Longitudinal trajectories of a claims-based frailty measure during adjuvant chemotherapy in women with stage I-III breast cancer.

BACKGROUND: Frailty is a dynamic syndrome characterized by reduced physiological reserve to maintain homeostasis. Prospective studies have reported frailty worsening in women with breast cancer during chemotherapy, with improvements following treatment. We evaluated whether the Faurot frailty index, a validated claims-based frailty measure, could identify changes in frailty during chemotherapy treatment and identified predictors of trajectory patterns. METHODS: We included women (65+ years) with stage I-III breast cancer undergoing adjuvant chemotherapy in the SEER-Medicare database (2003-2019). We estimated the Faurot frailty index (range: 0-1; higher scores indicate greater frailty) at chemotherapy initiation, 4 months postinitiation, and 10 months postinitiation. Changes in frailty were compared to a matched noncancer comparator cohort. We identified patterns of frailty trajectories during the year following chemotherapy initiation using K-means clustering. RESULTS: Twenty-one thousand five hundred and ninety-nine women initiated adjuvant chemotherapy. Mean claims-based frailty increased from 0.037 at initiation to 0.055 4 months postchemotherapy initiation and fell to 0.049 10 months postinitiation. Noncancer comparators experienced a small increase in claims-based frailty over time (0.055-0.062). We identified 6 trajectory patterns: a robust group (78%), 2 resilient groups (16%), and 3 nonresilient groups (6%). Black women and women with claims for home hospital beds, wheelchairs, and Parkinson's disease were more likely to experience nonresilient trajectories. CONCLUSIONS: We observed changes in a claims-based frailty index during chemotherapy that are consistent with prior studies using clinical measures of frailty and identified predictors of nonresilient frailty trajectories. Our study demonstrates the feasibility of using claims-based frailty indices to assess changes in frailty during cancer treatment.

Emotional and functional well-being in long-term breast cancer survivorship.

PURPOSE: Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) survivors. METHODS: The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50 years in age) women so that they each represent approximately 50% of the study population and assessed participants' EWB and FWB with the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline. RESULTS: Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race [OR 1.4 (95% CI 1.2-1.7) and 1.3 (95% CI 1.1-1.6), at 25-months and 84-months respectively], older age [OR 1.4 (95% CI 1.1-1.7) and 1.5 (95% CI 1.2-1.8), respectively], no chemotherapy, and recurrence [OR 2.9 (95% CI 1.8-4.8) and 3.1 (95% CI 2.1-4.6), respectively]. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints [ORs 4.7 (95% CI 2.7-8.0) and 4.3 (95% CI 2.8-6.6), respectively]. CONCLUSIONS: Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.

Performance of a Claims-Based Frailty Proxy Using Varying Frailty Ascertainment Lookback Windows.

BACKGROUND: Frailty is an aging-related syndrome of reduced physiological reserve to maintain homeostasis. The Faurot frailty index has been validated as a Medicare claims-based proxy for predicting frailty using billing information from a user-specified ascertainment window. OBJECTIVES: We assessed the validity of the Faurot frailty index as a predictor of the frailty phenotype and 1-year mortality using varying frailty ascertainment windows. RESEARCH DESIGN: We identified older adults (66+ y) in Round 5 (2015) of the National Health and Aging Trends Study with Medicare claims linkage. Gold standard frailty was assessed using the frailty phenotype. We calculated the Faurot frailty index using 3, 6, 8, and 12 months of claims prior to the survey or all-available lookback. Model performance for each window in predicting the frailty phenotype was assessed by quantifying calibration and discrimination. Predictive performance for 1-year mortality was assessed by estimating risk differences across claims-based frailty strata. RESULTS: Among 4253 older adults, the 6 and 8-month windows had the best frailty phenotype calibration (calibration slopes: 0.88 and 0.87). All-available lookback had the best discrimination (C-statistic=0.780), but poor calibration. Mortality associations were strongest using a 3-month window and monotonically decreased with longer windows. Subgroup analyses revealed worse performance in Black and Hispanic individuals than counterparts. CONCLUSIONS: The optimal ascertainment window for the Faurot frailty index may depend on the clinical context, and researchers should consider tradeoffs between discrimination, calibration, and mortality. Sensitivity analyses using different durations can enhance the robustness of inferences. Research is needed to improve prediction across racial and ethnic groups.

