bluuebunny/crossref_metadata_2025 huggingface dataset:
Process modeling radiation oncology clinic workflow from therapeutic simulation to treatment: Identifying impending strain and possible treatment delays.
Authors: Chowdhry Varun , Simpson Natalie
Published: September 2022

39

Background: The administration of safe, high-quality radiotherapy requires the systematic completion of a series of steps from CT simulation, physician contouring, dosimetric treatment planning, pre-treatment quality assurance, plan verification, and ultimately treatment delivery. Nevertheless, due consideration to the cumulative time required to complete each of these steps is often not given sufficient attention when determining patient start date. On one hand, the nature of cancer therapy relies on timely treatment delivery. On the other hand, overly ambitious treatment turnaround times can lead to staff burnout, and result in medical errors. We sought to better understand how changes in patient volume could impact turnaround time through a simulation-based study. Methods: We developed a process model workflow for a single physician, single linear-accelerator clinic that simulated arrival rates and processing times for patients undergoing radiation treatment using AnyLogic Simulation Modeling software (AnyLogic 8 University edition, v8.7.9). We varied the new patient arrival rate from 1 to 10 patients per week to understand the impact treatment turnaround times from simulation to treatment. We utilized processing time estimates for each of the required steps as was determined in a departmental focus group study. We assumed an eight hour workday, and that contouring, treatment planning, verification, and treatment delivery followed the following distributions, respectively (in hours): triangular (2, 4, 16); triangular (8, 16, 60); triangular (0.25, 0.5, 1). Results: Altering the number of patients simulated per week from 1-10 patients resulted in a corresponding increase average processing time from simulation to treatment from 4 to 7 days. The maximum processing time for patient from simulation to treatment ranged from 6-14 days. To compare individual distributions, we utilized the Kolmogorov-Smirnov (K-S) statistical test. We found that altering the arrival rate from 4 patients per week to 5 patients per week resulted in a statistically significant change in the distributions of processing times (p = 0.03) and resulted in a corresponding increase in the maximum patient processing time from approximately 6 days to 12 days, or from approximately 1 week to 2 weeks. Conclusions: The results of this simulation-based modeling study confirm the appropriateness of current staffing levels to ensure timely patient delivery while minimizing staff burnout. However, sustained increases in volume could require increased staffing to ensure timely treatment delivery while minimizing staff burnout. Simulation modeling can help guide staffing and workflow models to ensure timely treatment delivery.
Outcomes of a quality improvement project aimed at improving delivery of new anticancer drug education to nursing in an academic-community hybrid model.
Authors: Blouin Gayle C. , Derosier Crystal , Man Yun , Morris Amy , Roberts Daniel Aaron
Published: September 2022

50

Background: Educating staff on new anticancer medications is imperative for patient safety. Infusion nurses at Dana Farber Cancer Institute (DFCI) satellite infusion centers were surveyed on their comfort level administering newer oncology drugs. Results revealed only 57% of nurses were “extremely comfortable or somewhat comfortable,” while 32% of nurses were “somewhat uncomfortable or very uncomfortable.” This project aimed to increase percentage of nurses at the satellites indicating they are “extremely comfortable” or “somewhat comfortable” from baseline of 57% to ≥75%. Methods: An interdisciplinary team including pharmacy, medical oncology, and nursing was formed to analyze workflows around new drug onboarding, staff education, and satellite communication. The team utilized Plan-Do-Study-Act (PDSA) cycle methodology. Tools included process maps and fishbone to identify areas of improvement. Intervention development tools included a Pareto chart and a priority matrix. Results were analyzed using statistical process control charts. Results: PDSA cycle 1 consisted of making the pharmacy driven education sheet, At-A-Glance (AAG), more accessible for new drugs. AAGs for drugs approved by the FDA in the previous 18 months were posted on the DFCI pharmacy intranet page. Nurses were educated on how to access AAG weekly. For PDSA cycle 2, the survey was modified to target individual nurses administering new drugs rather than all nurses. A “Nursing consideration” section was added to the AAG template and workflow developed; Navigation and review of AAG was added to nursing competency. Monthly nursing/pharmacy huddles were established to optimize communication. These interventions increased the percentage of nurses indicating they are “extremely comfortable” or “somewhat comfortable” to ≥75% which was sustainable through PDSA cycle 2 (see Table). Conclusions: Making an easy-to-use nursing education resource accessible improved nursing comfort level. There were challenges with nursing survey due to COVID-19 surge and staff shortages. Routine huddles are essential for sustainability.[Table: see text]
Improving the uptake of prehabilitation interventions for older adults prior to cancer treatment using telehealth in the Geriatric Oncology One-Stop Clinic.
Authors: Ng Yean Shin , Said Noorhanah Mohd , Chen Matthew Zhixuan , Eng Wan Nghee , Ling Natalie Mun Wai , Low Jia Li , Yao Yao , Loy Yijun , Chun Meiling , Wong Wei Yee , Ong Jie Xin , Luah Vivian , Pang Shien Ling Angela , Ho Francis
Published: September 2022

