Prescreening to Increase Therapeutic Oncology Trial Enrollment at the Largest Public Hospital in the United States

2021 ◽  
Author(s):  
Jennifer Wu ◽  
Amin Yakubov ◽  
Maher Abdul-Hay ◽  
Erica Love ◽  
Gianna Kroening ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Income ◽  
Underserved Populations ◽  
The United States ◽  
Public Health Care ◽  
Tumor Board ◽  
Cancer Center ◽  
Therapeutic Trial ◽  
Improvement Program ◽  
Number Of Patients

PURPOSE: The recruitment of underserved patients into therapeutic oncology trials is imperative. The National Institutes of Health mandates the inclusion of minorities in clinical research, although their participation remains under-represented. Institutions have used data mining to match patients to clinical trials. In a public health care system, such expensive tools are unavailable. METHODS: The NYU Clinical Trials Office implemented a quality improvement program at Bellevue Hospital Cancer Center to increase therapeutic trial enrollment. Patients are screened through the electronic medical record, tumor board conferences, and the cancer registry. Our analysis evaluated two variables: number of patients identified and those enrolled into clinical trials. RESULTS: Two years before the program, there were 31 patients enrolled. For a period of 24 months (July 2017 to July 2019), we identified 255 patients, of whom 143 (56.1%) were enrolled. Of those enrolled, 121 (84.6%) received treatment, and 22 (15%) were screen failures. Fifty-five (38.5%) were referred to NYU Perlmutter Cancer Center for therapy. Of the total enrollees, 64% were female, 56% were non-White, and overall median age was 55 years (range: 33-88 years). Our participants spoke 16 different languages, and 57% were non–English-speaking. We enrolled patients into eight different disease categories, with 38% recruited to breast cancer trials. Eighty-three percent of our patients reside in low-income areas, with 62% in both low-income and Health Professional Shortage Areas. CONCLUSION: Prescreening at Bellevue has led to a 4.6-fold increase in patient enrollment to clinical trials. Future research into using prescreening programs at public institutions may improve access to clinical trials for underserved populations.

Pre-screening as a tool for increasing oncology trial enrollment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1577-1577
Author(s):  
Jennifer J. Wu ◽  
Amin Yakubov ◽  
Mohammad Maher Abdul Hay ◽  
Erica Love ◽  
Gianna Kroening ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Income ◽  
Screening Program ◽  
Underserved Populations ◽  
Fold Increase ◽  
Cancer Registries ◽  
Safety Net ◽  
Cancer Center ◽  
Therapeutic Trial ◽  
Improvement Program

1577 Background: Recruiting underserved patients onto therapeutic oncology trials is imperative in light of cancer disparities. Many institutions have increased enrollment with data mining tools that match patients to clinical trials, but such expensive tools are unavailable in a public safety net healthcare system. Methods: The NYU Perlmutter Cancer Center Clinical Trials Office implemented a quality improvement program aimed to increase therapeutic trial enrollment at Bellevue Cancer Center (BCC), an affiliated public hospital. The initiative utilized one employee to manually pre-screen patients via the EMR, cancer registries, and conferences. The program aimed to identify eligible patients for therapeutic trials and those subsequently enrolled. Results: During the two years preceding the pre-screening program, 31 patients were enrolled onto therapeutic clinical trials at BCC. For a period of two years (7/2017-7/2019) following the initiation of this program, 255 patients were identified, of which 143 (56.1%) enrolled onto trials. Of those enrolled, 55 were referred to NYU for trials not open at BCC. Among the 143 enrolled patients, 64% were female, 56% were non-white, and 57% did not speak English (spanning 16 languages). The median age was 55, and the top three disease groups were breast, GI, and thoracic. 83% of our patients reside in low-income areas, with 62% in both low income and Health Professional Shortage Areas (HPSA). Conclusions: Dedicating one employee to screening led to a 4.6 fold increase in accruals, successfully augmenting therapeutic trial enrollment in a healthcare setting with scarce resources, providing broader access to clinical trials for underserved populations.[Table: see text]

