Improvements in Health‐Related Quality of Life After Financial Navigation Among Cancer Survivors

ABSTRACT

Background

Financial toxicity is associated with worse health outcomes among cancer survivors. It is unknown if financial navigation (FN) can meaningfully improve the health of survivors experiencing financial toxicity.

Aims

This analysis assesses changes in health‐related quality of life (HRQoL) among cancer survivors receiving an FN intervention.

Methods

A single‐arm Type II Hybrid Implementation‐Effectiveness clinical trial was conducted at eight clinical oncology sites in North Carolina. Cancer survivors within five years of diagnosis or living with advanced disease with a COmprehensive Score for financial Toxicity (COST‐FACIT) score of < 23, and the ability to read and understand English were recruited to receive the Lessening the Impact of Financial Toxicity (LIFT) intervention, which included a comprehensive intake and at least one check‐in with a trained navigator. Participants completed the Patient‐Reported Outcomes Measurement Information System (PROMIS) Global Physical and Mental Health, Anxiety, Depression, and Psychosocial Illness Impact‐Positive measures.

Results

A total of N = 86 cancer survivors received the LIFT FN intervention and completed baseline and follow‐up surveys. Receipt of LIFT FN was associated with statistically significant improvements in measures of global mental health (change: 1.72, 95% CI: 0.07, 3.38), depression (change: −2.07, 95% CI: −3.90, −0.25), and anxiety (change: −3.33, 95% CI: −5.42, −1.24). From baseline to follow‐up, mean depression scores clinically improved from “mild” to “within normal limits,” and mean anxiety scores clinically improved from “moderate” to “mild.”

Conclusions

Our findings demonstrate that receipt of FN decreased anxiety and depression and improved global mental health. Findings highlight the crucial role of FN in cancer care.

Trial Registration

NCT04931251

1. Introduction

While diagnostic and therapeutic advances in oncology have improved survival rates, rising costs of care and cost sharing shifts have contributed to over one‐half of cancer survivors in the United States (US) experiencing financial hardship [1]. This cancer‐related financial hardship, or financial toxicity, is a multi‐dimensional construct that includes material (e.g., debt due to care), psychological (e.g., worry about affording care), and behavioral (e.g., cost‐related delayed or foregone care) harms [2]. Evidence suggests that financial toxicity can affect patients across the globe, but compared to other high‐income countries, the burden is particularly pronounced in the US, where incomplete coverage and high prices can leave patients more exposed to out‐of‐pocket costs [3, 4, 5, 6]. Financial toxicity can impair both clinical and psychosocial outcomes, with recent meta‐analyses demonstrating a consistent negative correlation between financial toxicity and health‐related quality of life (HRQoL) [7, 8].

Financial toxicity‐related research efforts have begun to shift from documentation of its scope and consequences toward testing interventions focused on prevention and alleviation, including financial navigation [9]. Typically delivered by a social worker, financial counselor, or specially trained lay navigator, financial navigation is a proactive intervention that involves identifying and accessing relevant financial resources; navigating complex billing, payment, and insurance systems; and minimizing cost‐related barriers to treatment [10]. Clinic‐based financial navigation programs have led to reductions in patients' out‐of‐pocket spending and increases in referrals to relevant resources, and pilot navigation efforts have shown promise in minimizing financial toxicity [11, 12, 13]. Despite this, there is limited evidence to demonstrate the impact of large‐scale interventions on financial and clinical outcomes, including HRQoL [9].

The Lessening the Impact of Financial Toxicity (LIFT) study sought to assess effectiveness and implementation outcomes of a single‐arm trial of oncology‐based financial navigation. LIFT navigators were existing employees at LIFT sites whose time was partially funded for the LIFT trial (0.5 full‐time equivalent). LIFT financial navigators received 17 hours of training, including content from national organizations (e.g., Association of Cancer Care Centers' Financial Advocacy Boot Camp) and the study‐specific content [14]. The primary outcome of the LIFT trial was financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST), and participation in LIFT was associated with a significant decrease in financial toxicity [15]. Secondary outcomes, meanwhile, included identification of implementation determinants and assessment of HRQoL, cost‐coping behaviors, and perception of the intervention.

This pre‐specified secondary outcomes analysis from the LIFT trial aims to determine the impact of financial navigation on HRQoL, including global physical and mental health, anxiety, depression, and illness impact [16].

