Abstract
PURPOSE:
Financial navigation could mitigate or prevent cancer-related financial hardship, but its effectiveness has not been established in real world settings. We developed an intervention that provided proactive, personalized financial navigation to individuals newly diagnosed with cancer.
PATIENTS AND METHODS:
We conducted a randomized controlled trial at two integrated health systems. Inclusion criteria were age 18+ and receiving care for a new cancer diagnosis of any type or stage. Participants were randomized 1:1:1 to either Brief intervention (one proactive outreach + 6 months of navigation), Extended intervention (3 proactive outreaches + 6 months of navigation) or enhanced usual care. All arms received a list of available financial assistance resources.
Primary outcomes were self-reported financial hardship (InCharge Financial Distress/Financial Well-Being Scale), and cancer-related quality of life (FACT-G7), at 12 months followup. We fit generalized linear models adjusting for site, cancer type, socioeconomic diversity, and demographics.
RESULTS:
We randomized 371 participants (26.2% enrollment of those reached and eligible). The sample was mean age 61.6 (SD 13.3); 62.8% female; 8.7% Asian, 8.5% Black, 10.7% Hispanic; 8.2% other or multiple race, and 63.9% White. Cancer types were primarily breast (37.7%) and prostate (14.6%). At 12 month followup (n=283), financial hardship and quality of life were similar between intervention groups (unadjusted mean (SD): Brief=7.39 (2.66); Extended=6.84 (2.55); Usual care=6.69 (2.66), adjusted p-value=0.73; FACT-G7: Brief=19.1 (5.1), Extended=19.0 (5.2), Usual care=19.2 (5.2), p=0.17).
CONCLUSION:
Financial navigation was not associated with improved financial hardship or cancer-related quality of life in patients newly diagnosed with cancer compared to enhanced usual care. Continued research on strategies to address the urgent problem of cancer-related financial hardship is needed.
Introduction
Up to 50% of cancer survivors report financial hardship and 12%−62% of cancer survivors report debt due to treatment costs.1,2 Financial hardship is associated with decreased treatment initiation and adherence,3,4 poor symptoms and quality of life,5,6 and increased mortality risk. 7,8 There is an urgent need for evidence-based interventions on how to prevent or mitigate financial hardship for people with cancer.9–11
Assessing financial hardship early in the treatment trajectory, communication about financial concerns and out-of-pocket (OOP) costs, and financial navigation programs could mitigate financial hardship and are consistent with patient and care team preferences.12,13 However, to date there is limited evidence from randomized trials about whether financial navigation soon after diagnosis reduces financial hardship. Further, the optimal dose of financial navigation is not established.
We conducted a randomized clinical trial (RCT) of a novel financial navigation intervention for people with newly diagnosed cancers. This manuscript reports our primary outcomes, comparing self-reported (a) financial hardship and (b) quality of life between patients receiving a financial navigation intervention versus a comparison group at 12-month follow up. Our primary hypothesis was that the financial navigation intervention would be associated with improved cancer-related quality of life and reduced financial hardship at 12 months follow-up.
Methods
The Cancer Financial Experience (CAFÉ) study was a multi-site RCT of a financial navigation intervention with individual-level randomization (Figure 1). The trial was conducted in medical oncology and radiation oncology clinics at two integrated health systems: Kaiser Permanente Washington (KPWA) in Seattle, WA, and Kaiser Permanente Northwest (KPNW) in Portland, OR.
Figure 1.
CONSORT diagram
The investigators obtained informed consent from each participant. All human investigations were performed after approval for all study activities was obtained from the Kaiser Permanente Interregional IRB. Data collection activities took place between August 2021 and March 2024. Intervention activities took place between August 2021 and September 2023.
Selection and description of participants
The trial protocol is described in detail elsewhere14 and in the supplemental materials. Current KPWA or KPNW members with a new cancer diagnosis within the previous 120 days, age 18 or older, and a scheduled visit to a study clinic were eligible to participate. After mailing study invitation letters, study staff conducted oral consent and administered the baseline survey by phone.
Randomization.
After completion of the baseline survey, participants were randomized via a computer-generated randomization scheme developed by a study biostatistician using a 1:1:1 ratio to study arms: Enhanced usual care, Brief intervention, or Extended intervention). Randomization was stratified by site (KPWA; KPNW), and cancer type (breast, lung, prostate, colorectal, other). We used random block sizes of 3 or 6 to ensure balance of groups over time.
Enhanced usual care.
Participants randomized to all intervention groups received a brief print document listing available KP and external resources who provide financial support to KP members with cancer. Enhanced usual care participants received only this resource and did not have any contact with study navigators.
Intervention description:
The CAFÉ intervention provided cancer-specific proactive, personalized financial navigation with ongoing support, and referrals for 6 months.12,15–18 Navigators assessed patient financial concerns according to one or more pathway informed by our preliminary work: acute financial or social need; considering cost of different care options; or anticipating out of pocket medical costs.16 Navigators provided proactive, personalized support, referrals, and navigation to internal and external resources as needed to resolve financial concerns. We defined one intervention cycle as one financial navigator-initiated financial concerns assessment, personalized resources and referrals based on concerns identified, and ongoing proactive navigation as until concerns were resolved. Navigators conducted intervention activities via phone, secure message, or mail. All navigators completed training in financial advocacy, resources, health equity, intervention procedures, study protocol and documentation procedures, and met regularly to discuss cases.
Intervention conditions:
Brief intervention participants received the resource sheet and one study-initiated financial navigation cycle. Extended intervention participants received the resource sheet and three study-initiated financial navigation cycles.
