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PURPOSE: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could affect accrual to optimization clinical trials and the generalizability of future findings. METHODS: We conducted a qualitative study with semistructured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders used a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists highlighted specific reasons to consider optimization trials. These included quality-of-life improvement by reducing toxicity, reduction in financial toxicity, fertility preservation, ability to avoid chemotherapy, minimization of overtreatment in patients with comorbid conditions, personalized treatment, opportunities to test novel therapies, and leveraging the availability of targeted therapies. Oncologists also identified accrual barriers, such as tumor-specific biology, individual (host) factors, prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support enrollment in optimization trials. CONCLUSION: Although oncologists are generally willing to enroll patients on optimization clinical trials, barriers affect their acceptance. A scientific focus on overcoming these barriers is needed to support future enrollment on trials tailoring therapy on the basis of risk and potential benefit to allow true personalization of treatment.

New developments in cancer research provide opportunities to reduce the amount or intensity of chemotherapy for patients with early-stage breast cancer (EBC), with the goal of achieving recurrence-free survival rates equivalent to the current standard of care while reducing the short- and long-term toxicities that are associated with more aggressive chemotherapy regimens. Clinical trials are necessary to determine the lowest effective dosage of chemotherapy, and there is interest from patients and providers to enroll eligible patients in these trials. Currently, the word being used to describe these trials is ‘de-escalation’. This paper considers the reactions of EBC patients and patient advocates to the word ‘de-escalation’ and how best to describe this approach and its anticipated benefits. Based on a patient survey and on interviews that were coded with the assistance of a content analysis program, we found that the participants tended to react negatively to ‘de-escalation’, with many associating this word with giving up in the war against cancer. Instead, the participants prefer positive, patient-centered language. This information will be useful to providers in considering how best to describe de-escalation clinical trials to eligible patients in ways that avoid therapeutic misconception and facilitate the shared decision-making process regarding treatment.

While vaccine hesitancy has been described for the general population, vaccine hesitancy among the chronically ill has not been well explored. This study assesses COVID‑19 vaccine hesitancy and uptake among individuals with chronic illness using nationwide survey data. We analyzed vaccine hesitancy prior to and after approval of the vaccines using multinomial logistic regression and binomial logistic regression, respectively. In the first survey, 39% reported they were unlikely or unsure about receiving the vaccine. In adjusted analyses, female sex, Black race, anti‑vaccination attitudes, media mistrust, and not following the media were associated with vaccine hesitancy. Despite this hesitance, in the follow‑up survey, 89% reported vaccine receipt, with those more fearful of COVID‑19, with more trust in the media, and closely following the development of the vaccine were most likely to move from hesitance to acceptance. Vaccine hesitancy is a mutable characteristic, underscoring the need for high-quality public health messaging.

