Use Of A Clinical Trials Screening Tool In The Nci Community Oncology Research Program (Ncorp) To Enhance Accrual And Promote Disparities Research.

JOURNAL OF CLINICAL ONCOLOGY(2019)

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摘要
e14587 Background: Despite the identification of multiple patient, clinician, and health systems barriers, accrual to a new generation of cancer clinical trials continues to present challenges. It may be that barrier data is not sufficiently granular. A clinical trial screening tool was developed for use in NCORP to collect trial- and site-specific information as well as broadened demographic data to determine factors that may impact accrual. Methods: The tool was developed with stakeholder input and the NCI Oncology Patient Enrollment Network was used for data input and analyses. Results: From February 2016 to December 2019, 14,340 entries were made in the screening tool. Eighty-two percent of participants consented to participate. Participants screened were female (77%), married (64%) and Caucasian (85%). Fourteen percent of the participants were racial minorities (1% not reported) and 5% were Hispanic or Latino. The mean age was 60 (range 1-95). Thirty-six percent were employed, ≥ 32 hours per week followed by 35% retirees. Income did not vary significantly ( < $25,000(16%), $25,000 - $50,00 (20%), $51,000 - $10,000 (26%), and > $100,000 (19%), and 19% of participants refused to provide income data. Four percent of the participants were uninsured at diagnosis. Seventy-two percent (8,501) of participants screened enrolled in a clinical trial. Of those not enrolled, 49% were ineligible and 48% were eligible but declined to participate. The most common reasons for ineligibility included concurrent disease, abnormal lab or other tests, and patient could not comply with eligibility criteria. The most common reasons eligible participants declined to participate were perception that toxicities were too great and social issues (child care, transportation). Further analysis of the data will include correlation of race/ethnicity, age, income and co-morbidities with enrollment status. Conclusions: The majority of participants approached agreed to participate in the screening tool protocol. Approximately half of the participants were eligible for a trial but declined to participate. These issues will be addressed within the network to enhance accrual. The data collected will also provide opportunities for investigators within the network to develop research questions focused on disparities and clinical trial accrual.
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