Evolving Landscape of Ethics in Oncology: A Journey Through the Past, Present, and Future.

Providing a brief overview of past, present, and future ethics issues in oncology, this article begins with historical contexts, including the paternalistic approach to cancer care. It delves into present-day challenges such as navigating cancer treatment during pregnancy and addressing health care disparities faced by LGBTQ+ individuals. It also explores the ethical implications of emerging technologies, notably artificial intelligence and Big Data, in clinical decision making and medical education.

Institution-Wide Retreats Foster Organizational Learning and Action at a Comprehensive Cancer Center.

Providing safe and informed healthcare for sexual and gender minority (SGM) individuals with cancer is stymied by the lack of sexual orientation and gender identity (SOGI) data reliably available in health records and by insufficient training for staff. Approaches that support institutional learning, especially around sensitive topics, are essential for hospitals seeking to improve practices impacting patient safety and research. We engineered annual institutional retreats to identify and unify stakeholders, promote awareness of gaps and needs, identify initiatives, minimize redundant projects, and coordinate efforts that promote improvements in SGM cancer care, education, and research. The 2022 and 2023 retreats employed a 4-h hybrid format allowing virtual and in-person engagement. Retreat organizers facilitated small-group discussions for brainstorming among participants. We performed descriptive statistics from retreat evaluations. The retreats engaged 104 attendees from distinct departments and roles. Participants expressed robust satisfaction, commending the retreat organization and content quality. Notably, the first retreat yielded leadership endorsement and funding for a Quality Improvement pilot to standardize SOGI data collection and clinical staff training. The second retreat provided a platform for updates on focused efforts across the institution and for receiving direction regarding national best practices for SGM care and research. We report the processes and outcomes of institution-wide retreats, which served as a platform for identifying gaps in organizational healthcare practices and research for SGM individuals with cancer. The strategies described herein may be readily scaled at other cancer hospitals seeking to learn and enact system-wide practice changes that support the needs of SGM patients and families.

The Feasibility and Acceptability of a Diabetes Survival Skills Intervention for Persons Transitioning from Prison to the Community.

Community evidenced-based diabetes self-management education (DSME) models have not been examined for feasibility, acceptability, or effectiveness among persons transitioning from prison to the community to independent diabetes self-management (DSM). In a non-equivalent control group design with repeated measures, we examined the feasibility, acceptability, and preliminary effect of a 6-week, 1-h per week Diabetes Survival Skills (DSS) intervention on diabetes knowledge, distress, self-efficacy, and outcome expectancy for transitioning incarcerated males. Of the 92 participants (84% T2D, 83% using insulin, 40% Black, 20% White, 30% Latino, 66% high school or less, mean age 47.3 years, 84% length of incarceration ≤4 years ), 41 completed the study (22 control/19 intervention [TX]). One-way repeated measures ANOVAs revealed significant changes in diabetes knowledge within each group (C, p = .002; TX, p = .027) at all time points; however, a two-way repeated measures ANOVA showed no differences between groups. Additionally, both groups showed improvement in diabetes-related distress and outcome expectancy with the treatment group experiencing greater and sustained improvement at the 12-week time point. Analysis of focus group data (Krippendorf) revealed acceptance of and enthusiasm for the DSS training and low literacy education materials, the need for skill demonstration, and ongoing support throughout incarceration and before release. Our results highlight the complexity of working with incarcerated populations. After most of the sessions, we observed some information sharing between the intervention and the control groups on what they did in their respective sessions. Due to high attrition, the power to detect effects was limited. Yet, results suggest that the intervention is feasible and acceptable with an increased sample size and refined recruitment procedure. NCT05510531, 8/19/2022, retrospectively, registered.

Development, Feasibility, and Acceptability of an Oncologist Group Peer Support Program From ASCO's Clinician Well-Being Task Force.