Overcoming clinical trial accrual barriers at UPMC: A successful experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14152-e14152
Author(s):  
Vincent Edgar Reyes ◽  
Terry L. Evans ◽  
Robert Alan VanderWeele ◽  
Christopher Ritchie Marsh ◽  
Sajid M. Peracha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Oncology ◽  
The United States ◽  
Cancer Center ◽  
Therapeutic Trial ◽  
Interventional Trial ◽  
Community Oncology ◽  
Community Physician ◽  
Clinical Trial Accrual

e14152 Background: UPMC Hillman Cancer Center Medical Oncology Network is one of the largest integrated community oncology network in the United States. A large gap exists between trial participation rates and the willingness of patients and physicians. There are numerous barriers to clinical trial accrual in the medical oncology community. UPMC identified and created solutions to overcome barriers, and thus dramatically increase clinical trial accrual in 2019. Methods: A physician led advisory board was created to identity problems and find solutions to increase clinical trial accrual in the community. Processes that were implemented in the community to increase physician engagement included identifying more community friendly clinical trials, highlighting high impact clinical trials, and reprioritizing available clinical trials. Also, community physician champions were selected and directly linked with the academic faculty by disease site at UPMC Hillman Cancer Center. Other marketing tools were utilized like a newly developed mobile clinical trial app, community physician dedicated clinical trial retreat, and clinical trial newsletter. High volume community sites were identified as flagship clinical trial accrual centers. Results: With the implementation of physician led initiatives, total (interventional + non interventional) clinical trial accrual increased in the UPMC medical oncology network from 216 in 2018 to 660 in 2019. In 2019 there were 631 interventional trial accruals and 363 therapeutic trial accruals. In 2018 there were only 186 interventional trial accruals and 46 therapeutic trial accruals. Conclusions: The community oncology-directed initiatives created a culture change among the community physicians. UPMC implemented new processes in the medical oncology network that significantly increased clinical trial accrual. [Table: see text]

scholarly journals Social Needs Screening and Referral Program at a Large US Public Hospital System, 2017

2020 ◽  
Vol 110 (S2) ◽  
pp. S211-S214
Author(s):  
Carolyn Berry ◽  
Margaret Paul ◽  
Rachel Massar ◽  
Roopa Kalyanaraman Marcello ◽  
Marian Krauskopf
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Low Income ◽  
Underserved Populations ◽  
Qualitative Evaluation ◽  
The United States ◽  
Social Needs ◽  
Public Health Care ◽  
Care Providers ◽  
Hospital System

Many health care providers and systems are developing and implementing processes to screen patients for social determinants of health and to refer patients to appropriate nonclinical and community-based resources. The largest public health care system in the United States, New York City Health + Hospitals, piloted such a program in 2017. A qualitative evaluation yielded insights into the implementation and feasibility of such screening and referral programs in health care systems serving low-income, minority, immigrant, and underserved populations.

Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 59-59 ◽  
Author(s):  
Matt D. Galsky ◽  
Asma Latif ◽  
Kristian D. Stensland ◽  
Erin L. Moshier ◽  
Russell McBride ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Geographic Distribution ◽  
The United States ◽  
First Line ◽  
Trial Site ◽  
Lorenz Curves ◽  
Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

Factors influencing treatment of inflammatory breast cancer in the United States.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 118-118
Author(s):  
Heather Y. Lin ◽  
Gildy Babiera ◽  
Isabelle Bedrosian ◽  
Simona Flora Shaitelman ◽  
Henry Mark Kuerer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Inflammatory Breast Cancer ◽  
Standard Of Care ◽  
High Volume ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Data ◽  
Number Of Patients ◽  
Facility Level

118 Background: Guidelines for treating inflammatory breast cancer (IBC) using trimodality (chemotherapy, surgery and radiation) therapy (TT) remain largely unchanged since 2000. However, many such patients did not receive TT. It is unknown how patient-level (PL) and facility-level (FL) factors contribute to TT utilization. Methods: Using the National Cancer Data Base (NCDB), patients who underwent surgical treatment of locoregional IBC from 2003-2011 were identified. We correlated patient, tumor, and treatment data with TT. An observed to expected (O/E) ratio of number of patients treated with TT was calculated for each hospital by adjusting for PL factors. Hierarchical mixed effects models were used to assess the proportion of variation in the use of TT attributable to PL and FL factors, respectively. Results: Among 5,537 patients who met the study criteria, the use of TT fluctuated annually (67.3%-75.7%) and was less likely for patients who were over 70, had a lower income or had an N0 tumor (all p < 0.05). By insurance type, TT use was lowest among Medicare patients. Of the 542 hospitals examined, 55 (10.1%) and 24 (4.4%) were identified as significantly low and high outliers for the use of TT (p < 0.05), respectively. While comprehensive cancer centers represented the majority of high outliers, the TT use by facility type overall was not significantly different demonstrating variability within comprehensive cancer center practice. The percentage of the total variance in the use of TT attributable to facility (11%) was almost triple the variance attributable to the measured PL factors (3.4%). Conclusions: The use of standard of care TT varied widely across facilities with some high volume centers clearly underutilizing TT. To improve clinical outcomes for this rare and aggressive malignancy, it is critical to identify facility level factors impacting the use of TT to ensure the guideline adherence of IBC treatment.

