Navigating financial toxicity in patients with cancer: A multidisciplinary management approach.

Approximately one-half of individuals with cancer face personal economic burdens associated with the disease and its treatment, a problem known as financial toxicity (FT). FT more frequently affects socioeconomically vulnerable individuals and leads to subsequent adverse economic and health outcomes. Whereas multilevel systemic factors at the policy, payer, and provider levels drive FT, there are also accompanying intervenable patient-level factors that exacerbate FT in the setting of clinical care delivery. The primary strategy to intervene on FT at the patient level is financial navigation. Financial navigation uses comprehensive assessment of patients' risk factors for FT, guidance toward support resources, and referrals to assist patient financial needs during cancer care. Social workers or nurse navigators most frequently lead financial navigation. Oncologists and clinical provider teams are multidisciplinary partners who can support optimal FT management in the context of their clinical roles. Oncologists and clinical provider teams can proactively assess patient concerns about the financial hardship and employment effects of disease and treatment. They can respond by streamlining clinical treatment and care delivery planning and incorporating FT concerns into comprehensive goals of care discussions and coordinated symptom and psychosocial care. By understanding how age and life stage, socioeconomic, and cultural factors modify FT trajectory, oncologists and multidisciplinary health care teams can be engaged and informative in patient-centered, tailored FT management. The case presentations in this report provide a practical context to summarize authors' recommendations for patient-level FT management, supported by a review of key supporting evidence and a discussion of challenges to mitigating FT in oncology care. CA Cancer J Clin. 2022;72:437-453.

Healthcare Access Domains and Treatment as Mediators of Ovarian Cancer Racial Disparities in Survival: A Structural Equation Modeling Analysis in SEER-Medicare.

Racial differences in healthcare access (HCA) may contribute to disparities in ovarian cancer (OC) survival. We used structural equation models (SEM) to examine associations between race and HCA domains (affordability, availability, accessibility) in relation to overall and OC-specific mortality. Non-Hispanic (NH)-Black and non-Black (Hispanic, NH-White) women diagnosed with OC in 2008-2015 were identified from SEER-Medicare. Cox proportional hazards regression was used to conduct mediation analysis for associations between race and HCA domains with overall and OC-specific mortality. SEM models adjusting for demographic and clinical covariates were used to estimate hazard ratios (HR) and 95% confidence intervals (CI). A total of 4,629 eligible OC patients were identified, including 255 (5.5%) patients who were NH-Black. In SEM adjusting for demographic, clinical, and HCA latent variables, there was a total effect of NH-Black race on overall (HR: 1.11, 95% CI: 1.03,1.19) and OC-specific mortality (HR: 1.16, 95% CI: 1.08, 1.24), which was primarily driven by a direct effect. There was a modest indirect association between NH-Black race and mortality through decreased treatment receipt, though not through HCA. There is a need for studies investigating additional social and biological mechanisms that contribute to worse cancer survival among NH-Black patients.

A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC.

PURPOSE: Opportunities exist for patients with metastatic breast cancer (MBC) to engage in shared decision-making (SDM). Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment plan decision may improve patient engagement in treatment decisions. METHODS: This randomized controlled trial evaluated the standard-of-care treatment planning process vs. a novel treatment planning process focused on SDM, which included oncologist review of patient-reported treatment preferences, prior to or during treatment decisions among women with MBC. The primary outcome was patient perception of shared decision-making. Secondary outcomes included patient activation, treatment satisfaction, physician perception of treatment decision-making, and use of treatment plans. RESULTS: Among the 109 evaluable patients from December 2018 to June 2022, 28% were Black and 12% lived in a highly disadvantaged neighborhood. Although not reaching statistical significance, patients in the intervention arm perceived SDM more often than patients in the control arm (63% vs. 59%; Cramer's V = 0.05; OR 1.19; 95% CI 0.55-2.57). Among patients in the intervention arm, 31% were at the highest level of patient activation compared to 19% of those in the control arm (V = 0.18). In 82% of decisions, the oncologist agreed that the patient-reported data helped them engage in SDM. In 45% of decision, they reported changing management due to patient-reported data. CONCLUSIONS: Oncologist engagement in the treatment planning process, with oncologist review of patient-reported data, is a promising approach to improve patient participation in treatment decisions which should be tested in larger studies. TRIAL REGISTRATION: NCT03806738.

