%, grade 2 = 11.7%, grade 3 = 0%. Most patients (66.5%) used to work before cancer and 44.7% reported ceasing work because of cancer. The time to go to the hospital was > 30min in 66.5% of cases. Unemployment, time to hospital > 30min, ceasing work because of cancer, and expenses on non-chemotherapy drugs exceeding 70 dinars (25 US dollars) were mostly associated with higher FT on univariate analysis. Distance to hospital and ceasing work because of cancer were the single most significant factors in multivariate analysis. Losing work due to cancer and unequal distribution of health care particularly in cities with long travel times to the nearest hospital are the main sources of financial distress.

The COmprehensive Score for financial Toxicity in China: Validation and Responsiveness

ContextFinancial toxicity is a priority concern faced by cancer patients and oncology providers. A validated instrument is important to measure this toxicity and improve health-related quality of life of patients. ObjectivesTo assess the validity and responsiveness of the Chinese version of the COmprehensive Score for financial Toxicity (COST) and to measure financial toxicity using the COST instrument in Chinese health care systems. MethodsA longitudinal observational study was performed at three cancer centers from March 2017 to October 2018 for eligible patients. Construct validity was assessed by exploratory and confirmatory factor analysis. The convergent and discriminant validity was tested by examining the correlation coefficient. Responsiveness was tested using the standardized response mean and effect size. Associations between the financial toxicity and variables were assessed by multivariable linear analysis. ResultsThere were 440 participants at baseline and 268 participants at 6-month follow up. A two-factor solution better represented the Chinese version of COST structure with good internal consistency and test-retest reliability. Convergent validity showed mild to moderate correlations between the domains of COST and the similar domains of Self-Perceived Burden Scale and Quality of Life Discriminant validity showed a low correlation between the COST and the subjective support of Social Support Rate Scale. Sensitivity to change at the sixth month showed effect sizes with global COST scores of 0.3. Multivariable analysis showed that age, household income, and health insurance were significantly associated with financial toxicity. ConclusionsThe Chinese version of COST is a valid and clinically responsive instrument. The identified baseline variables can be used to provide evidence for a financial toxicity intervention study.

Re-Validation of the COmprehensive Score for Financial Toxicity (COST): Assessing the Scale's Utility in Chronic Disease Populations.

Objective:To report the psychometric properties of the COmprehensive Score for financial Toxicity (COST) patient-reported outcome measure (PROM), an 11-item scale previously validated among patients diagnosed with cancer and receiving chemotherapy.Methods:Data come from a cross-sectional survey (n = 2755 response rate of 87%) of participants in a remote digital health coaching intervention collected between January 2017 and February 2019.Results:COST demonstrated very good internal consistency (Cronbach’s alpha = .89) and good convergent validity. Lower financial toxicity was associated with improved physical and mental well-being HRQOL measures after controlling for covariates (b = 0.13, P < .0001; b = 0.28, P < .0001, respectively). Supplemental analyses indicated that the COST instrument loaded on 2 factors.Conclusions:The COST measure of financial toxicity has good internal consistency and predictive validity in a sample of patients with chronic conditions. However, contrary to previous research examining the psychometric properties of COST in a sample of individuals with cancer, which found COST to be unidimensional, our analyses indicated that the COST measure of financial toxicity is multidimensional in a sample of individuals with chronic conditions. In particular, the items that asked about “general financial wellbeing” loaded on the second factor while “illness-related financial wellbeing” loaded on the first.

Financial toxicity in patients with gynecologic malignancies: a cross sectional study.

ObjectiveTo evaluate financial toxicity and assess its risk factors among patients with gynecologic cancers.MethodsThis is a cross sectional study that included 2 survey tools, as well as patient demographics, disease characteristics, and treatment regimen. Financial toxicity is measured by validated Comprehensive Score for Financial Toxicity (COST) tool. 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. Spearman's rank correlation was calculated to assess the relation between financial toxicity and patient/disease related variables. Graphpad Prism Software Version 8.0 was used for analyses.ResultsA total of 50 patients with various gynecologic malignancies were enrolled. Median COST score was 20.5 (range, 1–33). Sixty-five percent of the patients reported being in debt due to their cancer care and 4% filed bankruptcy. Correlation analysis showed that COST score was correlated with age (r=−0.3, p=0.028), malignancy type (r=0.3, p=0.039) and income (r=0.3, p=0.047). 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=0.043). 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.ConclusionFinancial toxicity is a significant burden even among highly insured gynecologic oncology patients. Age, malignancy type and income were correlated with high financial burden.