2. Methods

2.1. Sample and Setting

Eligible participants were diagnosed with in the past five years or were currently living with advanced disease, had a COST score of < 23 (indicating moderate to severe financial toxicity) [17], and were able to read and understand spoken English. Participants were drawn from eight demographically and geographically diverse clinical sites in North Carolina. All sites were part of an existing statewide cancer survivorship network created for pragmatic health services research.

2.2. LIFT Intervention

The LIFT financial navigation intervention consisted of a comprehensive intake and at least one subsequent check‐in with a trained financial navigator, with the number of follow‐up sessions determined by the complexity of the patient case. The study provided clinical sites with dedicated funding to support protected time for delivering the LIFT financial navigation intervention. Financial navigators connected patient participants to local and national financial support resources and provided guidance with financial assistance applications, but the intervention did not include specific mental health or quality of life components [18]. A detailed description of the LIFT trial protocol has been published elsewhere [16].

2.3. Outcomes

Secondary outcomes of the LIFT trial included HRQoL, measured using Patient‐Reported Outcomes Measurement Information System (PROMIS) Global Physical and Mental Health, Anxiety 6a, Depression 4a, and Psychosocial Illness Impact‐Positive (positive emotional response to illness) instruments.

2.4. Recruitment and Data Collection

At each clinical site, LIFT financial navigators approached, screened, and consented potential participants during or around in‐person clinical appointments. Outcome measures were administered at baseline prior to the intake appointment and at the conclusion of the intervention. Once a navigator could no longer provide additional assistance and/or a funding decision was made on all submitted assistance applications, intervention participation concluded, and participants completed follow‐up measures. Follow‐up surveys were completed, on average, 3.6 months (SD: 2.3) after baseline, and, on average, participants completed three intervention sessions.

Baseline and follow‐up surveys were collected in a password‐protected, secure Research Electronic Data Capture (REDCap) database. Financial navigators were given tablets to assist survivors in completing the baseline and follow‐up surveys while in clinic. Financial navigators were also able to email the surveys through REDCap or print them from REDCap, based on individual patient preference.

2.5. Statistical Analysis

Descriptive statistics characterized the sample. PROMIS measures were scored in alignment with scoring instructions available through HealthMeasures (www.healthmeasures.net). For all PROMIS scales, higher scores indicate more of the measured concept, and scores are standardized to the US general population, with an average of 50 and a standard deviation of 10 [19].

Paired t‐tests assessed change in PROMIS scores from baseline to follow‐up. Wilcoxon Rank Sum tests, for continuous variables, and Fisher's Exact tests, for categorical variables, compared characteristics between responders and non‐responders; two group t‐tests compared baseline PROMIS scores. Statistical significance was pre‐set at p < 0.05. Severity of construct being measured and minimal clinically important differences (MCID) were defined by HealthMeasures. A within person change of five or more points was considered a MCID. All analyses were conducted using SAS v9.4 (SAS Institute Inc., Cary, NC) and approved by the University of North Carolina Institutional Review Board (#20‐1997).

3. Results

Of 134 LIFT participants who completed the primary outcome measures (COST), 86 (64%) completed all secondary HRQoL measures (Supporting Information S1: Figure 1). Respondents were on average 52.7 years at baseline (SD: 12.4) and 1.1 years from diagnosis (SD: 1.8). Respondents were predominantly women (74%), and either Non‐Hispanic White (61%) or Non‐Hispanic Black (30%). Breast cancer was the most common diagnosis (49%), and 59% of the sample reported an annual income < $24,000 (Table 1). A vast majority of respondents were currently receiving cancer treatment (91%) with most reporting have received chemotherapy (77%) and/or surgery (50%). There were few differences between those who complete post HRQOL measures and those who didn't across baseline HRQOL scores. However, those who completed both pre/post HRQOL measures were farther from diagnosis (1.1 v 0.4 years), women (74% v 50%), insured (84% v 60%), more likely to have received surgery (50% v 31%) and had slightly higher baseline anxiety scores (62.4 v 59.2). (Supporting Information S1: Table 1)

TABLE 1.

Baseline patient characteristics of patients who completed secondary outcome measures in the LIFT trial.