Dedicated financial hardship screening adds value to routine distress screening among gynecologic cancer patients.

OBJECTIVES: To evaluate existing distress screening to identify patients with financial hardship (FH) compared to dedicated FH screening and assess patient attitudes toward FH screening. METHODS: We screened gynecologic cancer patients starting a new line of therapy. Existing screening included: (1) Moderate/severe distress defined as Distress Thermometer score ≥ 4, (2) practical concerns identified from Problem Checklist, and (3) a single question assessing trouble paying for medications. FH screening included: (1) Comprehensive Score for Financial Toxicity (COST) tool and (2) 10-item Financial Needs Checklist to guide referrals. FH was defined as COST score < 26. We calculated sensitivity (patients with moderate/severe distress + FH over total patients with FH) and specificity (patients with no/mild distress + no FH over total patients with no FH) to assess the extent distress screening could capture FH. Surveys and exit interviews assessed patient perspectives toward screening. RESULTS: Of 364 patients screened for distress, average age was 62 years, 25% were Black, 45% were Medicare beneficiaries, 32% had moderate/severe distress, 15% reported ≥1 practical concern, and 0 reported trouble paying for medications. Most (n = 357, 98%) patients also completed FH screening: of them, 24% screened positive for FH, 32% reported ≥1 financial need. Distress screening had 57% sensitivity and 77% specificity for FH. Based on 79 surveys and 43 exit interviews, FH screening was acceptable with feedback to improve the timing and setting of screening. CONCLUSIONS: Dedicated FH screening was feasible and acceptable, but sensitivity was low. Importantly, 40% of women with FH would not have been identified with distress screening alone.

Frailty in patients with ovarian cancer and the role of healthcare access, race, and ethnicity.

OBJECTIVE: Ovarian cancer has poor 5-year survival, particularly among non-Hispanic (NH) Black patients. Efforts to identify patients at high-risk of functional limitations and frailty may improve outcomes. In this study, we examined how healthcare access (HCA) and race/ethnicity relate to frailty among patients with ovarian cancer. METHODS: We identified Hispanic, NH Black, and NH White patients diagnosed at ages ≥6 5 years with ovarian cancer between 2009 and 2015 using SEER-Medicare. Log-binomial regression was used to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs) for the association between HCA and race/ethnicity with pre- or post-diagnosis frailty, adjusting for age and comorbidities. RESULTS: A total of 6041 patients with ovarian cancer were included, including 91.8% NH White, 6.6% NH Black, and 1.7% Hispanic. Pre-diagnosis, 14.7% of patients were defined as frail (NH White: 14.3%; NH Black: 17.9%; Hispanic: 20.8%). Post-diagnosis, frailty prevalence increased to 58.8% (NH White: 58.2%; NH Black: 65.2%; Hispanic: 70.2%). No statistically significant associations were observed between race/ethnicity and pre- or post-diagnosis frailty in fully adjusted models. After adjustment for patient characteristics and healthcare accessibility and availability, higher healthcare affordability was associated with a decreased prevalence of pre-diagnosis frailty (PR: 0.91, 95% CI: 0.8 5, 0.98). CONCLUSIONS: Patients with ovarian cancer have a high prevalence of frailty after diagnosis, particularly NH Black and Hispanic patients. Improving healthcare affordability may prevent or help manage frailty in Medicare patients, improve receipt of cancer treatment, and increase cancer survival.

Cancer-Related Financial Hardship Screening as Part of Practice Transformation.

BACKGROUND: Data on financial hardship, an "adverse event" in individuals with cancer, are needed to inform policy and supportive care interventions and reduce adverse economic outcomes. METHODS: Lay navigator-led financial hardship screening was piloted among University of Alabama at Birmingham oncology patients initiating treatment in October 2020. Financial hardship screening, including reported financial distress and difficulty, was added to a standard-of-care treatment planning survey. Screening feasibility and completion and proportions of reported financial distress and difficulty were calculated overall and by patient race and rurality. The risk of financial distress by patient sociodemographics was estimated. RESULTS: Patients who completed a treatment planning survey (N=2741) were 18% Black, Indigenous, or persons of color (BIPOC) and 16% rural dwelling. The majority of patients completed financial hardship screening (90%), surpassing the target feasibility completion rate of 75%. The screening revealed 34% of patients were experiencing financial distress, including 49% of BIPOC and 30% of White patients. Adjusted models revealed BIPOC patients had a 48% higher risk of financial distress compared with those who were White (risk ratio 1.48, 95% CI, 1.31-1.66). Large differences in reported financial difficulties were seen comparing patients who were BIPOC and White (utilities: 33% vs. 10%, upfront medical payments: 44% vs. 23%, transportation: 28% vs. 12%, respectively). CONCLUSIONS: The collection of patient-reported financial hardship data via routine clinical care was feasible and identified racial inequities at treatment initiation. Efforts to collect patient economic data should support the design, implementation, and evaluation of patient-centered interventions to improve equity and reduce the impact of financial hardship.

