Abstract
BACKGROUND Patients with cancer are at risk for both objective and subjective financial distress. Financial distress during treatment is adversely associated with physical and mental well-being. Little is known about whether patients’ subjective financial distress changes during the course of their treatment.
method This is a cross-sectional study of insured adults with solid tumors on anti-cancer therapy for ≥1 month, surveyed at a referral center and three rural oncology clinics. The goal was to investigate how financial distress varies depending on where patients are in the course of cancer therapy. Financial distress (FD) was assessed via a validated measure; out-of-pocket (OOP) costs were estimated and medical records were reviewed for disease/treatment data. Logistic regression was used to evaluate the potential association between treatment length and financial distress.
RESULTS Among 300 participants (86% response rate), median age was 60 years (range 27-91), 52.3% were male, 78.3% had stage IV cancer or metastatic recurrence, 36.7% were retired, and 56% had private insurance. Median income was $60,000/year and median OOP costs including insurance premiums were $592/month. Median FD score (7.4/10, SD 2.5) corresponded to low FD with 16.3% reporting high/overwhelming distress. Treatment duration was not associated with the odds of experiencing high/overwhelming FD in single-predictor (OR = 1.01, CI [.93, 1.09], P = .86) or multiple predictor regression models (OR = .98, CI [.86, 1.12], P = .79). Treatment duration was not correlated with FD as a continuous variable (P = .92).
LIMITATIONS This study is limited by its cross-sectional design and generalizability to patients with early-stage cancer and those being treated outside of a major referral center.
CONCLUSION Severity of cancer treatment-related financial distress did not correlate with time on treatment, indicating that patients are at risk for FD throughout the treatment continuum. Screening for and addressing financial distress should occur throughout the course of cancer therapy.
While advances in cancer treatment have improved outcomes for many patients with cancer, the associated rise in the cost of care due to new, expensive treatments has resulted in a growing financial burden borne by patients. These treatment-related expenses affect many aspects of patients’ lives, causing them to seek more work for additional income, spend less on food or clothing, and use their savings to pay for treatment [1]. Studies have also shown that relatively small increases in out-of-pocket health care costs can result in non-adherence to cancer treatment [2-4]. Treatment-related financial burden is adversely associated with physical and mental well-being [5-7]. A cancer diagnosis results in a 2.65 times higher risk of declaring personal bankruptcy [8]. The negative impact on patients’ well-being can cause such considerable distress that the term “financial toxicity” has been introduced to describe the negative side effects of high out-of-pocket costs in cancer care [9-11].
Studies have demonstrated that cancer treatment costs follow a U-shaped curve in which costs are highest in the year after diagnosis and in the last year of life, and lower in the intervening years [12]. These trends are consistent with higher-intensity treatments shortly after diagnosis, and the high costs of end-of-life care. The dimensions of these curves depend upon cancer site, stage at diagnosis, and type of treatment utilized. Much work remains to be done in describing whether personal, treatment-related financial burden varies over the course of cancer treatment [13]. Furthermore, the health system in its current form is often unable to identify patients before they fall into medical debt [14]. Understanding timing of financial burden would help health care providers identify patients who may benefit from targeted intervention to avoid financial toxicity.
In this study, we conducted a cross-sectional survey to explore the relationship between financial distress and the length of time the patient had been receiving anti-cancer treatment, and whether there are any patient or disease-related factors that increase the risk of financial distress.
Methods
Participants
Study design and methods have been previously described in detail [15-17]. Enrollment for the study occurred between November 2012 and June 2013 at a university-based cancer treatment center and three affiliated rural oncology clinics. Eligible patients had public or private insurance coverage, had a confirmed solid tumor cancer diagnosis, and were receiving anti-cancer hormonal therapy or chemotherapy for at least one month at the time of enrollment. Patients were excluded from the study if they were uninsured, were receiving radiation therapy, or did not speak English. Uninsured patients were excluded because we were focused primarily on the experiences of patients who were insured but were still at risk of financial distress. Underinsured patients were especially important to study because the hazard of being underinsured may remain despite the Affordable Care Act [18]. Underinsured was defined as having medical expenses greater than 10% of total income [19]. Patients receiving radiation were excluded due to the relatively short nature of a typical course of radiation therapy. The survey utilized in this study was pilot tested in a group of 20 patients at the Duke Cancer Institute and was approved by the Duke University Medical Center Institutional Review Board.
Study Design
A convenience sample of 349 patients who met eligibility criteria were approached while waiting in the clinic waiting room or receiving chemotherapy. Those who agreed to participate in the study were consented and given the survey in person by a trained interviewer. On rare occasions, the patient was enrolled and the survey administered on a second visit. Participants were given a gift of $10 for completion of the survey.
