Assessing the pre-implementation context for financial navigation in rural and non-rural oncology clinics.

Background: Financial navigation (FN) is an evidence-based intervention designed to address financial toxicity for cancer patients. FN's success depends on organizations' readiness to implement and other factors that may hinder or support implementation. Tailored implementation strategies can support practice change but must be matched to the implementation context. We assessed perceptions of readiness and perceived barriers and facilitators to successful implementation among staff at nine cancer care organizations (5 rural, 4 non-rural) recruited to participate in the scale-up of a FN intervention. To understand differences in the pre-implementation context and inform modifications to implementation strategies, we compared findings between rural and non-rural organizations. Methods: We conducted surveys (n = 78) and in-depth interviews (n = 73) with staff at each organization. We assessed perceptions of readiness using the Organizational Readiness for Implementing Change (ORIC) scale. In-depth interviews elicited perceived barriers and facilitators to implementing FN in each context. We used descriptive statistics to analyze ORIC results and deductive thematic analysis, employing a codebook guided by the Consolidated Framework for Implementation Research (CFIR), to synthesize themes in barriers and facilitators across sites, and by rurality. Results: Results from the ORIC scale indicated strong perceptions of organizational readiness across all sites. Staff from rural areas reported greater confidence in their ability to manage the politics of change (87% rural, 76% non-rural) and in their organization's ability to support staff adjusting to the change (96% rural, 75% non-rural). Staff at both rural and non-rural sites highlighted factors reflective of the Intervention Characteristics (relative advantage) and Implementation Climate (compatibility and tension for change) domains as facilitators. Although few barriers to implementation were reported, differences arose between rural and non-rural sites in these perceived barriers, with non-rural staff more often raising concerns about resistance to change and compatibility with existing work processes and rural staff more often raising concerns about competing time demands and limited resources. Conclusions: Staff across both rural and non-rural settings identified few, but different, barriers to implementing a novel FN intervention that they perceived as important and responsive to patients' needs. These findings can inform how strategies are tailored to support FN in diverse oncology practices.

Knowledge, Attitudes, and Resources of Frontline Oncology Support Personnel Regarding Financial Burden in Patients With Cancer.

PURPOSE: Financial navigation services support patients with cancer and address the direct and indirect financial burden of cancer diagnosis and treatment. These services are commonly delivered through a variety of frontline oncology support personnel (FOSP) including navigators, social workers, supportive care providers, and other clinic staff, but the perspective of FOSPs is largely absent from current literature on financial burden in oncology. We surveyed a national sample of FOSPs to understand their perspectives on patient financial burden, resource availability, and barriers and facilitators to assisting patients with cancer-related financial burden. METHODS: We used Qualtrics online survey software and recruited participants using multiple professional society and interest group mailing lists. Categorical responses were described using frequencies, distributions of numeric survey responses were described using the median and IQR, and two open-ended survey questions were categorized thematically using a priori themes, allowing additional emergent themes. RESULTS: Two hundred fourteen FOSPs completed this national survey. Respondents reported a high awareness of patient financial burden and felt comfortable speaking to patients about financial concerns. Patient assistance resources were commonly available, but only 15% described resources as sufficient for the observed needs. A substantial portion of respondents reported moral distress related to this lack of resources. CONCLUSION: FOSPs, who already have requisite knowledge and comfort in discussing patient financial needs, are a critical resource for mitigating cancer-related financial burden. Interventions should leverage this resource but prioritize transparency and efficiency to reduce the administrative and emotional toll on the FOSP workforce and reduce the risk of burnout.

Association between low-income subsidies and inequities in orally administered antimyeloma therapy use.

OBJECTIVES: The Medicare Part D low-income subsidy program drastically reduces patient cost sharing and may improve access to and equitable use of high-cost antimyeloma therapy. We compared initiation of and adherence to orally administered antimyeloma therapy between full-subsidy and nonsubsidy enrollees and assessed the association between full subsidies and racial/ethnic inequities in orally administered antimyeloma treatment use. STUDY DESIGN: Retrospective cohort study. METHODS: We used Surveillance, Epidemiology, and End Results-Medicare data to identify beneficiaries diagnosed with multiple myeloma between 2007 and 2015. Separate Cox proportional hazards models assessed time from diagnosis to treatment initiation and time from therapy initiation to discontinuation. Modified Poisson regression examined therapy initiation in the 30, 60, and 90 days following diagnosis and adherence to and discontinuation of treatment in the 180 days following initiation. RESULTS: Receipt of full subsidies was not associated with earlier initiation of or improved adherence to orally administered antimyeloma therapy. Full-subsidy enrollees were 22% (adjusted HR [aHR], 1.22; 95% CI, 1.08-1.38) more likely to experience earlier treatment discontinuation than nonsubsidy enrollees. Receipt of full subsidies did not appear to reduce racial/ethnic inequities in orally administered antimyeloma therapy use. Black full-subsidy and nonsubsidy enrollees were 14% less likely than their White counterparts to ever initiate treatment (full subsidy: aHR, 0.86; 95% CI, 0.73-1.02; nonsubsidy: aHR, 0.86; 95% CI, 0.74-0.99). CONCLUSIONS: Full subsidies alone are insufficient to increase uptake or equitable use of orally administered antimyeloma therapy. Addressing known barriers to care (eg, social determinants of health, implicit bias) could improve access to and use of high-cost antimyeloma therapy.

Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings.

BACKGROUND: Almost half of the patients with cancer report cancer-related financial hardship, termed "financial toxicity" (FT), which affects health-related quality of life, care retention, and, in extreme cases, mortality. This increasingly prevalent hardship warrants urgent intervention. Financial navigation (FN) targets FT by systematically identifying patients at high risk, assessing eligibility for existing resources, clarifying treatment cost expectations, and working with patients and caregivers to develop a plan to cope with cancer costs. This trial seeks to (1) identify FN implementation determinants and implementation outcomes, and (2) evaluate the effectiveness of FN in improving patient outcomes. METHODS: The Lessening the Impact of Financial Toxicity (LIFT) study is a multi-site Phase 2 clinical trial. We use a pre-/post- single-arm intervention to examine the effect of FN on FT in adults with cancer. The LIFT trial is being conducted at nine oncology care settings across North Carolina in the United States. Sites vary in geography (five rural, four non-rural), size (21-974 inpatient beds), and ownership structure (governmental, non-profit). The study will enroll 780 patients total over approximately 2 years. Eligible patients must be 18 years or older, have a confirmed cancer diagnosis (any type) within the past 5 years or be living with advanced disease, and screen positive for cancer-related financial distress. LIFT will be delivered by full- or part-time financial navigators and consists of 3 components: (1) systematic FT screening identification and comprehensive intake assessment; (2) connecting patients experiencing FT to financial support resources via trained oncology financial navigators; and (3) ongoing check-ins and electronic tracking of patients' progress and outcomes by financial navigators. We will measure intervention effectiveness by evaluating change in FT (via the validated Comprehensive Score of Financial Toxicity, or COST instrument) (primary outcome), as well as health-related quality of life (PROMIS Global Health Questionnaire), and patient-reported delayed or forgone care due to cost. We also assess patient- and stakeholder-reported implementation and service outcomes post-intervention, including uptake, fidelity, acceptability, cost, patient-centeredness, and timeliness. DISCUSSION: This study adds to the growing evidence on FN by evaluating its implementation and effectiveness across diverse oncology care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04931251. Registered on June 18, 2021.

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial.

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Design, Setting, and Participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. Interventions: In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. Main Outcomes and Measures: The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. Results: Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006). Conclusions and Relevance: In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival. Trial Registration: ClinicalTrials.gov Identifier: NCT03249090.

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings.

PURPOSE: Patients with cancer are at heightened risk of experiencing financial hardship. Financial navigation (FN) is an evidence-based approach for identifying and addressing patient and caregiver financial needs. In preparation for the implementation of a multisite FN intervention, we describe existing processes (ie, events and actions) and mechanisms (ie, how events work together) connecting patients to financial assistance, comparing rural and nonrural practices. METHODS: We conducted in-depth, semistructured interviews with stakeholders (ie, administrators, providers, and staff) at each of the 10 oncology care sites across a single state (five rural and five nonrural practices). We developed process maps for each site and analyzed stakeholder perspectives using thematic analysis. After reporting findings back to stakeholders, we synthesized themes and process maps across rural and nonrural sites separately. RESULTS: Eighty-three stakeholders were interviewed. We identified six core elements of existing financial assistance processes across all sites: distress screening (including financial concerns), referrals, resource connection points, and pharmaceutical, insurance, and community/foundation resources. Processes differed by rurality; however, facilitators and barriers to identifying and addressing patient financial needs were consistent. Open communication between staff, providers, patients, and caregivers was a primary facilitator. Barriers included insufficient staff resources, challenges in routinely identifying needs, inadequate preparation of patients for anticipated medical costs, and limited tracking of resource availability and eligibility. CONCLUSION: This study identified a clear need for systematic implementation of oncology FN to equitably address patient and caregiver financial hardship. Results have informed our current efforts to implement a multisite FN intervention, which involves comprehensive financial toxicity screening and systematization of intake and referrals.

Measuring Racial Inequities In The Quality Of Care Across Oncology Practices In The US.