The intervention period for both Brief and Extended groups was 6 months. Navigators informed each intervention participant’s care team about the participant’s involvement in the study. During the intervention period, intervention participants and their care teams were encouraged to contact the navigator directly with any financial concerns. At the end of their intervention period, intervention participants received a final outreach from the navigator to inform them that their participation had concluded, and to make warm handoffs back to usual care services as needed. They also asked four brief questions about the participant’s experience with the intervention using an exit interview format. Navigators attempted to reach participants by phone; if unsuccessful, they mailed the closure letter.
Data collection and measurements
Study endpoints.
Primary outcomes include participant-reported financial hardship and cancer-related quality of life assessed at 12 months. We measured financial hardship using the InCharge Financial Distress/Financial Well-Being Scale, an 8-item instrument designed to assess individuals’ subjective perceptions of their financial distress and well-being. Items measure current financial stress, general financial worry, satisfaction with financial circumstances, and perceived control over finances.19 To assess cancer-related quality of life we used the FACT-G7, a short-form version of the Functional Assessment of Cancer Therapy - General (FACT-G).20 Trained survey administrators conducted baseline and 12-month follow-up surveys via telephone using IRB-approved survey instruments.
Secondary outcomes included global quality of life assessed using the PROMIS global health measure21–24 and patient-centered communication assessed with the Patient Assessment of cancer Communication Experiences (PACE).25 Exploratory outcomes included cancer-specific financial hardship assessed using the COST-FACIT measure;26 patient trust in cancer care team;27 perceived care quality; treatment decision satisfaction;28 and self-reported use of several services available to all patients at the two Kaiser Permanente regions during the intervention period.
We assessed intervention fidelity as the number of navigation cycles delivered per the protocol and completion of the closure contact at the end of their 6-month intervention period.
To describe participant financial concerns we counted the number and types of concerns and the number of participant- or clinician-initiated contact with navigators. To describe the perceived value the intervention we summarized the responses to exit interview using a topical content analysis approach.29,30
Data sources
All recruitment, intervention, and survey data were collected and stored in a REDCap study database developed by the study team. The study team collected EHR-based data at baseline and 12 months, using data sources such as virtual data warehouse (VDW) elements developed by the Healthcare Systems Research Network (HCSRN) and EPIC® Clarity.
Statistical analysis
A detailed analysis plan is provided in the supplemental materials, including a description of sample size calculations and study power. Descriptive statistics for baseline characteristics are reported overall and by randomization group. Generalized linear regression models (GLM) were used to estimate intervention effects. Both primary outcomes (financial hardship and cancer-related quality of life) are continuous measures, and intervention effects were presented as differences in group means, with 95% confidence intervals. Each outcome was assessed in a separate model, adjusting for site, cancer type, diversity sample, baseline measure of the outcome, and characteristics related to both missing outcome data and baseline measures of the outcome at the p<.10 level. Additionally, models used inverse probability weights (IPW) to account for potential bias caused by survey non-response.
Heterogeneity of treatment effect was assessed by adding interaction terms to regression models to estimate separate intervention effects within subgroups defined by age, sex, baseline financial hardship, social need, and diversity sample. For all outcomes, we report p-values corresponding to the global test of any intervention effect.
Analysis of exploratory outcomes followed the same approach as outlined above for the primary outcomes. GLM models were used to estimate differences in group means for continuous outcomes. For binary outcomes, modified Poisson regression models were used to estimate relative risks and 95% confidence intervals.
All analyses followed a modified intent-to-treat approach, with individuals analyzed based on randomization group, regardless of their engagement with or exposure to the intervention.
Results
We invited 1800 patients to participate. Of these, 77 (4.3%) were ineligible, 1047 (58.2%) declined participation, 305 (16.9%) were unable to contact. In total, 371 (20.6% of those invited; 26.2% of those reached and eligible) consented and were randomized. A total of 283 participants (76.3% of those randomized) completed the 12-month survey. (Figure 1). There were no statistically significant differences between 12-month follow up completion between study arms (p=0.27). The characteristics of the sample are reported in Table 1. At baseline, 31% of participants had high, 19% had moderate, and 50% had low financial distress as measured by the InCharge Financial Distress/Financial Well-Being Scale.31
Table 1.
