Home Time Among Older Adults With Acute Myeloid Leukemia Following Chemotherapy.

Importance: Patients with acute myeloid leukemia (AML) recognize days spent at home (home time) vs in a hospital or nursing facility as an important factor in treatment decision making. No study has adequately described home time among older adults with AML. Objective: To describe home time among older adults with AML (aged ≥66 years) and compare home time between 2 common treatments: anthracycline-based chemotherapy and hypomethylating agents (HMAs). Design, Setting, and Participants: A cohort of adults aged 66 years or older with a new diagnosis of AML from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database in 2004 to 2016 was identified. Individuals were stratified into anthracycline-based therapy, HMAs, or chemotherapy, not otherwise specified (NOS) using claims. Main Outcomes and Measures: The primary outcome was home time, quantified by subtracting the total number of person-days spent in hospitals and nursing facilities from the number of person-days survived and dividing by total person-days. A weighted multinomial regression model with stabilized inverse probability of treatment weighting to estimate adjusted home time was used. Results: The cohort included 7946 patients with AML: 2824 (35.5%) received anthracyclines, 2542 (32.0%) HMAs, and 2580 (32.5%) were classified as chemotherapy, NOS. Median (IQR) survival was 11.0 (5.0-27.0) months for those receiving anthracyclines and 8.0 (3.0-17.0) months for those receiving HMAs. Adjusted home time for all patients in the first year was 52.4%. Home time was highest among patients receiving HMAs (60.8%) followed by those receiving anthracyclines (51.9%). Despite having a shorter median survival, patients receiving HMAs had more total days at home and 33 more days at home in the first year on average than patients receiving anthracyclines (222 vs 189). Conclusions and Relevance: This retrospective study of older adults with AML using SEER-Medicare data and propensity score weighting suggests that the additional survival afforded by receiving anthracycline-based therapy was entirely offset by admission to the hospital or to nursing facilities.

Sticking to the script: Breast cancer patients' decision making regarding oral endocrine therapy.

OBJECTIVES: We sought to understand why some women with early-stage breast cancer decide to forgo or discontinue endocrine therapy (ET), and to identify factors that might lead to greater acceptance of, and long-term adherence to, this treatment. METHODS: We conducted in-depth interviews with N = 53 stage I-III HR+ women who were either non-initiators of ET, initiators who discontinued or initiators who continued with variable daily patterns of adherence. An inductive content analysis was performed to explore the decision-making process of women prescribed ET. RESULTS: Qualitative analyses revealed 55 themes that drove complex decision making. The initiators generally trusted their physicians and did little research before starting the medication. Non-initiators were more suspicious of the medical system, believing that ET presented more risks than benefits. Most discontinuers stopped ET because of side effects. Both non-initiators and discontinuers indicated that push-back from their physicians could have changed their decision. Stories and social support were important in decision making. CONCLUSIONS: Although ET can significantly reduce the risk of breast cancer recurrence, substantial barriers prevent many women from initiating or continuing it. PRACTICE IMPLICATIONS: Physicians have powerful influence over patients' decisions to initiate ET and can be important levers for motivating patients to persist.

Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT.

PURPOSE: Long-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need. METHODS: In the ATEMPT phase II trial, patients with stage I centrally confirmed HER2-positive breast cancer were randomly assigned 3:1 to adjuvant T-DM1 for 1 year or paclitaxel plus trastuzumab (TH). Coprimary objectives were to compare the incidence of clinically relevant toxicities between arms and to evaluate invasive disease-free survival (iDFS) with T-DM1. Correlative analyses included the HER2DX genomic tool, multiomic evaluations of HER2 heterogeneity, and predictors of thrombocytopenia. RESULTS: After a median follow-up of 5.8 years, 11 iDFS events were observed in the T-DM1 arm, consistent with a 5-year iDFS of 97.0% (95% CI, 95.2 to 98.7). At 5 years, the recurrence-free interval (RFI) was 98.3% (95% CI, 97.0 to 99.7), the overall survival was 97.8% (95% CI, 96.3 to 99.3), and the breast cancer-specific survival was 99.4% (95% CI, 98.6 to 100). Comparable iDFS was observed with T-DM1 irrespective of tumor size, hormone receptor status, centrally determined HER2 immunohistochemical score, and receipt of T-DM1 for more or less than 6 months. Although ATEMPT was not powered for this end point, the 5-year iDFS in the TH arm was 91.1%. Among patients with sufficient tissue for HER2DX testing (n = 187), 5-year outcomes significantly differed according to HER2DX risk score, with better RFI (98.1% v 81.8%, hazard ratio [HR], 0.10, P = .01) and iDFS (96.3% v 81.8%, HR, 0.20, P = .047) among patients with HER2DX low-risk versus high-risk tumors, respectively. CONCLUSION: Adjuvant T-DM1 for 1 year leads to outstanding long-term outcomes for patients with stage I HER2-positive breast cancer. A high HER2DX risk score predicted a higher risk of recurrence in ATEMPT.

