Lay healthcare worker financial toxicity intervention: a pilot financial toxicity screening and referral program.

PURPOSE: Financial toxicity is a source of significant distress for patients with urologic cancers, yet few studies have addressed financial burden in this patient population. METHODS: We developed a financial toxicity screening program using a lay health worker (LHW) and social worker (SW) to assess and mitigate financial toxicity in a single academic medical clinic. As part of a quality improvement project, the LHW screened all newly diagnosed patients with advanced stages of prostate, kidney, or urothelial cancer for financial burden using three COST tool questions and referred patients who had significant financial burden to an SW who provided personalized recommendations. The primary outcome was feasibility defined as 80% of patients with financial burden completing the SW consult. Secondary outcomes were patient satisfaction, change in COST Tool responses, and qualitative assessment of financial resources utilized. RESULTS: The LHW screened a total of 185 patients for financial toxicity; 82% (n = 152) were male, 65% (n = 120) White, and 75% (n = 139) reported annual household income >$100,000 US Dollars; 60% (n = 114) had prostate cancer. A total of 18 (9.7%) participants screened positive for significant financial burden and were referred to the SW for consultation. All participants (100%) completed and reported satisfaction with the SW consultation and had 0.83 mean lower scores on the COST Tool post-intervention assessment compared to pre-intervention (95% confidence interval [0.26, 1.41]). CONCLUSION: This multidisciplinary financial toxicity intervention using an LHW and SW was feasible, acceptable, and associated with reduced financial burden among patients with advanced stages of urologic cancers. Future work should evaluate the effect of this intervention among cancer patients in diverse settings.

Patient perspectives on window of opportunity clinical trials in early-stage breast cancer.

PURPOSE: Window of opportunity trials (WOT) are increasingly common in oncology research. In WOT participants receive a drug between diagnosis and anti-cancer treatment, usually for the purpose of investigating that drugs effect on cancer biology. This qualitative study aimed to understand patient perspectives on WOT. METHODS: We recruited adults diagnosed with early-stage breast cancer awaiting definitive therapy at a single-academic medical center to participate in semi-structured interviews. Thematic and content analyses were performed to identify attitudes and factors that would influence decisions about WOT participation. RESULTS: We interviewed 25 women diagnosed with early-stage breast cancer. The most common positive attitudes toward trial participation were a desire to contribute to research and a hope for personal benefit, while the most common concerns were the potential for side effects and how they might impact fitness for planned treatment. Participants indicated family would be an important normative factor in decision-making and, during the COVID-19 pandemic, deemed the absence of family members during clinic visits a barrier to enrollment. Factors that could hinder participation included delay in standard treatment and the requirement for additional visits or procedures. Ultimately, most interviewees stated they would participate in a WOT if offered (N = 17/25). CONCLUSION: In this qualitative study, interviewees weighed altruism and hypothetical personal benefit against the possibility of side effect from a WOT. In-person family presence during trial discussion, challenging during COVID-19, was important for many. Our results may inform trial design and communication approaches in future window of opportunity efforts.

Defining the clinician's role in mitigating financial toxicity: an exploratory study.

BACKGROUND: Financial toxicity describes the financial burden imposed onto patients by a cancer diagnosis and is a growing concern. Many clinicians do not currently address financial toxicity despite patients' desire for them to do so. Current literature explores physicians' perspectives but does not clearly define an actionable role clinicians can take to address financial toxicity. We sought to fill this gap by first assessing clinicians' perspective on their role in alleviating financial toxicity at our institution. We subsequently aimed to identify current barriers to mitigating financial toxicity and to garner feedback on clinician-oriented interventions to address this growing problem. METHODS: We developed an 18-item electronic, anonymous survey through Redcap. We invited all oncology clinicians including attending physicians, advance practice providers, and trainees at our institution to participate. RESULTS: A total of 72 clinicians (30%) completed the survey. The majority agreed that clinicians have a role in addressing cost. The top three barriers to discussing cost with patients were knowledge of out of pocket costs, time, and awareness of resources. Less than half of respondents used an existing comparative cost tool to incorporate cost consciousness into treatment decisions. The most desired intervention was an institutional resource guide. In open-ended comments, the most common barrier described was transparency of out of pocket costs, and the most common solution proposed was a multi-disciplinary approach to addressing financial concerns patient face. DISCUSSION: Improving price transparency, incorporating existing resources into clinical practice, and streamlining multi-disciplinary support may help overcome barriers to addressing financial toxicity.

Teleoncology in the Veterans Health Administration: Models of Care and the Veteran Experience.