Trends and Predictors of Glycemic Control Among Adults With Type 2 Diabetes Covered by Alabama Medicaid, 2011-2019.

INTRODUCTION: Despite advances in diabetes management, only one-quarter of people with diabetes in the US achieve optimal targets for glycated hemoglobin A1c (HbA1c), blood pressure, and cholesterol. We sought to evaluate temporal trends and predictors of achieving glycemic control among adults with type 2 diabetes covered by Alabama Medicaid from 2011 through 2019. METHODS: We completed a retrospective analysis of Medicaid claims and laboratory data, using person-years as the unit of analysis. Inclusion criteria were being aged 19 to 64 years, having a diabetes diagnosis, being continuously enrolled in Medicaid for a calendar year and preceding 12 months, and having at least 1 HbA1c result during the study year. Primary outcomes were HbA1c thresholds of <7% and <8%. Primary exposure was study year. We conducted separate multivariable-adjusted logistic regressions to evaluate relationships between study year and HbA1c thresholds. RESULTS: We included 43,997 person-year observations. Mean (SD) age was 51.0 (9.9) years; 69.4% were women; 48.1% were Black, 42.9% White, and 0.4% Hispanic. Overall, 49.1% had an HbA1c level of <7% and 64.6% <8%. Later study years and poverty-based eligibility were associated with lower probability of reaching target HbA1c levels of <7% or <8%. Sex, race, ethnicity, and geography were not associated with likelihood of reaching HbA1c <7% or <8% in any model. CONCLUSION: Later study years were associated with lower likelihood of meeting target HbA1c levels compared with 2011, after adjusting for covariates. With approximately 35% not meeting an HbA1c target of <8%, more work is needed to improve outcomes of low-income adults with type 2 diabetes.

Effect of the GnRH stimulation test on Canine Prostatic-Specific Esterase (CPSE).

The gonadotropin-releasing hormone (GnRH) stimulation test is used to investigate testicular production of testosterone (T) when performing a breeding soundness examination. In male dogs with fertility problems, the prostate should also be investigated as prostatic conditions may frequently lower semen quality. Serum concentrations of canine prostatic-specific esterase (CPSE) increase in dogs with benign prostatic hyperplasia (BPH). When performing a breeding soundness examination in a male dog, GnRH administration is frequently done at the beginning of the process and then both T and CPSE are assayed on the same serum sample collected 1 h following the GnRH injection. The aim of this study was to assess whether or not the administration of GnRH may alter CPSE concentrations in dogs with a healthy prostate. Twenty-eight client-owned intact adult male dogs were included in the study. Following a 7-day sexual rest all male dogs underwent a clinical examination and an ultrasonographic examination of the prostatic gland. Prostatic size and parenchyma of every tested dog were evaluated by ultrasonography to assess prostatic conditions. Two different GnRH stimulation protocols were used, A = gonadorelin 50µg/dog SC (n = 15) and B = buserelin 0.12 µg/kg IV (n = 13). T and CPSE concentrations were measured before and 1 h after GnRH administration by a laser-induced fluorescence analysis. Buserelin and gonadorelin were equally effective in causing a significant increase in serum T concentrations in the post GnRH sample. When considering the 28 dogs together, CPSE concentrations did not change following the stimulation test with either GnRH compound; however, in 4/28 cases, the post GnRH value was markedly increased to values compatible with a diagnosis of BPH. There was no difference in the action of buserelin or gonadorelin in causing an increase in serum T concentrations. CPSE secretion was increased in approximately 15% of dogs treated with either buserelin or gonadorelin. Therefore, whenever performing diagnostic testing in intact male dogs, CPSE should not be assayed on a post-GnRH serum sample.

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers.