	Total (N = 86)
Demographic and cancer characteristics	Mean	SD
Age at baseline	52.7	12.4
Age at diagnosis	51.6	12.6
Time since diagnosis (years)	1.1	1.8
	N	%
Gender
Woman	64	74.4
Man	22	25.6
Race and ethnicity
Non‐hispanic white	52	60.5
Non‐hispanic black	26	30.2
Hispanic	7	8.1
Other	1	1.2
Insurance status a
Uninsured	14	16.5
Insured	71	83.5
Annual income a
<$12,000	23	27.1
$12,000–$23,999	27	31.7
$24,000–$35,999	13	15.3
$36,000–$59,999	12	14.1
$60,000–$83,999	6	7.1
$84,000–$119,000	4	4.7
Marital status a
Married	25	29.1
Divorced	21	24.4
Widowed	8	9.3
Never married	20	23.3
Unmarried but living with partner	7	8.1
Separated	4	4.7
Cancer type
Breast	42	48.8
Colorectal	7	8.1
Lung	12	14.0
Leukemia/Lymphoma	9	10.5
Hematologic	3	3.5
Gastrointestinal	5	5.8
Gynecologic	2	2.3
Pancreas	3	3.5
Prostate	2	2.3
Skin/Melanoma	1	1.2
Treatment phase at intake
Treatment plan in development	4	4.7
Currently receiving treatment	78	90.7
Finished with treatment	4	4.7
Treatment received b
Surgery	43	50.0
Chemo	66	76.7
Radiation	30	34.9
Survivor residence rurality
Non‐rural survivor	55	64.0
Rural survivor	31	36.0

^a One participant had missing data for this variable; column percentages were calculated using n = 85.

^b Participants could select more than one item, thus percentage sum to over 100%.

At baseline, LIFT trial participants reported fair global mental and physical health (mental mean: 39.76, SD: 7.61; physical mean: 37.26, SD: 6.59), moderate anxiety (mean: 62.43, SD: 8.58), and mild depression (mean: 57.05, SD: 9.60). The mean positive psychosocial illness impact score was 42.66 (SD: 9.05; Table 2). From baseline to follow‐up, receiving the LIFT financial navigation was associated with mean improvement in global mental health of 1.72 points (95% confidence interval [CI]: 0.07, 3.38), improvement in anxiety of 3.33 points (95% CI: −5.42, −1.24), and improvement in depression of 2.07 points (95% CI: −3.90, −0.25).

TABLE 2.

Change in health‐related quality of life from baseline to follow‐up in the LIFT financial navigation trial (N = 86).

	Baseline			Follow‐up			Mean change	95% CI	p‐value	Meaningful improvement
	Mean	SD	Severity	Mean	SD	Severity
PROMIS global mental health	39.76	7.61	Fair	41.49	7.83	Fair	1.72	0.07, 3.38	0.04*	24.4%
PROMIS anxiety	62.43	8.58	Moderate	59.10	9.37	Mild	−3.33	−5.42, −1.24	0.002*	41.9%
PROMIS depression	57.05	9.60	Mild	54.98	9.67	Normal	−2.07	−3.90, −0.25	0.03*	38.4%
PROMIS global physical health a	37.26	6.59	Fair	38.31	7.06	Fair	1.15	−0.22, 2.53	0.10	28.6%
PROMIS psychosocial illness impact–Positive	42.66	9.05	—	44.08	9.45	—	1.41	−0.82, 3.65	0.21	30.2%

Note: Higher scores indicate more of the concept being measured. Severity benchmarks were defined by HealthMeasures. As described by HealthMeasures, a within person change of five‐points was considered to be the minimal clinically important difference (MCID). The percent who met the MCID threshold and improved are listed as meaningful improvement.

^a Two participants had missing data for this measure.

^* Statistically significant at p < 0.05 using paired t‐tests.

While statistically significant, changes in the mean score of the PROMIS global mental health from baseline to follow‐up remained within the “fair” range, with 24% of participants reporting meaningful improvement (i.e., MCID). However, mean depression scores improved from “mild” depression at baseline to scores “within normal limits” at follow‐up, with 39% of participants reporting meaningful improvement in depression (Supporting Information S1: Figure 2). Further, mean anxiety scores improved from “moderate” anxiety at baseline to “mild” anxiety at follow‐up, with 42% of participants reporting meaningful improvement.

No statistically or clinically significant changes in global physical health or psychosocial illness impact were detected; however, 29% of participants reported meaningful improvement of global physical health, and 30% reported meaningful improvement in psychosocial illness impact.