The Veterans Health Administration (VHA) has pioneered teleoncology to address access challenges faced by Veterans requiring cancer care. This ASCO Educational Book highlights the development of teleoncology programs within the VHA: the local VA Pittsburgh Healthcare System (VAPHS) Virtual Cancer Care Center, the National TeleOncology Program (NTO), and the regional Clinical Resource Hub (CRH) Oncology Program. These initiatives provide oncology care using a hub-and-spoke model, which centralizes expertise at hub sites and reaches Veterans at distant spoke sites through synchronous and asynchronous care. The deployment of these teleoncology programs has resulted in significant benefits, such as decreased travel for Veterans, high levels of patient satisfaction, and improved access to specialized treatments. Despite these advancements, disparities in teleoncology utilization and access to clinical trials persist. This educational manuscript highlights the successes and challenges of tele-oncology within the VHA, underscoring the critical role of telehealth in overcoming access barriers.

Coaches Activating, Reaching, and Engaging Patients to Engage in Advance Care Planning: A Randomized Clinical Trial.

Importance: Advance care planning (ACP) remains low among patients with advanced cancer. Multilevel interventions compared with clinician-level interventions may be more effective in improving ACP. Objective: To evaluate whether a multilevel intervention could improve clinician-documented ACP compared with a clinician-level intervention alone. Design, Setting, and Participants: This randomized clinical trial, performed from September 12, 2019, through May 12, 2021, included adults with advanced genitourinary cancers at an academic, tertiary hospital. Data analysis was performed by intention to treat from May 1 to August 10, 2023. Intervention: Participants were randomized 1:1 to a 6-month patient-level lay health worker structured ACP education along with a clinician-level intervention composed of 3-hour ACP training and integration of a structured electronic health record documentation template (intervention group) or to the clinician-level intervention alone (control group). Main Outcome and Measures: The primary outcome was ACP documentation in the electronic health record by the oncology clinician within 12 months after randomization. Secondary, exploratory outcomes included shared decision-making, palliative care use, hospice use, emergency department visits, and hospitalizations within 12 months after randomization. Results: Among 402 participants enrolled in the study, median age was 71 years (range, 21-102 years); 361 (89.8%) identified as male. More intervention group participants had oncology clinician-documented ACP than control group participants (82 [37.8%] vs 40 [21.6%]; odds ratio [OR], 2.29; 95% CI, 1.44-3.64). At 12-month follow-up, more intervention than control group participants had palliative care (72 [33.2%] vs 25 [13.5%]; OR, 3.18; 95% CI, 1.91-5.28) and hospice use (49 [22.6%] vs 19 [10.3%]; OR, 2.54; 95% CI, 1.44-4.51). There were no differences in the proportion of participants between groups with an emergency department visit (65 [30.0%] vs 61 [33.0%]; OR, 0.87; 95% CI, 0.57-1.33) or hospitalization (89 [41.0%] vs 85 [46.0%]; OR, 0.82; 95% CI, 0.55-1.22). Intervention group participants had fewer hospitalizations than control group participants (mean [SD] number of hospitalizations per year, 0.87 [1.60] vs 1.04 [1.77]) and a lower risk of hospitalization (incidence rate ratio, 0.80; 95% CI, 0.65-0.98). Conclusions and Relevance: In this randomized clinical trial, a multilevel intervention improved oncology clinician-documented ACP compared with a clinician-level intervention alone for patients with genitourinary cancer. The intervention is one approach to effectively increase ACP among patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03856463.

Knowledge, attitudes and practices among parents and teachers about soil-transmitted helminthiasis control programs for school children in Guimaras, Philippines.

We determined the attitudes toward and practices regarding soil-transmitted helminthes (STH) control among parents and school teachers to identify reasons behind attitudes and practices that do not promote STH control. Written knowledge, attitudes and practices surveys were distributed to parents (N = 531) and teachers (N = 105) of students at 11 elementary schools in Guimaras Province, the Philippines. The survey addressed attitudes about mass drug administration (MDA), knowledge about STH control, hygienic practices, and acceptability of distributing deworming tablets among teachers. More than 90% of parents and teachers held favorable attitudes towards MDA. Sixty-nine percent of parents and 75.5% of teachers believed stool exams were necessary before MDA. Thirty-seven percent of parents stated they would not allow teachers to administer deworming tablets and 91.5% of parents feared teachers would not detect side effects of the medication. Forty-eight percent of teachers felt they could safely give deworming tablets and 81.4% of teachers were afraid of managing the side effects of deworming tablets. Forty-seven point eight percent of parents and 42.2% of teachers stated defecation in the open occured in their community. Although attitudes toward STH control were largely favorable, misconceptions about the MDA strategy, lack of support for teachers giving deworming tablets, and the practice of open defecation still exist as barriers to STH control efforts. The next step to achieve effective STH control will be to clarify misconceptions in education campaigns, to train teachers about medication administration, campaign to improve sanitation and hygiene and begin targeted mass treatment in Guimaras, the Philippines.