Introduction: Given excellent survival outcomes in breast cancer and new methods to predict treatment response, oncologists are interested in de-escalating the amount of chemotherapy delivered to patients. This is particularly important in the setting of COVID-19, where patient perspectives of de-escalation may be altered by perception of COVID-19 risk.Methods: This concurrent mixed methods study included (1) semi-structured interview data from patients with breast cancer treated at the University of Alabama at Birmingham and patient advocates from nationally representative advocacy organizations (10/2019-5/2020) and (2) cross-sectional survey data from a nationwide sample of women with breast cancer (11/19-12/2019). Questions evaluated interest in de-escalation study participation, perceived barriers/facilitators to participation, and language describing de-escalation. Participant perspectives surrounding COVID-19 impact on de-escalation were elicited in interviews post 3/2020.Results: Quantitative and qualitative findings were synergistic. Interviews were conducted with 40 female participants (24 patients, 16 patient advocates). Participant ages ranged from 33-79 years old; 30% were minorities; 35% didn’t have a college degree. Common barriers to acceptance of de-escalation included fear of recurrence, worry about decision regret, lack of clinical trial interest, and dislike for the focus on less treatment. Fear of recurrence was the most commonly expressed barrier, with one participant stating, “I’m just afraid it wouldn’t get it all”. Common facilitators included trust in the physician, toxicity avoidance, monitoring with the option of increasing treatment intensity, perception of good prognosis, and impact on daily life. Participants interviewed during the COVID-19 pandemic (n=16) expressed substantial virus-related fear, including fear of exposure, fear of infecting their personal contacts or health care team, fear of cancer-related complications, and fear about their immunocompromised state. These fears contributed to participants perspective on de-escalation, as highlighted by participants stating, “I wouldn't worry about getting the chemo as much as I would worry about getting the virus” and “Less is more for me right now”.Of 91 survey respondents (69% response rate), median age was 58 years (interquartile range [IQR] 48-69), 86% had early stage breast cancer. Many (43%) patients were not interested in participation in a study testing lower doses of chemotherapy than standard of care. Patients not interested in participating were more often unmarried (55% vs. 32%, V=.23), disabled (56% vs. 40%, V=.17), or diagnosed with early stage cancer (45% vs. 22%, V=.14). Barriers to participation included fear of cancer recurrence (85%) and regret about the decision to receive less chemotherapy if the cancer were to recur (79%). Few patients (19%) considered clinical trials themselves as a barrier. Patients were interested in participation due to lessened physical side effects of treatment (82%), lessened long-term problems related to treatment (76%), and lessened impact on daily life (72%). The most popular terminology describing chemotherapy de-escalation was “lowest effective chemotherapy dose” (53%); no patients preferred the term “de-escalation.” Conclusion: Fear of recurrence is a common barrier to de-escalation clinical trial participation in patients with breast cancer. Fears may be altered for patients considering treatment during the COVID-19 pandemic. Trust in the physician and use of patient-generated language, such as “customized” instead of “de-escalation”, are potential areas for future interventions engaging patients in trials. Citation Format: Gabrielle Rocque, Courtney P. Williams, Courtney J. Andrews, Kathleen Gallagher, Timothy C. Childers, Kimberly D. Wiseman, Alan Balch, Stacey A. Ingram, Thelma Brown, Tara Kaufman, Nadine Tung, Mary Lou Smith, Antonio C. Wolff, Angela DeMichele, Lynn Wagner. Patient perspectives on chemotherapy de-escalation: “Don’t de-escalate! I don’t want to die!” [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD3-10.

Mexican immigrant women come to the United States in pursuit of what they call la buena vida (the good life) for themselves and for their children. The research described here attempts to better un...

Mexican-born women in the U.S. are at high risk of depression. While acculturation is the primary analytical framework used to study immigrant mental health, this research suffers from (1) a lack of specificity regarding how cultural models of living and being take shape among migrants converging in new destinations in the U.S., and (2) methods to empirically capture the impact of cultural positioning on individual health outcomes. Instead of relying on proxy measures of age at arrival and time in the U.S. to indicate where an individual is located on the acculturation spectrum, this study uses cultural consensus analysis to derive the substance and structure of a cultural model for la buena vida (the good life) among Mexican immigrant women in Birmingham, Alabama, and then assesses the extent to which respondents are aligned with the model in their everyday lives. This measure of ‘cultural consonance’ is explored as a moderating variable between age at arrival in the U.S. and number of depressive symptoms. Results demonstrate that for those who arrived at an older age, those with lower consonance are at the highest risk for depression, while those who are more aligned with la buena vida are at lower risk.

Background Historically, clinical trials involved adding novel agents to standard of care to improve survival. There has been a shift to an individualized approach with testing less intense treatment, particularly in breast cancer where risk of recurrence is low. Little is known about physician perspectives on delivering less intense treatment for patients who are not well represented in clinical trials. Methods Open-ended, individual qualitative interviews with medical oncologists explored their perspectives on trials that test less intense treatment for patients with cancer, with a focus on breast cancer. Interviews were audio-recorded and transcribed. Four independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. Results Of the 39 participating physicians, 61.5% felt comfortable extrapolating, 30.8% were hesitant, and 7.7% would not feel comfortable extrapolating trial outcomes to underrepresented populations. Facilitators of comfort included the sentiment that “biology is biology” (such that the cancer characteristics were what mattered), the strength of the evidence, inclusion of subset analysis on underrepresented populations, and prior experience making decisions with limited data. Barriers to extrapolation included potential harm over the patient’s lifetime, concerns about groups that had minimal participants, application to younger patients, and extending findings to diverse populations. Universally, broader inclusion in trials testing lowering chemotherapy was desired. Conclusions The majority (92%) of physicians reported that they would de-implement treatment for patients poorly represented in clinical trials testing less treatment, while expressing concerns about applicability to specific subpopulations. Further work is needed to increase clinical trial representation of diverse populations to safely and effectively optimize treatment for patients with cancer. Trial registration NCT03248258