Racial inequities in clinical performance diminish overall health care system performance; however, quality assessments have rarely incorporated reliable measures of racial inequities. We studied care for more than one million Medicare fee-for-service beneficiaries with cancer to assess the feasibility of calculating reliable practice-level measures of racial inequities in chemotherapy-associated emergency department (ED) visits and hospitalizations. Specifically, we used hierarchical models to estimate adjusted practice-level Black-White differences in these events and described differences across practices. We calculated reliable inequity measures for 426 and 322 practices, depending on the measure. These practices reflected fewer than 10 percent of practices treating Medicare beneficiaries with chemotherapy, but they treated approximately half of all White and Black Medicare beneficiaries receiving chemotherapy and two-thirds of Black Medicare beneficiaries receiving chemotherapy. Black patients experienced chemotherapy-associated ED visits and hospitalizations at higher rates (54.2 percent and 35.8 percent, respectively) than White patients (45.7 percent and 31.9 percent, respectively). The median within-practice Black-White difference was 8.1 percentage points for chemotherapy-associated ED visits and 2.7 percentage points for chemotherapy-associated hospitalizations. Additional research is needed to identify other reliable measures of racial inequities in health care quality, measure care inequities in smaller practices, and assess whether providing practice-level feedback could improve equity.

Effect of an Antiracism Intervention on Racial Disparities in Time to Lung Cancer Surgery.

PURPOSE: Timely lung cancer surgery is a metric of high-quality cancer care and improves survival for early-stage non-small-cell lung cancer. Historically, Black patients experience longer delays to surgery than White patients and have lower survival rates. Antiracism interventions have shown benefits in reducing racial disparities in lung cancer treatment. METHODS: We conducted a secondary analysis of Accountability for Cancer Care through Undoing Racism and Equity, an antiracism prospective pragmatic trial, at five cancer centers to assess the impact on overall timeliness of lung cancer surgery and racial disparities in timely surgery. The intervention consisted of (1) a real-time warning system to identify unmet care milestones, (2) race-specific feedback on lung cancer treatment rates, and (3) patient navigation. The primary outcome was surgery within 8 weeks of diagnosis. Risk ratios (RRs) and 95% CIs were estimated using log-binomial regression and adjusted for clinical and demographic factors. RESULTS: A total of 2,363 patients with stage I and II non-small-cell lung cancer were included in the analyses: intervention (n = 263), retrospective control (n = 1,798), and concurrent control (n = 302). 87.1% of Black patients and 85.4% of White patients in the intervention group (P = .13) received surgery within 8 weeks of diagnosis compared with 58.7% of Black patients and 75.0% of White patients in the retrospective group (P < .01) and 64.9% of Black patients and 73.2% of White patients (P = .29) in the concurrent group. Black patients in the intervention group were more likely to receive timely surgery than Black patients in the retrospective group (RR 1.43; 95% CI, 1.26 to 1.64). White patients in the intervention group also had timelier surgery than White patients in the retrospective group (RR 1.10; 95% CI, 1.02 to 1.18). CONCLUSION: Accountability for Cancer Care through Undoing Racism and Equity is associated with timelier lung cancer surgery and reduction of the racial gap in timely surgery.

Evaluating the Contribution of Patient-Provider Communication and Cancer Diagnosis to Racial Disparities in End-of-Life Care Among Medicare Beneficiaries.

BACKGROUND: The quality of end-of-life (EOL) care in the USA remains suboptimal, with significant variations in care by race and across disease subgroups. Patient-provider communication may contribute to racial and disease-specific variations in EOL care outcomes. OBJECTIVE: We examined racial disparities in EOL care, by disease group (cancer vs. non-cancer), and assessed whether racial differences in patient-provider communication accounted for observed disparities. DESIGN: Retrospective cohort study using the 2001-2015 Surveillance, Epidemiology, and End Results - Consumer Assessment of Healthcare Providers and Systems data linked with Medicare claims (SEER-CAHPS). We employed stratified propensity score matching and modified Poisson regression analyses, adjusting for clinical and demographic characteristics PARTICIPANTS: Black and White Medicare beneficiaries 65 years or older with cancer (N=2000) or without cancer (N=11,524). MAIN MEASURES: End-of-life care measures included hospice use, inpatient hospitalizations, intensive care unit (ICU) stays, and emergency department (ED) visits, during the 90 days prior to death. KEY RESULTS: When considering all conditions together (cancer + non-cancer), Black beneficiaries were 26% less likely than their Whites counterparts to enroll in hospice (adjusted risk ratio [ARR]: 0.74, 95%CI: 0.66-0.83). Among beneficiaries without cancer, Black beneficiaries had a 32% lower likelihood of enrolling in hospice (ARR: 0.68, 95%CI: 0.59-0.79). There was no racial difference in hospice enrollment among cancer patients. Black beneficiaries were also at increased risk for ED use (ARR: 1.12, 95%CI: 1.01-1.26). Patient-provider communication did not explain racial disparities in hospice or ED use. There were no racial differences in hospitalizations or ICU admissions. CONCLUSION: We observed racial disparities in hospice use and ED visits in the 90 days prior to death among Medicare beneficiaries; however, hospice disparities were largely driven by patients without cancer. Condition-specific differences in palliative care integration at the end-of-life may partly account for variations in EOL care disparities across disease groups.