Main Outcome Measures
Demographic data such as cancer diagnosis, stage of disease, type of treatment (oral or IV chemotherapy or both), and duration of treatment were abstracted from the medical record. Patient-reported demographics were collected including annual household income, education, employment, medical costs, cost-related decision-making, and medication non-adherence [15-17]. Participants completed the InCharge Financial Distress/Financial Well-Being Scale, which is a validated, 8-item questionnaire that measures financial distress on a continuum [20]. Items were scored on a scale from 1 to 10 with 1 indicating overwhelming financial distress/lowest financial well-being, and 10 indicating no financial distress/highest financial well-being. From that a binary measure, “high/overwhelming financial distress” versus “low/average financial distress” was created. Time on treatment was abstracted from the medical record and defined as the length of time the patient had been receiving anti-cancer treatment at the time of study enrollment.
Statistical Analysis
The primary question of interest was whether time on treatment was related to subjective financial distress (FD). The correlation of months on treatment and continuous FD was tested using the Pearson correlation coefficient. To test for differences between those most affected by financial distress and those least affected, a binary version of the FD variable was created using < 4 as “high/overwhelming” distress and values of 4 or higher as “low/average” distress. Logistic regression was used to model binary FD. Patients were grouped by the binary FD variable and potential differences in demographic, clinical, and financial characteristics were evaluated using Wilcoxon rank sum tests for continuous variables and Fisher’s Exact or χ2 tests for categorical variables. To obtain appropriate odds ratios, two nested logistic models were fit: the base model with time on treatment as the sole predictor; and a second model (the anchor model) that adjusted for early versus late stage and receipt of oral chemotherapy. Both determined a priori to be important covariates. All statistical analyses were performed in SAS v9.4 (Cary, North Carolina).
Results
Patient demographics
As previously reported, 349 consecutive patients were approached in the clinic setting, and 300 were eligible and agreed to participate (86% response rate, Table 1) [15-17]. Median age was 60 years, 52.3% were male, and 72.3% had at least some postsecondary education. Full-time employment rate was 26.7% among participants, with 36.7% retirees. Overall, 40% of patients were underinsured and the median reported household income of study participants was $60,000. Of the 300 study participants, 290 (96.7%) had prescription drug coverage. All patients who participated in this study were receiving chemotherapy or hormonal therapy at the time of enrollment, with 72.3% receiving intravenous chemotherapy, 5.3% receiving oral anti-cancer agents, and 21.7% receiving both intravenous and oral therapies. Overall, 24.3% patients had metastatic recurrence and 54% were stage IV at diagnosis. As briefly reported in our previous work with this cohort (not included in this study), 22% did not fill a prescription because of cost; 52% expressed some desire to discuss treatment-related out-of-pocket costs; 19% had spoken to their doctor about costs; 57% reported lower out-of-pocket costs as a result of cost discussions; and there is 31% versus 10% relative cost of care for patients with high or overwhelming distress versus those with no, low, or average financial distress [15-17].
Demographic and Clinical Characteristics of Patient Cohort in Cross-Sectional Study Investigating Financial Distress
Time on Treatment and Financial Distress
The median duration of treatment was 4.6 months (range 1-156 months, Table 1). Although 4% of patients were on therapy for greater than five years, 73.7% were on chemotherapy or hormone treatment for a year or less with 55.3% on therapy for six months or less. Sixteen percent of patients (n = 49) classified their financial distress as high or overwhelming. The median financial distress score was 7.4, which corresponds to low degree of financial distress. The median monthly out-of-pocket expense was $591.50 (including insurance premiums).
Factors associated with financial distress
Factors associated with high financial distress are summarized in Table 2. Of respondents that had high-to-overwhelming financial distress, 57.1% were divorced, widowed, separated, or never married (versus 26.3% of respondents in the low-to-average FD group, P < .001). Similarly, employment was associated with financial distress. In participants with low-to-average financial distress, there was a 33.5% employment rate, with 42.2% retired and 20.3% unemployed and not seeking employment. In participants with high-to-overwhelming FD, there was a 28.6% employment rate with 8.2% retired and 57.1% unemployed and not seeking employment. Finally, underinsurance was associated with high financial distress (61.2% underinsured with high financial distress versus 35.9% underinsured with low financial distress, P < .001). These findings have been previously reported elsewhere by our group [17].
Factors Associated with Financial Distress Defined as Low to Average versus High to Overwhelming
Multivariate Analysis
Logistic regression on duration of treatment, early versus late stage, and receipt of oral anti-cancer therapy demonstrated that early stage cancer was associated with a higher probability of high or overwhelming financial distress than late stage cancer (OR = 2.22 ; 95% CI, 1.11–4.43, P = .02) (Table 3). There was no association between time on treatment and binary financial distress on adjusted analysis.
Multivariate Analysis with Comparison between Time on Treatment, Early Stage vs Late Stage, and Mode of Therapy
Comparison of the continuous financial distress to duration of treatment yielded no evidence of a correlation (P = .92).
Discussion
A large portion of cancer patients undergoing anti-cancer therapy experience financial distress as a direct result of their treatment [1, 21, 22]. In this cross-sectional study, we found no correlation between severity of their financial distress and duration of treatment. However, having early-stage cancer was associated with a higher level of financial distress.