Use of Machine Learning and Lay Care Coaches to Increase Advance Care Planning Conversations for Patients With Metastatic Cancer.

PURPOSE: Patients with metastatic cancer benefit from advance care planning (ACP) conversations. We aimed to improve ACP using a computer model to select high-risk patients, with shorter predicted survival, for conversations with providers and lay care coaches. Outcomes included ACP documentation frequency and end-of-life quality measures. METHODS: In this study of a quality improvement initiative, providers in four medical oncology clinics received Serious Illness Care Program training. Two clinics (thoracic/genitourinary) participated in an intervention, and two (cutaneous/sarcoma) served as controls. ACP conversations were documented in a centralized form in the electronic medical record. In the intervention, providers and care coaches received weekly e-mails highlighting upcoming clinic patients with < 2 year computer-predicted survival and no prior prognosis documentation. Care coaches contacted these patients for an ACP conversation (excluding prognosis). Providers were asked to discuss and document prognosis. RESULTS: In the four clinics, 4,968 clinic visits by 1,251 patients met inclusion criteria (metastatic cancer with no prognosis previously documented). In their first visit, 28% of patients were high-risk (< 2 year predicted survival). Preintervention, 3% of both intervention and control clinic patients had ACP documentation during a visit. By intervention end (February 2021), 35% of intervention clinic patients had ACP documentation compared with 3% of control clinic patients. Providers' prognosis documentation rate also increased in intervention clinics after the intervention (2%-27% in intervention clinics, P < .0001; 0%-1% in control clinics). End-of-life care intensity was similar in intervention versus control clinics, but patients with ≥ 1 provider ACP edit met fewer high-intensity care measures (P = .04). CONCLUSION: Combining a computer prognosis model with care coaches increased ACP documentation.

Safe administration of the seasonal trivalent influenza vaccine to children with severe egg allergy.

BACKGROUND: Anaphylaxis to egg or severe egg allergy has been considered a contraindication to receiving trivalent seasonal influenza vaccine (TIV). OBJECTIVE: To evaluate the safety of TIV among severely egg allergic children. METHODS: A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial. RESULTS: Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction. CONCLUSION: TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.

Long term cost comparisons of radical cystectomy versus trimodal therapy for muscle-invasive bladder cancer.

BACKGROUND: Earlier studies on the cost of muscle-invasive bladder cancer treatments are limited to short-term costs of care. We determined the 2- and 5-year costs associated with trimodal therapy (TMT) vs. radical cystectomy (RC). METHODS: We performed a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Total Medicare costs at 2 and 5 years following RC vs. TMT were compared using inverse probability of treatment-weighted propensity score models. RESULTS: A total of 2,537 patients aged 66 to 85 years were diagnosed with clinical stage T2-4a muscle-invasive bladder cancer. Total median costs for patients that received no definitive treatment(s) were $73,780 and $88,275 at 2-and 5-years. Costs were significantly higher for TMT than RC at 2-years ($372,839 vs. $191,363, Median Difference $127,815, Hodges-Lehmann Estimate (H-L) 95% Confidence Interval (CI), $112,663-$142,966) and 5-years ($424,570 vs. $253,651, Median Difference $124,466, H-L 95% CI, $105,711-$143,221). TMT had higher outpatient costs than RC (2-years: $318,221 vs. $100,900; 5-years: $367,092 vs. $146,561) with significantly higher costs with radiology, medications, pathology/laboratory, and other professional services. RC had higher inpatient costs than TMT (2-years: $62,240 vs. $33,631, Median Difference $-29,174, H-L 95% CI, $-32,364-$-25,984; 5-years: $75,499 vs. $45,223, Median Difference $-29,843, H-L 95% CI, $-33,905-$-25,781). CONCLUSIONS AND RELEVANCE: The excess spending associated with trimodal therapy vs. radical cystectomy was largely driven by outpatient expenditures. The relatively high long-term trimodal therapy costs are prime targets for cost containment strategies to optimize future value-based care.

Financial Toxicity of Cancer Care: An Analysis of Financial Burden in Three Distinct Health Care Systems.