Sample Characteristics
| Enhanced Usual Care | Brief Intervention | Extended Intervention | Total | |
|---|---|---|---|---|
| Number of randomized participants | N=123 | N=127 | N=121 | N=371 |
| Age at identification, mean (sd) | 62.1 (13.0) | 60.5 (14.4) | 60.6 (13.3) | 61.6 (13.3) |
| Female, n(%) | 77 (62.6) | 77 (60.3) | 79 (65.3) | 233 (62.8) |
| Race/ethnicity, n(%) | ||||
| Asian1 | 9 (7.4) | 11 (8.7) | 12 (10.2) | 32 (8.7) |
| White | 75 (61.5) | 88 (69.8) | 71 (60.2) | 234 (63.9) |
| Black or African American | 10 (8.2) | 10 (7.9) | 11 (9.3) | 31 (8.5) |
| Hispanic | 16 (13.1) | 9 (7.1) | 14 (11.9) | 39 (10.7) |
| Other or multiple race2 | 12 (9.8) | 8 (6.3) | 10 (8.5) | 30 (8.2) |
| Missing | 1 [0.8] | 1 [0.8] | 3 [2.5] | 5 [1.3] |
| Language, n(%) | ||||
| English | 118 (95.9) | 124 (97.6) | 114 (94.2) | 356 (96.0) |
| Spanish | 5 (4.1) | 3 (2.4) | 7 (5.8) | 15 (4.0) |
| Education Attainment, n(%) | ||||
| High school graduate or less3 | 19 (15.5) | 22 (17.5) | 22 (18.3) | 63 (17.1) |
| Some college or associate degree | 38 (30.9) | 37 (29.4) | 34 (28.3) | 109 (29.5) |
| 4-year college graduate or some graduate school | 34 (27.6) | 36 (28.6) | 36 (30.0) | 106 (28.7) |
| Graduate or professional degree | 32 (26.0) | 31 (24.6) | 28 (23.3) | 91 (24.7) |
| Don’t know/refused | 0 [0.0] | 1 [0.8] | 1 [0.8] | 2 [0.5] |
| Marital status, n(%) | ||||
| Married or living with partner | 78 (63.4) | 78 (61.9) | 69 (57.0) | 225 (60.8) |
| Single | 19 (15.5) | 17 (13.5) | 29 (24.0) | 65 (17.6) |
| Widowed | 10 (8.1) | 5 (4.0) | 10 (8.3) | 25 (6.8) |
| Divorced or separated | 16 (13.0) | 26 (20.6) | 13 (10.7) | 55 (14.9) |
| Don’t know/refused | 0 [0.0] | 1 [0.8] | 0 [0.0] | 1 [0.3] |
| Housing status, n(%) | ||||
| Own | 86 (69.9) | 84 (66.1) | 65 (53.7) | 235 (63.3) |
| Rent | 31 (25.2) | 38 (29.9) | 50 (41.3) | 119 (32.1) |
| Other arrangement | 6 (4.9) | 5 (3.9) | 6 (5.0) | 17 (4.6) |
| Household size, n(%) | ||||
| 1 | 27 (22.0) | 25 (19.7) | 33 (27.3) | 85 (22.9) |
| 2 | 61 (49.6) | 65 (51.2) | 48 (39.7) | 174 (46.9) |
| 3 | 24 (19.5) | 17 (13.4) | 21 (17.4) | 62 (16.7) |
| 4 | 5 (4.1) | 12 (9.5) | 9 (7.4) | 26 (7.0) |
| 5+ | 6 (4.9) | 8 (6.3) | 10 (8.3) | 24 (6.5) |
| Employment status, n(%) | ||||
| Employed full-time | 32 (26.2) | 42 (33.3) | 40 (33.1) | 114 (30.9) |
| Employed part-time | 16 (13.1) | 11 (8.7) | 21 (17.4) | 48 (13.0) |
| Unemployed4 | 9 (7.4) | 12 (9.5) | 9 (7.4) | 30 (8.1) |
| Retired | 55 (45.1) | 44 (34.9) | 39 (32.2) | 138 (37.4) |
| On disability | 10 (8.2) | 17 (13.5) | 12 (9.9) | 39 (10.6) |
| Don’t know/refused | 1 [0.8] | 1 [0.8] | 0 [0.0] | 2 [0.5] |
| Total annual household income, n(%) | ||||
| <$20,000 | 13 (11.4) | 10 (8.1) | 14 (12.1) | 37 (10.5) |
| $20,000-$49,999 | 26 (22.8) | 34 (27.4) | 36 (31.0) | 96 (27.1) |
| $50,000-$74,999 | 25 (21.9) | 25 (20.2) | 18 (15.5) | 68 (19.2) |
| $75,000-$109,999 | 24 (21.1) | 21 (16.9) | 16 (13.8) | 61 (17.2) |
| $110,000-$149,999 | 11 (9.7) | 21 (16.9) | 15 (12.9) | 47 (13.3) |
| $150,000+ | 15 (13.2) | 13 (10.5) | 17 (14.7) | 45 (12.7) |
| Don’t know/refused | 9 [7.3] | 3 [2.4] | 5 [4.1] | 17 [4.6] |
| Insurance Coverage Type, n(%) | ||||
| Commercial | 49 (39.8) | 55 (43.3) | 60 (49.6) | 164 (44.2) |
| Medicaid | 6 (4.9) | 13 (10.2) | 4 (3.3) | 23 (6.2) |
| Medicare | 61 (49.6) | 54 (42.5) | 53 (43.8) | 168 (45.3) |
| Other | 7 (5.7) | 5 (3.9) | 4 (3.3) | 16 (4.3) |
| History of KP Medical Financial Assistance (MFA), n(%) | ||||
| Denied | 6 (4.9) | 4 (3.1) | 5 (4.1) | 15 (4.0) |
| Approved | 16 (13.0) | 18 (14.2) | 24 (19.8) | 58 (15.6) |
| Pending | 2 (1.6) | 1 (0.8) | 1 (0.8) | 4 (1.1) |
| No history | 99 (80.5) | 104 (81.9) | 91 (75.2) | 294 (79.2) |
| Cancer site, n(%) | ||||
| Colorectal (CRC) | 6 (4.9) | 7 (5.5) | 8 (6.6) | 21 (5.7) |
| Breast | 47 (38.2) | 48 (37.8) | 45 (37.2) | 140 (37.7) |
| Lung | 5 (4.1) | 7 (5.5) | 5 (4.1) | 17 (4.6) |
| Prostate | 19 (15.4) | 18 (14.2) | 17 (14.0) | 54 (14.6) |
| Other | 46 (37.4) | 47 (37.0) | 46 (38.0) | 139 (37.5) |
| Days from cancer diagnosis to randomization, mean(sd) | 65.2 (37.2) | 63.5 (32.3) | 65.0 (36.8) | 64.5 (35.4) |
| Any social need5 | 40 (32.5) | 53 (41.7) | 55 (45.5) | 148 (39.9) |
| Baseline measures of primary outcomes, mean(sd) | ||||
| Financial hardship (range 1–10) 6 | 7.08 (2.65) | 6.42 (2.72) | 6.25 (2.83) | 6.58 (2.75) |
| Health related quality of life (range 0–28) 7 | 15.3 (2.6) | 15.4 (2.8) | 15.1 (2.7) | 15.3 (2.7) |
Includes participants who reported “Asian Indian”, “Chinese”, “Filipino”, and “Chamorro
Includes participants who reported Native Hawaiian, Pacific Islander, Alaska Native, American Indian, Other race, or reported more than one race
Includes participants who reported “High school graduate” and “Less than high school graduate”
Includes participants who reported “Unemployed and currently seeking employment”, “Unemployed and not seeking employment”, “Student”, and “Homemaker or stay at home parent”
Endorsed difficulty paying for food, housing, heat and electricity, medical needs, transportation, childcare, debts, or other in previous 3 months
InCharge Financial Distress/Financial Well-Being Scale (IFDFW); range 1–10, higher scores better; score>7 indicates low financial hardship
FACT-G7, range 1–28, higher scores better
Intervention fidelity.