BACKGROUND: Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. METHODS: Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. DISCUSSION: Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.

Therapeutic Use of Cerebellar Intermittent Theta Burst Stimulation (iTBS) in a Sardinian Family Affected by Spinocerebellar Ataxia 38 (SCA 38).

Spinocerebellar ataxia 38 (SCA 38) is an autosomal dominant disorder caused by conventional mutations in the ELOVL5 gene which encodes an enzyme involved in the synthesis of very long fatty acids, with a specific expression in cerebellar Purkinje cells. Three Italian families carrying the mutation, one of which is of Sardinian descent, have been identified and characterized. One session of cerebellar intermittent theta burst stimulation (iTBS) was applied to 6 affected members of the Sardinian family to probe motor cortex excitability measured by motor-evoked potentials (MEPs). Afterwards, patients were exposed to ten sessions of cerebellar real and sham iTBS in a cross-over study and clinical symptoms were evaluated before and after treatment by Modified International Cooperative Ataxia Rating Scale (MICARS). Moreover, serum BDNF levels were evaluated before and after real and sham cerebellar iTBS and the role of BDNF Val66Met polymorphism in influencing iTBS effect was explored. Present data show that one session of cerebellar iTBS was able to increase MEPs in all tested patients, suggesting an enhancement of the cerebello-thalamo-cortical pathway in SCA 38. MICARS scores were reduced after ten sessions of real cerebellar iTBS showing an improvement in clinical symptoms. Finally, although serum BDNF levels were not affected by cerebellar iTBS when considering all samples, segregating for genotype a difference was found between Val66Val and Val66Met carriers. These preliminary data suggest a potential therapeutic use of cerebellar iTBS in improving motor symptoms of SCA38.

Chronic treatment with hormonal contraceptives alters hippocampal BDNF and histone H3 post-translational modifications but not learning and memory in female rats.

Hormonal contraceptives prevent ovulation with subsequent reduction in endogenous levels of estradiol, progesterone and its neuroactive metabolite allopregnanolone. These neurosteroids modulate several brain functions, including neuronal plasticity, cognition and memory. We hypothesized that hormonal contraceptives might affect synaptic plasticity, learning and memory, as a consequence of suppressed endogenous hormones levels. Female rats were orally treated with a combination of ethinyl estradiol (EE, 0.020 mg) and levonorgestrel (LNG, 0.060 mg) once daily for four weeks. Decreased hippocampal brain-derived neurotrophic factor (BDNF) levels and altered histone H3 post-translational modifications (PTMs) were observed 14 days after discontinuation from chronic EE-LNG treatment. These effects were not accompanied by alterations in long-term plasticity at glutamatergic synapses, recognition memory in the novel object and novel place location tests, or spatial learning, memory, and behavioral flexibility in the Morris water maze test. Thus, decreased BDNF content does not affect synaptic plasticity and cognitive performance; rather it might be relevant for the occurrence of certain psychiatric symptoms, reported by some women using hormonal contraceptives. These results provide the first evidence of hippocampal epigenetic changes induced by hormonal contraceptives and complement previous studies on the neurobiological actions of hormonal contraceptives; the finding that effects of chronic EE-LNG treatment on BDNF content and histone PTMs are observed 14 days after drug discontinuation warrants further investigation to better understand the implications of such long-term consequences for women's health.

Navigating job and cancer demands during treatment: A qualitative study of ovarian cancer patients.

OBJECTIVE: Our objective was to obtain perspectives from ovarian cancer patients on job demands, cancer demands, and workplace or cancer resources and strategies to manage the cancer-work interface using the cancer-work management conceptual framework. METHODS: We recruited ovarian cancer patients receiving systemic therapy who screened positive for financial distress using Comprehensive Score for Financial Toxicity <26. Interviews were conducted with participants about their costs of care, including employment concerns. Interviews were recorded, transcribed verbatim, and analyzed by three researchers using an inductive thematic analysis. RESULTS: Of 22 participants, the average age was 57 years old, 36% were Black, 68% had income <$40,000, 41% had public insurance, and 68% were being treated for recurrent disease. Job demands included decreased productivity, inability to return to work, and worry about losing a job or employer-based health insurance coverage. Cancer demands included physical and cognitive limitations due to cancer treatment and reliance on caregivers, especially for transportation. Workplace resources/strategies including having a supportive employer, modifying job responsibilities, and utilizing family medical leave. Cancer care resources/strategies included planning appointments ahead of time and utilizing resources, such as disability. CONCLUSIONS: Cancer care teams should consider screening patients for employment concerns; streamline care to minimize the side effects, time, and transportation demands of treatment on patients and caregivers; maximize utilization of available resources; and proactively communicate with employers to accommodate patients and caregivers who want or need to work.

