bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of trial site selection on minority patient recruitment in prostate cancer trials.
Authors: Lagor Charles , Bhandari Sudip , Chawla Jitesh , Knight Margot , Mann Jeremy , Mueller Judith , Raska Paola , Southwick Steve , Whyte Warren 
Published: June 2022

1558 Background: Historically, minority patients have been underrepresented in clinical cancer trials. Despite recognition of this problem, trials in the early 2000’s showed a decrease from 10.5% to 6.2% in African American trial participation when compared to trials from the early 1990’s. The drop in trial participation is also reflected in prostate cancer trials, although Black men have a 1.76 higher prostate cancer incidence rate than White men. Using prostate cancer as an example, we investigated the impact of trial site selection on potential minority patient recruitment; thus, overcoming a major system-level barrier to trial access. Methods: We created a prostate cancer cohort by filtering our real-world data sources (CancerLinQ, Electronic Medical Office Logistics) for adult male patients with ICD10 CM code C61* or ICD9 CM code 185 on 1/1/2015 or later (cohort #1). As a pre-requisite for computing site level prostate cancer patient counts, we used claims data to attribute missing site information. Finally, to identify the most promising sites for minority trial recruitment, we ranked sites by the proportion of Black patients and the overall cohort patient count. We repeated the above steps for a subset of cohort #1, which was based on the criteria for trial NCT00887198 investigating the prostate cancer drug abiraterone (cohort #2). Results: The prostate cancer cohort (#1) had 151,261 patients, of which 99,152 (65.6%) were attributed to sites. The percentage of Black patients being treated at the top ten sites ranged from 33.0% to 66.4%, with a median of 45.2% (see table). All ten sites had participated in an interventional cancer trial, and eight had participated in prostate cancer trials. Half of them were community, and half were academic sites. The abiraterone cohort (#2) had 1,267 patients, of which 1,174 (92.7%) were attributed to sites. Among the top ten sites the Black patient percentages ranged from 23.8% to 85.7%, with a median of 39.3%. Conclusions: In an analysis of 17 recent FDA drug registration trials for prostate cancer, Black trial participation ranged from only 1.4% to 6.2%, with a median of 3.0%. In contrast, Black patients being treated at the top sites in our data ranged from 33.0% to 66.4%, with a median of 45.2% (cohort #1). The percentages for the abiraterone cohort (#2) were similar, suggesting that even after applying trial criteria the Black patient percentages remain in the double-digits at top sites. Our results demonstrate that informed trial site selection could have a substantial positive impact on minority patient recruitment. [Table: see text]
A novel support vector machine to predict sentinel lymph node status in elderly patients with breast cancer.
Authors: Hassan Abbas , Tamirisa Nina , Singh Puneet , Offodile Anaeze Chidiebele , Butler Charles E. 
Published: June 2022

1560 Background: Routine sentinel lymph node biopsy in older breast cancer patients with favorable tumor biology is not recommended. However, cases must be evaluated on an individual basis to avoid under or over-treatment. Many nomograms have been developed to calculate the risk of nodal positivity, but machine learning (ML) is a novel tool that may improve the accuracy of nodal prediction. In this study, we developed a support vector machine (SVM) model to delineate factors indicative of sentinel lymph node positivity and refine individualized nodal risk assessment for this heterogeneous patient population. Methods: We conducted a single-institution comprehensive retrospective review of patients 70 years or older diagnosed with unilateral stage I–III primary breast cancer from January 2005 to January 2016. Patient data was partitioned into training and testing sets. A SVM model was developed to predict lymph node status using patients’ demographics, tumor stage, genetic profile, and imaging data. Primary outcome was model performance determined by area under the curve (AUC). Secondary outcomes were accuracy, sensitivity and specificity. Permutation feature importance (PFI) analysis and accumulated local effect (ALE) plots were used to evaluate significant predictors identified by the SVM. Results: We identified 1706 consecutive patients who met the study criteria with a mean age of 76±4.5 years. The plurality of patients were Caucasian (82%), had ER+ (86%), PR+ (70%), HER2- (87%) stage I (72%) breast cancer. Sixteen percent of patients (n = 271) had a positive sentinel lymph node biopsy. The SVM model demonstrated good discriminatory performance for predicting sentinel lymph node positivity with mean AUC of 0.70 (95%CI, 0.62-0.77), mean accuracy of 84% (95%CI, 80-88%), mean sensitivity of 61% (95%CI, 57-66%), and mean specificity of 62% (95%CI, 52-73%). PFI and ALE identified higher disease stage, younger age, family history of breast cancer, margin status, estrogen and progesterone receptor positivity as independently associated with high risk of sentinel lymph node positivity. Conclusions: The proposed ML model accurately identified sentinel lymph node status in older patients with breast cancer. This model holds promise for counselling patients as to the potential risk for node positive disease which may impact surgical and adjuvant therapy recommendations.
