Cancer treatment can create a second burden beyond the disease itself: financial toxicity. In this large cancer-center cohort, the people facing more financial toxicity were identifiable—but financial toxicity alone did not predict survival or treatment timing.

Financial toxicity refers to the direct and indirect consequences of cancer diagnosis and treatment, and it is a key mediator of quality of life and survival in cancer patients. Financial navigation programs have been implemented in many cancer centers to address this problem.

At this tertiary care cancer center, the financial navigation program uses the Comprehensive Score for Financial Toxicity to screen patients undergoing first cancer treatment. The study aimed to better understand financial toxicity, its risk factors, and its association with outcomes in this cancer population.

The cost of cancer care in the United States has significantly increased over the last several decades for patients and their families, and treatment costs continue to rise with novel diagnostics and therapeutics. Financial toxicity includes direct treatment expenses, loss of income from job loss or unexpected leave, and indirect costs such as childcare, travel to the facility, and meals while onsite.

Financial toxicity is associated with poor quality of life, symptom burden, barriers to medication adherence, and survival. That is why the financial concerns of patients, caregivers, physicians, health systems, and payers are increasingly being investigated.

Financial navigation programs have emerged as a strategy to recognize and mitigate financial toxicity, using services such as case management, transportation support, financial education, and assistance with insurance and grant applications. At this cancer institute, a patient financial advocate, a financial navigator, and a social worker collaboratively assess financial and related psychosocial needs to address barriers and access to care.

Since twenty twenty-one, the team has used the Comprehensive Score for Financial Toxicity—Functional Assessment of Chronic Illness Therapy to identify patients who may benefit from grants, pharmaceutical programs, and co-pay assistance for medications. The study describes financial toxicity, risk factors for higher financial toxicity, and its association with health-related quality of life in a large cancer cohort.

This was a retrospective study of patients seen for a cancer diagnosis who completed a COST-FACIT survey at the Cleveland Clinic Cancer Institute from June twenty twenty-one to February twenty twenty-four. The primary objectives were to describe financial toxicity and its severity, and to identify sociodemographic, disease, and treatment-related risk factors.

Secondary objectives analyzed the association of financial toxicity with time to treat and overall mortality. Financial toxicity, additional patient-reported outcome measures, and patient demographic, disease, and treatment data came from the institutional Tumor Registry Database and Electronic Health Record.

The Cleveland Clinic Institutional Review Board approved the study. The COST-FACIT is a validated and standardized patient-reported outcome measure that evaluates financial toxicity with an eleven-item questionnaire. Its score ranges from zero to forty-four, with lower scores indicating higher financial toxicity.

The score was categorized into four grades: no impact at twenty-six or higher, mild impact from fourteen to twenty-five, moderate impact from one to thirteen, and high impact at zero. The COST-FACIT was offered at the first outpatient treatment for a cancer diagnosis, and only the initial COST-FACIT data were analyzed because follow-up surveys were limited.

Additional patient-reported outcome measures included PROMIS-10, the NCCN Distress Thermometer, and the Patient Health Questionnaire-9. Financial toxicity was modeled as an ordinal outcome using four validated COST-FACIT categories: no, mild, moderate, and high financial toxicity.

Cumulative logistic regression estimated the odds of belonging to a higher financial toxicity category, and the odds ratios represent those odds. Variables with a univariable p-value below zero point twenty were considered for multivariable modeling, and all odds ratios were adjusted for diagnosis.

The study identified sixteen thousand eight hundred fourteen unique patients seen for at least one appointment between June twenty twenty-one and February twenty twenty-four. Of these patients, one thousand nine hundred six completed at least one COST-FACIT assessment and met the inclusion criteria.

Among one thousand nine hundred six patients, eight hundred fifteen, or forty-three percent, reported no financial toxicity at initial treatment; six hundred thirty-two, or thirty-three percent, reported low financial toxicity; four hundred fourteen, or twenty-two percent, reported moderate financial toxicity; and forty-five, or two percent, reported high financial toxicity.

Higher financial toxicity categories were associated with younger age, female sex, Black race, Hispanic ethnicity, single marital status, Medicaid insurance, smoking, and higher Area Deprivation Index. The association with Hispanic ethnicity was limited by very small numbers.

Higher distress, depression measured by higher Patient Health Questionnaire-9 scores, and lower physical and mental PROMIS-10 scores were also associated with higher financial toxicity. Across the dashed mean lines, the NCCN and PHQ2 panels rise with financial-toxicity impact, while both PROMIS panels trend downward.

The spread is substantial: NCCN moves from roughly three to five, PHQ2 remains near one, and PROMIS mental and physical scores fall by about five to seven points across the groups. In univariable analysis, younger age, female sex, non-Hispanic Black and Hispanic race and ethnicity compared with non-Hispanic White, Medicaid and Medicare payer, smoking, single marital status, lower physical and mental well-being, and increased distress were associated with increasing financial toxicity.

In multivariable analysis, younger age remained associated with higher financial toxicity, with an odds ratio of one point eighteen per five-year decrease. Non-Hispanic Black compared with non-Hispanic White, and Hispanic compared with non-Hispanic White, also remained associated with higher financial toxicity, with odds ratios of one point sixty-two and two point zero, respectively.

Medicaid and Medicare compared with private insurance remained associated with higher financial toxicity, with odds ratios of two point thirty-five and one point eighty-five. Former or current smoking history and increasing Area Deprivation Index also remained significantly associated with higher financial toxicity.

The study found no significant differences in overall survival among the no, mild, and moderate-to-high financial toxicity groups. There was also no difference in time to treat among the financial toxicity groups. Although the initial analysis found no association between higher financial toxicity and survival, a sensitivity analysis measuring survival from COST-FACIT completion found a significant association between moderate-to-high financial toxicity and worse survival.

The median interval between diagnosis and COST-FACIT completion was eighty-eight days; twenty-five percent of assessments were completed within forty-six days, and ten percent within twenty-eight days of diagnosis. This timing reflects financial toxicity as a patient-reported outcome that evolves after diagnosis and initiation of cancer care, rather than a baseline characteristic measurable at diagnosis.

Requiring survival until COST-FACIT completion introduces the possibility of guarantee-time bias. The study included a broad and heterogeneous cohort, and some diseases were more represented than others, while genitourinary, gynecological, head and neck, and skin cancers were under-represented.

Because of that composition, the study may lack generalizability to specific diagnoses. The purpose was to describe and provide a scoping overview of financial toxicity at a large cancer center, while future studies can examine specific subgroups using longitudinal data.

Follow-up COST-FACIT data may better inform the impact of financial navigation programs and interventions. Because of the timing of routine patient-reported outcome collection and COST-FACIT results, the study cannot infer causality or directionality between health-related quality of life and financial toxicity.

COST-FACIT captured meaningful differences in financial toxicity across age, race and ethnicity, insurance, smoking, and neighborhood deprivation, alongside distress and poorer well-being. But this cohort did not show that financial toxicity itself was associated with overall survival or time to treatment.