Reporting time toxicity in prospective cancer clinical trials: A scoping review.

PURPOSE: This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies. METHODS: On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity. RESULTS: The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric "days alive and out of the hospital" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. "Time spent at home" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care. CONCLUSIONS: Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.

Gaps in Patient-Centered Decision-Making Related to Complex Surgery: A Mixed-Methods Study.

INTRODUCTION: We sought to understand the perceptions of surgeons around patient preferred roles in decision-making and their approaches to patient-centered decision-making (PCDM). METHODS: A concurrent embedded mixed-methods design was utilized among a cohort of surgeons performing complex surgical procedures. Data were collected through online surveys. Associations between perceptions and PCDM approaches were examined. RESULTS: Among 241 participants, most respondents were male (67.2%) with an average age of 47.6 y (standard deviation = 10.3); roughly half (52.4%) had practiced medicine for 10 or more years. Surgeons most frequently agreed (94.2%) with the statement, "Patients prefer to make health decisions on their own after seriously considering their physician's opinion." Conversely, surgeons most frequently disagreed (73.0%) with the statement, "Patients prefer that their physician make health decisions for them." Nearly one-third (30.4%) of surgeon qualitative responses (n = 115) indicated that clinical/biological information would help them tailor their approach to PCDM. Only 12.2% of respondents indicated that they assess patient preferences regarding both decision-making and information needs. CONCLUSIONS: Surgeons most frequently agree that patients want to make their own health decisions after seriously considering their physicians opinion. A greater focus on what information surgeons should know before treatment decision-making may help optimize patient experience and outcomes related to complex surgical procedures.

Identifying Factors Associated With Code Status Changes After Emergency General Surgery.

INTRODUCTION: Surgical emergencies are time sensitive. Identifying patients who may benefit from preoperative goals of care discussions is critical to ensuring that operative intervention aligns with the patient's values. We sought to identify patient factors associated with acute changes in a patient's goals using code status change (CSC) as proxy. METHODS: A retrospective analysis of single-institution data for patients undergoing urgent laparotomy was performed. Patients were stratified based on whether a postoperative CSC occurred. Parametric, nonparametric, and regression analyses were used to identify variables associated with CSC. RESULTS: Of 484 patients, 13.8% (n = 67) had a postoperative CSC. Patients with postoperative CSC were older (65 versus 60 years, P < 0.001). Odds of CSC were significantly higher in patients who were transferred between facilities (odds ratio [OR] 2.1), had a higher Charlson Comorbidity Index (3-4: OR 3.9, 5+: OR 6.8), and had a higher quick sequential organ failure assessment score (2: OR 5.0; 3: OR 38.7). Patients with anemia (OR 1.9) and active cancer (OR 3.0) had higher odds of CSC. CONCLUSIONS: Timely intervention in emergency general surgery may result in high-risk interventions and subsequent complications that do not align with a patient's goals and values. Our analysis identified a subset of patients who undergo surgery and have a postoperative CSC leading to transition to comfort-focused care. In these patients, a pause in clinical momentum may help ensure operative intervention remains goal concordant.

The Role of Palliative Care in Heart Failure, Part 2: Characteristics of Patients Undergoing Outpatient Palliative Care Evaluation for Advanced Cardiac Therapies.