Quality assessment of tumor boards across an academic and community cancer network.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 122-122
Author(s):  
Daniel Aaron Roberts ◽  
Robert Stuver ◽  
Igor Schillevoort ◽  
Jessica A. Zerillo
Keyword(s):  
Quality Assessment ◽  
Response Rate ◽  
Gynecologic Oncology ◽  
The United States ◽  
Tumor Board ◽  
Cancer Center ◽  
Measurement Tool ◽  
Tumor Boards ◽  
Assessment Survey ◽  
Cancer Network

122 Background: Cancer tumor boards (TB), or multidisciplinary team meetings are standard of care in oncology care worldwide. Specific components are described by the American College of Surgeon's Commission on Cancer Program. Most data show consistent improvement in outcomes including a change in diagnostic findings, treatment, and possibly improved survival with TBs. Methods: We adapted a performance assessment tool based on a validated survey implemented in the United Kingdom. An initial survey aimed at assessing tumor board structure and design was sent to 21 TB leaders, and subsequently a tumor board quality assessment survey was sent to 175 participants throughout an academic and community network. The quality assessment survey required participants to identify an answer on a 5-point Likert scale in the categories of "very poor, poor, average, good, and very good". Results: TB leaders representing 16 of 21 (response rate 76%) TBs responded to the structure/design survey. Twelve TBs were from the academic center and included diseases such as Gynecologic Oncology, Cutaneous Oncology, Genitourinary Oncology, and Sarcoma, while four were from community sites. TB leaders indicated that 55% of TBs did not receive CME credit and 60% did not document their recommendations. One hundred eleven TB participants of 175 (response rate 63%) responded to the quality assessment survey. Participants identified the following strengths: 1) all relevant subspecialties present for meetings, 2) respectful teamwork and culture, and 3) operating on an organized agenda. Areas for improvement included: 1) inconsistent tumor board recommendation documentation and 2) post-meeting coordination of care. Results were reviewed with network and cancer center leadership as well as with the Cancer Committee. Conclusions: We assessed our own tumor boards across our cancer network by utilizing an adapted version of a validated TB performance measurement tool for the first time in the United States. Through this assessment we identified key areas for improvement including the need for obtaining CME credit for TB attendance, and developed a policy, process, and template for documenting TB recommendations in an easily accessible centralized location.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

scholarly journals Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials

2021 ◽  
Author(s):  
Andrew Hantel ◽  
Marlise R. Luskin ◽  
Jacqueline S Garcia ◽  
Wendy Stock ◽  
Daniel J DeAngelo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Native American ◽  
Acute Leukemia ◽  
Race And Ethnicity ◽  
Disease Incidence ◽  
The United States ◽  
Reporting Requirements ◽  
Number Of Patients ◽  
Hispanic Patients ◽  
Race Ethnicity

Data regarding racial and ethnic enrollment diversity for acute myeloid (AML) and lymphoid leukemia (ALL) clinical trials in the United States (US) are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for US ALL and AML trials from 2002-2017 as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML and 97 ALL trials with results, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML N=6,554; ALL N=4,149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared to NH-white patients after adjusting for race-ethnic disease incidence (AML odds: 0.68, 0.31, 0.75, and 0.83; ALL: 0.74, 0.27, 0.67, and 0.64; all p≤0.01). The proportion of trials reporting race increased significantly after the reporting requirements (44.2 to 60.2%; p=0.02), but race-ethnicity reporting did not (34.8 to 38.6%; p=0.57). Reporting proportions by number of patients enrolled increased significantly after the reporting requirements (race: 51.7 to 72.7%, race-ethnicity: 39.5 to 45.4%; both p&lt;0.001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds: 0.79 and 0.77; ALL: 0.35 and 0.25; both p≤0.01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.