PURPOSE: The COVID-19 pandemic has had deleterious effects on oncologist professional and personal well-being, the optimal delivery of quality cancer care, and the future cancer care workforce, with many departing the field. Hence, the identification of evidence-based approaches to sustain oncologists is essential to promote well-being. MATERIALS AND METHODS: We developed a brief, oncologist-centered, virtual group peer support program and tested its feasibility, acceptability, and preliminary impact on well-being. Trained facilitators provided support to peers on the basis of burnout research in oncology with available resources to enhance oncologist resilience. Peers completed pre- and postsurvey assessment of well-being and satisfaction. RESULTS: From April to May 2022, 11 of 15 (73%) oncologists participated in its entirety: mean age 51.1 years (range, 33-70), 55% female, 81.8% Ca, 82% medical oncologists, 63.6% trained ≥15 years, average 30.3 patients/wk (range, 5-60), and 90.9% employed in hospital/health system practice. There was a statistically significant difference in pre- and postintervention well-being (7.0 ± 3.6 v 8.2 ± 3.0, P = .03) with high satisfaction with postgroup experience (9.1 ± 2.5). These quantitative improvements were affirmed by qualitative feedback. These themes included (1) an enhanced understanding of burnout in oncology, (2) shared experience in practice of oncology, and (3) fostering connections with diverse colleagues. Future recommendations proposed included (1) restructuring group format and (2) tailoring groups according to practice setting (academic v community). CONCLUSION: Preliminary results suggest that a brief, innovative oncologist-tailored group peer support program is feasible, acceptable, and beneficial for enhancing well-being dimensions including burnout, engagement, and satisfaction. Additional study is required to refine program components (optimal timing, format) to support oncologist well-being, now during the pandemic and well into recovery.

Implementation Strategy Fidelity and Organizational Outcomes in a Randomized Trial: Implications for Reentry from Corrections to Community Treatment.

Background: This study examined fidelity of implementation strategies used in an organizational process improvement intervention (OPII) designed to improve evidence-based practices related to assessments for drug-involved clients exiting incarceration. Leadership was studied as a moderating factor between fidelity and outcomes. Methods: A mixed-method cluster randomized design was used to randomize 21 sites to early- or delayed-start within 9 research centers. Parent study protocol was reviewed to develop fidelity constructs (i.e., responsiveness, dose, quality, adherence). Outcomes were site-level success in achieving goals and objectives completed during the OPII (e.g., percent goals achieved). Correlations, analyses of covariance, regressions and moderation analyses were performed. Qualitative interviews assessed facilitators/barriers to implementation. Results: Fidelity constructs related to outcomes. No differences were found in fidelity by early or delayed condition. At low levels of leadership, high staff responsiveness (i.e., engagement in the OPII) related to poorer outcome. Conclusions: It is important to consider contextual factors (e.g., leadership) that may influence implementation strategy fidelity when deploying evidence-based practices. Findings are relevant to researchers, clinicians, administrators and policy makers, and suggest that goal completion during implementation of evidence-based practices requires monitoring of leadership competence, fidelity to implementation strategies (i.e., staff responsiveness to strategies) and attendance to goal importance.

Becoming Inclusive: Actionable Steps to Diversify the Field of Clinical Ethics.

At the 2022 Clinical Ethics Unconference, the authors perceived a significant lack of racial and ethnic diversity, which was consistent with their experiences in other clinical ethics settings. As a result, they convened a working group to address the pervasive lack of diversity present in the field of clinical ethics and to propose strategies to increase the representation of people from racial and ethnic minority populations. This article identifies the harms associated with the lack of diversity in the healthcare setting and translates these to the field of clinical ethics. The article then proposes a framework that may be used to help diversify the field of clinical ethics. Specifically, the authors identify existing barriers to appropriate diversity, actionable steps to increase diversity, and tools the field can utilize to systematically assess its progress with respect to achieving diversity.

Incarceration status and cancer mortality: A population-based study.

BACKGROUND: The complex relationship between incarceration and cancer survival has not been thoroughly evaluated. We assessed whether cancer diagnosis during incarceration or the immediate post-release period is associated with higher rates of mortality compared with those never incarcerated. METHODS: We conducted a population-based study using a statewide linkage of tumor registry and correctional system movement data for Connecticut adult residents diagnosed with invasive cancer from 2005 through 2016. The independent variable was place of cancer diagnosis: during incarceration, within 12 months post-release, and never incarcerated. The dependent variables were five-year cancer-related and overall survival rates. RESULTS: Of the 216,540 adults diagnosed with invasive cancer during the study period, 239 (0.11%) people were diagnosed during incarceration, 479 (0.22%) within 12 months following release, and the remaining were never incarcerated. After accounting for demographics and cancer characteristics, including stage of diagnosis, the risk for cancer-related death at five years was significantly higher among those diagnosed while incarcerated (AHR = 1.39, 95% CI = 1.12-1.73) and those recently released (AHR = 1.82, 95% CI = 1.57-2.10) compared to the never-incarcerated group. The risk for all-cause mortality was also higher for those diagnosed with cancer while incarcerated (AHR = 1.92, 95% CI = 1.63-2.26) and those recently released (AHR = 2.18, 95% CI = 1.94-2.45). CONCLUSIONS AND RELEVANCE: There is a higher risk of cancer mortality among individuals diagnosed with cancer during incarceration and in the first-year post-release, which is not fully explained by stage of diagnosis. Cancer prevention and treatment efforts should target people who experience incarceration and identify why incarceration is associated with worse outcomes.