Financial burden among metastatic breast cancer patients: a qualitative inquiry of costs, financial assistance, health insurance, and financial coping behaviors.

PURPOSE: Metastatic breast cancer (MBC) patients often face substantial financial burden due to prolonged and expensive therapy. However, in-depth experiences of financial burden among MBC patients are not well understood. METHODS: Qualitative interviews were conducted to describe the experiences of financial burden for MBC patients, focusing on the drivers of financial burden, their experience using their health insurance, accessing financial assistance, and any resulting cost-coping behaviors. Interviews were transcribed and qualitatively analyzed using a descriptive phenomenological approach to thematic analysis. RESULTS: A total of n = 11 MBC patients or caregiver representatives participated in the study. MBC patients were on average 50.2 years of age (range: 28-65) and 72.7% non-Hispanic White. MBC patients were diagnosed as metastatic an average of 3.1 years (range: 1-9) before participating in the study. Qualitative analysis resulted in four themes including (1) causes of financial burden, (2) financial assistance mechanisms, (3) health insurance and financial burden, and (4) cost-coping behaviors. Both medical and non-medical costs drove financial burden among participants. All participants reported challenges navigating their health insurance and applying for financial assistance. Regardless of gaining access to assistance, financial burden persisted for nearly all patients and resulted in cost-coping behaviors. CONCLUSION: Our findings suggest that current systems for health insurance and financial assistance are complex and difficult to meet patient needs. Even when MBC patients accessed assistance, excess financial burden persisted necessitating use of financial coping-behaviors such as altering medication use, maintaining employment, and taking on debt.

Functional Status Associations With Treatment Receipt and Outcomes Among Older Adults Newly Diagnosed With Multiple Myeloma.

PURPOSE: Multiple myeloma (MM) is a prevalent hematologic malignancy in older adults, who often experience physical disability, increased health care usage, and reduced treatment tolerance. Home health (HH) services are frequently used by this group, but the relationship between disability, HH use, and MM treatment receipt is unclear. This study examines the connections between disability, treatment receipt, and survival outcomes in older adults with newly diagnosed MM using a nationwide data set. METHODS: The SEER-Medicare data set was used to identify adults aged 66 years and older diagnosed with MM from 2010 to 2017, who used HH services the year before diagnosis. Disability was assessed with the Outcome and Assessment Information Set, using a composite score derived from items related to ability to complete activities of daily living. Mortality, therapy receipt, and health care utilization patterns were evaluated. RESULTS: Of 37,280 older adults with MM, 6,850 (18.2%) used HH services before diagnosis. Moderate disability at HH assessment resulted in similar MM-directed therapy receipt as mild disability, with comparable health care usage after diagnosis to severe disability. HH users had a higher comorbidity burden and higher mortality (adjusted risk ratio for 3-year mortality: 1.59 [95% CI, 1.55 to 1.64]). Severe functional disability before diagnosis was strongly related to postdiagnosis mortality. CONCLUSION: Among older adults with MM receiving HH services, disability is a predictor of early mortality. Moderately disabled individuals undergo similar therapy intensity as the mildly disabled but experience increased acute care utilization. Previous HH use could identify patients with MM requiring intensive support during therapy initiation.

Disparities in OncotypeDx Testing and Subsequent Chemotherapy Receipt by Geography and Socioeconomic Status.