scholarly journals Individualized Molecular Profiling for Allocation to Clinical Trials Singapore Study—An Asian Tertiary Cancer Center Experience

2021 ◽  
pp. 859-875
Author(s):  
Amanda O. L. Seet ◽  
Aaron C. Tan ◽  
Tira J. Tan ◽  
Matthew C. H. Ng ◽  
David W. M. Tai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tumor Tissue ◽  
Molecular Profiling ◽  
Tumor Board ◽  
Cancer Center ◽  
Precision Oncology ◽  
Molecular Tumor Board ◽  
Tumor Types ◽  
Tertiary Cancer Center

PURPOSE Precision oncology has transformed the management of advanced cancers through implementation of advanced molecular profiling technologies to identify increasingly defined subsets of patients and match them to appropriate therapy. We report outcomes of a prospective molecular profiling study in a high-volume Asian tertiary cancer center. PATIENTS AND METHODS Patients with advanced cancer were enrolled onto a prospective protocol for genomic profiling, the Individualized Molecular Profiling for Allocation to Clinical Trials Singapore study, at the National Cancer Center Singapore. Primary objective was to identify molecular biomarkers in patient's tumors for allocation to clinical trials. The study commenced in February 2012 and is ongoing, with the results of all patients who underwent multiplex next-generation sequencing (NGS) testing until December 2018 presented here. The results were discussed at a molecular tumor board where recommendations for allocation to biomarker-directed trials or targeted therapies were made. RESULTS One thousand fifteen patients were enrolled with a median age of 58 years (range 20-83 years). Most common tumor types were lung adenocarcinoma (26%), colorectal cancer (15%), and breast cancer (12%). A total of 1,064 NGS assays were performed, on fresh tumor tissue for 369 (35%) and archival tumor tissue for 687 (65%) assays. TP53 (39%) alterations were most common, followed by EGFR (21%), KRAS (14%), and PIK3CA (10%). Of 405 NGS assays with potentially actionable alterations, 111 (27%) were allocated to a clinical trial after molecular tumor board and 20 (4.9%) were enrolled on a molecularly matched clinical trial. Gene fusions were detected in 23 of 311 (7%) patients tested, including rare fusions in new tumor types and known fusions in rare tumors. CONCLUSION Individualized Molecular Profiling for Allocation to Clinical Trials Singapore demonstrates the feasibility of a prospective broad molecular profiling program in an Asian tertiary cancer center, with the ability to develop and adapt to a dynamic landscape of precision oncology.

scholarly journals Transportation and Other Nonfinancial Barriers Among Uninsured Primary Care Patients

2018 ◽  
Vol 5 ◽  
pp. 233339281774968 ◽  
Author(s):  
Akiko Kamimura ◽  
Samin Panahi ◽  
Zobayer Ahmmad ◽  
Mu Pye ◽  
Jeanie Ashby
Keyword(s):  
Health Care ◽  
Low Income ◽  
Underserved Populations ◽  
Unmet Need ◽  
Care Facility ◽  
Well Being ◽  
Safety Net ◽  
The United States ◽  
Free Clinic ◽  
Transportation Barriers

Introduction: Nonfinancial barriers are frequent causes of unmet need in health-care services. The significance of transportation barriers can weigh more than the issues of access to care. The purpose of this cross-sectional study was to examine transportation and other nonfinancial barriers among low-income uninsured patients of a safety net health-care facility (free clinic). Methods: The survey data were collected from patients aged 18 years and older who spoke English or Spanish at a free clinic, which served uninsured individuals in poverty in the United States. Results: Levels of transportation barriers were associated with levels of other nonfinancial barriers. Higher levels of nonfinancial barriers were associated with elevation in levels of stress and poorer self-rated general health. Higher educational attainment and employment were associated with an increase in other nonfinancial barriers. Conclusion: Focusing only on medical interventions might not be sufficient for the well-being of the underserved populations. Future studies should examine integrative care programs that include medical treatment and social services together and evaluate such programs to improve care for underserved populations.

Sign in / Sign up

Export Citation Format

Share Document