To identify factors associated with reproductive decision-making for women living with HIV in Western Jamaica, to assess their confidence in anti-retroviral therapy to reduce the chances of mother to child transmission of HIV, and to better understand the experience of stigmatization surrounding becoming pregnant after HIV diagnosis.Two focus groups were conducted among women living with HIV in the four parishes of Western Jamaica in 2011. A trained moderator conducted the focus groups along with two student notetakers. Qualitative coding and content analysis were used to identify common themes and exemplary quotations characterizing those themes.Participants agree that adherence to antiretroviral therapy as prescribed by a physician facilitates better health and longevity; however, they were conflicted on the efficacy of the therapy to prevent mother to child transmission of the virus. Participants report that becoming pregnant after HIV diagnosis continues to be highly stigmatized. Among participants, fear of MTCT and concern that their children will be mistreated are the primary drivers of reproductive decision-making.Despite advances in HIV treatment and assisted technologies to prevent MTCT, participants show skepticism that ARV medication is effective at preventing MTCT. Stigma and discriminatory behavior by community members and health-care professionals continue to shape reproductive decision-making for the women who participated in this study. More informed counseling that includes education on recent advancements in HIV treatment and its efficacy at preventing MTCT should be more widely available to pregnant women. To reduce stigma and discriminatory behavior, this education should extend to the larger community.

Protecting the sanctity of human life is an important issue for Alabamians. After signing the Alabama Human Life Protection Act (HB 314)1 on May 16, 2019, Governor Kay Ivey called the bill “a power...

Mexican immigrants in the U.S. show high incidence of type 2 diabetes, and increased risk is associated with longer duration of residency. This study considers the impact of culture over time for Mexican immigrant women in a southern U.S. city. Using cultural consensus analysis to empirically derive the substance and structure of a cultural model for

Background As the combination of systemic and targeted chemotherapies is associated with severe adverse side effects and long-term health complications, there is interest in reducing treatment intensity for patients with early stage breast cancer (EBC). Clinical trials are needed to determine if it is feasible to reduce treatment intensity while maintaining 3-year recurrence-free survival of greater than 92%. In order to recruit patients for de-implementation trials, it is important to understand patient perspectives on barriers and facilitators to reducing treatment intensity. Methods We collected qualitative interview data from patients with Stage II-III breast cancer (N=24) and patient advocates (N=16). Interviews explored interest in de-implementation trial participation and identified potential barriers and facilitators to participation. 17 participants were asked about the potential impact of COVID-19 on de-implementation efforts. Interviews were audio-recorded and transcribed, and researchers used qualitative content analysis (NVIVO and Atlas.ti) to code for dominant themes. Results 17 participants (42.5%) expressed interest in participating in a trial of reduced chemotherapy. Barriers to reducing chemotherapy included (1) fear of recurrence and inefficacy, (2) preference for aggressive treatment, (3) disinterest in clinical trials, (4) lack of information about expected outcomes, (5) fear of regret, and (6) having young children. Facilitators included (1) avoiding physical toxicity, (2) understanding the scientific rationale of reducing chemotherapy, (3) confidence in providers, (4) consistent monitoring and the option to increase dosage, (5) fewer financial and logistical challenges, and (6) contributing to scientific knowledge. Of those asked, nearly all participants said they would be more motivated to reduce treatment intensity in the context of Covid-19, primarily in order to avoid exposure to the virus while receiving treatment. Conclusions We recommend framing de-implementation strategies and recruitment to trials in terms of customizing treatment to the individual patient and added benefit—reduced toxicities, higher quality of life during treatment and lower risk of long-term complications—rather than in terms of taking treatments away or doing less than the standard of care. Doctor-patient rapport and provider support will be crucial in this process.