Healthcare Access Dimensions and Guideline-Concordant Ovarian Cancer Treatment: SEER-Medicare Analysis of the ORCHiD Study.

BACKGROUND: Racial disparities exist in receipt of guideline-concordant treatment of ovarian cancer (OC). However, few studies have evaluated how various dimensions of healthcare access (HCA) contribute to these disparities. METHODS: We analyzed data from non-Hispanic (NH)-Black, Hispanic, and NH-White patients with OC diagnosed in 2008 to 2015 from the SEER-Medicare database and defined HCA dimensions as affordability, availability, and accessibility, measured as aggregate scores created with factor analysis. Receipt of guideline-concordant OC surgery and chemotherapy was defined based on the NCCN Guidelines for Ovarian Cancer. Multivariable-adjusted modified Poisson regression models were used to assess the relative risk (RR) for guideline-concordant treatment in relation to HCA. RESULTS: The study cohort included 5,632 patients: 6% NH-Black, 6% Hispanic, and 88% NH-White. Only 23.8% of NH-White patients received guideline-concordant surgery and the full cycles of chemotherapy versus 14.2% of NH-Black patients. Higher affordability (RR, 1.05; 95% CI, 1.01-1.08) and availability (RR, 1.06; 95% CI, 1.02-1.10) were associated with receipt of guideline-concordant surgery, whereas higher affordability was associated with initiation of systemic therapy (hazard ratio, 1.09; 95% CI, 1.05-1.13). After adjusting for all 3 HCA scores and demographic and clinical characteristics, NH-Black patients remained less likely than NH-White patients to initiate systemic therapy (hazard ratio, 0.86; 95% CI, 0.75-0.99). CONCLUSIONS: Multiple HCA dimensions predict receipt of guideline-concordant treatment but do not fully explain racial disparities among patients with OC. Acceptability and accommodation are 2 additional HCA dimensions which may be critical to addressing these disparities.

Health care utilization among beneficiaries with diabetes from federally qualified health centers: Analysis from a Medicaid managed care organization.

We examined health care utilization among federally qualified health center (FQHCs) users from a Medicaid managed care organization based on 2016 administrative claims data (n = 8,402). FQHC users had fewer primary care visits (Adjusted Incidence Rate Ratios (aIRR): 0.82; 95% CI: 0.76-0.88) compared with non-FQHC users. Statistically significant differences were not observed in emergency department visits (aIRR: 1.19; 95% CI: 0.98-1.46) and hospitalizations (aIRR: 1.03; 95% CI: 0.80-1.34). FQHCs provide comprehensive primary care to Medicaid managed care beneficiaries with diabetes in fewer PCP visits. Results provide evidence to health policy experts and MCOs to increase provider network contracting with FQHCs.

Telemedicine in rheumatology: a reliable approach beyond the pandemic.

OBJECTIVES: The SARS-CoV-2 outbreak has imposed considerable restrictions on people's mobility, which affects the referral of chronically ill patients to health care structures. The emerging need for alternative ways to follow these patients up is leading to a wide adoption of telemedicine. We aimed to evaluate the feasibility of this approach for our cohort of patients with CTDs, investigating their attitude to adopting telemedicine, even after the pandemic. METHODS: We conducted a telephonic survey among consecutive patients referred to our CTD outpatients' clinic, evaluating their capability and propensity for adopting telemedicine and whether they would prefer it over face-to-face evaluation. Demographical and occupational factors were also collected, and their influence on the answers has been evaluated by a multivariate analysis. RESULTS: A total of 175 patients answered our survey (M/F = 28/147), with a median age of 62.5 years [interquartile range (IQR) 53-73]. About 80% of patients owned a device allowing video-calls, and 86% would be able to perform a tele-visit, either alone (50%) or with the help of a relative (36%). Telemedicine was considered acceptable by 78% of patients and 61% would prefer it. Distance from the hospital and patient's educational level were the strongest predictive factors for the acceptance of telemedicine (P < 0.05), whereas age only affected the mastering of required skills (P < 0.001). CONCLUSION: Telemedicine is a viable approach to be considered for routine follow-up of chronic patients, even beyond the pandemic. Our data showed that older patients would be willing to use this approach, although a proper guide for them would be required.