Background: Characteristics of patients undergoing outpatient evaluation for advanced cardiac therapies are largely unknown. Objective: To describe demographics, baseline quality of life, and frailty of patients undergoing evaluation for advanced therapies at the time of presentation for evaluation in an outpatient cardiac palliative care clinic and examine key quality of life differences across patients. Design: Retrospective chart review to report baseline demographics and quality of life. Settings/Subjects: Patients at a large academic medical center in the United States referred for advanced cardiac therapies in 2021. Measurements: Depression and anxiety were measured using the Hospital Anxiety and Depression Scale; quality of life was measured using the Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) tool; and frailty was measured using the Fried Frailty Phenotype. Differences in quality of life by disease etiology, demographic characteristics, and frailty were assessed. Results: Fifty-four patients were seen in the outpatient cardiac palliative care clinic for advanced therapy evaluation. Most were Caucasian (80%) and male (74%). Patients traveled an average of 61 minutes to the clinic. All but five lived in a rural, medically underserved, or health professional shortage area. Forty percent scored abnormal or borderline abnormal for anxiety; 22% scored abnormal or borderline abnormal for depression. The FACIT-Pal mean score was 129 (standard deviation 23), with emotional and functional well-being domains contributing most to poor quality of life. Seventy-one percent were frail. Patients with a nonischemic etiology had a 3.32 times higher rate of anxiety than nonischemic patients (95% confidence interval = 1.05-10.54, p = 0.041). Conclusion: As patients undergoing transplant evaluation have high levels of depression, anxiety, and frailty, interdisciplinary care teams will be needed to properly manage the needs of this complex population. These results can inform efforts to integrate palliative care into advanced cardiac therapy and improve patients' experiences.

Association of Race/Ethnicity, Persistent Poverty, and Opioid Access Among Patients with Gastrointestinal Cancer Near the End of Life.

BACKGROUND: Social determinants of health (SDoH) can impact access to healthcare. We sought to assess the association between persistent poverty (PP), race/ethnicity, and opioid access among patients with gastrointestinal cancer near the end-of-life (EOL). METHODS: SEER-Medicare patients with gastric, liver, pancreatic, biliary, colon, and rectal cancer were identified between 2008 and 2016 near EOL, defined as 30 days before death or hospice enrolment. Data were linked with county-level poverty from the American Community Survey and the US Department of Agriculture (2000-2015). Counties were categorized as never high-poverty (NHP), intermittent high-poverty (IHP) and persistent poverty (PP). Trends in opioid prescription fills and daily dosages (morphine milligram equivalents per day) were examined. RESULTS: Among 48,631 Medicare beneficiaries (liver: n = 6551, 13.5%; pancreas: n = 13,559, 27.9%; gastric: n = 5486, 1.3%; colorectal: n = 23,035, 47.4%), there was a steady decrease in opioid prescriptions near EOL. Black, Asian, Hispanic, and other racial groups had markedly decreased odds of filling an opioid prescription near EOL (Black: OR 0.84, 95% CI 0.79-0.90; Asian: OR 0.86, 95% CI 0.79-0.94; Hispanic: OR 0.90, 95% CI 0.84-0.95; Other: OR 0.83, 95% CI 0.74-0.93; all p < 0.05). Even after filling an opioid prescription, this subset of patients received lower daily doses versus White patients (Black: -16.5 percentage points, 95% CI -21.2 to -11.6; Asian: -11.9 percentage points, 95% CI -18.5 to -4.9; Hispanic: -19.1 percentage points, 95%CI -23.5 to -14.6; all p < 0.05). The disparity in opioid access and average daily doses among was attenuated in IHP/PP areas for Asian, Hispanic, and other racial groups, yet exacerbated among Black patients. CONCLUSIONS: Race/ethnicity-based disparities in EOL pain management persist with SDoH-based variations in EOL opioid use. In particular, PP impacted EOL opioid access and utilization.

Impact of early vs late palliative care referrals on healthcare utilization in patients with pancreatic cancer.