55

Background: Prehabilitation in older patients aged ≥ 65 years undergoing cancer surgery and systemic therapy is crucial in reducing treatment complications and improving physical health, psychological well-being, quality of life (QOL) and cancer-related outcomes. However, a majority of older patients (80%) attending our Geriatric Oncology (GO) One-Stop clinic do not receive same day Comprehensive Geriatric Assessment (CGA)-directed Allied Health Interventions (AHI) for prehabilitation during their First Visit (FV). Objectives: The objective of this study is to increase the uptake of same day CGA-directed AHI for prehabilitation from 20% to 60% using telehealth. Methods: Older patients planned for an FV at the GO One-Stop clinic in an academic tertiary center, the National University Cancer Institute, Singapore (NCIS) were recruited. Our workflow was revised so that all FV patients underwent CGA via telehealth prior to the physical visit. Based on the preliminary CGA findings, a multidisciplinary geriatric oncology board planned for prehabilitation interventions which would be performed on the same day as the physical visit. Interim follow-up via telehealth by GO nurses helped to monitor patients for treatment-related toxicities and development of new geriatric syndromes. QOL was assessed during the FV and 3 months later. Results: Two hundred seventy-five patients were recruited from July 2020 to January 2022. 60% (n = 165) received prehabilitation interventions in the One-Stop clinic. The average time spent per visit was shortened from 4 hours to 2.5hours, but completed interventions on same day rose from 1 to 3. The proportion of patients who responded that they benefited from the program on the patient satisfactory survey remained high at 96%. 84.8% were satisfied with the hybrid telehealth model and 80.8% of them reported a maintained or improved QOL after being enrolled into the program. Conclusions: Adoption of telehealth for CGA is a feasible and effective method in improving prehabilitation interventions uptake for GO patients. GO hybrid model of care is a sustainable practice with no additional cost incurred.
Fostering a high-functioning team in cancer care using the 4R Oncology model: Assessment in a large health system.
Authors: Liu Raymond , Weldon Christine B. , Linehan Elizabeth Shurell , Gordon Nancy P. , Abbe Thea , Hennings Marti , James Henie , Katzel Jed Abraham , Ng Chun Fai , Tomita Megumi , Velotta Jeffrey B. , Ossowski Stephanie , Sakoda Lori C. , Sprague Sharon , Dowling Anna , Beringer Kimberly , Ravelo Arliene , Yu Elaine , Trosman Julia R.
Published: September 2022

57

Background: Delivering cancer care by high-functioning multidisciplinary teams promises to address care fragmentation and complexity, which threaten care quality, impact patient outcomes, and strain the oncology workforce. We assessed whether the 4R Oncology model (Trosman et al 2021) for team-based interdependent care delivery and patient self-management impacted team functioning at Kaiser Permanente Northern California (KPNC), a large community-based health system. Methods: We deployed the 4R intervention in breast and lung cancers at 4 KPNC centers. The intervention encompassed team development and care delivery optimizations enabling teamwork. 4R Care Sequences – novel patient-facing care plans outlining timing and sequence of care – informed team formation, activities and functioning. We assessed intervention along 4 characteristics of high-functioning teams (Vogel JOP 2016). Results: 4R facilitated development of a high-functioning team along all 4 characteristics. (1) We formed an internally and externally recognized multidisciplinary team of 24 specialties who assumed team responsibilities for relevant care. (2) All participants committed to a shared goal of delivering interdependent care at the optimal time and sequence based on Care Sequences. (3) The team conducted 40 optimizations to enable effective interdependent care: 22 in breast, 7 in lung, and 11 in both cancers (Table). The optimizations impacted 6 care domains at 4 points in care continuum. Half of optimizations entailed low effort; 70% resulted in improved process efficiency. (4) An ongoing teamwork adaptation process was established. Conclusions: 4R is an effective and feasible approach to fostering high-functioning teams, which may contribute to improvement of multidisciplinary care delivery and support viability of the oncology workforce. Our intervention and taxonomy of results inform other institutions motivated to strengthen teamwork and improve delivery of complex interdependent care.[Table: see text]
Expanding the role of advanced practice providers (APPs) in cancer clinical trials.
Authors: Williams Erin Fenske , Macchiaroli Alyssa , Bazzell Angela F. , Brucker Edie , Gerber David E
Published: September 2022

