Protocol for a type 3 hybrid implementation cluster randomized clinical trial to evaluate the effect of patient and clinician nudges to advance the use of genomic medicine across a diverse health system.

Background: Germline genetic testing is recommended for an increasing number of conditions with underlying genetic etiologies, the results of which impact medical management. However, genetic testing is underutilized in clinics due to system, clinician, and patient level barriers. Behavioral economics provides a framework to create implementation strategies, such as nudges, to address these multi-level barriers and increase the uptake of genetic testing for conditions where the results impact medical management.

Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients.

NCCN guidelines indicate that cancer clinical trials (CCTs) are the best management for patients with cancer. However, only 5% of patients enroll in them. We examined oncologists' perceived barriers and facilitators to discussing CCTs.

Barriers to Clinical Trial Implementation Among Community Care Centers.

Importance: While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol.

Objective: To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment.

Design, Setting, And Participants: This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)-ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents.

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke.

Purpose: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology.

Methods: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients.

Behavioural economic interventions to embed palliative care in community oncology (BE-EPIC): study protocol for the BE-EPIC randomised controlled trial.

Introduction: Palliative care (PC) is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. Early outpatient specialty PC concurrent with cancer-directed treatment improves quality of life and symptom burden, decreases aggressive end-of-life care and is an evidence-based practice endorsed by national guidelines. However, nearly half of patients with advanced cancer do not receive specialty PC prior to dying.

Toward Predicting 30-Day Readmission Among Oncology Patients: Identifying Timely and Actionable Risk Factors.

Purpose: Predicting 30-day readmission risk is paramount to improving the quality of patient care. In this study, we compare sets of patient-, provider-, and community-level variables that are available at two different points of a patient's inpatient encounter (first 48 hours and the full encounter) to train readmission prediction models and identify possible targets for appropriate interventions that can potentially reduce avoidable readmissions.

Methods: Using electronic health record data from a retrospective cohort of 2,460 oncology patients and a comprehensive machine learning analysis pipeline, we trained and tested models predicting 30-day readmission on the basis of data available within the first 48 hours of admission and from the entire hospital encounter.

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials.

Purpose: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients.

Materials And Methods: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them.

Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment.

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI.

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing and Screening to Guide Chemotherapy Dosing.

Background: Fluoropyrimidines (fluorouracil [5-FU], capecitabine) and irinotecan are commonly prescribed chemotherapy agents for gastrointestinal (GI) malignancies. Pharmacogenetic (PGx) testing for germline and variants associated with reduced enzyme activity holds the potential to identify patients at high risk for severe chemotherapy-induced toxicity. Slow adoption of PGx testing in routine clinical care is due to implementation barriers, including long test turnaround times, lack of integration in the electronic health record (EHR), and ambiguity in test cost coverage.

Digital Health Applications in Oncology: An Opportunity to Seize.

Digital health advances have transformed many clinical areas including psychiatric and cardiovascular care. However, digital health innovation is relatively nascent in cancer care, which represents the fastest growing area of health-care spending. Opportunities for digital health innovation in oncology include patient-facing technologies that improve patient experience, safety, and patient-clinician interactions; clinician-facing technologies that improve their ability to diagnose pathology and predict adverse events; and quality of care and research infrastructure to improve clinical workflows, documentation, decision support, and clinical trial monitoring.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials.

Policies and Practices to Address Cancer's Long-Term Adverse Consequences.

As cancer detection and treatment improve, the number of long-term survivors will continue to grow, as will the need to improve their survivorship experience and health outcomes. We need to better understand cancer and its treatment's short- and long-term adverse consequences and to prevent, detect, and treat these consequences effectively. Delivering care through a collaborative care model; standardizing information offered to and collected from patients; standardizing approaches to documenting, treating, and reducing adverse effects; and creating a data infrastructure to make population-based information widely available are all actions that can improve survivors' outcomes.

Maintaining and Advancing Quality Cancer Care During a Global Pandemic.

The care of patients with cancer occurs in a fast-moving, high-pressure, and high-stakes ecosystem. Early in 2020, that complex ecosystem was further complicated by the advent of the COVID-19 pandemic. We address actions taken by care providers and systems during the initial phases of the pandemic, and how those actions preserved lifesaving and life-sustaining cancer care despite severely constrained resources.

Cancer Care at the Beginning of the COVID-19 Pandemic: Effects on Patients and Early Interventions to Mitigate Stresses on Care.

Purpose: A multidisciplinary panel of experts convened to review the early effects of the COVID-19 pandemic on cancer care in the United States as part of a symposium convened by the National Cancer Policy Forum in July 2021.

Methods: Representatives from the cancer care community, patients, infection prevention, and a government agency provided insight into key elements of the response to and impact of the COVID-19 pandemic on cancer care in the United States in 2020.

Results: Multiple stakeholders worked quickly to adapt to provide seamless care to cancer patients with considerable success despite the profound uncertainties that faced us in the early days of the pandemic.