Navigators successfully contacted 100% of Brief intervention participants and 98.3% of extended intervention participants. Brief intervention participants received a mean of 0.96 (SD 0.20) intervention cycles, and Extended intervention participants received a mean of 2.64 (SD 0.84) intervention cycles. Completion of the closure call at 6 months was 82.7% in the Brief and 86.0% in the Extended group. Participant- or clinician-initiated navigator encounters were similar between the intervention arms (Brief: mean 0.06 SD 0.23; Extended: mean 0.04 SD 0.20) (Data supplement, Figure 1).
Participant financial concerns.
Navigators documented 491 financial concerns assessments. Number of concerns per participant ranged from zero to 6 (mean 2.0) [n=248]). The most common financial concern was planning/budgeting (67%), followed by acute needs (31%) and care decision-making (2%).
Financial hardship assessed with the InCharge Financial Distress/Financial Well-Being Scale (1–10 scale, higher levels indicate lower distress).
Financial hardship was similar between baseline and 12 months for all randomized groups. Baseline financial hardship was 7.08 (SD 2.65) in enhanced usual care; 6.42 (SD 2.72) for Brief intervention; and 6.25 (SD 2.83) for Extended intervention (Table 1). At 12 months, there were no statistically significant differences between groups (unadjusted mean (SD): Brief,7.39 (2.66); Extended,6.84 (2.55); Enhanced usual care,6.69 (2.66), adjusted p=0.73. (Table 2).
Table 2.
Primary Outcomes: Results
| Unadjusted mean 12-month outcome | Difference between groups1 | ||||||
|---|---|---|---|---|---|---|---|
| Enhanced Usual Care | Brief Intervention | Extended Intervention | Brief vs Usual Care | Extended vs Usual Care | Extended vs Brief | ||
| N=100 | N=93 | N=90 | p-value2 | ||||
| Mean (sd) | Mean (sd) | Mean (sd) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | ||
| Financial hardship3 | 7.39 (2.66) | 6.84 (2.55) | 6.69 (2.66) | −0.05 (−0.46, 0.35) | −0.17 (−0.58, 0.25) | −0.11 (−0.55, 0.32) | 0.73 |
| Cancer-related quality of life4 | 19.1 (5.1) | 19.0 (5.2) | 19.2 (5.2) | 0.99 (−0.22, 2.20) | 1.02 (−0.17, 2.21) | 0.03 (−1.17, 1.23) | 0.17 |
Difference between groups is adjusted for site, cancer type, diversity sample baseline measure of the outcome, age, education, marital status, housing status (own vs rent), and insurance type (commercial, Medicare, other).
Global p-value for any difference between groups
InCharge Financial Distress/Financial Well-Being Scale; range 1–10, higher scores indicate higher well-being
FACT-G7, range 1–28, higher scores better quality of life).
Health-related quality of life assessed with the FACT-G7 (range 1–28, higher scores indicate higher quality of life.
Scores increased between baseline and 12 months in all groups. Baseline scores were 15.3 (2.6) in enhanced usual care, 15.4 (2.8) in Brief intervention, and 15.1 (2.7) in Extended intervention. At 12 months, scores were similar between groups: Enhanced usual care,19.1 (5.1); Brief,19.0 (5.2); Extended,19.2 (5.2), p=0.17 (Table 2).
Exploratory and subgroup analyses.
There were no differences between study arms by COST score, treatment decision satisfaction, or trust. Perceived care quality was higher in the Extended intervention arm (mean 4.26, SD 0.86) compared to the Brief intervention arm (4.08, SD 0.79). Self-reported use of patient support services was similar between intervention arms (Table 3). There was little evidence of heterogeneous treatment effect in subgroup analyses, including baseline level of financial hardship (Table 4).
Table 3.