Comparative effectiveness of different interventions for cancer-related fatigue delivered digitally by online platforms.
Authors: Kosmidis Paris A. , Deligianni Elena , Kosmidis Thanos 
Published: June 2022

1576 Background: As cancer treatments improve, patients’ quality of life becomes even more important. In parallel, supportive care delivery is increasingly challenging, also due to resource pressures and COVID19. The effectiveness of digital and remote patient support tools as a complementary approach to improve patients’ quality of life is under evaluation. Fatigue is considered among the most prevalent and persistent side effects regardless of tumour type; also, despite ongoing research, there is no single approach established. We compare the effectiveness of different self-care interventions delivered by online platforms to cancer patients in several countries. Methods: Patients report side effects (including Fatigue) on the CareAcross online platforms and receive tailored support to help them improve their quality of life. The supportive material encompasses many topics, and patients may receive several combinations. For Fatigue, different topics (nutrition, hydration, rest etc) were analysed to evaluate effectiveness based on prospectively collected patient reported outcomes. Results: 1456 breast, lung, colorectal or prostate cancer patients from 8 countries (mainly UK, Germany, France, Spain, Italy) reported Fatigue at least once. This analysis focuses on persistent fatigue: 1215 patients reported Fatigue more than once, receiving up to 7 permutations of topics (F1-F7; F4-7 consist of F1-3 combinations). All permutations include the “Physical Activity” topic (see Table). Overall, the “Hydration” topic stands out as consistently linked with the most effective material (all except F3). Comparative analysis between similar combinations shows that those with “Anemia warnings” and “Rest” tend to be more effective (F7>F6). Ambiguously, the “Physical activity before & after treatment”, “Relaxation exercises” and “Fatigue diary” topics contribute to effectiveness (F5>F1), but do not counterbalance absence of the previous 3 (F1>F3). Food-related topics have unclear impact, too: “Food types” is absent from the top combination (F2) where “Food timing” is used; however, that topic is linked with a slightly inferior combination (F7>F5). Conclusions: Fatigue is a complex, multifactorial challenge; digitally delivered interventions can lower its incidence. Hydration appears effective, but the nature of these interventions complicates their thorough evaluation. Randomised studies may enhance these findings and enable additional personalisation towards further quality of life improvements. [Table: see text]
Electronic capture of cancer-related distress in a community oncology program.