60

Background: Advanced Practice Providers (APPs) represent a growing and increasingly important component of the oncology workforce. However, APP roles in clinical research are not clearly understood, and certain policies may limit participation. For instance, National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) historically prohibited APPs from signing orders on CTEP-sponsored studies, even at centers where APPs have antineoplastic privileges allowing them to order cancer treatments as standard therapy or on non-CTEP studies. At the UT Southwestern Harold C. Simmons Comprehensive Cancer Center (SCCC), more than 100 active CTEP-sponsored trials account for approximately 30% of therapeutic enrollment. Given these considerations, we approached CTEP regarding potential policy change. Methods: In early 2020, we raised the issue of disparities in allowed APP delegation between (1) CTEP trials and (2) standard practice and non-CTEP trials to NCI/CTEP leadership. Later that year, CTEP organized a discussion on the topic with SCCC representatives and other stakeholders. Subsequently, NCI deployed a survey to National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) centers asking about the role of APPs at their respective institutions. Results: Following the survey, CTEP revised its policy, allowing appropriately credentialed APPs to sign treatment orders on CTEP-sponsored trials, effective September 1, 2021. After completing required regulatory steps to update trial protocols at UTSW SCCC, approved APPs began signing cancer clinical trial treatment orders in January 2022. Since that time, the proportion of trial treatment orders signed by APPs at SCCC has increased from 1% in January 2022 to 20% in May 2022. Conclusions: The role of APPs in cancer care can be further enhanced by alleviating barriers and allowing providers to perform at the full scope of practice, thereby further integrating care teams critical to compliant and safe clinical trial participation.
Decreases in emergency department and hospitalization visits over 5 years of the Oncology Care Model.
Authors: Jensen Terry Lynn , Mikan Sabrina Q. , Books Holly , Escudier Susan , Pearson Lisa
Published: September 2022

64

Background: In the last five years of the Oncology Care Model (OCM) our community oncology practice developed standardized processes throughout the practice to impact hospital and emergency department (ED) utilization. OCM feedback reports were evaluated and compared to practice baseline data to assess the effectiveness of these interventions in improving patient care. Within the practice continuous tracking allowed for timely reviews and process improvement. Methods: A multimodal triage approach was created, including development of individual patient treatment plans and weekly clinical team huddles where new treatment patients or high-risk patients were discussed. The “Call Us First” campaign was initiated through wallet cards. These cards were provided to patients outlining regimen details and indications for patients seeking urgent or emergent medical care. An improved triage program with Navigating Cancer (NC) reduced call back times to patients regarding patient symptoms and care needs, increased faster symptom management and decreased ED visits. Additionally, nursing check in calls were made to patients after initial chemotherapy treatments and hospital admissions. These statewide programs were rolled out through a systematic process over the first year of the OCM. Results: Admissions for the practice’s OCM patients were 22% in 2015 and decreased to 17% in 2021. For the practice’s OCM population in 2015, the baseline ED visits were 16% and decreased to 14% in late Fall 2021. Home health utilization increased from 17.9% at baseline to 22.3% after five years. Long term care days decreased from 10.7 days to 4.5 days. Skilled nursing facility days decreased from 67.6 days in 2015 to 36.80 days in 2021. By comparison, overall national OCM practices had similar declines in ED visits and hospital admissions. Conclusions: Through OCM participation there were systematic changes reducing ED visits and hospital admissions over five years. We believe that early intervention projects enable patients to avoid ED/hospital visits. Home health care visits may have contributed to less admissions. Patient outcomes were favorably impacted by the practice wide processes guided by the feedback reports. Future iterations of value-based care are undecided, and practices will build on these enhancements.
Impact of biopsychosocial screening program on hospital admissions: Observational study from a Brazilian cancer center.
Authors: Bergerot Cristiane Decat , Bergerot Paulo Gustavo , Molina Lorena Nascimento Manrique , Freitas Alici Natalia de Sousa , Nascimento Karla Lúcia Lucia , Philip Errol James , Lee David , Sacchi Luana , Nazario Jose , Vieira Natalia Barros Salgado , Matos Neto Joao Nunes , Buso Marco Murilo , Soto Pérez de Celis Enrique , Florez Narjust
Published: September 2022

72

Background: The integration of biopsychosocial screening programs (BSP) has been promoted as a way by which to identify unmet needs and to provide tailored treatments to patients. Studies have reported mixed outcomes regarding the impact of such services on hospital admissions during cancer treatment. This study sought to evaluate the effect of a BSP on hospital admissions and length of stay among a large, heterogenous sample of patients diagnosed with cancer (March 2020 to December 2021). Methods: We enrolled consecutive patients diagnosed with cancer receiving treatment at a single institution located in the capital of Brazil. We assessed patients’ characteristics via chart review (e.g., age, sex, histology, hospital admission, length of hospitalization). In addition, as per the BSP protocol, patients were assessed via standardized self-report questionnaires (Distress Thermometer, FACT-G, Patient-Generated Subjective Global Assessment), and appropriate interventions are provided. This program was offered at no cost to all patients and engagement was voluntary. We compared the number of hospital admissions and length of stay between groups (patients who participated in the BSP vs. those who did not). Mixed linear models adjusted for selected characteristics (age, type of cancer and disease stage) were assessed. Results: A total of 1014 patients were included in this analysis. From the total sample, 84% participated in the BSP and 20% were hospitalized for an average of 9 days (ranging from 1-80 days). Mostly patients were female (63%), median age was 63 years old. Breast cancer (26%), hematological (18%), and gastrointestinal cancer (14%) were the most common types of cancer, and the majority had advanced disease (stage III-IV; 67%). Compared to those who engaged in the BSP, patient’s characteristics were well balanced, however, the proportion of patients hospitalized during their cancer treatment was higher among patients who did not participate in the BSP (27% vs 8%: P = 0.001), as was the length of hospitalization spent more days in the hospital than patients who has participated in the BSP (M = 9.5 days vs M = 4.2 days; P = 0.001). Conclusions: Our findings suggest the benefit of a BSP in reducing hospitalizations and length of stay among patients with cancer. An integrated model of care may assist in targeting patient’s unmet needs and may positively impact clinical and hospital-based outcomes. This is the first study to evaluate the effects of a BSP among a Brazilian population using real world data.
Characterizing “no treatment” decisions in patients with advanced-stage cancers.
Authors: Akpoviroro Ogheneyoma , Akpoviroro Oghenetejiro Princess , Yossef Kristena , Castagne Myriam , Rodrigues Elga , Uwandu Queeneth , Bolden Brian , Mirza Wasique
Published: September 2022