PURPOSE: The purpose of this study was to examine the impact of early versus late palliative care referral (PCR) following pancreatic cancer diagnosis. METHODS: Patients diagnosed with PDAC who received a PCR between 2014 and 2020 at a major academic institution were identified. PCR was classified as early (< 30 days) or late (≥ 30 days) based on time from definitive diagnosis. Data were obtained on number of emergency department (ED) visits, intensive care unit (ICU) admissions, and hospital admissions. RESULTS: Among 1458 patients with PDAC, 419 (28.7%) received PCR, among which 67.3% (n = 282) received a late PCR. Of those who received PCR, the majority were White (85%) and male (54.8%), with a median age of 62 years at time of diagnosis. Patients who received an early PCR more commonly presented with stage 4 disease at diagnosis (early: n = 91, 69% vs. late: n = 132, 47%), whereas patients who received a late PCR more commonly presented with stage 1, 2, or 3 disease (early: n = 40, 30.5% vs. late: n = 150, 53.2%) (p < 0.001). Patients who received early PCR had fewer median ED visits (1 vs. 2, p < 0.001) and hospital admissions (1 vs. 2, p < 0.001) compared with patients who received late PCR. However, after performing recurrent-event Cox-proportional hazards models, the timing of PCR did not impact hospital admission (HR 0.88, 95% CI 0.68, 1.14; p = 0.3). CONCLUSION: Timing of PCR for patients with PDAC was not associated with healthcare utilization. Further prospective trials are needed to study the patient-centered impact of early integration of palliative care services into multidisciplinary pancreatic cancer teams.

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Importance: Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations. Objective: To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers. Design, Setting, and Participants: From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients. Intervention: Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation. Main Outcomes and Measures: The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed. Results: In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99). Conclusions and Relevance: To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers. Trial Registration: ClinicalTrials.gov Identifier: NCT03611309.

Utilization of Palliative and Hospice Care Among Pancreatic Cancer Patients at an Academic Center.

INTRODUCTION: Pancreatic ductal adenocarcinoma has the lowest 5-y relative survival of all solid tumor malignancies. Palliative care can improve the quality of life of both patients and their caregivers. However, the utilization patterns of palliative care in patients with pancreatic cancer are unclear. METHODS: Pancreatic cancer patients who were diagnosed between October 2014 and December 2020 at the Ohio State University were identified. Palliative care and hospice utilization and referral patterns were assessed. RESULTS: Of the 1458 pancreatic cancer patients, 55% (n = 799) were male, median age at diagnosis was 65 y (interquartile range [IQR]: 58, 73), and most were Caucasian (n = 1302, 89%). Palliative care was utilized by 29% (n = 424) of the cohort, with the initial consultation obtained after an average of 6 ± 9 mo from diagnosis. Patients who received palliative care were younger (62 y, IQR: 55, 70 versus 67 y, IQR: 59, 73; P < 0.001) and more frequently members of racial and ethnic minorities (15% versus 9%; P < 0.001) versus those who did not receive palliative care. Among the 344 (24%) patients who received hospice care, 153 (44%) had no prior palliative care consultation. Patients referred to hospice care survived a median of 14 d (95% CI, 12-16) after hospice referral. CONCLUSIONS: Only 3 out of 10 patients with pancreatic cancer received palliative care at an average of 6 mo from initial diagnosis. More than two out of every five patients referred to hospice had no previous palliative care consultation. Efforts to understand the impact of improved integration of palliative care into pancreatic cancer programs are needed.

Prevalence of Violence against Providers in Heart and Lung Transplant Programs.

Workplace violence in healthcare institutions is becoming more frequent. The objective of this study was to better understand the nature of threat and physical acts of violence from heart and lung transplant patients and families toward healthcare providers and suggest programmatic mitigation strategies. We administered a brief survey to attendees at the 2022 International Society of Heart and Lung Transplantation Conference in Boston, Massachusetts. A total of 108 participants responded. Threats of physical violence were reported by forty-five participants (42%), were more frequently reported by nurses and advanced practice providers than physicians (67% and 75% vs. 34%; p < 0.001) and were more prevalent in the United States than abroad (49% vs. 21%; p = 0.026). Acts of physical violence were reported by one out of every eight providers. Violence against providers in transplant programs warrants closer review by health systems in order to ensure the safety of team members.

Assessing the Impact of Provider Training and Perceived Barriers on the Provision of Spiritual Care: a Mixed Methods Study.

