Background
The rising cost of cancer care is an increasingly recognized problem and potentially devastating facet of the cancer experience for patients and their caregivers.1 Recent studies indicate high levels of financial distress, significant material hardship leading to financial crises including bankruptcy,2 and harmful care-altering behaviors among patients with cancer.3–5 A disproportionately higher burden of these consequences affects marginalized populations, including racial and ethnic minority,3,6–10 low-income,11 and rural populations.12,13 Financial toxicity has been shown to affect the majority of patients with cancer and their caregivers.14 The effects can last for many years after diagnosis, adversely altering patients’ quality of life15,16 and increasing cancer outcome disparities.17
Although patients with cancer and their caregivers are often burdened with concerns about the affordability of their treatments,18–20 rarely do providers discuss cost and patients’ financial barriers to care.18,21 Part of this is due to the opaqueness of cost and insurance benefit information to providers and because providers do not know where to direct their patients for financial assistance. Financial assistance programs directly serve patients by helping them afford recommended treatments.22–24 However, these programs may be unknown to providers and patients, unequally distributed, cumbersome to use, ineffectively coordinated, and/or logistically difficult to navigate.25–29 Common barriers to obtaining financial assistance reported by oncology navigators include insufficient financial support resources (50%), lack of knowledge about existing financial support resources (46%), and complex and burdensome paperwork (20%).26
Consequently, there is a pressing need for interventions to reduce cancer-related financial toxicity, with a particular focus on addressing the complex social determinants of poor health outcomes facing marginalized populations.23–25 Patients and their caregivers require dedicated and easily accessible assistance from a trained professional who can assess eligibility, assist with applications for which patients are eligible, help explain and manage convoluted medical bills, and arrange and pay for transportation, accommodations, and other nonmedical issues.19,21 Importantly, such interventions need to systematically identify patients at risk for financial toxicity, comprehensively assess the nature of those risks, and provide direct patient assistance.
Accordingly, the objective of this study was to decrease the burden of financial toxicity by developing and testing a novel, multiphase, patient-centered financial navigation (FN) intervention that is fully integrated within existing care coordination services at a large academic medical center. Here, we report on 3 primary components and outcomes of the intervention: (1) the development of a financial distress screening strategy and FN clinic for patients experiencing the greatest financial burden; (2) preliminary effectiveness outcomes of the FN intervention (ie, quantified reduction in a validated measure of financial toxicity); and (3) implementation outcomes associated with delivery of the intervention, including fidelity, uptake, and acceptability.
Methods
Financial Toxicity Screening
This study was conducted at the North Carolina Basnight Cancer Hospital (NCBCH) and focused on people diagnosed with cancer and potentially at risk for, or currently experiencing, financial hardship associated with their cancer care. We first interviewed NCBCH staff to understand existing financial support referral processes and developed process flow diagrams to inform intervention planning. Because there was no standardized method of financial distress screening being used, we explored the usability of several existing financial distress screening measures, including the Comprehensive Score for Financial Toxicity (COST) measure, validated among patients with advanced cancer30,31; the InCharge Financial Distress/Financial Well-Being Scale, validated among the general US population32; the NCCN Distress Thermometer33; and several financial toxicity questions previously developed and used by the study team.
To determine the readability, acceptability, and efficacy of the candidate screening questions, we recruited 15 NCBCH patients who were identified by NCBCH staff to be potentially in need of financial assistance. Eligibility included self-identification as uninsured, Medicaid insured, and/or privately insured with high deductibles. We conducted 30- to 45-minute, semistructured, in-depth interviews with patients, asking them about comprehension, wording preferences, timing of the screening process, and other process-related factors attributed to successful screening implementation. Patients were compensated $20 for their study participation.
Patient interviews were audio recorded and transcribed. During each interview, the screening tools were ranked based by participants on overall satisfaction, clarity, appropriateness, length, and readability, each of which guided the overall selection of the final financial toxicity screening instrument. Researchers then conducted a rapid qualitative analysis by reading through transcripts and noting participants’ perceptions of each screening tool. Screening tools were then ranked by the research team based on aggregate perceptions provided by participants. The final number of screening questions was determined by participant perceptions of length and distribution of positive perceptions on each tool.