BACKGROUND: OncotypeDx is a prognostic and predictive genomic assay used in early-stage hormone receptor-positive, HER2- (HR+/HER2-) breast cancer. It is used to inform adjuvant chemotherapy decisions, but not all eligible women receive testing. We aimed to assess variation in testing by demographics and geography, and to determine whether testing was associated with chemotherapy. METHODS: For 1,615 women in the Carolina Breast Cancer Study with HR+/HER2-, Stage I-II tumors, we estimated prevalence differences (PD) and 95% confidence intervals (CI) for receipt of OncotypeDx genomic testing in association with and sociodemographic characteristics. We assessed associations between testing and chemotherapy receipt overall and by race. Finally, we calculated the proportion of eligible women receiving OncotypeDx by county-level rurality, census tract-level socioeconomic status, and Area Health Education Center regions. RESULTS: 38% (N = 609) of potentially eligible women were tested, with lower testing prevalences in Black (31%; PD, -11%; 95% CI, -16%-6%) and low-income women (24%; PD, -20%; 95% CI, -29% to -11%) relative to non-Black and higher income women. Urban participants were less likely to be tested than rural participants, though this association varied by region. Among women with low genomic risk tumors, tested participants were 29% less likely to receive chemotherapy than untested participants (95% CI, -40% to -17%). Racial differences in chemotherapy were restricted to untested women. CONCLUSIONS: Both individual and area-level socioeconomics predict likelihood of OncotypeDx testing. IMPACT: Variable adoption of OncotypeDx by socioeconomics and across geographic settings may contribute to excess chemotherapy among patients with HR+/HER2- cancers. See related In the Spotlight, p. 635.

Understanding mechanisms of racial disparities in breast cancer: an assessment of screening and regular care in the Carolina Breast Cancer Study.

PURPOSE: Screening history influences stage at detection, but regular preventive care may also influence breast tumor diagnostic characteristics. Few studies have evaluated healthcare utilization (both screening and primary care) in racially diverse screening-eligible populations. METHODS: This analysis included 2,058 women age 45-74 (49% Black) from the Carolina Breast Cancer Study, a population-based cohort of women diagnosed with invasive breast cancer between 2008 and 2013. Screening history (threshold 0.5 mammograms per year) and pre-diagnostic healthcare utilization (i.e. regular care, based on responses to "During the past ten years, who did you usually see when you were sick or needed advice about your health?") were assessed as binary exposures. The relationship between healthcare utilization and tumor characteristics were evaluated overall and race-stratified. RESULTS: Among those lacking screening, Black participants had larger tumors (5 + cm) (frequency 19.6% vs 11.5%, relative frequency difference (RFD) = 8.1%, 95% CI 2.8-13.5), but race differences were attenuated among screening-adherent participants (10.2% vs 7.0%, RFD = 3.2%, 0.2-6.2). Similar trends were observed for tumor stage and mode of detection (mammogram vs lump). Among all participants, those lacking both screening and regular care had larger tumors (21% vs 8%, RR = 2.51, 1.76-3.56) and advanced (3B +) stage (19% vs 6%, RR = 3.15, 2.15-4.63) compared to the referent category (screening-adherent and regular care). Under-use of regular care and screening was more prevalent in socioeconomically disadvantaged areas of North Carolina. CONCLUSIONS: Access to regular care is an important safeguard for earlier detection. Our data suggest that health equity interventions should prioritize both primary care and screening.

Simulating the population impact of interventions to reduce racial gaps in breast cancer treatment.