The current study evaluated formal training around spiritual care for healthcare providers and the relationships between that training, perceived barriers to spiritual care, and frequency of inquiry around spiritual topics. A mixed methods explanatory sequential design was used. Quantitative methods included an online survey administered to providers at The Ohio State University Comprehensive Cancer Center. Main and interactive effects of formal training and barriers to spiritual care on frequency of inquiry around spiritual topics were assessed with two-way ANOVA. Qualitative follow-up explored provider strategies to engage spiritual topics. Among 340 quantitative participants, most were female (82.1%) or White (82.6%) with over one-half identifying as religious (57.5%). The majority were nurses (64.7%) and less than 10% of all providers (n = 26) indicated formal training around spiritual care. There were main effects on frequency of inquiry around spiritual topics for providers who indicated "personal discomfort" as a barrier (p < 0.001), but not formal training (p = 0.526). Providers who indicated "personal discomfort" as a barrier inquired about spirituality less frequently, regardless of receiving formal training (M = 8.0, SD = 1.41) or not (M = 8.76, SD = 2.96). There were no interactive effects between training and "may offend patients" or "personal discomfort" (p = 0.258 and 0.125, respectively). Qualitative analysis revealed four strategies with direct and indirect approaches: (1) permission-giving, (2) self-awareness/use-of-self, (3) formal assessment, and (4) informal assessment. Training for providers should emphasize self-awareness to address intrapersonal barriers to improve the frequency and quality of spiritual care for cancer patients.

Training to Promote Empathic Communication in Graduate Medical Education: A Shared Learning Intervention in Internal Medicine and General Surgery.

Background: Empathic communication skills have a growing presence in graduate medical education to empower trainees in serious illness communication. Objective: Evaluate the impact, feasibility, and acceptability of a shared communication training intervention for residents of different specialties. Design: A randomized controlled study of standard education v. our empathic communication skills-building intervention: VitalTalk-powered workshop and formative bedside feedback using a validated observable behavioral checklist. Setting/Subjects: During the 2018-2019 academic year, our intervention was implemented at a large single-academic medical center in the United States involving 149 internal medicine and general surgery residents. Measurements: Impact outcomes included observable communication skills measured in standardized patient encounters (SPEs), and self-reported communication confidence and burnout collected by surveys. Analyses included descriptive and inferential statistics, including independent and paired t tests and multiple regression model to predict post-SPE performance. Results: Of residents randomized to the intervention, 96% (n = 71/74) completed the VitalTalk-powered workshop and 42% (n = 30/71) of those residents completed the formative bedside feedback. The intervention demonstrated a 33% increase of observable behaviors (p < 0.001) with improvement in all eight skill categories, compared with the control who only showed improvement in five. Intervention residents demonstrated improved confidence in performing all elicited communication skills such as express empathy, elicit values, and manage uncertainty (p < 0.001). Conclusions: Our educational intervention increased residents' confidence and use of essential communication skills. Facilitating a VitalTalk-powered workshop for medical and surgical specialties was feasible and offered a shared learning experience for trainees to benefit from expert palliative care learning outside their field.

Spiritual Motivations to Practice Medicine: A Survey of Cancer Care Providers.