Recruitment and Eligibility
Following development of the financial toxicity screening tool, the research team developed a process for screening and intervening with potentially eligible patients that was compatible with current NCBCH outpatient referral processes. Potentially eligible patients were identified through multiple different mechanisms, such as indicating financial concerns through distress screening (using the NCCN Distress Thermometer) and through provider encounters (including physicians, nurses, and supportive care professionals). Patients were then referred to an oncology social worker through several pathways, including self-referral and staff and clinician referral, allowing for multiple opportunities for referral within the patient’s cancer experience. During the social work intake process, all patients were invited to participate in the study. Interested patients consented to the study and completed the screening questionnaire. All 50 patients assessed for study eligibility screened positive for financial distress (COST score <23), were referred directly to the FN intervention, and all consented and joined the study (Figure 1).
Schematic of financial navigation intervention.
Abbreviation: COST, Comprehensive Score for Financial Toxicity.
Citation: Journal of the National Comprehensive Cancer Network 22, 8; 10.6004/jnccn.2024.7030
FN Intervention Components
The FN intervention consisted of 2 appointment types: (1) an initial comprehensive intake appointment for patients who screened positive for financial distress, during which eligibility for a variety of financial assistance resources was ascertained; and (2) follow-up appointments to meet with the financial navigator and discuss the applications and information necessary to apply for the resources identified during the initial appointment. Both appointment types included a one-on-one consultation with a trained financial navigator (either a social work trainee, licensed clinical social worker, or patient assistance fund coordinator). At the initial appointment, the financial navigator reviewed the patient’s personal situation, including employment status, current NCBCH billing information, insurance status, and any other potentially relevant indicators used to triage patients to the appropriate financial resource(s). During the initial appointment, the financial navigator and patient also worked together to set financial goals for securing financial assistance resources, including reviewing timelines and required materials for application submissions, over the intervention period. At the conclusion of this appointment, patients were given a checklist of resources they were eligible for and the personal paperwork (eg, tax forms, W-2, pay stubs) required for subsequent applications. During the follow-up appointments, the financial navigator reviewed the initial appointment sheet, verified that the patient had the necessary paperwork, and reviewed applications for completeness or worked with the patient to complete the resource applications. Patients were contacted every 2 weeks by phone for follow-up appointments to assess patients’ progress toward their financial assistance goals, or were met by the financial navigator at an existing NCBCH clinic appointment. Throughout the intervention, patients were educated about and referred to NCBCH nonmedical and medical financial assistance and pharmacy assistance programs. External program referrals included Medicaid, Social Security and Disability, pro bono Legal Aid, assistance to enroll in Affordable Care Act insurance plans, and linkage to national and local private and not-for-profit financial assistance resources. The FN intervention differed from standard of care social work in a variety of ways, including (1) standardized financial hardship screening, (2) newly developed educational support and case management infrastructure for financial navigators, (3) new tracking and documentation protocols, (4) proactive and regularly scheduled follow-ups informed by tracking and documentation, and (5) preset goal endpoints.
At the conclusion of the FN intervention, defined as either patients reporting that they had met ≥1 of their financial goals or the end of the 4-month follow-up period, patients completed the financial distress instrument again and a postprogram survey, administered in person or via phone, depending on patient preference.
Outcomes and Analyses
Our primary outcome for assessing preliminary intervention effectiveness was the pre/postintervention difference in a participant’s COST score (higher COST score indicates less perceived financial toxicity), which we assessed using paired t tests. We used McNemar’s chi-square tests to assess differences in the categorical responses to the 6 study-specific questions added to the COST tool. Implementation outcomes were assessed using postintervention patient survey data and FN data logs on appointments, referrals, and resources captured throughout the study, with t tests and chi-square tests used as appropriate. This study was approved by the University of North Carolina Institutional Review Board (IRB #18-2765).
