ReCAP: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial and Related Activities at a Community Cancer Center in Rural Nebraska

摘要

AbstractQUESTION ASKED:What is the impact of participating in the National Cancer Institute Community Cancer Centers Program (NCCCP) on the number of clinical trials available, number of patients enrolled in trials, and trial-related services provided to patients at a rural community-based cancer program?SUMMARY ANSWER:Significant increases in the number and percentage of patients enrolled in clinical trials, in the number of available treatment and non-treatment (eg, prevention, biospecimen, cancer control) trials, in clinical trial staffing, and in the number of tissue samples collected and/or stored were observed during the 5-year period of NCCCP. Biospecimen trials helped promote standardization of collection and storage processes in our community cancer program. Employment and utilization of a genetic counselor, smoking cessation counselor, outreach project coordinator, and two nurse navigators enabled delivery of improved cancer care continuum services to our rural patient population.METHODS:SFCTC clinical trial activities data from July 2002 to June 2007, the 5 years before participation in the NCCCP, and from July 2007 to June 2012, the 5 years during the program, were gathered and compared. Data capture included information on the number and percentage of patients on clinical trials, number and type of available clinical trials, percentage of underserved patients in clinical trials, clinical trial staffing, collection and storage of tissue samples, organizational infrastructure, linkage to NCI-designated cancer centers, and availability of new cancer care services. Percentages of patients in clinical trials were calculated as the ratio of the number of patients enrolled onto clinical trials over the number of analytic new patient cases of cancer through our tumor registry per year. Percentages of tissue samples collected and/or stored were similarly measured as the number of biospecimens collected over the number of analytic new patient cases of cancer per year. Statistical analyses were performed using chi-square and Wilcoxon tests.BIAS, CONFOUNDING FACTOR(S), DRAWBACKS:Data 5 years prior to and 5 years during NCCCP were prospectively collected. Analysis of data was performed after the completion of NCCCP.REAL-LIFE IMPLICATIONS:Improving access of all adult cancer patients to clinical trials in the communities where they live is crucial to provide the best cancer care. Participation in the NCCCP had a positive impact on our clinical trial and related activities, providing our rural Nebraska population with enhanced access to both clinical trials and cancer care services. Implementing programs and policies that facilitate the delivery of high-quality care in the community setting is feasible and greatly needed. The NCCCP had a positive impact by providing expanded spectrum of clinical trial types and programs to the population of patients in our cancer program service area.Table 1. Clinical Trial–Related Activities 5 Years Before and During NCCCP at SFCTCTable 1. Clinical Trial–Related Activities 5 Years Before and During NCCCP at SFCTCActivity5 Years Before NCCCP, July 2002 to June 20075 Years of NCCCP, July 2007 to June 2012PFirst Year of NCORP, July 2014 to June 2015No. of dedicated clinical trial staffing (FTE)2 (1.2)5 (3.9).0126 (5)Total No. of accruals (range)83 (9-35)640 (51-230)90Overall participation rate in trials, % (range)3.2 (2-7)23 (9-41) .00118Average accrual No. per clinical trial13.215.8.51.61No. of clinical trials by sponsor (range)????Cooperative46 (5-14)130 (14-29)43????Industry3 (1-2)48 (3-15)5????Investigator initiated5 (0-1)33 (2-10)8????Total54 (6-17)211 (19-54)56No. of clinical trials by type (range)????Total treatment40 (4-14)138 (14-36).01546??Average No. per year828NA????Total nontreatment15 (0-10)61 (3-33).00910??Average No. per year312NA???Supportive care010 (0-10)???Prevention03 (0-1)0???Quality of life4 (0-1)8 (1-2)0???Cancer care delivery07 (1-2)2???Biospecimen10 (2-5)33 (3-9)1Annu