PURPOSE: The financial toxicity of cancer care is a source of significant distress for patients with cancer. The purpose of this study is to understand factors associated with financial toxicity in three distinct care systems. METHODS: We conducted a cross-sectional survey of patients in three care systems, Stanford Cancer Institute (SCI), VA Palo Alto Health Care System (VAPAHCS), and Santa Clara Valley Medical Center (SCVMC), from October 2017 to May 2019. We assessed demographic factors, employment status, and out-of-pocket costs (OOPCs) and administered the validated COmprehensive Score for financial Toxicity tool. We calculated descriptive statistics and conducted linear regression models to analyze factors associated with financial toxicity. RESULTS: Four hundred forty-four of 578 patients (77%) completed the entire COmprehensive Score for financial Toxicity tool and were included in the analysis. Most respondents at SCI were White, with annual household income (AHI) > $50,000 USD and Medicare insurance. At the VAPAHCS, most were White, with AHI ≤ $50,000 USD and insured by the Veterans Administration. At SCVMC, most were Asian and/or Pacific Islander, with AHI ≤ $25,000 USD and Medicaid insurance. Low AHI (P < .0001), high OOPCs (P = .003), and employment changes as a result of cancer diagnosis (P < .0001) were associated with financial toxicity in the pooled analysis. There was variation in factors associated with financial toxicity by site, with employment changes significant at SCI, OOPCs at SCVMC, and no significant factors at the VAPAHCS. CONCLUSION: Low AHI, high OOPCs, and employment changes contribute to financial toxicity; however, there are variations based on site of care. Future studies should tailor financial toxicity interventions within care delivery systems.

Healthcare delivery interventions to reduce cancer disparities worldwide.

Globally, cancer care delivery is marked by inequalities, where some economic, demographic, and sociocultural groups have worse outcomes than others. In this review, we sought to identify patient-facing interventions designed to reduce disparities in cancer care in both high- and low-income countries. We found two broad categories of interventions that have been studied in the current literature: Patient navigation and telehealth. Navigation has the strongest evidence base for reducing disparities, primarily in cancer screening. Improved outcomes with navigation interventions have been seen in both high- and low-income countries. Telehealth interventions remain an active area of exploration, primarily in high income countries, with the best evidence being for the remote delivery of palliative care. Ongoing research is needed to identify the most efficacious, cost-effective, and scalable interventions to reduce barriers to the receipt of cancer care globally.

Characteristics of Patients With ROS1+ Cancers: Results From the First Patient-Designed, Global, Pan-Cancer ROS1 Data Repository.

PURPOSE: The discovery of driver oncogenes, such as ROS1, has led to the development of targeted therapies. Despite clinical advancements, gaps remain in our understanding of characteristics of patients with ROS1-positive (ROS1+) cancers. The purpose of this study was to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers worldwide. METHODS: In collaboration with a panel of patients with ROS1+ cancer, we designed and conducted a 204-question online assessment regarding the demographic, clinical, and environmental factors of patients with ROS1+ cancers. We invited patients with ROS1+ cancers to participate in the study from May 2016 to December 2018. RESULTS: A total of 277 patients from 18 countries worldwide responded and completed at least 90% of the survey. The majority of respondents were female (n = 191; 69%), non-Hispanic white (n = 202; 73%), never-smokers (n = 180/240; 75%). Most were diagnosed with lung cancer (n = 261/277; 94%) and stage IV disease (n = 201/277; 76%). The majority received chemotherapy in first (n = 137/199; 69%) and second (n = 103/199; 52%) lines of therapy. For patients diagnosed with lung cancer after the availability of crizotinib (n = 199), only a minority (n = 55/199; 28%) reported receiving crizotinib in the first line of therapy. CONCLUSION: This study is the first global, patient-designed approach, to our knowledge, to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers. Future efforts include assessing these characteristics as well as patient-reported outcomes and treatment responses longitudinally.

Pathogenic Variants in Less Familiar Cancer Susceptibility Genes: What Happens After Genetic Testing?