Artificial Intelligence-Augmented Propensity Score, Cost Effectiveness and Computational Ethical Analysis of Cardiac Arrest and Active Cancer with Novel Mortality Predictive Score.

Background and objectives: Little is known about outcome improvements and disparities in cardiac arrest and active cancer. We performed the first known AI and propensity score (PS)-augmented clinical, cost-effectiveness, and computational ethical analysis of cardio-oncology cardiac arrests including left heart catheterization (LHC)-related mortality reduction and related disparities. Materials and methods: A nationally representative cohort analysis was performed for mortality and cost by active cancer using the largest United States all-payer inpatient dataset, the National Inpatient Sample, from 2016 to 2018, using deep learning and machine learning augmented propensity score-adjusted (ML-PS) multivariable regression which informed cost-effectiveness and ethical analyses. The Cardiac Arrest Cardio-Oncology Score (CACOS) was then created for the above population and validated. The results informed the computational ethical analysis to determine ethical and related policy recommendations. Results: Of the 101,521,656 hospitalizations, 6,656,883 (6.56%) suffered cardiac arrest of whom 61,300 (0.92%) had active cancer. Patients with versus without active cancer were significantly less likely to receive an inpatient LHC (7.42% versus 20.79%, p < 0.001). In ML-PS regression in active cancer, post-arrest LHC significantly reduced mortality (OR 0.18, 95%CI 0.14−0.24, p < 0.001) which PS matching confirmed by up to 42.87% (95%CI 35.56−50.18, p < 0.001). The CACOS model included the predictors of no inpatient LHC, PEA initial rhythm, metastatic malignancy, and high-risk malignancy (leukemia, pancreas, liver, biliary, and lung). Cost-benefit analysis indicated 292 racial minorities and $2.16 billion could be saved annually by reducing racial disparities in LHC. Ethical analysis indicated the convergent consensus across diverse belief systems that such disparities should be eliminated to optimize just and equitable outcomes. Conclusions: This AI-guided empirical and ethical analysis provides a novel demonstration of LHC mortality reductions in cardio-oncology cardiac arrest and related disparities, along with an innovative predictive model that can be integrated within the digital ecosystem of modern healthcare systems to improve equitable clinical and public health outcomes.

A prospective cohort study examining exposure to incarceration and cardiovascular disease (Justice-Involved Individuals Cardiovascular Disease Epidemiology - JUSTICE study): a protocol paper.

BACKGROUND: People who have been incarcerated have high rates of cardiovascular risk factors, such as hypertension and smoking, and cardiovascular disease (CVD) is a leading cause of hospitalizations and mortality in this population. Despite this, little is known regarding what pathways mediate the association between incarceration exposure and increased rates of CVD morbidity and especially what incarceration specific factors are associated with this risk. The objective of this study is to better understand CVD risk in people exposed to incarceration and the pathways by which accumulate cardiovascular risk over time. METHODS AND ANALYSIS: The Justice-Involved Individuals Cardiovascular Disease Epidemiology (JUSTICE) study is a prospective cohort study of individuals released from incarceration with known cardiovascular risk factors. We are recruiting 500 individuals within three months after release from jail/prison. At baseline we are assessing traditional risk factors for CVD, including diet, exercise, and smoking, and exposure to incarceration-related policies, psychosocial stress, and self-efficacy. Cardiovascular risk factors are measured at baseline through point of care testing. We are following these individuals for the 12 months following the index release from incarceration with re-evaluation of psychosocial factors and clinical risk factors every 6 months. Using these data, we will estimate the direct and indirect latent effects of incarceration on cardiovascular risk factors and the paths via which these effects are mediated. We will also model the anticipated 10-year burden of CVD incidence, health care use, and mortality associated with incarceration. DISCUSSION: Our study will identify factors associated with CVD risk factor control among people released from incarceration. Our measurement of incarceration-related exposures, psychosocial factors, and clinical measures of cardiovascular risk will allow for identification of unique targets for intervention to modify CVD risk in this vulnerable population.

Preexposure Prophylaxis for Women Across the Criminal Justice System: Implications for Policy and Practice.