4. Discussion

Findings from this multi‐site single‐arm trial highlight the promise of financial navigation in improving HRQoL. Receipt of the financial navigation intervention was associated with statistically significant pre‐post improvements in global mental health, depression, and anxiety. Clinically meaningful reductions in anxiety and depression were also observed from baseline to follow‐up. These results are among the first, to our knowledge, to demonstrate the benefits of financial navigation on mental health outcomes, outside of the pilot setting. These findings, in combination with previously demonstrated reductions in financial toxicity after financial navigation, suggest the value of financial navigation in improving both financial and clinical psychosocial outcomes [12, 15, 20, 21]. While, the LIFT trial was conducted in a single state, the Type II Hybrid trial design and recruitment embedded in eight diverse oncology sites, suggests that LIFT may be generalizable to other settings across North Carolina and the United States [22]. To further solidify the impact of comprehensive LIFT‐style financial navigation, future inquiry would benefit from conducting a larger scale trial across the United States.

Our findings are particularly noteworthy given the strong association found across the literature between financial toxicity and measures of anxiety [23]. Our results support prior work that demonstrated reductions in anxiety in survivors following a pilot financial navigation intervention [24]. Although we did not explicitly measure anxiety in the LIFT pilot study, our prior work suggested that financial navigation could reduce cost‐related distress, which was reinforced through the findings from the current study [21]. As LIFT was a single‐arm trial, we are unable to compare findings to patients who did not receive financial navigation; however, the existing literature does not suggest that cancer survivors experience significant improvements in their mental health within the first year of diagnosis—the timeframe in which most patients participated in the LIFT trial—making it unlikely that observed improvements reflect a natural trajectory alone [25, 26].

4.1. Implications

Given that the LIFT intervention did not explicitly target mental health components, our findings highlight the capacity of financial navigation to reduce anxiety (moderate to mild) and depression (mild to normal) indirectly through assistance with a key cancer‐associated stressor. These reductions in anxiety and depression are likely due to the multi‐faceted nature of financial toxicity, whereby material hardships intersect with psychosocial concerns and coping behaviors. Furthermore, LIFT financial navigation directly addresses healthcare access and portions of economic instability, which are known determinants of health. Future iterations of LIFT and other forms of financial navigation interventions could include psychosocial components to directly address poor mental health outcomes or include specific components to reduce the financial toxicity of mental health care.

4.2. Study Limitations

These results must be interpreted in the context of several limitations, including the non‐randomized study design, which limits our ability to attribute observed changes solely to LIFT financial navigation. Furthermore, we were unable to assess if participants were receiving other services concurrently with LIFT that may have contributed to increased HRQoL. The high administrative burden of LIFT resulted in prioritization of primary endpoints (i.e., COST) and resulted in fewer than anticipated follow‐up surveys with our secondary outcomes—including HRQoL measures. Additionally, we were unable to capture the number of patients that were approached to participate in LIFT but did not consent limiting our assessment of the reach of LIFT. Finally, to minimize burden on the patient some demographic and clinical characteristics were not collected such as stage of the patients' cancer diagnosis.

5. Conclusions

Cancer survivors who received financial navigation across eight sites reported statistically significant decreases in anxiety and depression scores as well as an improvement in global mental health scores. Notably, mean anxiety scores improved from the moderate to mild range and mean depression scores improved from mild depression to within normal limits at follow‐up. In addition, nearly 40% of survivors experienced clinically meaningful improvements in anxiety or depression. These findings add to a growing body of evidence suggesting that the benefits of financial navigation may extend beyond financial outcomes alone. Given the established relationship between financial hardship and psychological distress among cancer survivors, addressing financial concerns through financial navigation may contribute to improved mental health. Contextualized in the literature, these findings highlight the important role of financial navigation in ensuring high quality cancer care and optimizing health outcomes across multiple dimensions.

Funding

This research was supported by the National Cancer Institute (NCI) (1‐R01‐CA240092‐02, PI: Wheeler and Rosenstein), T32CA092203 (ARW), K01CA304478 (BT), K01CA250989 (LPS), T32CA116339 (CRM, KP), and P30‑CA016086‑44‑S4. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Conflicts of Interest

SBW and LPS have received unrelated grant funding paid to their institution from Pfizer and Astra Zeneca in the past 3 years. BT has received unrelated grant funding from Pfizer paid to her institution in the past 3 years.

Supporting information

Supporting Information S1

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.