Social support and diabetes distress among adults with type 2 diabetes covered by Alabama Medicaid.

AIMS: Diabetes distress affects approximately 36% of adults with diabetes and is associated with worse diabetes self-management and poor glycaemic control. We characterized participants' diabetes distress and studied the relationship between social support and diabetes distress. METHODS: In this cross-sectional study, we surveyed a population-based sample of adults with type 2 diabetes covered by Alabama Medicaid. We used the Diabetes Distress Scale assessing emotional burden, physician-related, regimen-related and interpersonal distress. We assessed participants' level of diabetes-specific social support and satisfaction with this support, categorized as low or moderate-high. We performed multivariable logistic regression of diabetes distress by level of and satisfaction with social support, adjusting for demographics, disease severity, self-efficacy and depressive symptoms. RESULTS: In all, 1147 individuals participated; 73% were women, 41% White, 58% Black and 3% Hispanic. Low level of or satisfaction with social support was reported by 11% of participants; 7% of participants had severe diabetes distress. Participants with low satisfaction with social support were statistically significantly more likely to have severe diabetes distress than those with moderate-high satisfaction, adjusted odds ratio 2.43 (95% CI 1.30, 4.54). CONCLUSIONS: Interventions addressing diabetes distress in adults with type 2 diabetes may benefit from a focus on improving diabetes-specific social support.

Determining patient needs to enhance exercise program implementation and uptake in rural settings for women after a cancer diagnosis.

PURPOSE: To qualitatively explore exercise barriers and facilitators experienced by rural female cancer survivors from the program interventionist and recipient perspective for the purpose of enhancing exercise program implementation and uptake in rural settings. METHODS: A descriptive qualitative study design was utilized. Focus groups were conducted prior to implementation of an evidence-based exercise program by a rural non-research cancer clinical site. Nineteen rural female cancer survivors (mean age = 61.7 ± 10.9 years) and 11 potential interventionists (mean age = 42.3 ± 15.3 years) completed focus groups (stratified by participant role). Focus groups were audio recorded, transcribed, coded, and analyzed using inductive thematic analysis with NVivo 11. RESULTS: Cancer survivors identified 12 barrier themes (cancer specific adverse effects, lack of support, lack of knowledge, perceived negative aspects of exercise, cost, lack of resources, motivation, inconvenience, lack of program flexibility, time, weather, safety) and eight facilitator themes (knowledge, ease of access, resources, awareness, cost, options, organized, fun) related to exercise. Interventionists identified seven barrier themes (cost, transportation, lack of cancer survivor and interventionist knowledge, fear, motivation, lack of support, lack of resources) and four facilitator themes (resources, support, knowledge, motivation). Narratives revealed differing role-specific perspectives on shared themes between survivors and interventionists as well as potential implementation strategies for enhancing exercise participation and exercise program uptake among rural female cancer survivors. CONCLUSION: Exploring multi-level stakeholder perspectives on cancer survivors' exercise needs and related strategies yields important information for organizations to consider when implementing exercise programs in rural contexts.

Evaluating meaningful levels of financial toxicity in gynecologic cancers.

OBJECTIVE: The Comprehensive Score for Financial Toxicity (COST) is a validated instrument measuring the economic burden experienced by patients with cancer. We evaluated the frequency of financial toxicity at different COST levels and stratified risk factors and associations with cost-coping strategies by financial toxicity severity. METHODS: We analyzed previously collected survey data of gynecologic oncology patients from two tertiary care institutions. Both surveys included the COST tool and questions assessing economic and behavioral cost-coping strategies. We adapted a proposed grading scale to define three groups: no/mild, moderate, and severe financial toxicity and used χ2, Fisher's exact test, and Wilcoxon rank sum test to compare groups. We used Poisson regression to calculate crude and adjusted risk ratios for cost-coping strategies, comparing patients with moderate or severe to no/mild financial toxicity. RESULTS: Among 308 patients, 14.9% had severe, 32.1% had moderate, and 52.9% had no/mild financial toxicity. Younger age, non-white race, lower education, unemployment, lower income, use of systemic therapy, and shorter time since diagnosis were associated with worse financial toxicity (all p<0.05). Respondents with moderate or severe financial toxicity were significantly more likely to use economic cost-coping strategies such as changing spending habits (adjusted risk ratio (aRR) 2.7, 95% CI 1.8 to 4.0 moderate; aRR 3.6, 95% CI 2.4 to 5.4 severe) and borrowing money (aRR 5.5, 95% CI 1.8 to 16.5 moderate; aRR 12.7, 95% CI 4.3 to 37.1 severe). Those with severe financial toxicity also had a significantly higher risk of behavioral cost-coping through medication non-compliance (aRR 4.6, 95% CI 1.2 to 18.1). CONCLUSIONS: Among a geographically diverse cohort of gynecologic oncology patients, nearly half reported financial toxicity (COST <26), which was associated with economic cost-coping strategies. In those 14.9% of patients reporting severe financial toxicity (COST <14) there was also an increased risk of medication non-compliance, which may lead to worse health outcomes in this group.