Validation of the comprehensive score for financial toxicity for Brazilian culture.

Financial toxicity is a side effect of cancer treatment showing the financial burden experienced by cancer patients for funding their treatment. An instrument for its evaluation can contribute towards the creation of coping strategies. In Brazil, a developing country, cancer patients certainly feel the effects of this serious adverse event, however, the discussion on the theme and research concerning these issues is scarce and an instrument for evaluation can help in the promotion of coping strategies. Thus, the study objective was to: 1) translate and adapt the COmprehensive Score for financial Toxicity (COST) questionnaire to Brazilian culture and 2) evaluate the COST psychometric properties in Brazil. Thus, a methodological study was developed in two stages. In the first stage, the translation and cross-cultural adaptation were performed, and in the second stage, two groups of participants were recruited to evaluate the psychometric properties. In the first stage, 21 individuals participated, including translators and cancer patients, and in the second stage, 126 patients participated who were undergoing cancer treatment. For validation, exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and Cronbach’s alpha coefficient were performed to verify internal consistency. For the first stage’s outcome, the pre-test Cronbach’s alpha was 0.83. The EFA and CFA carried out in the second stage of the study revealed that the COST Brazilian version measures a single construct with a value of—χ2/gl = 179.78, comparative fit index = 0.00, Parsimony goodness of fit index = 0.302, root mean square error of approximation = 1.196 and p-value of close fit = 0.000. When comparing the average of the COST score and the standard deviation of the two samples, the significance value was p = 0.001. Therefore, it is possible to confirm that the COST is a valid and reliable questionnaire to measure the financial toxicity of cancer patients in Brazil.

Correlation Between Financial Toxicity, Quality of Life, and Patient Satisfaction in an Insured Population of Breast Cancer Surgical Patients: A Single-Institution Retrospective Study

The relationship between treatment-related, cost-associated distress "financial toxicity" (FT) and quality-of life (QOL) in breast cancer patients remains poorly characterized. This study leverages validated patient-reported outcomes measures (PROMs) to analyze the association between FT and QOL and satisfaction among women undergoing ablative breast cancer surgery. This is a single-institution cross-sectional survey of all female breast cancer patients (>18 years old) who underwent lumpectomy or mastectomy between January 2018 and June 2019. FT was measured via the 11-item COmprehensive Score for financial Toxicity (COST) instrument. The BREAST-Q and SF-12 were used to asses condition-specific and global QOL, respectively. Responses were linked with demographic and clinical data. Pearson correlation coefficient and multivariable regression were used to examine associations. Our analytical sample consisted of 532 patients; mean age 58, mostly white (76.7%), employed (63.7%), married/committed (73.7%), with 64.3% undergoing reconstruction. Median household income was $80,000 to $120,000/year, and mean COST score was 28.0. After multivariable adjustment, a positive relationship for all outcomes was noted; lower COST (greater cost-associated distress) was associated with lower BREAST-Q and SF-12 scores. This relationship was strongest for BREAST-Q psychosocial well-being, for which we observed a 0.89 (95% CI 0.76-1.03) change per unit change in COST score. Financial toxicity captured in this study correlates with statistically significant and clinically important differences in BREAST-Q psychosocial well-being, patient satisfaction with reconstructed breasts, and SF-12 global mental and physical quality of life. Treatment costs should be included in the shared decision-making for breast cancer surgery. Future prospective outcomes research should integrate COST.

Abstract PO-208: Patient-reported out-of-pocket costs and financial toxicity during early- phase oncology clinical trials