76

Background: Cancer (CA) is one of the leading causes of death worldwide. In 2020 CA was the second leading cause of mortality in the US. Novel treatments for various malignancies are discovered each passing year. Despite these advancements, some patients refuse to receive treatment. Our study focused on characterizing the group of patients with advanced malignancies who refused therapy. Methods: We performed a retrospective chart review of patients diagnosed with advanced malignancies, aged 18-75 years, between 01/01/ 2010 and 12/31/2015, who refused any therapy. We used Geisinger Health System’s data. Results: Our search provided 644 patients who met our inclusion criteria. The mean age of patients was 63.2 years (standard deviation (σ) 8.3). Female patients made up 40.4% (260/644), while 59.6% (384/644) were male. Most patients were Caucasian (96.9%, 624/644), 1.9% (12/644) were Black; 0.6% (4/644) were Asian, and 0.6% (4/644) were of unknown racial background. Marital status was evenly distributed with 50.0% (322/644) being married and 50.0% (322/644) being non-married. Most of the study population (52.3%, 337/644) had government-funded insurance at the time of CA diagnosis; 46.6% (300/644) had private insurance, and 1.1% (7/644) had no insurance. Stage 3 disease, according to American Joint Committee on Cancer staging was noted in 21.1% (136/644), while 78.9% (508/644) had stage 4 disease. The mean BMI was 28.2 (σ 8.3). Most patients were either overweight or obese (60.6%, 350/577; 67 patients did not have data on BMI available). A history of cigarette smoking was present in 73.0% (438/600). Adenocarcinomas (323/639, 50.5%) were the most prominent histological subtype. The most common site of malignancy was the respiratory system (220/644, 34.2%). Only 9.6% (62/644) of patients had a history of previous CA, while a family history of CA was present in 29.5% (190/644). Most patients (62.1%, 400/644) had a Charleston Comorbidity Index (CCI) > 5; the mean CCI was 6.4 (σ 3.7). In 17.1% (110/644) a palliative medicine referral was made. Substance use disorders were present in 23.8% (153/644); 14.4% (93/644) had a history of depression, and anxiety 10.1% (65/644). Conclusions: Male patients made up a larger proportion of the group of advanced-stage patients who declined therapy. The racial distribution in this group of patients appeared to reflect the local population. Most patients who refused therapy had stage 4 disease, and they appeared to have severe underlying comorbidities, with an average CCI >5. Despite treatment refusal, a surprisingly low percentage of patients were referred to palliative medicine.[Table: see text][Table: see text]
Use of non-curative oncological care in osteosarcoma.
Authors: McMahon Kevin , Eaton Vincent , Cichon Gregory , Griffin Julia , Dahl Mary , Silberstein Peter T. , McKillip Kate
Published: September 2022

78

Background: Osteosarcoma is the most common form of bone cancer, but the utilization of palliative care (PC) in patients with this cancer has not previously been investigated in the NCDB. Methods: This study retrospectively evaluated the use of palliative care in osteosarcoma patients diagnosed and recorded in the National Cancer Database (NCDB) between 2004 and 2017. Patients were identified by the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) coding, and patients with other malignancies or missing follow-up data were excluded. Cross tabulations with Chi-square analysis were performed to evaluate frequencies of different patient and tumor characteristics. Multivariable logistic binary regression was performed to evaluate relationships between patient and tumor characteristics and the use of palliative care. Results: A total of 7498 patients were analyzed with 2.8% of all patients diagnosed having any form of palliative care utilization. Of this group, 53.37% received PC within the first 12 months after diagnosis. Those receiving PC were most likely to be treated with non-curative surgery, radiation, chemotherapy, or any combination of these modalities (56.7%). No significant increase in PC utilization was noted over the 13-year duration of this study. Palliative care usage was increased in patients with greater tumor diameter, tumors in the bones of the trunk & skull, or stage IV tumors. Palliative care usage was decreased in patients living 25-49 miles of their treatment facility, those living in pacific states, those with chondroblastic osteosarcoma, or those with private insurance. Conclusions: Palliative care use in patients with osteosarcoma increases with tumor stage, tumor size, or more proximal tumors, but overall utilization remains markedly low. Future studies should further define these patterns of care and help expand the utilization of PC.
Associations between insurance status and the cancer clinical trial enrollment process.
Authors: Caston Nicole E. , Lalor Fallon , Wall Jaclyn , Sussell Jesse , Patel Shilpen A. , Williams Courtney , Azuero Andres , Arend Rebecca Christian , Liang Margaret Irene , Rocque Gabrielle Betty
Published: September 2022