Data that inform preexposure prophylaxis (PrEP) implementation for women involved in criminal justice (WICJ) systems are scarce. In a survey of PrEP attitudes, acceptability, and barriers across the criminal justice system, incarcerated women (n = 48) were more likely than WICJ on probation (n = 125) to be eligible for PrEP (29% vs. 15%; p = .04) and willing to take PrEP if offered (94% vs. 78%; p = .01). In multivariate models, PrEP eligibility directly correlated with being incarcerated (adjusted odds ratio [aOR] 4.81, 95% confidence interval [CI] 1.76-13.1) and inversely correlated with Hispanic/Latina ethnicity (aOR 0.31; 95% CI 0.10-0.96). Recent partner violence exposure was associated with PrEP eligibility (aOR 3.29; 95% CI 1.54-7.02) and discordant risk perception (aOR 2.36; 95% CI 1.18-4.70). Findings demonstrate high potential for PrEP for all WICJ, though implementation efforts will need to address partner violence.

Impact of COVID-19 on Patients Supported with a Left Ventricular Assist Device.

Patients on left ventricular assist device (LVAD) support may be susceptible to severe disease and complications from coronavirus disease-19 (COVID-19). The purpose of this study was to describe the clinical course of COVID-19 in LVAD patients. A retrospective review was performed at our center; 28 LVAD patients who developed COVID-19 between March 2020 and March 2021, and six patients with a prior COVID-19 infection who underwent LVAD implantation, were identified and examined. Of the 28 patients, nine (32%) died during the study period, five (18%) during their index hospitalization for COVID-19. Two patients (7%) presented with suspected pump thrombosis. In a nonadjusted binary regression logistic analysis, admission to the intensive care unit (unadjusted odds ratio, 7.6 [CI, 1.2-48], P = 0.03), and the need for mechanical ventilation (unadjusted odds ratio 14 [CI, 1.3-159], P = 0.03) were associated with mortality. The six patients who previously had COVID-19 and subsequently received a LVAD were on intra-aortic balloon pump and inotropic support at time of surgery. All six experienced a complicated and prolonged postoperative course. Three patients (50%) suffered from ischemic stroke, and there was one (17%) 30 day mortality. We observed an increased risk of morbidity and mortality in LVAD patients with COVID-19.

Occupational and Personal Consequences of the COVID-19 Pandemic on US Oncologist Burnout and Well-Being: A Study From the ASCO Clinician Well-Being Task Force.

INTRODUCTION: The COVID-19 pandemic is an unprecedented global crisis profoundly affecting oncology care delivery. PURPOSE: This study will describe the occupational and personal consequences of the COVID-19 pandemic on oncologist well-being and patient care. MATERIALS AND METHODS: Four virtual focus groups were conducted with US ASCO member oncologists (September-November 2020). Inquiry and subsequent discussions centered on self-reported accounts of professional and personal COVID-19 experiences affecting well-being, and oncologist recommendations for well-being interventions that the cancer organization and professional societies (ASCO) might implement were explored. Qualitative interviews were analyzed using Framework Analysis. RESULTS: Twenty-five oncologists were interviewed: median age 44 years (range: 35-69 years), 52% female, 52% racial or ethnic minority, 76% medical oncologists, 64% married, and an average of 51.5 patients seen per week (range: 20-120). Five thematic consequences emerged: (1) impact of pre-COVID-19 burnout, (2) occupational or professional limitations and adaptations, (3) personal implications, (4) concern for the future of cancer care and the workforce, and (5) recommendations for physician well-being interventions. Underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment. Oncologists noted personal and familial stressors related to COVID-19 exposure fears and loss of social support. Many participants strongly considered working part-time or taking early retirement. Yet, opportunities arose to facilitate personal growth and rise above pandemic adversity, fostering greater resilience. Recommendations for organizational well-being interventions included psychologic or peer support resources, flexible time-off, and ASCO and state oncology societies involvement to develop care guidelines, well-being resources, and mental health advocacy. CONCLUSION: Our study suggests that the COVID-19 pandemic has adversely affected oncologist burnout, fulfillment, practice health, cancer care, and workforce. It illuminates where professional organizations could play a significant role in oncologist well-being.

Creating a Blueprint of Well-Being in Oncology: An Approach for Addressing Burnout From ASCO's Clinician Well-Being Taskforce.