This study presents qualitative results from a mixed-method investigation conducted between May and August 2012 into the prevalence and consequences of four forms of intimate partner violence among women living with HIV who attended the Comprehensive Care Clinic at the Kenyatta National Hospital in Nairobi. As a part of the research, a quantitative survey found that among 600 sexually active women living with HIV aged 18–69, all reported experiencing emotional abuse; 20%, 17%, and 15% experienced controlling behavior, physical violence, and sexual violence, respectively. Qualitative research using focus group discussions with 19 women from the quantitative survey sought to contextualize these experiences and place them within a larger social structure where institutionalized gender inequality sets the tone for intimate partner violence against women in households. Participants reported that intimate partner violence led to their exposure to the virus and made them leery of disclosing their positive status or seeking support from a male partner for fear of a violent reaction. This fear and the socio-structural conditions in Kenya limit their ability to actively pursue comprehensive care, the stress of which can exacerbate symptoms and make managing the disease more difficult.

148 Background: The World Health Organization cited vaccine hesitancy as one of 2019’s top ten threats to global health, a threat that has been further exacerbated by COVID-19 pandemic. Existing COVID-19 vaccine hesitancy research focuses on the general population, but less is known about the specific concerns of medically vulnerable populations, including individuals with cancer. Methods: This cross-sectional analysis used data that assessed likelihood of COVID-19 vaccination (likely vs unlikely/unsure) among past or current patients with cancer from a nationwide survey administered in December 2020 by the Patient Advocate Foundation (PAF), a non-profit organization that provides case management and financial aid to patients diagnosed with a chronic illness. Inclusion criteria included previous or current cancer treatment, aged ≥ 19, and a valid e-mail address. Age, sex, race/ethnicity, and urban/rural residence were abstracted from the PAF database. Respondents self-reported education level, employment status, trust in media regarding COVID-19 pandemic, and media viewership on COVID-19 vaccine development. The Group-Based Medical Mistrust Scale assessed respondents’ level of mistrust in medical providers based on ethnicity. Likelihood of COVID-19 vaccine acceptance was evaluated using risk ratios (RR) and 95% confidence intervals (CI) from modified Poisson regression models with robust error variance. All variables were included in our model. Results: Of 429 respondents, 48% were unlikely/unsure about accepting the COVID-19 vaccine, primarily due to concerns about vaccine safety (32%) and worry about health conditions (12%). When compared to those likely to accept COVID-19 vaccine, respondents who were unlikely/unsure were more often Black, Indigenous, or People of Color (40% vs. 23%), aged 36-55 (40% vs. 29%), and female (80% vs. 65%). In adjusted analysis, Black respondents were 55% less likely to accept a COVID-19 vaccine, when compared to White respondents (RR 0.55; 95% CI 0.4-0.8). When compared to those who did not follow the media regarding COVID-19 vaccine development, those who followed the media very closely were 4.5 times more likely to accept a COVID-19 vaccine (RR 4.5; 95% CI 1.6-13.2). Respondents who reported below average trust in the media were 60% less likely to accept a COVID-19 vaccine (RR 0.6; 95% CI 0.5-0.8), compared to those who reported above average trust in the media. Conclusions: Despite being at high risk of COVID-19 morbidity and mortality, a substantial proportion of under-resourced individuals with cancer were unlikely/unsure about vaccination, exposing a significant disconnect between risk of severe disease and vaccine acceptance. Our analysis also reveals a need to assess for and debunk misinformation to increase vaccine enthusiasm among medically vulnerable populations.

