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.

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.

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.

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).

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.

"We Didn't Consent to This".

Patients and their families have identified the need for ongoing and effective communication as one of the important aspects of medical care, especially when the cessation of disease-modifying therapies is being considered at the end-of-life (EOL). Despite recognizing that this communication is extremely important, clinicians are uneasy and find themselves inadequately trained to "break bad news" and manage emotional responses from the patient/family. The inherent difficulties in accurately predicting prognosis and discussing potential complications make these conversations even more challenging. In most circumstances, patients and their families want to know the truth about their disease and what will be done to make them feel better, and to receive enough information to help them choose a course of action. For many terminally ill patients and their families who have elected to transfer to the palliative care unit (PCU) for EOL care, the assumption is that most of these conversations have already been held, and the ongoing focus becomes managing these patients' physical and psychological sources of distress, validating their and their families' emotional responses and preparing them for what is to come. This case report illustrates the need for cultural understanding and clear communication among physicians, members of the clinical team, and patients and their family members.

Identifying and Managing Undue Influence From Family Members in End-of-Life Decisions for Patients With Advanced Cancer.

Undue influence from family members of patients with advanced cancer remains a serious ethical problem in end-of-life decision making. Despite the wealth of articles discussing the problem of undue influence, little has been written by way of practical guidance to help clinicians identify and effectively manage situations of undue influence. This article briefly lays out how to identify and manage situations of undue influence sensitively and effectively. We explain how undue influence may present itself in the clinic and distinguish it from ethically permissible expressions of relational autonomy. In addition, we lay out a process by which any clinician suspecting undue influence may gather additional information and, if necessary, conduct a family meeting to address the undue influence. It is our hope that by providing clinicians at all levels of patient care with such guidance, they will feel empowered to respond to cases of undue influence when they arise.

Reframing Medical Appropriateness: A Case Study Concerning the Use of Life-Sustaining Technologies for a Patient With Profoundly Diminished Quality of Life.

This case study considers the clinical ethics issues of medical appropriateness and quality of life for patients who are critically ill. The case involves a terminally ill cancer patient with a profoundly diminished quality of life and an extremely poor prognosis; his spouse desires to bring him home, where she will arrange to keep him alive for as long as possible via life-sustaining interventions. The analysis engages with the complicated notion of medical appropriateness, both in general and as it pertains to life-sustaining interventions in a critical care setting, and considers the ethical implications of the various ways in which one might understand this concept. It also addresses the significance of quality-of-life determinations, emphasizing the role of individualized values in determining the importance of quality of life for clinical decision-making. The discussion concludes with a description of the two strategies employed by the ethics team in helping to alleviate the medical team's concerns about this case.

I don't know why I called you.

This case study details a request from a patient family member who calls our service without an articulated ethical dilemma. The issue that arose involved the conflict between continuing further medical interventions versus transitioning to supportive or palliative care and transferring the patient home. Beyond the resolution of the ethical dilemma, this narrative illustrates an approach to ethics consultation that seeks practical resolution of ethical dilemmas in alignment with patient goals and values. Importantly, the family's suffering is addressed through a relationship driven, humanistic approach that incorporates elements of compassion, empathy and dialog.

Incidence and management of gastrointestinal bleeding with continuous flow assist devices.

BACKGROUND: Continuous flow left ventricular assist devices (CF-LVADs) have emerged as the standard of care for patients in advanced heart failure (HF) requiring long-term mechanical circulatory support. Gastrointestinal (GI) bleeding has been frequently reported within this population. METHODS: A retrospective analysis of 101 patients implanted with the Heart Mate II from January 2005 to August 2011 was performed to identify incidence, etiology, and management of GI bleeding. Univariate and multivariate regression analysis was conducted to identify related risk factors. RESULTS: A significant incidence of GI bleeding (22.8%) occurred in our predominantly destination therapy (DT) (93%) population. Fifty-seven percent of the patients with bleeding episodes bled from the upper GI (UGI) tract (with 54% bleeding from gastric erosions and 37% from ulcers/angiodysplasias), whereas 35% of patients bled from the lower GI (LGI) tract. Previous history of GI bleeding (odds ratio [OR], 22.7; 95% CI, 2.2-228.6; p=0.008), elevated international normalized ratio (INR) (OR, 3.9; CI, 1.2-12.9; p=0.02), and low platelet count (OR, -0.98; CI, 0.98 -0.99; p=0.001) were independent predictors of GI hemorrhage. Recurrent bleeding was more common in older patients (mean, 70 years; p=0.01). The majority of bleeders (60%) rebled from the same site. Management strategies included temporarily withholding anticoagulation, decreasing the speed of LVADs, and using octreotide. Octreotide did not impact the amount of packed red blood cells used, rebleeding rates, length of hospital stay, or all-cause mortality. Only 1 patient died as a direct consequence of GI bleeding. CONCLUSIONS: Multiple factors account for GI bleeding in patients on CF-VADs. A previous history of bleeding increases risk significantly and warrants careful monitoring.