Authors: Sanyal Amit , Bowen Heather , Janssen Clemens Walter , Weber Alissa Ashley 
Published: June 2022

1577 Background: Cancer related distress can be seen in as many as one in two patients. Many organizations such as the Commission on Cancer require distress screening. National Comprehensive Cancer Network (NCCN) distress thermometer is a common tool used for screening. We studied feasibility of embedding the NCCN thermometer into oncology electronic health record (EHR) for routine patient care. We concurrently studied feasibility of using a mobile health tool for serial evaluation of cancer related distress. Methods: A flowsheet containing NCCN distress thermometer questions was created in Epic EHR (Epic Systems, Verona, WI). Oncology nurses used the flowsheet for routine patient assessment. Patients with distress level ≥ 4 answered additional questions. Ancillary care providers such as palliative care nurses or social workers addressed the identified needs by providing appropriate ‘services’. A field to capture these interventions was created. We also adapted our previously reported web based mobile tool [1] for monitoring cancer distress. Patients rated their distress on a 1-10 scale and highlighted the distress domain (physical, emotional, practical, family). Distress level ≥ 4 generated a color-coded flag for provider review and intervention. Data from both electronic tools was periodically analyzed to inform patient care and quality improvement. Results: Between January and December 2021, Epic EHR based distress flowsheet collected 28,594 distinct responses in 911 patients. 57.4%, 14.9%, 14.1%, 9.4% and 2.3% of the responses were in the physical, emotional, practical, familial and spiritual domains respectively. ‘Other’ responses were 1.4%. Cumulative frequency of non-physical problems was 42.5%. 1819 ‘services’ were provided with 357 emotional, 351 work, 351 housing, 350 transportation and 350 financial need-based interventions. Of 1231 patients who used the distress scale and provided additional comments, 315 (25.5%) had distress levels ≥ 4. The mobile tool captured 849 unique patient responses to the distress question between April 2020 and February 2022. Distress level ≥ 4 was flagged by 281 unique patients (33.09%). Average distress level was 2.7. Emotional domain problems generated the greatest distress level followed by family, physical and practical problems in decreasing order. Conclusions: We demonstrate feasibility of electronic capture of cancer related distress to facilitate holistic patient care in a community-based oncology program. EHR based and mobile tool distress evaluations generated concordant results. Distress caused by emotional, practical and familial domain problems was nearly as frequent and often more severe than distress caused by physical problems, underscoring the need for comprehensive cancer care. References:Sanyal, A. Mobile health tool for monitoring cancer treatment complications. 2020 ASCO Quality Care Symposium: American Society of Clinical Oncology.
Disparity in initiation of checkpoint inhibitors among metastatic melanoma and lung cancer.
Authors: Li Meng , Liao Kai-Ping Eric , Chen Alice , Wehner Mackenzie , Shih Ya-Chen Tina 
Published: June 2022

1583 Background: Checkpoint inhibitors are transforming cancer care. However, the high prices of these medicines raise concerns over their affordability and disparity in use. The objective of this study is to describe the disparity in initiating checkpoint inhibitors and examine patient- and area-level factors associated with delayed initiation. Methods: This study is a retrospective cohort study using Optum data. We identified commercially insured patients newly diagnosed with metastatic lung cancer and melanoma since the introduction of checkpoint inhibitors in these cancers (lung cancer cohort: diagnosed between January 2015 and December 2020; melanoma cohort: diagnosed between January 2011 and December 2020). Time from metastatic cancer diagnosis to initiating checkpoint inhibitors was analyzed using Cox proportional hazard models. Independent variables included county-level measures (percentage of black population, percentage of Hispanic population, percentage of other minority, percentage of population living below poverty line, rurality, number of medical oncologist per population, and having a National Cancer Institute designated cancer center) and patient-level characteristics (age, sex, Charlson comorbidity index, any dual eligibility, Medicare Advantage, and year of diagnosis). We clustered standard errors at the county level. Results: The percentage of metastatic lung cancer and metastatic melanoma patients on checkpoint inhibitors increased from 23% to 52% from 2015 to 2020 and from 22% to 58% from 2011 to 2020. Counties with greater percentage of black, Hispanics, and other minorities were high urban with greater density of medical oncologists and NCI-designated cancer centers. However, greater percentage of Hispanic population in a county was associated with significantly slower initiation of checkpoint inhibitors for both the lung cancer and the melanoma cohorts (hazard ratios [HR]: 0.937 and 0.946, respectively; p-values: < 0.001 and 0.014, respectively). Percentage of other minority population in a county was associated with slower initiation for metastatic lung cancer (HR: 0.983; p-value: < 0.001). No other county-level factors had a significant coefficient from the multivariate Cox models. In terms of patient-level characteristics, older age, female, more comorbidities, any dual eligibility, and Medicare Advantage were associated with significantly slower initiation for the lung cancer cohort and older age and female were associated with significantly slower initiation for the melanoma cohort. Conclusions: Commercially insured metastatic lung cancer and melanoma patients who lived in counties with greater percentage of Hispanic population had slower initiation of checkpoint inhibitors after their cancer diagnosis, despite the fact that those counties had greater density of medical oncologists and NCI-designated cancer centers.