Cost-effectiveness of CYP2C19-guided antiplatelet therapy in patients with acute coronary syndrome and percutaneous coronary intervention informed by real-world data.

Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a P2Y12 inhibitors following percutaneous coronary intervention (PCI). CYP2C19 genotype can guide DAPT selection, prescribing ticagrelor or prasugrel for loss-of-function (LOF) allele carriers (genotype-guided escalation). Cost-effectiveness analyses (CEA) are traditionally grounded in clinical trial data. We conduct a CEA using real-world data using a 1-year decision-analytic model comparing primary strategies: universal empiric clopidogrel (base case), universal ticagrelor, and genotype-guided escalation. We also explore secondary strategies commonly implemented in practice, wherein all patients are prescribed ticagrelor for 30 days post PCI. After 30 days, all patients are switched to clopidogrel irrespective of genotype (nonguided de-escalation) or to clopidogrel only if patients do not harbor an LOF allele (genotype-guided de-escalation). Compared with universal clopidogrel, both universal ticagrelor and genotype-guided escalation were superior with improvement in quality-adjusted life years (QALY's). Only genotype-guided escalation was cost-effective ($42,365/QALY) and demonstrated the highest probability of being cost-effective across conventional willingness-to-pay thresholds. In the secondary analysis, compared with the nonguided de-escalation strategy, although genotype-guided de-escalation and universal ticagrelor were more effective, with ICER of $188,680/QALY and $678,215/QALY, respectively, they were not cost-effective. CYP2C19 genotype-guided antiplatelet prescribing is cost-effective compared with either universal clopidogrel or universal ticagrelor using real-world implementation data. The secondary analysis suggests genotype-guided and nonguided de-escalation may be viable strategies, needing further evaluation.

Extensive financial hardship among gynecologic cancer patients starting a new line of therapy.

OBJECTIVE: Our objective was to evaluate the three domains of financial hardship (psychological response, material conditions, and coping behaviors) among gynecologic cancer patients receiving treatment. METHODS: We conducted a single-institution survey of gynecologic cancer patients starting a new line of therapy for primary or recurrent disease. Psychological response was measured using Comprehensive Score for Financial Toxicity, with score < 26 indicating financial distress. We measured material conditions by patient-reported changes in employment or spending and coping behaviors by patient-reported medication non-adherence. We performed descriptive statistics, bivariate analysis, and multivariate logistic regression. RESULTS: Among 121 participants, the mean age was 59 years, 28% were African-American, 50% reported income < $40,000, 74% had private insurance, 20% had only public insurance, and 7% were uninsured. Sixty-five (54%) participants screened positive for financial distress. Age < 65 years (aOR 2.61, 95% CI 1.04-6.52) and income < $40,000 (aOR 3.41, 95% CI 1.28-9.09) were associated with increased odds of screening positive for financial distress. Participants with financial distress were significantly more likely to report material hardship, including losing wages (46% vs. 18%, p < 0.01), not paying bills on time (40% vs. 7%, p < 0.01), and borrowing money (39% vs. 4%, p < 0.01). Financial distress was not associated with coping behaviors, such as not taking (6% vs. 2%, p = 0.37) or refilling medications (5% vs. 2%, p = 0.62). CONCLUSIONS: Financial distress affects over half of gynecologic cancer patients starting a new line of treatment and is associated with material hardship. Younger age and lower income can be used to identify patients at increased risk.