Optimizing the well-being of the oncology clinician has never been more important. Well-being is a critical priority for the cancer organization because burnout adversely impacts the quality of care, patient satisfaction, the workforce, and overall practice success. To date, 45% of U.S. ASCO member medical oncologists report experiencing burnout symptoms of emotional exhaustion and depersonalization. As the COVID-19 pandemic remains widespread with periods of outbreaks, recovery, and response with substantial personal and professional consequences for the clinician, it is imperative that the oncologist, team, and organization gain direct access to resources addressing burnout. In response, the Clinician Well-Being Task Force was created to improve the quality, safety, and value of cancer care by enhancing oncology clinician well-being and practice sustainability. Well-being is an integrative concept that characterizes quality of life and encompasses an individual's work- and personal health-related environmental, organizational, and psychosocial factors. These resources can be useful for the cancer organization to develop a well-being blueprint: a detailed start plan with recognized strategies and interventions targeting all oncology stakeholders to support a culture of community in oncology.

Incarceration and Cancer-Related Outcomes (ICRO) study protocol: using a mixed-methods approach to investigate the role of incarceration on cancer incidence, mortality and quality of care.

INTRODUCTION: Incarceration is associated with decreased cancer screening rates and a higher risk for hospitalisation and death from cancer after release from prison. However, there is a paucity of data on the relationship between incarceration and cancer outcomes and quality of care. In the Incarceration and Cancer-Related Outcomes Study, we aim to develop a nuanced understanding of how incarceration affects cancer incidence, mortality and treatment, and moderates the relationship between socioeconomic status, structural racism and cancer disparities. METHODS AND ANALYSIS: We will use a sequential explanatory mixed-methods study design. We will create the first comprehensive linkage of data from the Connecticut Department of Correction and the statewide Connecticut Tumour Registry. Using the linked dataset, we will examine differences in cancer incidence and stage at diagnosis between individuals currently incarcerated, formerly incarcerated and never incarcerated in Connecticut from 2005 to 2016. Among individuals with invasive cancer, we will assess relationships among incarceration, quality of cancer care and mortality, and will assess the degree to which incarceration status moderates relationships among race, socioeconomic status, quality of cancer care and cancer mortality. We will use multivariable logistic regression and Cox survival models with interaction terms as appropriate. These results will inform our conduct of in-depth interviews with individuals diagnosed with cancer during or shortly after incarceration regarding their experiences with cancer care in the correctional system and the immediate postrelease period. The results of this qualitative work will help contextualise the results of the data linkage. ETHICS AND DISSEMINATION: The Yale University Institutional Review Board (#2000022899) and the Connecticut Department of Public Health Human Investigations Committee approved this study. We will disseminate study findings through peer-reviewed publications and academic and community presentations. Access to the deidentified quantitative and qualitative datasets will be made available on review of the request.

Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial.

CONTEXT: No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in patients with cancer. OBJECTIVES: In this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic nausea. METHODS: This double-blind, parallel, randomized trial enrolled patients with cancer and chronic nausea for at least 1 month, intensity ≥4/10 and not on moderately or highly emetogenic systemic therapies. Patients started with a placebo run-in period from days 1 to 5; those without a placebo response proceeded to the double-blinded phase between days 6 to 15 (NEPA: placebo 2:1 ratio). The primary outcome was within-group change in average nausea over the 24 hours on a 0-10 numeric rating scale between day 5 and 15. RESULTS: Among the 53 enrolled patients, 46 proceeded to placebo run-in and 33 had blinded treatment (22 NEPA and 11 placebo). We observed a statistically significant within-group improvement in nausea numeric rating scale between day 5 and 15 in the NEPA group (mean change, -2.0; 95% CI, -3.1 to -0.8) and the placebo group (mean change, -2.3; 95% CI, -3.9 to -0.7). A complete response was achieved in 8 (38%) patients in the NEPA group and 2 (20%) in the placebo group by day 15. No grade 3-4 toxicities were attributed to NEPA. There were no statistically significant between-group differences for the primary/secondary outcomes. CONCLUSIONS: NEPA and placebo were associated with similar magnitude of within-group improvement in chronic nausea without significant between-group differences (Clinicaltrials.gov NCT03040726).

Outcomes Following Left Ventricular Assist Device Exchange: Focus on the Impacts of Device Infection.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.

A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology.

Oncologist well-being is critical to initiating and maintaining the physician-patient relationship, yet many oncologists suffer from symptoms of burnout. Burnout has been linked to poor physical and mental health, as well as increased medical errors, patient dissatisfaction, and workforce attrition. In this Call to Action article, we discuss causes of and interventions for burnout and moral distress in oncology, highlight existing interventions, and provide recommendations for addressing burnout and improving well-being at the individual and organizational levels to deliver ethical, quality cancer care.