Reliability of cancer registry primary payer information and implications for policy research.
Authors: Davidoff Amy J. , Enewold Lindsey , Williams Courtney , Bhattacharya Manami , Sanchez Janeth I. 
Published: June 2022

1587 Background: Researchers commonly use “Primary Payer at Diagnosis” measured in cancer registry data to assess the impact of health policy, such as the Affordable Care Act, on insurance, and the impact of insurance on cancer care and outcomes. Measurement error may bias estimated effect size and significance. Little is known about patterns of Medicaid or Medicare misreporting in registry databases commonly used for policy analysis. Methods: We used the National Cancer Institute’s Surveillance, Epidemiology and End Results registry data for adults aged 19-64 years at diagnosis with known cancer stage, linked to most recently available (2007-2011) CMS records on Medicaid and Medicare enrollment at diagnosis month. We recoded the registry Primary Payer variable into 6 categories: private/managed care, Medicare, Medicaid, other government, status unknown, uninsured. State-year policy data regarding Medicaid eligibility and managed care enrollment were also linked. We compared the registry data to Medicaid and/or Medicare enrollment data, and calculated underreporting rates by patient characteristics and state policy. Results: The linked sample (N = 896,031) was 68% non-Hispanic white, 49% male. Overall, the registry data reported 7.8% Medicare and 10.1% Medicaid, while enrollment was 5.5% Medicare, 10.4% Medicaid, and 3.4% dual Medicare-Medicaid. The registry data concordantly identified 61.4% and 57.7% of persons identified per enrollment data to be Medicaid-only and Medicare-only, respectively (Table). Most Medicaid-only enrollees without concordant registry information were reported to have private insurance or be uninsured. Medicaid underreporting (39% overall), was higher for males (43%) vs females (37%), in low (46%) vs high (38%) poverty areas, for Medicaid poverty expansion or waiver enrolled (50%) vs cash assistance related eligibility (33%), and in states with large managed care enrollment, all at p<.001. If Medicaid and Medicare enrollment data were used to edit the registry data, 8% of persons would switch insurance assignment. Conclusions: Primary Payer data reported by cancer registries are subject to measurement error and may result in biased estimates of insurance-related policy impacts. Enhancement with objective Medicaid and Medicare enrollment data will reduce measurement error and may result in unbiased estimates necessary to support policy assessment. [Table: see text]
Responses to telehealth expansion for older adults with cancer during the COVID-19 pandemic.
Authors: Higashi Robin T , Etingen Bella , Cole Suzanne , Mansour John C. , Sweetenham John W. , Lee Jessica L. , Hogan Timothy P. 