BACKGROUND: There is increased interest in the role of spirituality in the cancer care context, but how it may inspire individuals to pursue a career as a healthcare provider is unknown. We sought to determine the relationship between intrinsic religiosity, religious identity, provider role, and spiritual motivations to practice medicine. METHODS: A cross-sectional survey was administered to healthcare providers at a large, Midwest Comprehensive Cancer Center. The relationship between provider type, intrinsic religiosity, religious identity, and spiritual motivations to practice medicine was assessed with binary logistic regression. RESULTS: Among 340 participants, most were female (82.1%) or Caucasian (82.6%) and identified as being religious (57.5%); median age was 35 years (IQR: 31-48). Providers included nurses (64.7%), physicians (17.9%), and "other" (17.4%). Compared with physicians, nurses were less likely to agree that they felt responsible for reducing pain and suffering in the world (OR: 0.12, p = 0.03). Similarly, "other" providers were less likely than physicians to believe that the practice of medicine was a calling (OR: 0.28, p = 0.02). Providers with a high self-reported intrinsic religiosity demonstrated a much greater likelihood to believe that the practice of medicine is a calling (OR:1.75, p = 0.001), as well as believe that personal R&S beliefs influence the practice of medicine (OR:3.57, p < 0.001). Provider religious identity was not associated with spiritual motivations to practice medicine (all p > 0.05). CONCLUSION: Intrinsic religiosity had the strongest relationship with spiritual motivations to practice medicine. Understanding these motivations may inform interventions to avoid symptoms of provider burnout in cancer care.

Top Ten Tips Palliative Care Clinicians Should Know About End-Stage Liver Disease.

End-stage liver disease (ESLD) is an increasingly prevalent condition with high morbidity and mortality, especially for those ineligible for liver transplantation. Patients with ESLD, along with their family caregivers, have significant needs related to their quality of life, and there is increasing attention being paid to integration of palliative care (PC) principles into routine care throughout the disease spectrum. To provide upstream care for these patients and their family caregivers, it is essential for PC providers to understand their complex psychosocial and physical needs and to be aware of the unique challenges around medical decision making and end-of-life care for this patient population. This article, written by a team of liver and PC experts, shares 10 high-yield tips to help PC clinicians provide better care for patients with advanced liver disease.

Loss of Community-Dwelling Status Among Survivors of High-Acuity Emergency General Surgery Disease.

OBJECTIVES: To examine loss of community-dwelling status 9 months after hospitalization for high-acuity emergency general surgery (HA-EGS) disease among older Americans. DESIGN: Retrospective analysis of claims data. SETTING: US communities with Medicare beneficiaries. PARTICIPANTS: Medicare beneficiaries age 65 years or older hospitalized urgently/emergently between January 1, 2015, and March 31, 2015, with a principal diagnosis representing potential life or organ threat (necrotizing soft tissue infections, hernias with gangrene, ischemic enteritis, perforated viscus, toxic colitis or gastroenteritis, peritonitis, intra-abdominal hemorrhage) and an operation of interest on hospital days 1 or 2 (N = 3319). MEASUREMENTS: Demographic characteristics (age, race, and sex), comorbidities, principal diagnosis, complications, and index hospitalization disposition (died; discharged to skilled nursing facility [SNF], long-term acute care [LTAC], rehabilitation, hospice, home (with or without services), or acute care hospital; other) were measured. Survivors of index hospitalization were followed until December 31, 2015, on mortality and community-dwelling status (SNF/LTAC vs not). Descriptive statistics, Kaplan-Meier plots, and χ2 tests were used to describe and compare the cohort based on disposition. A multivariable logistic regression model, adjusted for age, sex, comorbidities, complications, and discharge disposition, determined independent predictors of loss of community-dwelling status at 9 months. RESULTS: A total of 2922 (88%) survived index hospitalization. Likelihood of discharge to home decreased with increasing age, baseline comorbidities, and in-hospital complications. Overall, 418 (14.3%) HA-EGS survivors died during the follow-up period. Among those alive at 9 months, 10.3% were no longer community dwelling. Initial discharge disposition to any location other than home and three or more surgical complications during index hospitalization were independent predictors of residing in a SNF/LTAC 9 months after surviving HA-EGS. CONCLUSION: Older Americans, known to prioritize living in the community, will experience substantial loss of independence due to HA-EGS. Long-term expectations after surviving HA-EGS must be framed from the perspective of the outcomes that older patients value the most. Further research is needed to examine the quality-of-life burden of EGS survivorship prospectively. J Am Geriatr Soc 67:2289-2297, 2019.