BACKGROUND: Inequities in guideline-concordant treatment receipt contribute to worse survival in Black breast cancer (BCa) patients. Inequity-reduction interventions (eg, navigation, bias training, tracking dashboards) can close such treatment gaps. We simulated the population-level impact of statewide implementation of inequity-reduction interventions on racial BCa inequities in North Carolina. METHODS: Using registry-linked multi-payer claims data, we calculated Black/White inequities in endocrine (ET; n = 12,033) and chemotherapy (CTx; n = 1,819) receipt. We then built cohort- (ET and CTx), and race-stratified Markov models to simulate the potential increase in the proportion of patients receiving ET or CTx and subsequent improvements in BCa outcomes if inequity-reducing intervention were implemented statewide. We report uncertainty bounds representing 95% of simulation results. RESULTS: 75.6% and 72.1% of Black patients received ET and CTx over the 2006-2015 and 2004-2015 periods (vs 79.3 and 78.9% of White patients, respectively). Inequity-reduction interventions could increase ET and CTx receipt among Black patients to 89.9% (85.3, 94.6%) and 85.7% (80.7, 90.9%). Such interventions could also decrease 5-and 10-year BCa mortality gaps from 3.4 to 3.2 (3.0, 3.3) and from 6.7 to 6.1 (5.9, 6.4) percentage points in the ET cohorts and from 8.6 to 8.1 (7.7, 8.4) and from 8.2 to 7.8 (7.3, 8.1) percentage points in the CTx cohorts. CONCLUSIONS: Inequity-focused interventions could improve cancer outcomes for Black patients. However, they would not fully close the racial BCa mortality gap. Addressing other inequities along cancer continuum (eg, screening, pre-and post-diagnosis risk factors) is required to achieve full equity in BCa outcomes.

Patterns of chemotherapy receipt among patients with hormone receptor-positive, HER2-negative breast cancer.

BACKGROUND: Breast cancer chemotherapy utilization not only may differ by race and age, but also varies by genomic risk, tumor characteristics, and patient characteristics. Studies in demographically diverse populations with both clinical and genomic data are necessary to understand potential disparities by race and age. METHODS: In the Carolina Breast Cancer Study Phase 3 (2008-2013), chemotherapy receipt (yes/no) and regimen type were assessed in association with age and race among hormone receptor (HR) positive and HER2-negative tumors (n = 1862). Odds ratios were estimated for the association between demographic factors and chemotherapy receipt. RESULTS: Monotonic decreases in frequency of adjuvant chemotherapy receipt were observed over time during the study period, while neoadjuvant chemotherapy was stable. Younger age was associated with chemotherapy receipt (OR [95% CI]: 2.9 [2.4, 3.6]) and with anthracycline-based regimens (OR [95% CI]: 1.7 [1.3, 2.4]). Participants who had Medicaid (OR [95% CI]: 1.8 [1.3, 2.5]), lived in rural settings (OR [95% CI]: 1.4 [1.0, 2.0]), or were Black (OR [95% CI]: 1.5 [1.2, 1.8]) had slightly higher odds of chemotherapy, but these associations were non-significant with adjustment for stage and grade. Associations between younger age and chemotherapy receipt were strongest among women who did not receive genomic testing. CONCLUSIONS: While race was not strongly associated with chemotherapy receipt, younger age remains a strong predictor of chemotherapy receipt, even with adjustment for clinical factors and among women who receive genomic testing.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

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.

From Race to Racism and Disparities to Equity: An Actionable Biopsychosocial Approach to Breast Cancer Outcomes.

PURPOSE: Racial disparities in outcomes of breast cancer in the United States have widened over more than 3 decades, driven by complex biologic and social factors. In this review, we summarize the biological and social narratives that have shaped breast cancer disparities research across different scientific disciplines in the past, explore the underappreciated but crucial ways in which these 2 strands of the breast cancer story are interwoven, and present 5 key strategies for creating transformative interdisciplinary research to achieve equity in breast cancer treatment and outcomes. DESIGN: We first review the key differences in tumor biology in the United States between patients racialized as Black versus White, including the overrepresentation of triple-negative breast cancer and differences in tumor histologic and molecular features by race for hormone-sensitive disease. We then summarize key social factors at the interpersonal, institutional, and social structural levels that drive inequitable treatment. Next, we explore how biologic and social determinants are interwoven and interactive, including historical and contemporary structural factors that shape the overrepresentation of triple-negative breast cancer among Black Americans, racial differences in tumor microenvironment, and the complex interplay of biologic and social drivers of difference in outcomes of hormone receptor positive disease, including utilization and effectiveness of endocrine therapies and the role of obesity. Finally, we present 5 principles to increase the impact and productivity of breast cancer equity research. RESULTS: We find that social and biologic drivers of breast cancer disparities are often cyclical and are found at all levels of scientific investigation from cells to society. To break the cycle and effect change, we must acknowledge and measure the role of structural racism in breast cancer outcomes; frame biologic, psychosocial, and access factors as interwoven via mechanisms of cumulative stress, inflammation, and immune modulation; take responsibility for the impact of representativeness (or the lack thereof) in genomic and decision modeling on the ability to accurately predict the outcomes of Black patients; create research that incorporates the perspectives of people of color from inception to implementation; and rigorously evaluate innovations in equitable cancer care delivery and health policies. CONCLUSIONS: Innovative, cross-disciplinary research across the biologic and social sciences is crucial to understanding and eliminating disparities in breast cancer outcomes.

Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol.

BACKGROUND: Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women. METHODS: The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months. DISCUSSION: This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods. TRIAL REGISTRATION: Clinicaltrials.gov NCT04379570 . Registered on 7 May 2020.

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.

Multidimensional financial hardship among uninsured and insured young adult patients with metastatic breast cancer.

BACKGROUND: Little is known about the heterogeneous nature of financial hardship in younger patients with metastatic disease and the extent to which insurance protects against it. We examine the association between insurance status and multidimensional indicators of financial hardship in a national sample of women with metastatic breast cancer. METHODS: We conducted a national, retrospective online survey in partnership with the Metastatic Breast Cancer Network. Eligible participants were ≥18 years, diagnosed with metastatic breast cancer, and able to respond in English. We estimated multivariate generalized linear models predicting two distinct dimensions of financial hardship-financial insecurity (the ability to afford care and living costs) and financial distress (the extent of emotional/psychological distress experienced due to costs)-as a function of insurance status. RESULTS: Participants responded from 41 states (N = 1054; median age: 44 years). Overall, 30% were uninsured. Financial insecurity was more frequently reported by uninsured respondents. In adjusted analyses, uninsured participants were more likely than insured participants to report contact by debt collectors (adjusted risk ratio [aRR]: 2.38 [2.06, 2.76]) and being unable to meet monthly expenses (aRR: 2.11 [1.68, 2.66]). Financial distress was reported more frequently by insured participants. For example, insured participants were more likely to worry about future financial problems due to cancer and distress about lack of cost transparency. After adjustment, uninsured participants remained about half as likely as insured participants to report financial distress. CONCLUSIONS: Young adult women with metastatic cancer reported a high burden of financial toxicity. Importantly, insurance does not protect against financial distress; however, the uninsured are the most materially vulnerable.

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients.

BACKGROUND: Oral endocrine therapy (ET) is an inexpensive and effective therapy for hormone receptor-positive (HR+) breast cancer that prevents recurrence but relies upon long-term adherence for up to ten years. More than 80% of breast cancer patients have an HR+ phenotype and are candidates for ET, but approximately half discontinue or become non-adherent by five years. ET underuse is more prevalent in Black and young (<50 yrs) women, which may contribute to outcome disparities in these groups. The objective of this study was to evaluate the feasibility, acceptability, and utility of a patient-centered counseling intervention to enhance ET adherence, with a focus on the needs of Black and younger women. METHODS: We conducted a single-arm pilot study of a twelve-month motivational interviewing (MI) intervention consisting of five MI counseling sessions, an interactive workbook, a resource guide, and an educational video developed and revised with iterative patient and clinician input. The eligible participants were >18 years old, English speaking, and with stage I-III HR+ breast cancer. Participants were recruited across a large academic medical center and four community sites. Feasibility and acceptability were assessed by measures of participant recruitment, retention, session participation, and patient-reported satisfaction. ET adherence at 12 months was assessed by self-report and medication event monitoring system (MEMS) caps using a continuous measure of the proportion of days covered (PDC) as well as a dichotomous measure of the optimal adherence, defined as >80% PDC. RESULTS: Forty-two women initiated the intervention, of whom thirty-five participants (83%) completed outcome assessments at 12 months, including thirteen Black and twenty-two non-Black participants. The average participant age was 54.8 years (range: 25-73). Overall, 97% completed at least three MI sessions and 83% completed at least four sessions. Participant retention and satisfaction were high, particularly among Black women. Self-reported adherence at 12 months was 88% overall (100% in Black women and 81% in non-Black women). The majority of women also achieved 80% of days adherent using MEMS caps, with a greater adherence in Black women. CONCLUSIONS: This study demonstrates the feasibility, acceptability, and early promise of the effectiveness of an MI counseling-based intervention to promote ET adherence and prevent breast cancer recurrence in diverse populations.