Results
The rapid qualitative analysis assessing patient preferences (n=15) for financial distress screening resulted in a final financial distress instrument (hereafter referred to as COST Plus), which included the COST measure,30,31 plus 6 additional questions (including 1 from InCharge,32 1 from the NCCN Distress Thermometer,33 and 4 NCBCH-specific questions). Patients scored the COST tool and NCBCH investigator–developed questions higher than the InCharge and NCCN Distress Thermometer, finding the graphics in the latter 2 instruments harder to understand. To adequately capture the complexity of financial toxicity experienced by patients, we used the COST measure and added questions about psychological financial toxicity and cost-saving behaviors (eg, skipping or delaying treatments, forgoing vacations).34,35
Between January and June 2019, a total of 50 patients were recruited to and participated in the FN program, and 46 patients answered both the preintervention and postintervention COST Plus measures. Most participants were female (61%), White (61%), and not currently working (85%) (Table 1), and 50% had attended some college or completed technical/vocational school, and 72% had no dependent children in their household. Approximately one-third of participants reported being privately insured, 28% were publicly insured, and 39% were uninsured. More than three-quarters of the participants reported that their cancer diagnosis had decreased their income (76%), and only 26% had received any type of social or financial assistance at baseline.
Descriptive Statistics for Patients With Cancer Who Completed the Financial Navigation Intervention (N=46)
Figure 2 reports the mean COST score pre- and post-FN for all participants, stratified by insurance status (uninsured vs insured). For the overall sample, the mean COST score improved from 6.4 at baseline to 13.3 post-FN (P<.0001), indicating a statistically significant alleviation of perceived financial toxicity. Significant differences in the baseline and postintervention COST scores were found among both uninsured (6.6 vs 15.2; P=.003) and insured samples (6.3 vs 12.1; P=.0002), with a greater improvement observed in uninsured than insured patients.
Impact of financial navigation intervention.
Financial toxicity was measured using the COST score, an 11-item validated patient-reported outcome measure, at baseline and following intervention completion. A higher COST score indicates less financial toxicity. P values were calculated using paired t tests comparing baseline and postintervention COST scores.
Abbreviations: COST, Comprehensive Score for Financial Toxicity; FN, financial navigation.
Citation: Journal of the National Comprehensive Cancer Network 22, 8; 10.6004/jnccn.2024.7030
After the FN intervention, we observed a decrease in the proportion of participants experiencing distress from not knowing their cancer costs (72% to 54%; P=.01) and the proportion worried about the financial stress on their family as a result of their cancer diagnosis (91% to 38%; P=.002) (see Figure S1 in the Supplementary Materials, available with this article at JNCCN.org). Other measures of financial toxicity showed no statistically significant decreases; at both baseline and post-FN, most patients continued to have no or little confidence that they would be able to find money to pay for a $1,000 financial emergency (80%) and reported often or always finding themselves living “paycheck to paycheck” (74%). At both baseline and post-FN, 28% reported “often” or “always” finding it hard to pay for basic necessities.
Table 2 reports intervention completion, fidelity, and uptake. Fidelity to the intervention was high, with 100% of participants completing the intake form and 100% completing at least 2 FN sessions. The average number of follow-up appointments required to successfully navigate the patient through the financial assistance process was 4. In total, 98% of participants applied for financial assistance, and 96% of participants received financial assistance. A total of 153 benefit applications were submitted, and 88% were approved. Most benefits received included those from private charitable foundations and NCBCH medical and pharmaceutical financial assistance programs. Additionally, transportation assistance in the form of gas cards, parking vouchers, and the American Cancer Society Road to Recovery program were widely used.
Financial Navigation Implementation Outcomes
Participants also reported high intervention acceptability (Supplementary Table S1). More than 95% of participants reported being satisfied with the FN services they received and were glad that they participated in the intervention. In particular, FN made it easier for participants to understand how to apply for financial assistance (91%) and what financial help was available to them (96%). Most participants reported having fewer financial worries after participating in the FN intervention (63%); 96% of participants reported that scheduling FN appointments was convenient and easy, and only 28% wished that there had been more FN appointments.