Secondary and Exploratory Outcomes: Results
| Unadjusted mean 12-month outcome | Difference between groups1 | ||||||
|---|---|---|---|---|---|---|---|
| Enhanced Usual Care (N=100) | Brief Intervention (N=93) | Extended Intervention (N=90) | Brief vs Usual Care | Extended vs Usual Care | Extended vs Brief | p-value2 | |
| Mean (sd) | Mean (sd) | Mean (sd) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | ||
| Financial toxicity (COST-FACIT)3 | 29.1 (11.7) | 27.0 (10.4) | 28.2 (11.3) | −0.4 (−2.4, 1.6) | 1.0 (−0.8, 2.9) | 1.5 (−0.5, 3.4) | 0.29 |
| PROMIS - physical health4 | 46.0 (8.1) | 45.8 (8.1) | 45.5 (7.7) | −0.1 (−1.8, 1.6) | 0.5 (−1.3, 2.3) | 0.6 (−1.2, 2.5) | 0.77 |
| PROMIS - mental health4 | 49.4 (9.1) | 48.3 (7.6) | 47.6 (7.4) | 0.1 (−1.9, 2.0) | −0.6 (−2.5, 1.4) | −0.6 (−2.5, 1.3) | 0.79 |
| Perceived care quality5 | 4.15 (0.93) | 4.08 (0.79) | 4.26 (0.86) | −0.21 (−0.43, 0.01) | 0.13 (−0.10, 0.36) | 0.34 (0.11, 0.56) | <0.01 |
| Treatment decision satisfaction6 | 4.44 (0.64) | 4.40 (0.71) | 4.36 (0.60) | −0.05 (−0.24, 0.14) | −0.05 (−0.22, 0.12) | 0.00 (−0.19, 0.19) | 0.82 |
| Patient-centered communication7 | 2.54 (0.48) | 2.55 (0.55) | 2.52 (0.47) | 0.01 (−0.11, 0.13) | 0.02 (−0.09, 0.13) | 0.01 (−0.10, 0.12) | 0.95 |
| Trust in cancer care team8 | 10.0 (9.3) | 9.9 (9.6) | 10.1 (9.8) | −0.1 (−2.9, 2.7) | −0.0 (−2.9, 2.8) | 0.1 (−2.6, 2.7) | 1.00 |
| KP Services used last 12 mo, n(%) | n (%) | n (%) | n (%) | RR (95% CI) | RR (95% CI) | RR (95% CI) | |
| Member services/Customer Service9 | 52 (52.0) | 73 (78.5) | 47 (52.2) | 1.48 (1.20, 1.84) | 1.00 (0.76, 1.31) | 0.67 (0.54, 0.84) | <0.01 |
| Patient or nurse navigator | 44 (44.0) | 49 (52.7) | 44 (48.9) | 1.19 (0.89, 1.58) | 1.11 (0.82, 1.50) | 0.94 (0.71, 1.24) | 0.50 |
| Financial counselor/patient financial services9 | 31 (31.0) | 44 (47.3) | 41 (45.6) | 1.48 (1.04, 2.09) | 1.34 (0.95, 1.89) | 0.91 (0.67, 1.23) | 0.08 |
| Community resource specialist/health navigator9 | 16 (16.0) | 18 (19.4) | 24 (26.7) | 1.19 (0.64, 2.21) | 1.35 (0.77, 2.38) | 1.13 (0.62, 2.07) | 0.58 |
| Social work | 17 (17.0) | 19 (20.4) | 18 (20.0) | 1.16 (0.65, 2.09) | 1.29 (0.71, 2.32) | 1.11 (0.61, 2.00) | 0.70 |
| Pharmacy help desk | 45 (45.0) | 48 (51.6) | 41 (45.6) | 1.14 (0.85, 1.54) | 0.99 (0.72, 1.36) | 0.87 (0.64, 1.18) | 0.57 |
| Other | 14 (14.0) | 10 (10.8) | 11 (12.2) | 0.63 (0.28, 1.45) | 0.77 (0.36, 1.64) | 1.22 (0.52, 2.88) | 0.54 |
| Services outside KP | 17 (17.0) | 19 (20.4) | 15 (16.7) | 1.12 (0.62, 2.01) | 1.00 (0.52, 1.92) | 0.90 (0.49, 1.64) | 0.92 |
Difference between groups is adjusted for site, cancer type, diversity sample baseline measure of the outcome, age, education, marital status, housing status (own vs rent), and insurance type (commercial, Medicare, other).
Global p-value for any difference between groups
COST: A FACIT Measure of Financial Toxicity (FACIT-COST) (range 0–44) Higher scores mean better financial well-being (low financial hardship >=26, high 1–13)
PROMIS Global Health (GH-10) is a 10-item patient-reported questionnaire assessing overall health-related quality of life. Physical health includes domains such as physical function, pain, fatigue, and general health; mental health includes emotional distress, social roles, and psychological well-being. T-score of 50 represents the average of the U.S. general population. A T-score of 40 is 1 SD below average
Single item, range 1–5, 5 is highest quality
Single item, range 1–5, 5 is most satisfied); not measured/applicable at baseline, therefore model does not adjust for baseline measure.
Patient Assessment of Cancer Communication Experiences scale (0–3, 3 is best experience)
Single item, 1–10, 10 is highest trust
Reflects different names for same or similar service between study sites
Table 4.
Subgroup Analyses
| Unadjusted mean (12-month outcome) | Difference between groups1 | ||||||
|---|---|---|---|---|---|---|---|
| Financial Hardship3 | Enhanced Usual Care | Brief Intervention | Extended Intervention | Brief vs Usual Care | Extended vs Usual Care | Extended vs Brief | |