Risk Factors for Return to the Emergency Department and Readmission in Patients With Hospital-Diagnosed Advanced Lung Cancer.

BACKGROUND: Advanced lung cancer (ALC) is a symptomatic disease often diagnosed in the context of hospitalization. The index hospitalization may be a window of opportunity to improve care delivery. OBJECTIVES: We examined the patterns of care and risk factors for subsequent acute care utilization among patients with hospital-diagnosed ALC. RESEARCH DESIGN, SUBJECTS, AND MEASURES: In Surveillance, Epidemiology, and End Results-Medicare, we identified patients with incident ALC (stage IIIB-IV small cell or non-small cell) from 2007 to 2013 and an index hospitalization within 7 days of diagnosis. We used a time-to-event model with multivariable regression to identify risk factors for 30-day acute care utilization (emergency department use or readmission). RESULTS: More than half of incident ALC patients were hospitalized around the time of diagnosis. Among 25,627 patients with hospital-diagnosed ALC who survived to discharge, only 37% ever received systemic cancer treatment. Within 6 months, 53% had been readmitted, 50% had enrolled in hospice, and 70% had died. The 30-day acute care utilization was 38%.Small cell histology, greater comorbidity, precancer acute care use, length of index stay >8 days, and prescription of a wheelchair were associated with higher risk of 30-day acute care utilization. Age >85 years, female sex, residence in South or West regions, palliative care consultation, and discharge to hospice or a facility were associated with lower risk. CONCLUSIONS: Many patients with hospital-diagnosed ALC experience an early return to the hospital and most die within 6 months. These patients may benefit from increased access to palliative and other supportive care during index hospitalization to prevent subsequent health care utilization.

A phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects.

BACKGROUND: Cognitive difficulties have been described after chemotherapy for breast cancer, but there is no standard of care to improve cognitive outcomes in these patients. This trial examined the feasibility, tolerability, acceptability, and preliminary effects of memantine to prevent cognitive decline during chemotherapy for breast cancer. METHODS: Patients with stage I-III breast cancer, scheduled for neo/adjuvant chemotherapy, completed a cognitive battery prior to and 4 weeks after completing chemotherapy. Memantine (10 mg BID) was administered concurrent with chemotherapy. Our primary cognitive outcome was visual working memory assessed by the Delayed Matching to Sample test. We used the Brief Medication Questionnaire to assess acceptability. RESULTS: Of 126 patients approached, 56 (44%) enrolled. Forty-five (80%) received ≥1 dose of memantine and completed pre-post assessments. Seventy-six percent reported taking ≥90% of scheduled doses. Participants were mean age of 56, 77% White, and 57% had stage I disease. Sixty-four percent had stable or improved Delayed Matching to Sample test scores. Stable or improved cognition was observed in 87%-91% across objective cognitive domain composite measures. Sixty-six percent self-reported stable or improved cognitive symptoms. There were seven greater than or equal to grade 3 adverse events; two were possibly related to memantine. Only 5% reported that taking memantine was a disruption to their lives. CONCLUSIONS: Memantine was well-tolerated and consistently taken by a large majority of patients receiving breast cancer chemotherapy. The majority demonstrated stable or improved cognition from pre- to post-assessment. Randomized trials are needed to determine memantine's efficacy to ameliorate cognitive loss. TRIAL REGISTRATION: ClinicalTrials.gov NCT04033419.