85

Background: Most patients with cancer experience multi-leveled barriers to clinical trial participation, potentially including financial concerns due to the complexity surrounding trial-related insurance coverage. Our study sought to understand the association between insurance status and cancer clinical trial eligibility, offer, and enrollment. Methods: This retrospective cohort study included patients with breast or ovarian cancer receiving a therapeutic cancer drug at the University of Alabama at Birmingham between January 2017 and February 2020. Available clinical trials and eligibility criteria were abstracted from OnCore and ClinicalTrials.gov. Patient trial eligibility, offer from provider, demographics, and clinical characteristics were abstracted from electronic medical records. Patient trial enrollment was determined via OnCore. Odds of clinical trial eligibility, offer, and enrollment by insurance status (private, public [Medicaid, Medicare]) were estimated using logistic regression models. Models estimating odds of trial offer and enrollment contained only eligible patients. Models were adjusted for patient age at diagnosis, race and ethnicity, rural-urban residence, Area Deprivation Index, cancer type, and cancer stage (early, late). Results: A total of 513 patients with breast (71%) or ovarian (29%) cancer were included in our analyses. Median age at diagnosis was 60 (interquartile range: 49-67) years; the majority were White (69%) and had early stage cancer (65%). Half of patients had private insurance (54%), and 46% of patients had public insurance (38% Medicare, 8% Medicaid). Patients with private insurance more often had early stage cancer compared to patients with public insurance (73% vs 57%). Almost two-thirds of patients (65%) were eligible for clinical trial enrollment. Of eligible patients (n = 333), 68% were offered a trial and 47% enrolled onto a trial. In adjusted analyses, patients with public vs private insurance had similar odds of clinical trial eligibility (odds ratio [OR] 0.95, 95% confidence intervals [CI] 0.61-1.48), being offered to participate (OR 1.23, 95% CI 0.71-2.14), and clinical trial enrollment (OR 1.13, 95% CI 0.68-1.89). Conclusions: Our results suggest oncologists do not assess trial eligibility or offering a trial based on insurance status, and patients do not differentially participate based on their insurance coverage. Further research is needed to understand implications of trial participation (e.g., out-of-pocket and time costs) for patients covered by differing insurance.
Best practices in achieving patient diversity in oncology clinical trials.
Authors: Curry Andrea , Vidal Gregory A. , Greener Judith R
Published: September 2022

87

Background: The underrepresentation of Black patients in cancer clinical trials in the United States has been well documented. While a multitude of recommendations exist from government organizations, academic institutions, industry sponsors, and commercial groups on approaches designed to increase enrollment, there is a lack of evidence as to the effectiveness of these recommendations in real-world settings. The West Cancer Center & Research Institute (WCCRI), a community oncology center in the greater Memphis, TN area, has consistently conducted trials in which Black patients are well-represented. Of all oncology clinical trials conducted at WCCRI in 2021, Black patients represented 29.9% of the total enrolled population. To further extend the literature on successful methods to achieve greater trial diversity, enrollment tactics used by WCCRI were explored to understand best practices and assess scalability to other oncology centers. Methods: A total of 35 qualitative in-depth interviews were conducted with multiple constituencies associated with WCCRI to obtain a holistic view of clinical trial practices. Interviews were held between March and April 2022. Included were Black patients who participated in a clinical trial, Black patients that declined participation in a clinical trial, caregivers of these patients, WCCRI staff, and community leaders in the Memphis, TN area. All patients interviewed had a history of solid malignancies and were treated at WCCRI between January 2018 and December 2021. The study was considered minimal risk research and all participants provided informed consent before study participation. Results: This research underscored the fact that barriers to enroll Black patients are complex and involve challenges at various structural levels including the system, individual, and interpersonal levels. WCCRI practices were found to incorporate tactics at each of these levels, leading to the ability of this community oncology center to enroll representative proportions of Black patients into its oncology trials. Examples of tactics that reach into the community include coordinating with local leaders to provide residents with health education; outreach by Black WCCRI staff, diverse PIs, and ambassadors to dispel myths about a cancer diagnosis and treatment; and faith-based leaders guiding patients to helpful resources and supportive services provided by WCCRI. Conclusions: Results of this research build upon previous literature that suggest although some success has been identified through interventions at any one level, the greatest opportunity for achieving diversity in oncology trials comes from multilevel interventions. Emphasis should be placed on crafting tactics that simultaneously address factors in each of these levels to consistently achieve enrollment diversity.
Racial disparities among patients with multiple myeloma enrolled in clinical trials.
Authors: Nishat Nabilah , Bari Thoasin , Islam Shahidul , Braunstein Marc Justin
Published: September 2022