Discussion
Our development and evaluation of a financial distress screening approach and FN intervention for an academic medical center demonstrated that FN can: (1) be feasibly delivered with fidelity by trained professionals with varying levels of experience; (2) improve care processes through establishing standardized systems, tracking, and workflows; (3) effectively reduce financial distress among patients with cancer enrolled in a pre-post study; and (4) be acceptable to participants. This study adds to the nascent literature evaluating the implementation and effectiveness of FN programs.36–38 Given the complexity of financial and social needs that contribute to financial hardship, patient-centered interventions such as FN, if shown to be effective on a broader scale in diverse geographic and socioeconomic contexts, could be a critical approach to addressing patient and caregiver financial needs.
According to a study of NCI-designated Cancer Centers, nearly all centers reported offering help with medical and pharmaceutical assistance applications, and 86% reported helping patients with understanding medical bills and out-of-pocket costs; however, there is a high degree of variability in these financial support structures.28 Moreover, the availability of financial support resources does not guarantee that patients and caregivers have access to those services. The availability of dedicated and trained financial navigators can help patients understand their financial status and risk, direct patients to resources that match their needs, and reduce anxiety and the burden of financial toxicity, which has become almost ubiquitous.14 Indeed, all participants we screened at NCBCH showed signs of financial stress or risk.
Other work has similarly shown that FN can reduce financial distress, improve financial literacy, and reduce hospital uncompensated care.39,40 However, it remains critical to understand whether a multicomponent, multiphase FN intervention can be adapted, implemented, and sustained in other settings beyond NCBCH and can achieve the same benefits. For example, rural clinics may have fewer material and personnel resources to dedicate to addressing financial hardship,41–43 and clinics serving lower-income communities may lack local financial assistance programs to which they can direct patients for additional support.44 For these reasons, efforts to understand the local contextual reality can be helpful prior to FN implementation to clarify workflows, examine intervention processes, and develop or refine appropriate strategies to support implementation in specific settings.44 Currently, there are at least 5 ongoing NCI-supported studies to further test interventions designed to address financial toxicity in diverse settings and populations, including an expansion of our FN intervention in rural cancer clinics.45–49 The results of these studies will be vital to building the evidence base for financial support interventions.
Our work has several limitations. First, due to the limited duration of this study, we were unable to follow up and report on all levels of benefits acquired through the intervention due to length of time in certain application processes; nonetheless, this limitation’s impact reflects an underrepresentation of the number and types of financial supports received and is thus a conservative estimate of support services received. Second, our results are specific to an academic medical center in a single state and thus may not be representative of other settings. We are currently conducting a R01 clinical trial among 10 sites that lends itself greatly to generalizability and scalability and involves 22 hours of training for our financial navigators, primarily based on lessons learns (eg, financial issues more often discussed with patients) from the present study.45 Third, our pre-post design was pragmatic and responsive to local needs (eg, randomizing patients to a control/no-intervention condition was felt to be infeasible and potentially unethical); as a result, selection into the intervention may have yielded participants who were already more inclined to be responsive to the intervention. Although we cannot discount this potential influence of nonrandomization and convenience sampling, the preliminary effectiveness of our FN program, in addition to navigation now being a reimbursable service,50,51 demonstrated a need for future investigation of such a program within a larger trial. Fourth, our sample size precluded us from having sufficient power to examine to what extent intervention effects may be different for patient populations. Finally, a key component of intervention sustainability is cost ascertainment, which was not within the scope of the current study but is a vital part of our ongoing clinical trial expanding this FN program to 9 additional sites.45
Despite these limitations, our work has a number of strengths. In particular, our results demonstrate robust effect sizes across both insured and uninsured patients, with high implementation fidelity and broad acceptability of the program to both patients and staff. Future work should devote resources to better understanding under which contexts and for which patient populations adaptations may be needed to extend the reach and impact of FN. Although more work is needed to identify best practices for future interventions, we refer readers to our publication that details the core intervention and implementation components necessary for conducting a financial navigation program.52 It is only through patient-directed and system-embedded interventions, combined with policy-level changes, that the catastrophic effects of cancer care costs can be meaningfully addressed.
Conclusions
A patient-centered FN intervention fully integrated into an existing care coordination model can help to decrease the burden of cancer-related financial toxicity among patients with cancer experiencing financial distress. Further studies are needed to test FN interventions in various oncology settings and among targeted populations.
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