Preemptive pharmacogenetic testing to guide chemotherapy dosing in patients with gastrointestinal malignancies: a qualitative study of barriers to implementation.

Background: Pharmacogenetic (PGx) testing for germline variants in the DPYD and UGT1A1 genes can be used to guide fluoropyrimidine and irinotecan dosing, respectively. Despite the known association between PGx variants and chemotherapy toxicity, preemptive testing prior to chemotherapy initiation is rarely performed in routine practice.

Methods: We conducted a qualitative study of oncology clinicians to identify barriers to using preemptive PGx testing to guide chemotherapy dosing in patients with gastrointestinal malignancies.

Secret Sauce-How Diverse Practices Succeed in Centers for Medicare & Medicaid Services Oncology Care Model.

Purpose: CMS' Oncology Care Model (OCM) is an episode-based alternative payment model designed to incent high-value care through the use of monthly payments for enhanced services and performance-based payments on the basis of decreases in spending compared with risk-adjusted historical benchmarks. Transitioning from a fee-for-service model to a value-based, alternative payment model in oncology can be difficult; some practices will perform better than others. We present detailed experiences of four successful OCM practices, each operating under diverse business models and in different geographic areas.

CD8 T cells contribute to survival in patients with COVID-19 and hematologic cancer.

Patients with cancer have high mortality from coronavirus disease 2019 (COVID-19), and the immune parameters that dictate clinical outcomes remain unknown. In a cohort of 100 patients with cancer who were hospitalized for COVID-19, patients with hematologic cancer had higher mortality relative to patients with solid cancer. In two additional cohorts, flow cytometric and serologic analyses demonstrated that patients with solid cancer and patients without cancer had a similar immune phenotype during acute COVID-19, whereas patients with hematologic cancer had impairment of B cells and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibody responses.

CD8 T cells compensate for impaired humoral immunity in COVID-19 patients with hematologic cancer.

Cancer patients have increased morbidity and mortality from Coronavirus Disease 2019 (COVID-19), but the underlying immune mechanisms are unknown. In a cohort of 100 cancer patients hospitalized for COVID-19 at the University of Pennsylvania Health System, we found that patients with hematologic cancers had a significantly higher mortality relative to patients with solid cancers after accounting for confounders including ECOG performance status and active cancer status. We performed flow cytometric and serologic analyses of 106 cancer patients and 113 non-cancer controls from two additional cohorts at Penn and Memorial Sloan Kettering Cancer Center.

DPYD and UGT1A1 Pharmacogenetic Testing in Patients with Gastrointestinal Malignancies: An Overview of the Evidence and Considerations for Clinical Implementation.

Gastrointestinal (GI) malignancies are among the most commonly diagnosed cancers worldwide. Despite the introduction of targeted and immunotherapy agents in the treatment landscape, cytotoxic agents, such as fluoropyrimidines and irinotecan, remain as the cornerstone of chemotherapy for many of these tumors. Pharmacogenetics (PGx) is a rapidly evolving field that accounts for interpatient variability in drug metabolism to predict therapeutic response and toxicity.

Lack of Tularemia Among Health Care Providers With Close Contact With Infected Patients-A Case Series.

has a low infectious dose and can infect laboratory staff handling clinical specimens. The risk to health care providers exposed during patient care is poorly defined. We describe 9 examples of health care providers who did not develop tularemia after significant exposures to infected patients.

Developing and Sustaining an Effective and Resilient Oncology Careforce: Opportunities for Action.

Advances in cancer care have led to improved survival, which, coupled with demographic trends, have contributed to rapid growth in the number of patients needing cancer care services. However, with increasing caseload, care complexity, and administrative burden, the current workforce is ill equipped to meet these burgeoning new demands. These trends have contributed to clinician burnout, compounding a widening workforce shortage.

Anticancer Therapy at the End of Life: Lessons From a Community Cancer Institute.

Introduction: Studies have shown aggressive cancer care at the end of life is associated with decreased quality of life, decreased median survival, and increased cost of care. This study describes the patients most likely to receive systemic anticancer therapy at the end of life in a community cancer institute.

Materials And Methods: We performed a retrospective cohort study of 201 patients who received systemic anticancer therapy in our institution and died between July 2016 and April 2017.

The Centers for Medicare & Medicaid Services Oncology Care Model Halfway Through: Perspectives from Diverse Participants.

The Oncology Care Model (OCM) is a 5-year model developed and tested by the Centers for Medicare & Medicaid Services that uses an episode-based payment model triggered by the receipt of chemotherapy to test if changing payment mechanisms, in conjunction with a requirement for enhanced patient services, can generate clinical transformation that will orient practices toward more patient-centered, high-value care to reduce expenditures and preserve or enhance quality of care for beneficiaries. The model is geographically diverse with practices in 34 states and encompasses practices ranging in size from 1 to more than 400 practitioners, with a multitude of business structures. Given these varied clinical and business environments, we believe that OCM-participating practices will have different opportunities and challenges as they work toward practice transformation, but they will likely share similarities with other practices in similar clinical and business settings.