89

Background: Tremendous therapeutic progress has been made over the past decade in the field of multiple myeloma (MM). Although the incidence of MM is twice as high for black compared to white individuals, mortality rates remain higher for black patients (Marinac, et al. Blood Ca J 2020). In addition, black Americans are significantly less likely to participate in clinical trials in general (Hong, et al. Am J Prev Med 2021), leading to disproportionate enrollment in studies of novel agents. Various factors may account for these disparities, including access to clinical trials, clinician bias, and hesitancy to enroll in clinical trials among different patient populations. Furthermore, underrepresentation of racial groups within clinical trials impacts the generalizability of important findings from these studies. Here we characterized the racial representation of MM clinical trials. Methods: Randomized clinical trials focused on MM interventions published between 2012-2022 were included. We screened 431 publications during this period and characterized racial demographics as available in the literature. A two-sided Cochran-Armitage Trend Test was used to assess if there was a linear trend in the percentage of black participants in clinical trials over time. Results: Among 431 studies published over the past 10 years, 76 collected over past 5 years that included racial demographic details were included. Among the 38,830 participants, 87.5% were white, 4.8% were black, and 7.7% were other (reported as either “Asian”, “mixed”, or “other”). There was a significant trend toward increased enrollment comparing over time between 2018 to 2021 (2.1 to 7.0%, p < 0.001 for trend), however black individual remained largely underrepresented in all these studies. Conclusions: While the number of black participating in randomized controlled trials involving MM patients over the past five years is significantly increasing, these studies included a disproportionate number of white participants, despite the incidence of MM being higher for black patients. Efforts are underway in the field to enhance enrollment of underrepresented populations, including a recent randomized study that included 19% black MM patients (Richardson, et al. New Eng J Med 2022). Our study was limited due to many trials not reporting details about racial demographics until relatively recently. Further investigations required to examine the reasons underlying racial disparities in MM trial recruitment and enrollment.
Understanding feasibility and patient experiences with a ride share program to facilitate uninsured, Hispanic participation in clinical trials: A pilot survey study.
Authors: Raygoza Jhenitza , Rosenblatt Robert , Austin Jessica , Omar Farhia , Cuellar Idali , Northfelt Donald W. , Pisano Etta , Patel Bhavika K.
Published: September 2022

91

Background: Most screening clinical trials are not representative of the populations susceptible to disparities in breast cancer outcomes. Strategies are needed to address known structural barriers to clinical trial participation. We partnered with a federally qualified health center to provide no-cost ride-share services as a strategy to facilitate enrollment of uninsured, Hispanic women in Maricopa County, Arizona into a national trial offering no-cost mammography screening. Objective: This pilot survey study explored the feasibility and experiences of uninsured, Hispanic women with a no-cost ride share program as part of the National Cancer Institute funded ECOG-ACRIN clinical trial, TMIST, studying mammography screening at the Mayo Clinic Arizona in Phoenix. Methods: Participants completed a validated survey by phone and interview-style. Survey items assessed women’s use of and experiences with the ride share service including barriers, benefits, and if the ride share service facilitated their participation in the screening trial. Descriptive statistics were calculated using SAS. Results: A total of 30 women completed the survey (response rate = 30/33). All women first-time Mayo Clinic trial participants and 90% lived at least 30 minutes away from trial facility. The mean age of women was X years, 90% had a high school degree or less, and 97% were Spanish speaking. Most women (73.7%) said that travel distance was a barrier to participation in prior clinical trials. A large proportion of women (73%) reported using ride share services for this trial and all agreed that the ride service made it easier for them to attend their trial visit. Nearly 1/3 (64%) said that they were uncertain or would not have been able to participate without the ride-share as an option. Among women using the ride share service, the main benefits of the program included at-home pick up and the service being of no-cost. Other benefits included flexible timing (86%) and one-on-one service (86%). The primary barrier of the program was the driver not speaking the dominant native language (27.3%). Conclusions: Despite lengthy travel distances, women reported overwhelming positive experiences with the no-cost ride share program and agreed that the service helped facilitate their participation in the clinical trial. Thus, no-cost ride share programs are a promising and feasible strategy to reduce barriers to clinical trial participation among historically underserved populations. Future studies should continue to explore the benefits and sustainability of ride-share programs, including benefits to clinical trial retention.
Reasons for declining a pharmacist-led telehealth study among oncology patients initiating oral anti-cancer drugs.
Authors: Lichtenstein Morgan RL , Harden Erik , Collins Nicole , Faheem Khadija , Campbell Peter , Patel Khilna , Nguyen Michelle K. , Abramova Rachel , Beauchemin Melissa Parsons , Hershman Dawn L.
Published: September 2022