PURPOSE: As genetic testing expands, patients are increasingly found to carry pathogenic variants in cancer susceptibility genes that are less familiar to most clinicians, specifically genes other than those causing hereditary breast ovarian cancer syndrome (BRCA1 and BRCA2) and Lynch syndrome. Little is known about the subsequent behaviors of such patients in terms of managing cancer risks and informing relatives. METHODS: All adult patients who were counseled and tested at the Stanford Cancer Genetics Clinic from January 2013 to July 2015 and had a pathogenic variant in a non-BRCA1/2, non-Lynch syndrome gene were invited to participate in a telephone interview about adherence to risk-reducing recommendations, genetic testing by relatives, and new cancer incidence. RESULTS: Fifty-seven (40%) of 142 eligible patients were successfully contacted, and all 57 patients participated; median follow-up was 677 days (range, 247 to 1,401 days). Most patients (82%; 95% CI, 70% to 90%) recalled that a risk-reducing intervention (screening, medication, or surgery) was recommended, and most patients (85%; 95% CI, 72% to 93%) adhered to the recommendation. Nearly all patients (91%; 95% CI, 81% to 97%) shared results with relatives, and most patients (78%; 95% CI, 64% to 88%) reported that a relative was subsequently tested. During the follow-up period, 9% of patients (95% CI, 3% to 19%) developed second cancers, and in 14% of patients (95% CI, 7% to 26%), a first-degree relative developed cancer, some of which were detected by recommended screening. CONCLUSION: Patients with a pathogenic variant in a less familiar cancer susceptibility gene report high adherence to risk-reducing interventions. Furthermore, in the 57 carriers and subsequently tested relatives with two years of follow-up, a total of three cancers (one in a proband and two in relatives) were detected through interventions recommended on the basis of the pathogenic variant. These results suggest a potential benefit of genetic counseling and testing for pathogenic variants in less familiar genes.

Impact of patient demographics, tumor characteristics, and treatment type on treatment delay throughout breast cancer care at a diverse academic medical center.

PURPOSE AND OBJECTIVE: The aim of this study was to examine the impact of patient demographics, tumor characteristics, and treatment type on time to treatment (TTT) in patients with breast cancer treated at a safety net medical center with a diverse patient population. PATIENTS AND METHODS: A total of 1,130 patients were diagnosed and treated for breast cancer between 2004 and 2014 at our institution. We retrospectively collected data on patient age at diagnosis, race/ethnicity, primary language spoken, marital status, insurance coverage, American Joint Committee on Cancer (AJCC) stage, hormone receptor status, and treatment dates. TTT was determined from the date of breast cancer biopsy to treatment start date. Nonparametric Mann-Whitney U-test (or Kruskal-Wallis test when appropriate) and multivariable quantile regression models were employed to assess for significant differences in TTT associated with each factor. RESULTS: Longer median TTT was noted for Black (P=0.002) and single (P=0.002) patients. AJCC stage IV patients had shorter TTT (27.5 days) compared to earlier AJCC patients (36, 35, 37, 37 days for stage 0, I, II, III, respectively), P=0.028. Age, primary language spoken, insurance coverage, and hormone receptor status had no significant impact on TTT. On multivariate analysis, race/ethnicity remained the only significant factor with Black reporting longer TTT, P=0.025. However, race was not a significant factor for time from first to second treatment. More Black patients were noted to be single (P<0.0001) and received chemotherapy as first treatment (P=0.008) compared to White, Hispanic, or other race/ethnicity patients. CONCLUSION: In this retrospective analysis, Black patients had longer TTT, were more likely to receive chemotherapy as first treatment, and have a single marital status. These patient factors will help identify vulnerable patients and guide further research to understand the barriers to care and the impact of treatment delays on outcomes.

Race/Ethnicity, Primary Language, and Income Are Not Demographic Drivers of Mortality in Breast Cancer Patients at a Diverse Safety Net Academic Medical Center.

Objective. To examine the impact of patient demographics on mortality in breast cancer patients receiving care at a safety net academic medical center. Patients and Methods. 1128 patients were diagnosed with breast cancer at our institution between August 2004 and October 2011. Patient demographics were determined as follows: race/ethnicity, primary language, insurance type, age at diagnosis, marital status, income (determined by zip code), and AJCC tumor stage. Multivariate logistic regression analysis was performed to identify factors related to mortality at the end of follow-up in March 2012. Results. There was no significant difference in mortality by race/ethnicity, primary language, insurance type, or income in the multivariate adjusted model. An increased mortality was observed in patients who were single (OR = 2.36, CI = 1.28-4.37, p = 0.006), age > 70 years (OR = 3.88, CI = 1.13-11.48, p = 0.014), and AJCC stage IV (OR = 171.81, CI = 59.99-492.06, p < 0.0001). Conclusions. In this retrospective study, breast cancer patients who were single, presented at a later stage, or were older had increased incidence of mortality. Unlike other large-scale studies, non-White race, non-English primary language, low income, or Medicaid insurance did not result in worse outcomes.