Race, geography, and risk of breast cancer treatment delays: A population-based study 2004-2015.

BACKGROUND: Treatment delays affect breast cancer survival and constitute poor-quality care. Black patients experience more treatment delay, but the relationship of geography to these disparities is poorly understood. METHODS: We studied a population-based, retrospective, observational cohort of patients with breast cancer in North Carolina between 2004 and 2017 from the Cancer Information and Population Health Resource, which links cancer registry and sociodemographic data to multipayer insurance claims. We included patients >18 years with Stage I-III breast cancer who received surgery or chemotherapy as their first treatment. Delay was defined as >60 days from diagnosis to first treatment. Counties were aggregated into nine Area Health Education Center regions. Race was dichotomized as Black versus non-Black. RESULTS: Among 32,626 patients, 6190 (19.0%) were Black. Black patients were more likely to experience treatment delay >60 days (15.0% of Black vs. 8.0% of non-Black). Using race-stratified modified Poisson regression, age-adjusted relative risk of delay in the highest risk region was approximately twice that in the lowest risk region among Black (relative risk, 2.1; 95% CI, 1.6-2.6) and non-Black patients (relative risk, 1.9; 95% CI, 1.5-2.3). Adjustment for clinical and sociodemographic features only slightly attenuated interregion differences. The magnitude of the racial gap in treatment delay varied by region, from 0.0% to 9.4%. CONCLUSIONS: Geographic region was significantly associated with risk of treatment delays for both Black and non-Black patients. The magnitude of racial disparities in treatment delay varied markedly between regions. Future studies should consider both high-risk geographic regions and high-risk patient groups for intervention to prevent delays.

Cost-Effectiveness of Pharmacologic Treatment Options for Women With Endocrine-Refractory or Triple-Negative Metastatic Breast Cancer.

PURPOSE: Treatments for endocrine-refractory or triple-negative metastatic breast cancer (mBC) are modestly effective at prolonging life and improving quality of life but can be extremely expensive. Given these tradeoffs in quality of life and cost, the optimal choice of treatment sequencing is unclear. Cost-effectiveness analysis can explicitly quantify such tradeoffs, enabling more informed decision making. Our objective was to estimate the societal cost-effectiveness of different therapeutic alternatives in the first- to third-line sequences of single-agent chemotherapy regimens among patients with endocrine-refractory or triple-negative mBC. METHODS: Using three dynamic microsimulation models of 10,000 patients each, three cohorts were simulated, based upon prior chemotherapy exposure: (1) unexposed to either taxane or anthracycline, (2) taxane- and anthracycline-exposed, and (3) taxane-exposed/anthracycline-naive. We focused on the following single-agent chemotherapy regimens as reasonable and commonly used options in the first three lines of therapy for each cohort, based upon feedback from oncologists treating endocrine-refractory or triple-negative mBC: (1) for taxane- and anthracycline-unexposed patients, paclitaxel, capecitabine (CAPE), or pegylated liposomal doxorubicin; (2) for taxane- and anthracycline-exposed patients, Eribulin, CAPE, or carboplatin; and (3) for taxane-exposed/anthracycline-naive patients, pegylated liposomal doxorubicin, CAPE, or Eribulin. RESULTS: In each cohort, accumulated quality-adjusted life-years were similar between regimens, but total societal costs varied considerably. Sequences beginning first-line treatment with paclitaxel, carboplatin, and CAPE, respectively, for cohorts 1, 2, and 3, had lower costs and similar or slightly better outcomes compared with alternative options. CONCLUSION: In this setting where multiple single-agent chemotherapy options are recommended by clinical guidelines and share similar survival and adverse event trajectories, treatment sequencing approaches that minimize costs early may improve the value of care.