94

Background: During the COVID-19 pandemic, remote cancer care, and video communication in particular, has become increasingly common in the context of routine visits and clinical trials. Though this medium has the potential to augment patient-provider communication, telehealth also raises concerns about the digital divide promoting disparities in access to cancer care. In this study, we surveyed oncology patients who declined to participate in a pilot study looking at a one-time pharmacist-led video visit for patients initiating oral anti-cancer medications to evaluate their primary reason for declining the intervention. Methods: Between June 2021 and June 2022, we conducted a prospective survey among adult oncology patients at Columbia University Medical Center (CUMC) who declined a pilot study looking at a video visit intervention for patients initiating oral anti-cancer medications to assess the primary barriers to participation. The survey categorized specific reasons for decline into telehealth-related barriers (no access to electronic device, inability to navigate video visits specifically, patient preference for in person care) and trial-related barriers (patient too tired/unwell, no time to participate, not interested in this study specifically, not interested in clinical trial participation in general), and patients were asked to select the primary reason for declining among the list of options. Results: Twenty-three patients completed the survey (82% completion rate). Among 23 respondents, 9 patients (39%) described a technology-related barrier to participation, including 7 (30%) who owned a mobile device with video capacity, but did not know how to use video technology well enough for the visit, 1 (4%) who did not own a device with video capacity, and 1 (4%) who preferred in person visits. Fourteen respondents cited a reason unrelated to telehealth for declining participation, including 7 (30%) who did not feel the study would benefit them, 3 (13%) who did not have time, 2 (9%) who were too tired to participate in a study, and 2 (9%) who were not interested in participating in any kind of clinical trial. Conclusions: Video-based telehealth visits have become increasingly common in routine cancer care and clinical trials. Among oncology patients who declined participation in a pilot study looking at a pharmacist-led video consultation, over a third cited telehealth-related barriers to participation, the majority of whom had a mobile device, but did not know how to use video technology well enough to participate. Focusing efforts on training patients to use technology, particularly video communication, may help address the digital divide in cancer care.
Reasons for declining participation in breast cancer trials among minorities at a safety-net health system.
Authors: Robles Fabian E. , Qureshi Nasir , Unni Nisha , Syed Samira K. , Li Hsiao Ching , Sadeghi Navid
Published: September 2022

95

Background: Despite increasing awareness, racial and ethnic minorities remain under-represented in clinical trials. Understanding patients’ reasons to decline participation can help tailor solutions to improve minority enrollment in cancer trials. Methods: Parkland Health (Dallas County, TX) is a safety-net health system, and affiliated with the UT Southwestern/Harold C. Simmons Comprehensive Cancer Center (SCCC). Over 80% of the breast cancer patients treated at Parkland belong to racial and ethnic minorities. Potential study candidates are referred to the clinical trial support team, which includes a Hispanic bilingual patient navigator. Patients who decline to participate are asked to describe their reasons. Data for screening and accrual to therapeutic breast cancer trials at Parkland between January 2021 and May 2022 is presented here. Results: A total of 193 potential study candidates were referred to the trial support team in the pre-screening phase. Ninety-five patients (49%) were excluded after screening (screen-fails). Of the 98 patients who met all study specific eligibility criteria, 93% belonged to minorities: 69% (68/98) Hispanics and 23% (23/98) Blacks. Thirty-one patients (32%) declined participation in clinical trials. Compared to Hispanics, Black patients were more likely to decline participation: Blacks 65% (15/23) vs Hispanics 19% (13/68); p < 0.0001. Patients' reasons for declining to participate in trials included: lack of interest (14/31), excessive trial requirements such as extra biopsies (8/31), and potential delay in treatment due to additional tests (5/31). Four patients declined participation in a de-escalation trial due to the fear of inferior outcomes with less treatment. Among patients who declined participation, 53% of Blacks and 23% of Hispanics cited lack of interest as the reason (p = NS). Conclusions: We observed a higher participation rate among Hispanics, which may in part reflect the impact of having a bilingual research navigator from the same ethnic background. Lack of interest was a major reason to decline, particularly among Blacks. Strategies focused on patient education and trust are being implemented to further improve minority participation in trials at our institution.
Access to Medicaid dental services and distant-stage oral cancer diagnoses in Utah: A quasi-experimental approach.
Authors: Semprini Jason
Published: September 2022

106

Background: Late detection may contribute to disparities in oral cancer outcomes, as most low-income oral cancer patients are diagnosed at distant stages. Because dentists are the most likely provider to screen for oral cancer, access to Medicaid dental services could improve outcomes. However, states are not mandated to cover adult Medicaid dental benefits. In 2010, Utah’s Medicaid program added dental benefits. My study leverages this policy change to test if dental coverage is associated with distant stage diagnoses and if this association changes with the number of dentists per capita. Methods: I analyzed SEER data for all oral cancers diagnosed between 2007-2013. The outcome is a binary variable, indicating if the oral cancer patient was diagnosed at a distant stage. All analyses control for age, race, and gender as well as state and year fixed-effects. Under a Difference-in-Differences design, where DD = Post2010*Utah, I estimate the effect of adding dental coverage for Medicaid enrollees in Utah compared to Medicaid enrollees in states that did not change their Medicaid program. Then, to account for differential trends, I implement a Triple Differences design, where DDD = Post2010*Utah*Medicaid, and estimate the effect of adding dental coverage for Medicaid enrollees in Utah compared to adults in Utah who are not on Medicaid. Finally, I interact the DDD variable with a variable measuring Utah's dentists per 100,000 population (county-level data from AHRQ). Results: Compared to Medicaid enrollees in other states, adding Medicaid dental coverage in Utah was associated with a decline in the probability of a distant-stage oral cancer diagnosis (DD = -0.046; ci = -0.078, -0.014). The Triple Difference result was similar (DDD = -0.074; ci = -0.107, -0.041). The heterogeneity analysis reveals that the association between adding Medicaid dental coverage and distant stage diagnoses are small and insignificant in Utah counties without dentists. However, the interaction term between adding dental coverage and dentists per capita yields a significant decline for every additional dentist in the county (DDD*Dentists/100,000Capita. = -.001 ci = [-0.002, -0.0009]. Putting these results into context, the marginal effect of adding dental coverage in counties with 80 dentists/100,000 is associated with a 0.104-percentage point decline in distant diagnoses: a 20% decline relative to pre-2010 rates. Conclusions: Access to dental services could improve outcomes for low-income oral cancer patients, but the persistent barriers to dental care may perpetuate disparities.
Multi-level determinants of endometrial cancer diagnosis as experienced by Black women.
Authors: Asad Sarah S , Brewster Wendy R. , Kent Erin E. , Choi Youngjee , Spees Lisa , Birken Sarah A
Published: September 2022

