Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

BACKGROUND: Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. METHODS: Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. RESULTS: A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; P<.001), psychosocial distress (r = -0.26; P<.001), and HRQOL, as measured by the FACT-G (r = 0.42; P<.001) and by the EORTC QOL instruments (r = 0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P = .04), employment status (P<.001), income (P = .003), number of inpatient admissions (P = .01), and psychological distress (P = .003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P = .49). CONCLUSIONS: The COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society.

The development of a financial toxicity patient-reported outcome in cancer: The COST measure.

BACKGROUND: Considering patients' experience is essential for optimal decision-making. However, despite increasing recognition of the impact of costs on oncology care, there is no patient-reported outcome measure (PROM) that specifically describes the financial distress experienced by patients. METHODS: The content for a comprehensive score for financial toxicity (COST) was developed with a stepwise approach: step 1) a literature review and semistructured, qualitative interviews with patients for content generation; step 2) patients' assessment of the items for importance to their quality of life; step 3) pilot testing assessing interitem (IIC) and item-total (ITC) correlations to identify redundancy (Spearman rho, > 0.7) and statistically unrelated content (P > .05); and step 4) exploratory factor analysis. Sociodemographic data were collected. RESULTS: In total, 155 patients with advanced cancer who were receiving treatment (20 patients in step 1, 35 patients in step 2, and 100 patients in steps 3 and 4) participated in the PROM development. In step 1, the literature was reviewed, and 20 patients generated 147 items, which were reduced to 58 items because of redundancy. In step 2, 35 patients rated the 58 items on importance, and 30 items were retained. In step 3, 46 patients assessed the 30 items, 14 items were excluded because of high IIC, and 3 were excluded because of nonsignificant ITC. In step 4, 2 items were discarded because of poor loadings in a factor analysis of 100 patients, resulting in an 11-item PROM. CONCLUSIONS: The content for a financial toxicity PROM was developed in 155 patients. The provisional COST measure demonstrated face and content validity as well as internal consistency and should be validated in larger samples.

Determinants of Patient-Centered Financial Stress in Patients With Locally Advanced Head and Neck Cancer.

PURPOSE: To prospectively estimate patient-centered financial stress and its relationship with health care utilization in patients with head and neck cancer. This was a survey-based, longitudinal, prospective study of treatment-naïve patients with stage III, IVa, or IVb locally advanced head and neck cancer at a single-institution tertiary care hospital from May 2013 to November 2014. With 121 patients approached, 73 (60%) agreed to participate. METHODS: Self-reported data were collected on demographics, income, wealth, cost-coping strategies, out-of-pocket costs, supportive medication compliance, and perceived social isolation. Health care utilization was measured by hospital admissions and outpatient appointments on a 6-month timeline. Logistic regression models were constructed to identify factors associated with use of cost-coping strategies. Covariates included all demographics, measures of income, wealth, out-of-pocket costs, indirect costs, and perceived social isolation. RESULTS: Fifty-one patients (69%) relied on at least one coping strategy. On multivariable analysis, Medicaid patients were more likely than privately insured patients to use cost-coping strategies (odds ratio, 42.3; P = .0042). Decreased wealth ( P = .002) and higher total out-of-pocket costs ( P = .003) were independently associated with using cost-coping strategies. Patients with high perceived social isolation were also more likely to use cost-coping strategies (odds ratio, 11.5; P = .01). Patients with high perceived social isolation were more likely to report nonadherence to supportive medications (21.4 v 5.45 days over 6 months; P = .0278) and missed appointments (seven v three; P = .0077). CONCLUSION: A majority of patients used at least one cost-coping strategy during their treatment, highlighting the financial stress that patients experience. Perceived social isolation is an important social determinant of increased medication nonadherence, missed appointments, and use of cost-coping strategies. Interventions should be investigated in at-risk patients who may suffer from financial stress.