Introduction: A growing trend in cancer research is the study of de-escalation of treatment, particularly chemotherapy. The hope is that eliminating or reducing drug(s) from treatment regimens will reduce toxicity burden and increase quality of life without increasing risk of recurrence and death. Large well-designed clinical trials are needed to ensure this hope is a reality. One such trial is EA1181 CompassHER2 pCR, which has an accrual goal of 1,250 patients. Methods: This qualitative study included: (A) 2 focus groups with patients diagnosed with HER2+ breast cancer 3-5 years ago, for their ability to draw on their experience and react to the trial and (B) 3 focus groups with consumers who have never had a cancer diagnosis, for their ability to provide the “cancer-naïve” perspective that may more closely match that of newly diagnosed patients (the EA1181 population). One of the consumer groups was composed of Black women and moderated by a Black facilitator to allow issues to surface that may be specific to this group. Patients were identified via Living Beyond Breast Cancer; consumers were identified via a nationwide market research panel. Groups took place online in April and May 2020, after the COVID pandemic had begun. After a brief introduction to the trial, questions focused on: Reactions and questions, motivations, concerns, and descriptive language. Results: A total of 30 women (11 patients and 19 consumers) participated, representing a mix of age groups, educational attainment, and racial and ethnic social identities. The trial description raised many questions in participants’ minds. Some of the more frequent responses from both patients and consumers related to the rationale for reducing treatment and the side effects and benefits of each drug. Consumers demonstrated confusion between what is to be tested in the trial versus what is part of the neoadjuvant process. Patients questioned the timeline and length of each step. Motivations for participation centered on avoiding some chemotherapy and the associated side effects, costs, and recovery time. Some discussed taking only what is needed. Concerns were significant and centered on: (A) Fear and the feeling that it is best to take everything, (B) Possible lengthened duration of treatment since chemotherapy may be needed after surgery (versus the certainly of having all chemo prior to surgery). The duration issue generated strongly negative reactions among patients who felt they would prefer chemo and its side effects all at once. Some motivations and barriers also seemed tied to the likelihood of not needing post-surgical chemo, with participants expecting thresholds (unaided) of 50% to 80% of the perceived desirable outcome. Language around the concept is a critical issue. Participants expressed many ideas related to possible milder treatment that is modified. The word, de-escalation, garnered very negative reactions including many comparisons to military action. Toxicity is also a term that was less familiar to consumers and disliked by many as it elicits additional fear; “side effects” seems more familiar and palatable. Conclusion: Communication about trials with reduced chemotherapy will need to be effective to lead to successful accrual. Providing tools to oncologists and patients to enhance two-way communication may be necessary to ensure concepts are understood. Since de-escalation is already becoming a term commonly used by researchers, replacing it with a more effective descriptor that is clear and connects to the benefits appears time-critical. Quantifying reactions to language options and other qualitative findings via a survey with a larger sample of consumers and patients is advised. Including patient voices in trial design, as well as consumers particularly for trials for the newly-diagnosed, sheds light on communication needs. Citation Format: Mary L Smith, Elda Railey, Carol B White, Janine Hill, Courtney J Andrews, Gabrielle B Rocque. Consumer and patient reactions to trials of chemotherapy reductions reveal an urgent need to name and explain the concept [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-01.

We describe a case study involving obesity, health, and body image on the small island of Nayau, in the Lau Group, Fiji. Nayau is a remote island of Fiji where traditional subsistence activ...

Context: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) created the Medicare Advantage (MA) program, which promotes the entry of private Preferred Provider Organization (PPO) plans into regions that have not previously had Medicare managed care plans. The assumption that a competitive environment will develop is based on experiences in the Federal Employees Health Benefits Program (FEHBP). Purpose: The authors test the hypothesis that the FEHBP has fostered an environment of competing health plans, especially preferred provider organizations (PPOs), in rural areas. Methods: Data from the US Office of Personnel Management are used to quantify the number of FEHBP-certified plans in each US county and the number of enrollees in each plan. Data from the Area Resource File are used to measure independent variables in multivariate analysis to account for the number of FEHBP-certified health plans competing in each US county. Findings: While 98% of all counties have at least 3 plans with enrollment, in many sparsely populated rural areas, only 1 of the plans is an open-enrollment plan (excludes plans for letter carriers). There is a strong relationship between the number of FEHBP plans and areas with high population counts and high population density. In many counties with low population counts (under 3,000), most PPOs are not contracting with the nearest primary care provider. Conclusions: The FEHBP is not a perfect predictor of MA plan activity because the MA program does not use the FEHBP approach of certifying regional plans that must offer local access. However, the FEHBP experience indicates that plans are attracted to areas with high population counts and high population density.

