Researchers in Chicago have developed a financial toxicity grading system based on independent and clinically meaningful changes in health-related quality of life. According to data presented at the 2016 Cancer Survivorship Symposium, the tool has been validated in 2 separate cohorts of cancer patients, with plans for a larger, prospective study under way.
“Financial toxicity is a meaningful event that can be objectively measured and should be included in the assessment of patient-centered outcomes,” said lead author of the study, Jonas A. de Souza, MD, Assistant Professor of Medicine at the University of Chicago, IL. “It’s a side effect just like nausea or vomiting....There’s no survivorship care without addressing the distress caused by cost of care.”
As Dr de Souza explained, cancer is the second most expensive disease in the United States, next to heart disease, with estimated annual costs of $263.8 billion in 2010. And yet, there is no prior validated method to grade financial toxicity based on clinically meaningful and statistically significant changes in health-related quality of life.
Research and Development
Dr de Souza and colleagues developed the patient-reported outcome measure (PROM) by interviewing 155 patients over the course of 3 years. “The goal is to try to put a numerical figure on distress,” he said. “We started with 80 items of concern related to finances that were important to patients and tried to narrow it down to 11 questions.”
After developing the patient survey, the researchers turned to quantifying financial toxicity by placing it in the context of quality of life. What they devised was the Comprehensive Score for Financial Toxicity (COST). “It was important to find a way to grade financial toxicity to give it practical applications,” he explained. “Now we’re starting to apply it.”
Using COST, the researchers analyzed a total of 600 participants in 2 separate groups. The first cohort consisted of 233 patients with stage IV cancers on chemotherapy.
Similar to the National Cancer Institute’s Common Terminology Criteria for Adverse Events, Dr de Souza and colleagues relied on a grading system to assess financial toxicity:
- Grade 0 – No symptoms
- Grade 1 – Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
- Grade 2 – Moderate symptoms; minimal, local or noninvasive intervention indicated
- Grade 3 – Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living
While 42% of patients showed no symptoms of financial toxicity (grade 0), 31% and 25% of patients experienced grade 1 and grade 2 COST scores, respectively.
The second cohort was comprised of patients and survivors with thyroid cancer within 3 years of diagnosis. Researchers applied the PROM survey alongside 2 established quality-of-life instruments in order to determine the causes of quality of life. “We discovered that financial toxicity is an even more important driver of quality of life than fatigue and pain,” said Dr de Souza.
Treating the Side Effects
Although the researchers have developed the system to quantify these side effects, the question of how—and when—to intervene remains.
“We’re still trying to determine what to do with this information,” he acknowledged. “Maybe with Grade 3 financial toxicity, physicians should intervene.”
With recognized side effects like severe fatigue or pain, said Dr de Souza, there is typically an effort by the provider to establish cause.
“That’s where we’re trying to get with financial toxicity,” he said. “With fatigue and pain, I might give a patient a break for 2 weeks to see if he or she recovers. Maybe I should give patients the same break to see if they recover from their financial problems as well.”
Dr de Souza and colleagues intend to follow a large population of cancer patients prospectively to understand how cancer type and treatment affect financial toxicity over time.
“Our goal is follow them for 6 months to see how financial toxicity is related to treatment,” he said. “We’d like to determine the drivers of financial distress.”
According to Dr de Souza, preliminary evidence suggests that different diagnoses lead to different financial outcomes.
“There are some cancers, like head and neck, that have more of an effect on patients not being able to work,” he explained, “and that is causing this distress. Thyroid cancer, on the other hand, has lot of out-of-pocket expenses.”
“I think every cancer is going to have a different driver,” he concluded. “But what are the drivers per cancer, and how can we try to personalize interventions?”