107

Background: Black women experience inequity in access to timely endometrial cancer (EC) diagnosis compared to non-Hispanic white women. Delays in obtaining a timely diagnosis and referral for treatment can amplify poorer outcomes in Black women. Communication between Black patients and providers are likely influenced by determinants at multiple levels (e.g., individual, community, systems). Examining determinants at multiple levels can provide insight on how they influence guideline-concordant EC diagnosis in Black women through patient-provider communication. This study reports on Black women’s EC diagnosis experience, from the time of symptom onset to obtaining a diagnosis. Methods: We conducted a qualitative study using semi-structured interviews guided by the socio-cultural framework for the study of health service disparities (SCF-HSD). We used deductive thematic analysis using codes from the SCF-HSD framework, and inductive thematic analysis for new themes arising in the data. Participants were recruited using a study posting on an online patient research platform associated with an academic hospital in North Carolina. Eligible patients had to identify as Black, English-speaking, aged 40 years or older, and have a diagnosis of EC within the last 3 years. Results: Thirteen Black women with EC participated in online & phone interviews ranging from 22-50 minutes. Participants were primarily between 40-49 years of age (mean age = 45), stage II (100%), and either had private (47%), Medicare (23%) or Medicaid (30%) health insurance. Participants identified determinants at 3 levels: individual (symptom misinformation; delay in seeking support for symptoms - competing needs with work and family; fear and anxiety while waiting for tests and results), community (convenience of primary care clinics; existing relationships with providers; delay in referral by primary care providers; lack of information on testing rationale and expectations), and environment (distance to cancer centers; difficulty in obtaining appointments). Many participants reported that the onus was on them to find a cancer center and oncologist to conduct further diagnostic testing after seeing a primary care provider for their symptoms. When asked whether participants felt they were treated differently (positively/negatively) because of their race, many participants mentioned being Black negatively affected their ability to obtain timely appointments for diagnostic testing (e.g. biopsy, vaginal ultrasound). A few participants specifically mentioned reaching out to Black providers for management of their cancer. Conclusions: Black women with EC report several determinants to timely diagnosis at multiple levels. These findings will be mapped onto implementation strategies in a system-strengthening intervention to improve guideline-concordant diagnosis.
Physician referral patterns and use of adjuvant therapy among patients with stage IB-IIIA non–small cell lung cancer (NSCLC) (2010-2017).
Authors: Kale Hrishikesh , Wang Wei-Jhih , Chirikov Viktor , Shah Anne , Apple Jon
Published: September 2022

114

Background: As the treatment landscape for early-stage NSCLC continues to evolve with the recent approvals of targeted and immunotherapy agents in the adjuvant setting, it is important to understand physician referral patterns and predictors of adjuvant therapy (AT). This study examined physician referral patterns at key treatment phases and assessed predictors of receiving AT in stages IB-IIIA NSCLC patients. Methods: A retrospective study using the linked SEER-Medicare database (01/01/2010-12/31/2017) included patients newly diagnosed with stages IB-IIIA NSCLC who received surgical resection. Specialties were identified by linking NSCLC claims to AMA Physician Masterfile. AT was defined as the use of systemic chemotherapy or radiation therapy within 4 months of surgery. Multivariable logistic regression was conducted to assess predictors of receiving AT. Results: A total of 7,108 patients met study criteria (53% IB; 9% IIA; 19% IIB; 20% IIIA). Primary care physician (PCP) (71%), surgical oncologist (29%), medical oncologist (36%) were the most frequently visited first specialist during pre-diagnosis, diagnosis to surgery, and post-surgery phases, respectively. The median time from diagnosis to surgery was 44 days. After surgery, 74% patients visited medical oncologist (62% IB; 87% IIA; 83% IIB; 88% IIIA). About 41% received AT (21% IB; 64% IIA; 56% IIB; 69% IIIA). Of those, the median time from surgery to adjuvant therapy was 46 days. Later stage at diagnosis and shorter referral time to medical oncologist significantly increased the odds of receiving AT (Table). Conclusions: The strongest predictors of receiving adjuvant therapy were time to medical oncologist post-surgery and stage at diagnosis. Future studies in the era of targeted therapies can use our results as a benchmark to optimize management and outcomes as well as assess changes in referral patterns in IB-IIIA NSCLC patients.[Table: see text]