| Mean (sd) | Mean (sd) | Mean (sd) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p-value2 | |
| Age | |||||||
| <65 | N=52 | N=51 | N=44 | ||||
| 6.23 (2.80) | 6.02 (2.61) | 5.73 (2.80) | 0.22 (−0.37, 0.81) | −0.07 (−0.74, 0.59) | −0.29 (−0.97, 0.39) | 0.65 | |
| 65+ | N=48 | N=42 | N=46 | ||||
| 8.64 (1.83) | 7.84 (2.10) | 7.61 (2.18) | −0.40 (−0.94, 0.14) | −0.26 (−0.73, 0.21) | 0.13 (−0.42, 0.69) | 0.30 | |
| Sex | |||||||
| Male | N=37 | N=33 | N=31 | ||||
| 7.74 (2.53) | 7.22 (2.47) | 6.87 (2.46) | −0.25 (−0.75, 0.25) | −0.04 (−0.57, 0.48) | 0.20 (−0.38, 0.79) | 0.61 | |
| Female | N=63 | N=60 | N=59 | ||||
| 7.18 (2.73) | 6.63 (2.59) | 6.59 (2.78) | 0.05 (−0.51, 0.61) | −0.23 (−0.83, 0.37) | −0.28 (−0.89,0.33) | 0.64 | |
| Baseline financial hardship | |||||||
| High (<5) | N=20 | N=27 | N=27 | ||||
| 3.85 (2.03) | 4.12 (1.93) | 4.09 (2.17) | 0.24 (−0.76, 1.24) | 0.23 (−0.82, 1.27) | −0.02 (−0.87,0.84) | 0.88 | |
| Moderate (5–7) | N=23 | N=21 | N=17 | ||||
| 5.87 (1.71) | 6.20 (1.69) | 5.76 (1.58) | 0.21 (−0.66, 1.07) | −0.34 (−1.22, 0.54) | −0.55 (−1.52, 0.42) | 0.53 | |
| Low (>7) | N=57 | N=45 | N=46 | ||||
| 9.24 (1.04) | 8.78 (1.25) | 8.56 (1.58) | −0.30 (−0.76, 0.17) | −0.34 (−0.81, 0.12) | −0.05 (−0.56, 0.47) | 0.27 | |
| Any social need | |||||||
| No | N=73 | N=57 | N=52 | ||||
| 8.41 (1.93) | 8.31 (1.63) | 8.12 (1.87) | 0.03 (−0.37, 0.43) | −0.25 (−0.70, 0.20) | −0.28 (−0.75, 0.18) | 0.44 | |
| Yes | N=27 | N=36 | N=38 | ||||
| 4.62 (2.41) | 4.52 (1.94) | 4.73 (2.34) | −0.08 (−0.95, 0.79) | 0.09 (−0.79, 0.97) | 0.17 (−0.63, 0.98) | 0.92 | |
| Diversity sample | |||||||
| No | N=56 | N=60 | N=53 | ||||
| 8.56 (1.81) | 7.71 (2.19) | 7.05 (2.33) | −0.11 (−0.59, 0.38) | −0.33 (−0.79, 0.13) | −0.22 (−0.73, 0.29) | 0.37 | |
| Yes | N=44 | N=33 | N=37 | ||||
| 5.90 (2.85) | 5.27 (2.44) | 6.18 (3.05) | −0.02 (−0.75, 0.70) | 0.02 (−0.70, 0.74) | 0.05 (−0.74, 0.83) | 0.99 | |
| Unadjusted mean | Difference between groups1 | ||||||
| Cancer-related quality of life4 | Enhanced Usual Care | Brief Intervention | Extended Intervention | Brief vs Usual Care | Extended vs Usual Care | Extended vs Brief | |
| Mean (sd) | Mean (sd) | Mean (sd) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p-value2 | |
| Age | |||||||
| <65 | N=52 | N=51 | N=44 | ||||
| 18.4 (5.0) | 18.8 (5.0) | 17.9 (5.7) | 1.7 (0.1, 3.3) | 1.0 (−0.8, 2.8) | −0.7 (−2.3, 1.0) | 0.13 | |
| 65+ | N=48 | N=42 | N=46 | ||||
| 19.9 (5.1) | 19.3 (5.5) | 20.4 (4.5) | 0.1 (−1.8, 2.0) | 1.0 (−0.4, 2.5) | 0.9 (−0.9, 2.7) | 0.34 | |
| Sex | |||||||
| Male | N=37 | N=33 | N=31 | ||||
| 18.9 (3.9) | 18.5 (5.0) | 19.6 (4.8) | 0.7 (−1.2, 2.7) | 1.2 (−0.6, 2.9) | 0.4 (−1.8, 2.7) | 0.40 | |
| Female | N=63 | N=60 | N=59 | ||||
| 19.2 (5.7) | 19.3 (5.4) | 19.0 (5.5) | 1.1 (−0.4, 2.6) | 0.9 (−0.7, 2.6) | −0.2 (−1.8, 1.4) | 0.31 | |
| Baseline financial hardship | |||||||
| High (<5) | N=20 | N=27 | N=27 | ||||
| 16.2 (6.3) | 17.1 (5.6) | 16.1 (5.4) | 1.5 (−0.2, 3.1) | 0.6 (−0.3, 1.6) | −0.8 (−3.4, 1.7) | 0.63 | |
| Moderate (5–7) | N=23 | N=21 | N=17 | ||||
| 18.6 (3.8) | 19.8 (4.2) | 17.9 (4.5) | 2.1 (2.0, 2.3) | 0.5 (−1.8, 2.9) | −1.6 (−3.8, 0.6) | 0.06 | |
| Low (>7) | N=57 | N=45 | N=46 | ||||
| 20.3 (4.7) | 19.8 (5.2) | 21.5 (4.3) | 0.6 (−0.8,1.9) | 1.6 (1.3, 1.9) | 1.1 (−0.1, 2.2) | 0.07 | |
| Any social need | |||||||
| No | N=73 | N=57 | N=52 | ||||
| 19.7 (4.9) | 20.1 (4.2) | 21.4 (4.2) | 1.2 (−0.1, 2.5) | 2.0 (0.6, 3.3) | 0.8 (−0.6, 2.2) | 0.014 | |
| Yes | N=27 | N=36 | N=38 | ||||
| 17.4 (5.2) | 17.3 (6.1) | 16.3 (5.2) | 0.8 (−1.7, 3.3) | −0.1 (−2.4, 2.1) | −0.9 (−2.9, 1.1) | 0.65 | |
| Diversity sample | |||||||
| No | N=56 | N=60 | N=53 | ||||
| 19.9 (4.9) | 19.8 (5.0) | 19.1 (5.6) | 1.0 (−0.4, 2.5) | 0.3 (−1.2, 1.8) | −0.8 (−2.2, 0.7) | 0.34 | |
| Yes | N=44 | N=33 | N=37 | ||||
| 18.1 (5.2) | 17.7 (5.4) | 19.3 (4.8) | 0.7 (−1.6, 3.0) | 2.0 (0.1,3.8) | 1.3 (−0.8, 3.4) | 0.09 | |
Difference between groups is adjusted for site, cancer type, diversity sample baseline measure of the outcome, age, education, marital status, housing status (own vs rent), and insurance type (commercial, Medicare, other).