Our data suggest that, unlike systemic costs, subjective financial burden does not necessarily vary over the course of treatment. The potential for financial distress regardless of time on treatment is supported by studies that suggest long-term cancer survivors are also at risk for experiencing financial burden. Kent and colleagues, using data from the National Health Interview Survey, found that 32% of cancer survivors reported cancer-related financial problems [21]. Guy and colleagues found that the financial burden related to cancer treatment, including direct and indirect costs, remained high years after diagnosis [23]. An explanation for the durability of financial burden might relate to employment in survivorship as well: De Boer and colleagues found that cancer survivors were more likely to be unemployed than healthy control participants [24-26]. Indeed, our current study shows unemployment is significantly associated with financial distress.
While duration of treatment was not associated with severity of financial distress, stage might serve as a more predictable marker of financial burden for certain types of cancers [27]. This may be due to higher costs incurred in the initial period following diagnosis [12, 27]. This is further underscored by the increasing frequency of plans with higher deductibles (promising lower premiums) as well as new, expensive oral regimens. Oral medications have become an increasingly common mode of anti-cancer drug delivery compared to traditional intravenous chemotherapy. This has presented unique challenges for the patient including medication adherence and cost partly due to limited prescription drug coverage [28-30]. Financial assistance continues to remain small in such cases [30]. Similarly, our study suggests that lack of prescription drug coverage is associated with financial distress. It is an area that will require greater scrutiny and policy-level changes [31]. As previously reported [6, 7, 17] and demonstrated in this study, characteristics such as age and marital status might be useful for targeting early interventions in patients who are at risk for treatment-related financial distress. This is not unique to patients in the United States. Similar results were reported in a study evaluating financial distress in patients with advanced cancer in France [32].
An alternative to patients making significant lifestyle changes to accommodate unexpected out-of-pocket costs, clear predictors of financial distress could help providers anticipate distress and direct patients to the appropriate resources. Our results indicate that patients are at risk for significant financial distress throughout their care and that health care providers should intermittently inquire about financial well-being during a patient visit as they would about medication side effects or new symptoms. Recently developed measures have demonstrated reliability and validity in measuring financial toxicity in patients with advanced cancer [33, 34]. These measures have shown correlation to health-related quality of life and may be utilized in the clinical setting to help guide efforts with patients.
Limitations
This study has several limitations. First, we reported a cross-sectional analysis of the sample population at one point in their treatment, which may not account for changes in financial distress over time. Second, financial distress was self-reported, leading to the possibility of recall bias and socially desirable response bias. Third, there were fewer than 50 total patients who reported high to overwhelming distress, limiting the power to detect differences. Fourth, we surveyed a consecutive but nonrandom sample of cancer patients, most of whom were treated at a major referral center. However, the study had a high response rate and non-responders only differed to responders in age, suggesting that at least within this center, this was a representative population. Fifth, the median monthly out-of-pocket cost estimates provided by study participants approximated those from larger, population-based studies [35, 36]. This study was conducted at a large referral center and three rural oncology clinics, and median annual household income in the study was higher than median household income in the United States. However, that suggests that financial distress might be even higher in a more nationally representative population. Sixth, since our patient cohort included majority advanced cancer patients, it may not adequately represent financial distress in patients with early stage cancer. Furthermore, uninsured patients were excluded in this study since we were focused primarily on the experiences of patients who were insured but were still at risk of financial distress. Patients receiving radiation were excluded due to the relatively short nature of a typical course of radiation therapy. Finally, since not all potentially eligible patients were approached due to study staff availability, selection bias might have been introduced.
Conclusion
In this study, duration of cancer treatment was not found to be associated with treatment-related financial distress, suggesting patients may be at risk for developing financial distress throughout their treatment continuum. Receiving curative-intent treatment was found to be significantly associated with high financial distress, independent of treatment duration. Underinsurance, unemployment, and single/divorced/widowed marital status were other factors found associated with high financial distress. Further research is needed to develop and apply innovative interventions to identify patients at risk for treatment-related financial burden.
Acknowledgments
S.M. Qasim Hussaini, Fumiko Chino, and Christel Rushing helped with hypothesis generation, data interpretation, and writing the manuscript. Christel Rushing and Greg Samsa helped in data collection and interpretation. Ivy Altomare, Jonathan Nicolla, Jeffrey Peppercorn, and S. Yousuf Zafar provided overall guidance and support in successful completion of this project. This work was supported by the Duke Cancer Institute Cancer Control Pilot Studies Program (S. Yousuf Zafar) and Duke Clinical Research Institute Comparative Effectiveness KM1 Award No. 1KM1CA156687-01 (S. Yousuf Zafar)
Potential conflicts of interest. S.Y.Z. reports other from AIM Specialty Health, non-financial support and other from Vivor, LLC, nonfinancial support and other from SamFund, non-financial support from Family Reach Foundation, other from Copernicus-WCG IRB, personal fees from RTI, personal fees from McKesson, other from Shattuck Labs, grants from Astrazeneca, grants from NIH, outside the submitted work. J.N. is listed as contributor on Duke-filed Inventor Disclosure Form for Pathlight, a research-based application built to help patients have financial discussions with their oncologist. J.P. reports other from GlaxoSmithKline, grants from Pfizer, outside the submitted work. All other authors list no conflicts of interest. We have full control of primary data, and we agree to have the journal review the data if needed.
- ©2021 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.
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