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.

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.

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.

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 patients with breast cancer. 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 breast cancer inequities in North Carolina. METHODS: Using registry-linked multipayer claims data, we calculated inequities between Black and White patients receiving endocrine therapy (n = 12 033) and chemotherapy (n = 1819). We then built cohort-stratified (endocrine therapy and chemotherapy) and race-stratified Markov models to simulate the potential increase in the proportion of patients receiving endocrine therapy or chemotherapy and subsequent improvements in breast cancer outcomes if inequity-reducing intervention were implemented statewide. We report uncertainty bounds representing 95% of simulation results. RESULTS: In total, 75.6% and 72.1% of Black patients received endocrine therapy and chemotherapy, respectively, over the 2006-2015 and 2004-2015 periods (vs 79.3% and 78.9% of White patients, respectively). Inequity-reduction interventions could increase endocrine therapy and chemotherapy receipt among Black patients to 89.9% (85.3%, 94.6%) and 85.7% (80.7%, 90.9%). Such interventions could also decrease 5-year and 10-year breast cancer 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 endocrine therapy 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 chemotherapy cohorts. CONCLUSIONS: Inequity-focused interventions could improve cancer outcomes for Black patients, but they would not fully close the racial breast cancer mortality gap. Addressing other inequities along the cancer continuum (eg, screening, pre- and postdiagnosis risk factors) is required to achieve full equity in breast cancer outcomes.

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.

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.

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.

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.

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.

Physical activity regulates the immune response to breast cancer by a hematopoietic stem cell-autonomous mechanism.

Physical activity is a modifiable lifestyle factor that is associated with a decreased risk for the development of breast cancer. While the exact mechanisms for the reduction in cancer risk due to physical activity are largely unknown, it is postulated that the biological reduction in cancer risk is driven by improvements in inflammation and immune function with exercise. Hematopoietic stem cells (HSCs) are the progenitor for all of the cells of the immune system and are involved in cancer immunosurveillance through differentiation into cytotoxic cell population. In this study, we investigate the role of physical activity (PA) in a spontaneously occurring model of breast cancer over time, with a focus on tumor incidence, circulating and tumor-infiltrating immune cells as well gene expression profiles of tumors and hematopoietic stem cells. Furthermore, we show that, in addition to a direct effect of PA on the immune cells of tumor-bearing mice, PA reduces the oxidative stress in HSCs of wildtype and tumor-bearing mice, and by doing so, alters the differentiation of the HSCs towards T cells in order to enhance cancer immunosurveillance.

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.

"It was Just Good to Have an Outlet for Other Parents to Talk to": Feasibility and Acceptability of Integrating Mental Health and Wellness Services into Predominantly Black Early Childhood Education Centers During the COVID-19 Pandemic.

Racial disparities in mental health care access and quality are associated with higher levels of unmet need for Black parents and families, a population disproportionately affected by the COVID-19 pandemic. Integrating services within early childhood education centers may increase mental health care access for Black families with young children. The current study examined the feasibility, acceptability, and perceived impact of an integrated program offering mental health care for parents, children, and dyads during the pandemic. Black parents (N = 61) completed measures of program satisfaction and perceived benefits of participation, and 47 parents also participated in focus groups further assessing perceptions of the program. Results demonstrated high levels of satisfaction and perceived benefit of the program for parents and children. Themes generated through analysis included: social support, creating a safe space, prioritizing self-care, and sharing parenting strategies. Parents' feedback provides preliminary feasibility and acceptability for the integrated mental health program.

Leveraging the Expertise of the Community: A Case for Expansion of a Peer Workforce in Child, Adolescent, and Family Mental Health.

The rise in child and adolescent mental health concerns has led to the need for an expanded workforce to meet the needs of our nation's families. Peer paraprofessionals (PPs) have proven to be impactful in the areas of adult mental health (MH) and substance use disorders, and for persons with chronic medical conditions. PPs can contribute to addressing child, adolescent, and family MH needs by being deployed in community settings and providing both emotional and tangible support to families and children. Additional use of PPs can address equity gaps in MH services by improving access to support and enhancing the cultural acceptability of MH interventions. A concentrated effort to expand and develop this workforce may help to alleviate the strain on the current MH system. The Georgetown University Infant and Early Childhood Certificate program is a paraprofessional training program that prepares community members to meet the MH needs of families with young children. The authors will describe the results of a qualitative study examining the landscape of peer paraprofessional services in DC that was conducted to support the expansion of the peer workforce to include individuals with expertise in infant and early childhood mental health.