Global p-value for any difference between intervention groups, within demographic subgroup
InCharge Financial Distress/Financial Well-Being Scale; range 1–10, higher scores indicate higher well-being
FACT-G7, range 1–28, higher scores better) the clinically meaningful difference for the FACT-G7 is typically around 2 to 3 points 44
Qualitative appraisal of intervention.
201 participants (81.0% of participants randomized to either brief or extended intervention) completed exit interviews at 6 months. Favorable expressions of usefulness of the program were nearly universal, most often related to proactive navigation and ongoing support (75% of respondents) and to navigator skills and knowledge (75%). Participants appreciated navigators’ assistance with planning for anticipated costs even in the absence of immediate financial concerns. Participants also reported that interactions with the navigators helped lessen stress, anxiety, or overwhelm related to the financial stresses of cancer and its treatment, particularly in the extended intervention arm (Table 5).
Table 5.
Summary of Findings From Exit Interviews With Intervention Participants About the Value of the Financial Navigation Program
| Domain | Total (N=201) | Illustrative Quotes |
|---|---|---|
|
Overall usefulness
· Majority described overall satisfaction, positive regard, and helpfulness of program · Majority would like to see service continue |
99% (199) |
“The financial aspect is such a huge stress for so many people, I think it’s a really helpful program. I hope it goes forward as something that’s offered to everyone.” - (extended ppt 10000403) “I was very happy that I got help, as I didn’t have this program when I first got my colon cancer…I was very glad I got to know the program and [CN].” - (brief ppt 20000613) |
|
Proactive support and advocacy · Felt cared for and listened to by the CN · Felt less “passed around” by the health care system · Appreciated CN advocacy on their behalf with departments or resources |
75% (151) |
“It’s great to feel like someone cares. As big as [health system] is, it’s easy to get swallowed up and get passed around or lost in the system. That didn’t happen with [CN] - it felt good to know someone was keeping track of the situation.” - (extended ppt 10000764) “It was nice to have somebody that sort of proactively contacted you - because it’s easy to feel that you’re just sort of floating out there by yourself. Someone reaching out made it less overwhelming.” - (brief ppt 10000855) |
|
Navigator knowledge, skill set, and follow up · Satisfied with CN ability to ask and answer relevant financial questions · Appreciated CN knowledge of financial resources and insurance plans/coverage · Appreciated consistent follow up by CN to make aware/educate on financial resources |
75% (150) |
“[CN] very skilled at asking questions and listening and applying good practical answers.” - (extended ppt 20000539) “If it weren’t for the [CN] I would not have known that I could apply for financial assistance on a very simple form…I now know that is an option.” - (brief ppt 10000150) |
|
Reassuring even if minimal or no current needs · Helpful in organizing thinking or planning related to cancer-related costs · Appreciated being made aware of possible future resources · Reassured knowing they could reach out to CN if needed |
45% (90) |
“Since I didn’t have too many problems we didn’t need to go through too much. I believe if I did need help, I’m sure [CN] would have helped me… just having somebody that is there for you, someone you can call and count on. In the situations of having cancer, that kind of support is really appreciated.” (extended ppt 10000020) “I just didn’t have any pressing issues that came up during this period of time. Helpful to know I had a resource on hand if something came up.” - (brief ppt 20000010) |
|
Accountability and problem-solving · Helped participants stay activated and organized, and accountable to next steps (e.g. filling out application) · Supported problem-solving related to complex topics (e.g. insurance coverage) · Helped organize thinking during a time participant might be suffering from treatment side effects |
34% (68) |
“[CAFÉ] gave time in between to figure out other questions or do more research to see if we had more concerns. There’s kind of a progression of understanding what the medical needs were and then questions arose as we got into the treatment.” - (extended ppt 10001038) “Having a regular check in with someone was helpful. It kept me on track. I have a tendency to bury my head in the sand and pretend that nothing was going on. Sometimes I didn’t want to think about money and cancer. But [CN] helped me stay on target.” - (brief ppt 10000855) |
|
Relieved stress and anxiety · Discussions with CN alleviated stress and anxiety about the financial impacts of their cancer treatment/care, · Lessened feelings of “overwhelm” regarding finances and cancer treatment |
30% (61) |
“I was glad I was participating, as the [CN] saved me a lot of agony and despair” - (extended ppt 20000604) “It was kind of funny because [CN] called me right when I was getting stressed out about money...It was almost like an answer to some prayers I had going on.” - (brief ppt 10000192) |
CN=Café Navigator
Discussion
The CAFE randomized trial assessed the impact of a novel financial navigation intervention in patients with a new cancer diagnosis. We found no statistically significant differences in either financial hardship or cancer-related quality of life between groups receiving brief navigation, extended navigation, or enhanced usual care at 12-month followup. Subgroup analyses and exploratory outcomes findings were similar.
Despite similar levels of financial hardship and quality of life at 12 months, perceived care quality was higher in the Extended intervention group than the Brief intervention group. Further, exit interviews found high perceived value of the navigation program, even in participants with no immediate financial concerns. The majority of financial concerns were related to anticipating and planning for medical expenses. Navigator fidelity to the intervention protocol was high.
Our findings are largely consistent with previous feasibility and pilot intervention studies evaluating financial navigation. A 2025 scoping review of financial navigation intervention studies (7 studies) found mixed results, and none of the three included randomized trials found improvements on financial hardship outcomes.32 Similarly, a 2024 systematic review and meta-analysis (11 studies) found that these interventions can improve financial worry, but mixed results regarding financial hardship outcomes. Meta-analysis suggested that interventions were effective when pre-intervention COST scores indicated high financial hardship.10 In contrast, our study’s subgroup analysis found no intervention effect based on baseline financial hardship.