Polyurethane shape memory polymers (PU-SMPs) are active materials that can be transformed into complex shapes with the ability to recover their original shape even after undergoing large deformations. Because of their light weight, large recoverability, low cost, and high compliance, SMPs can be potentially employed as actuators, MEMS devices, temperature sensors, and damping elements to name a few. One of the key challenges in implementing SMPs is the response time which is limited by the method of heating and cooling and the material. Unlike shape memory alloys, SMPs can be activated by multiple stimuli including lasers, resistive heating, electric fields, and magnetic fields. While these methods may provide an efficient way of heating the SMP, they rely on the slow process of passive conduction for cooling. In this paper, a self regulating SMP (SR-SMP) composite is introduced, whereby a novel heating and cooling system consisting of embedded silica capillary tubes in the SMP (DiAPLEX® MP4510: SMP Technologies, Inc.) has been developed. The tubes are used to pump hot/cold fluid through the SMP membrane and hence provide a local temperature source. In order to show the effectiveness and efficiency of the mechanism, the thermomechanical response of the SR-SMP is compared experimentally to a SMP with "conventional" i.e. global heating and cooling mechanisms. It is shown that the SR-SMP has a faster thermomechanical response. It has been demonstrated previously that soft SMPs can be controlled by an electric field while in the rubbery phase, thus taking advantage of the Maxwell stress or electrostatic stress effect. Thermomechanical characterization of PU-SMPs is described for different weight percentages of resin (Diphenylmethane-4, 4'-diisocyanate) and hardener (1,4-Butanediol). Varying the percent hardener reduced the effective cross-link density of the polymer and hence the thermomechanical properties. The electromechanical response of pure SMP and SR-SMP is predicted numerically. The numerical computation indicates that the softer SMPs (resin:hardener = 5:4, 8:7, and 9:8) could be used as electroactive polymers.

In what percentage of married couples do wives outearn their husbands, and, moreover, how persistent are these patterns? This study systematically examined variation in point-in-time estimates across alternative measures of earnings, definitions of types of couples, and data sources and gauged the persistence of these patterns for a period of three calendar years using data from the 2000 Current Population Survey and the 1996–2000 Survey of Income and Program Participation. Among the findings are that in 19% to 30% of all married couples, wives have higher earnings than their husbands. In 60% of such couples, this arrangement persists over the three-year period; for the rest, this arrangement is transitory.

Information about patterns of individual health insurance coverage is limited. Knowledge gaps include the extent to which individual insurance provides transitional versus long-term coverage, and participants’ insurance status before and after being covered by an individual plan. In this study we use data from the 1996–2000 Survey of Income and Program Participation (SIPP) to examine how long the individually insured maintain their coverage; sources of coverage before and after enrolling in an individual health plan; and characteristics of those who rely on individual insurance coverage. Understanding the dynamics of this market will better inform federal and state insurance reform efforts.

In places where the competing health plans are unlikely to ever emerge, any policy predicated on assumptions that competing plans will deliver health insurance benefits needs to have a "fallback" option that is guaranteed to work.

This Policy Brief examines the viability of introducing private competition into the Medicare program by studying the availability of Medicare+Choice (M+C), commercial HMO, and Federal Employees Health Benefits Program (FEHBP) plans in rural (nonmetropolitan) counties. The Brief also presents evidence regarding the variables that influence plan availability and impact plan choice across counties in the U.S. The findings in this Brief will be useful to policymakers considering using a competitive model to design a Medicare prescription drug benefit or to redesign the entire Medicare program. As changes in the Medicare program are considered, the information in this Brief will provide background regarding rural participation in earlier Medicare program changes and in other programs said to be models for change.