Researchers in Chicago have developed a financial toxicity grading system based on clinically meaningful changes in health-related quality of life. According to lead investigator Jonas A. de Souza, MD, Assistant Professor of Medicine, University of Chicago, at the 2016 Cancer Survivorship Symposium, the tool has been validated in 2 separate cohorts of patients with cancer, with plans for a larger, prospective study underway.
“Financial toxicity is a meaningful event that can be objectively measured and should be included in the assessment of patient-centered outcomes,” said Dr de Souza. “It is a side effect just like nausea or vomiting….There is no survivorship care without addressing the distress caused by cost of care.”
Cancer is the second most expensive disease in the United States, behind heart disease. And yet, there is no validated method to grade financial toxicity based on clinically meaningful and statistically significant changes in health-related quality of life.
Dr de Souza and colleagues developed the patient-reported outcome measure by interviewing 155 patients over 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 devised the Comprehensive Score for Financial Toxicity (COST). “It was important to find a way to grade financial toxicity to give it practical applications,” Dr de Souza explained. “Now we are starting to apply it.”
Using COST, the researchers analyzed data from 600 patients in 2 separate groups. The first cohort consisted of 233 patients with stage IV cancers who were receiving 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.
Although 42% of patients showed no symptoms of financial toxicity 31% had a grade 1 COST score, and 25% had a grade 2 score.
The second cohort was comprised of patients and survivors with thyroid cancer within 3 years of diagnosis. The researchers applied the patient-reported outcome measure survey alongside 2 established quality-of-life instruments 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
Questions of how and when to intervene remain. “We are still trying to determine what to do with this information,” Dr de Souza acknowledged. “Maybe with grade 3 financial toxicity, physicians should intervene.”
With side effects such as severe fatigue or pain, there is typically an effort to establish cause. “That is where we are trying to get with financial toxicity,” Dr de Souza said. “With fatigue and pain, I may 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.”
“There are some cancers, like head and neck, that have more of an effect on patients not being able to work, and that is causing this distress,” he explained. “Thyroid cancer, on the other hand, has a lot of out-of-pocket expenses.”
“I think every cancer is going to have a different driver,” Dr de Souza concluded. “But what are the drivers per cancer, and how can we try to personalize interventions?”