Several points may help to contextualize our findings. Given the widespread prevalence of financial hardship across sociodemographic groups, the goal of the CAFÉ intervention was to mitigate financial hardship in adult patients with cancer, regardless of cancer type, stage, sex, or pre-existing financial circumstances. This aligns with a population-based approach to addressing financial hardship in real-world settings, where financial concerns may be assessed at initial diagnosis, in contrast to prior studies focused on patients already in active treatment, with a specific type of cancer, or at a defined financial hardship threshold at enrollment.9,11,33–35
Also, cancer-related financial hardship can accumulate over time and is dynamic in the period after diagnosis. 36–39 For example, Shankaran and colleagues published results from the S1417CD study showing financial hardship continued rising through 12 months.40 Accordingly, our design included reaching patients for enrollment as soon as possible after diagnosis, including individuals at all levels of baseline financial hardship, extending the followup period to 12 months; and selecting 12 month follow up scores between groups as the primary endpoint rather than change over time. Additionally, some resources available to KP members (e.g. medical financial assistance, which includes payment of up to 6 months medical care costs) would be observable beyond the 6 month intervention period. Similarly, our choice of a general measure of financial wellbeing and distress rather than a cancer-specific one enabled us to detect financial hardship among patients with cancer who had not yet experienced cancer treatment.{Banegas, 2024 #15930}
Our intervention included the core components of financial navigation programs: education to anticipate out of pocket costs; guidance on health insurance; and facilitated access to financial assistance resources,9 delivered using an intentional, proactive and personalized approach to meaningfully supporting participants. The majority of financial concerns reported during the intervention were related to planning and anticipating upcoming out-of-pocket expenses—a primary cause of cancer-related financial distress41—and immediate financial needs; cost-related care decision concerns were rare. This distribution of financial concerns may help plan for other future interventions.
We note that the integrated health system setting included multiple existing financial assistance resources available to patients. Neither site had formal screening or proactive financial navigation during the study period, but both had centralized services for explaining benefits and coverage, medical financial assistance programs, social work, pharmacy, and community resource connections. Our finding that financial hardship was stable between baseline and follow-up in all three study arms could suggest that financial hardship was not as dynamic in our study population as reported in other studies, or that both enhanced usual care and navigation could be helping to mitigate or prevent accumulation of financial hardship.
Exit interviews with intervention participants found high reported value with the program. Triangulated with the exploratory finding of increased reported care quality in the extended intervention group and the high frequency of concerns about anticipating medical out of pocket costs, this suggests unmet patient needs that warrant further study. Further research can explore use of more nuanced patient-reported outcomes (e.g. financial coping, financial worry, or financial depression)42 that emerging current models of financial hardship increasingly highlight.42
The CAFÉ trial presents seminal randomized trial evidence about the effectiveness of financial navigation for people with cancer, as well as longitudinal measures of financial hardship, the nature of participant financial concerns, and participant-reported experiences of financial navigation. This study is theory-informed, clinic-based, and was designed to meet patient need identified in our preliminary studies and to work within existing clinic workflows. Other strengths include its multisite three-arm design, broad inclusion criteria, high fidelity, novel intervention, and mixed methods approach.
We note also certain limitations. We began recruitment in 2021, when many health systems and patients were actively responding to the COVID pandemic. Also, due to organizational constraints, study navigators’ role was limited to assessment, support, and connection to resources, with no direct ability to alter insurance coverage or patient out-of-pocket charges. Given the intended personalized nature of the intervention, we could not quantitatively evaluate specific intervention components, such as psychosocial support, education, or financial concerns assessment. While we designed the 12-month followup assessment to capture enduring impacts of the intervention, shorter term impacts may have been measurable at earlier time points. However, we qualitatively assessed patient experience of the intervention at the close of each participant’s intervention period. While we intentionally attempted to recruit individuals close to diagnosis, reflecting both a population-based approach to assessing financial concerns and centering patient preferences, the relatively low enrollment rates warrant further consideration by future interventions. Finally, the generalizability of the intervention to other settings besides integrated health systems is not clear. However, KP populations are demographically similar to their surrounding communities,43 and baseline prevalence of financial hardship in the CAFÉ population were in line with published estimates.31
Conclusions.
This multisite randomized trial of a novel financial navigation intervention found similar levels of financial hardship and quality of life at 12 months follow-up in people who had received 6 months of prior financial navigation compared to enhanced usual care. However, high participant-reported value of the intervention suggests unmet needs and warrants further investigation to identify optimal ways to support patients more proactively. Future research needs include development of higher intensity or multi-level interventions to mitigate cancer-related financial hardship; study designs that can assess individual components of financial navigation; and the effectiveness of financial navigation in lower resource settings. These results demonstrate the continued need for research into strategies for to address the urgent problem of cancer-related financial hardship.
Supplementary Material
Context summary.
Key objective:
What is the impact of a novel financial navigation intervention for people newly diagnosed with cancer on financial hardship and health-related quality of life at 12 months follow up?
Knowledge generated:
Groups receiving 6 months of brief navigation (one proactive outreach), 6 months of extended financial navigation (three proactive outreaches) or enhanced usual care had similar levels of financial hardship and quality of life at 12 months follow up. Participants reported that the intervention was of value.
Relevance:
Financial navigation programs can assist patients with navigating resources, but more research is needed to discover how to address financial hardship after cancer diagnosis over time.
Funding:
National Institutes of Health R01CA237322 (Henrikson / Banegas)
Footnotes
Results reported here were accepted for presentation at the 2025 ASCO Quality Care Symposium, October 11–12, Chicago IL
Trial registration: ClinicalTrials.gov NCT05018000
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