Abstract Background Clinical trials are an important therapeutic option for cancer patients (pts). Although financial burden in cancer treatment is well-documented, the financial burden associated with clinical trials is not well understood, especially for pts with lower income. Methods We conducted a survey regarding economic burden and financial toxicity in cancer pts who had been on Phase I clinical trials for ≥1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicate worse toxicity). Pts also reported monthly out-of-pocket (OOP) medical and non-medical expenses. We applied multivariable logistic regression to analyze risk of financial toxicity, and unanticipated expenses. Results Early-phase clinical trial pts (N=213, median age = 59y; 59% female; 74% White, 45% w/ annual income ≤$60K; 54% had employer sponsored insurance; 37% had Medicare; 50% lived &amp;gt;300 miles from the clinic; 37% required air travel) had a median FTS of 20, with interquartile range of 12. Median monthly OOP costs for non-medical expenses was $1075, and for medical expenses was $475. Median total monthly OOP costs was $1750. 55% and 64% of pts reported that actual medical and non-medical expenses were higher than expected, respectively. Worse financial toxicity (≤ median FTS) in pts was associated with yearly household income &amp;lt;$60K (OR: 2.7, P=0.008), having medical costs higher than expected (OR: 3.2, P=0.024), participation on ≥1 Phase I clinical trial prior to their current trial (OR: 2.2, P=0.028), and living &amp;gt;100 miles away from the clinical trials hospital (OR: 2.3, P=0.043). 29% of pts received partial/full reimbursement of clinical trial-related travel costs from study sponsor/other/insurance. Racial/ethnic minority (OR: 2.6, P=0.008) and pts who were unemployed or not working outside the home (OR: 2.4, P=0.023) were more likely to report that actual medical costs were much higher than expected. 53% of pts used savings and 19% borrowed money from friends/family or had a personal fundraiser to pay for treatment. Conclusions Among cancer pts participating on clinical trials, economic burden is high, and most of pts’ OOP costs were on non- medical expenses. Financial toxicity is disproportionally higher in pts with lower income and those who travel farther, and unexpected medical costs were more common among minorities. OOP costs can be substantial and are often unexpected for pts. Future work should focus on methods to reduce disparities in clinical trial participation, including the role of reimbursement of trial-related expenses. Citation Format: Ryan W. Huey, Goldy C. George, Penny Phillips, Revenda White, Filip Janku, Daniel D. Karp, Aung Naing, Sarina Piha-Paul, Vivek Subbiah, Apostolia M. Tsimberidou, Shubham Pant, Timothy A. Yap, Jordi Rodon, Funda Meric-Bernstam, Ya-Chen Tina Shih, David S. Hong. Patient-reported out-of-pocket costs and financial toxicity during early- phase oncology clinical trials [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-208.

Abstract PO-084: Time from bladder cancer diagnosis and financial toxicity

Abstract Background: The term “financial toxicity” (FT) describes the negative financial impact of a cancer diagnosis on the household; and research suggests that FT has a prevalence of 25-50% among cancer patients. In bladder cancer (BC), the 5th most common malignancy in the U.S., but one of the highest cost per capita of cancer sites, prevalence has been reported to be 25%. No published studies to date, however, have assessed FT using a validated measure and in-depth exploration of the association between patient factors and time from diagnosis in BC. The goal for the present study was to investigate the association between time since BC diagnosis (TSD) and FT. Methods: Patients with high risk non-muscle invasive and muscle invasive BC were enrolled from an NCI designated cancer center (N = 100). The 12- item Comprehensive Score for Financial Toxicity (COST) was used to assess FT. Additional data, such as BC diagnosis date, was abstracted from the medical records and conversations with patients. In order to determine the associations between sociodemographic and clinicopathologic variables and FT, bivariate analyses were conducted. Multivariable logistic regression models were conducted to determine whether TSD (1 year or less vs. more than 1 year) was associated with FT. Results: Bivariate analyses showed that FT was not statistically significantly associated with TSD and that TSD was not statistically significantly associated with any sociodemographic characteristics (e.g. race/ethnicity, primarily language, education, gender) in our study. Simple and adjusted multivariable logistic regression results showed that TSD was not statistically significantly associated with FT. Next, we explored individual items in the 12-item COST scale, and found that patients who have been diagnosed 1 year or less had higher odds of not feeling in control of their current financial situation compared to those who had been diagnosed more than 1 year ago (OR = 2.933; CI:1.009, 8.547). Conclusion: While TSD was not statistically significantly associated with the full COST scale measuring FT in our study, we did find an association between TSD and feeling of control in one’s current financial situation. These results suggest that different aspects of FT may be more/less relevant for BC patients at different points in the cancer care continuum, and that feeling in control of one’s finances can potentially increase as TSD increases. To better understand the influence of socioeconomic resources on BC care related outcomes, further research is needed to explicate the specific aspects of FT that are relevant to patients as they manage and navigate cancer care. Citation Format: Sumeet K. Bhanvadia, Leora Steinberg, Kailyn Koh, Siamak Daneshmand, Weizhou Tang, Reginald Tucker-Seeley. Time from bladder cancer diagnosis and financial toxicity [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-084.