Published: June 2022

1591 Background: Synchronous video visits (“telehealth”) were rapidly adopted to facilitate provision of cancer care during the COVID-19 pandemic, with little time to comprehensively assess patient and provider needs. Attitudes toward telehealth use during active treatment (vs. survivorship care) were largely unknown, as were perceptions of, experiences with, and needed support for telehealth use among older adults with cancer. Older adults in particular may face increased vulnerability to inequities in access to care due to limited digital literacy. Methods: We conducted surveys and semi-structured interviews with providers, staff, and older patients (age ≥60) from a comprehensive cancer center. Data collection occurred between Dec 2020 - Nov 2021. Results: We completed a total of 106 provider/staff surveys, 128 patient surveys, 20 provider/staff interviews, and 15 patient interviews. A majority of surveyed providers/staff felt that telehealth should “definitely be offered” during treatment-phase encounters (55.9% treatment follow-up; 69.1% results communication; 70.2% discussing treatment side effects). Similarly, most patients indicated they would be willing to have video visits with a member of their care team for: discussing treatment side-effects (73.5%), results communication (69.6%), and treatment follow-up (65.7%). Patients reported experiencing challenges with joining video visits (29%) and understanding the telehealth process (28%). Similarly, less than a third (30.8%) of providers/staff agreed or strongly agreed that the institution did a good job of preparing patients for their first telehealth encounter. Patients felt the institution should do more to communicate the advantages of telehealth to older adults in handouts and videos, which included: engaging multiple family members in critical appointments (e.g., treatment decisions, end-of-life), seeing their doctor when they were too sick to travel, and reducing potential exposure to infectious disease at the clinic. Participants suggested several strategies to assist patients with limited digital literacy: offering video tutorials of the connection process, creating “fake appointments” to practice online connections, and hiring a digital navigator to assist with technical difficulties and setup of the online portal. Despite challenges, a majority of surveyed patients (65.7%) and providers/staff (76.9%) intend to continue using telehealth after the COVID-19 pandemic passes. Conclusions: Use of telehealth for cancer care was received positively by older patients and providers/staff. Taking targeted steps to enhance implementation could reduce barriers to care, including among older adults and other populations with limited digital literacy, thereby promoting greater equity of access to telehealth benefits beyond the pandemic.
Evaluation of a pharmacist-led video consultation to identify drug interactions among patients initiating oral anticancer drugs.
Authors: Lichtenstein Morgan RL , Patel Khilna , Campbell Peter , Nguyen Michelle K. , Harden Erik , Spivack John , Collins Nicole , Faheem Khadija , Beauchemin Melissa Parsons , Crew Katherine D. , Accordino Melissa Kate , Trivedi Meghna S. , Elkin Elena B. , Hershman Dawn L. 
Published: June 2022

1592 Background: The past decade has seen a dramatic increase in the number of oral anti-cancer drug (OACD) approvals in the United States. Though polypharmacy and drug-drug interactions (DDIs) likely contribute to OACD toxicity, the prevalence of these features in patients on OACDs remains largely unknown. We aimed to evaluate a one-time 30-minute pharmacist-led video consultation among metastatic cancer patients initiating OACDs to identify medication list inaccuracies as well as the prevalence, characteristics, and severity of OACD-related potential DDIs. Methods: We conducted a single-arm, prospective telehealth intervention study among 29 patients initiating OACDs to evaluate a one-time 30-minute pharmacist-led video consultation. The video visits focused on identifying and discussing polypharmacy and potential DDIs, and pharmacists then communicated recommendations to each patient's oncologist. We estimated the prevalence, characteristics (QTc prolongation, absorption interactions, etc.), and severity of OACD-related potential DDIs. Lexicomp and Micromedex were used to assess potential DDIs and measure severity on a standardized scale (A – D, X). In addition, we assessed the prevalence of medication list inaccuracies, polypharmacy, and patient satisfaction. Results: Twenty-five patients completed the intervention (86% completion rate) of whom 40% were 75 years of age or older and 60% were men. The majority were white (68%) and non-Hispanic (76%). Sixteen patients (68%) had a solid tumor diagnosis. Nearly half (48%) were insured by Medicare. The median number of medications per patient was 9 with a range of 4 – 21, and 96% of patients had at least 5 prescriptions listed. The median number of medication list errors was 2 with a range of 0 – 16, with at least 1 error for 76% and more than 1 error for 52% of patients. Pharmacists identified potential OACD-related interactions in 9 cases (40%). These included change in drug absorption or metabolism (7), QTc prolongation (1), hypotension (1), and bleeding (1). Interactions were classified as either category C (8) or D (2), requiring close monitoring or a change in treatment, respectively. All patients expressed a high level of satisfaction with the video visit. Conclusions: Polypharmacy, medication list errors, and potential DDIs are prevalent among patients initiating OACDs despite use of an electronic medical record requiring medication reconciliation. Our study suggests that a one-time remote 30-minute pharmacist-led video consultation can effectively identify and address OACD-related potential DDIs, which may decrease medication complexity and improve adherence in this population.