CHICAGO—Expanding the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) within a rural community can increase the number of patients enrolled in clinical trials, results from one of the 16 pilot sites concluded at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
In addition, by affiliating with the NCI-designated Eppley Cancer Institute, the Saint Francis Cancer Treatment Center in Grand Island, Nebraska, enhanced linkage to NCI programs, including cancer care services, Mehmet Sitki Copur, MD, said.
“Community oncologists lack adequate time, resource, infrastructure, and reimbursement to engage in clinical trials,” he noted, adding that although 85% of patients with cancer are diagnosed and treated in the community, only 3% to 5% enroll in clinical trials.
To support clinical trials and delivery of cancer care, in July 2007 the NCCCP awarded 5-year contracts to 16 hospitals in diverse communities nationwide.
For 5 years before (2002-2006) and 5 years after the NCCCP contract was awarded (2007-2011), the Saint Francis Cancer Treatment Center gathered data on clinical trial activities. This included the number of patients in clinical trials, the percent underserved in clinical trials, the number and types of clinical trials available, staffing, collection and storage of tissue samples, organizational structure and linkage to NCI-designated cancer centers, and availability of new cancer care services.
When the before and after data were compared, Copur said the number of patients on clinical trials had increased significantly, from 83 (3.2%) to 640 (23%; P < 0.001, Chi-square).
All patients were rural Nebraskans, and 70% were older than 60 years. Following initiation of the NCCCP program, the number of available clinical trials increased four-fold, from 5 to 40, he said, “with more prevention, quality of life, supportive care, cancer care delivery, biospecimen, and treatment trials.” Clinical trials by sponsorship—cooperative group, industry sponsored, and investigator sponsored—all increased during NCCCP participation.
Nontreatment-type trials increased from an average of 3 to 12 annually (P = 0.009, Wilcoxon), while treatment-type trials increased from 8 to 28 annually (P = 0.015, Wilcoxon). The average patient accrual per clinical trial increased from 13.2 to 15.8 (P = 0.5, Wilcoxon). Also increased was clinical trial staffing, from an average of 1.2 to 3.9 full-time employees (P = 0.012, Wilcoxon), which included the hiring of two nurse navigators/genetic counselors and one smoking cessation counselor/outreach project coordinator.
The collection and storage of tissue samples increased significantly, from 24 (19%) to 330 (52%) (P < 0.001, Chi-square).
Copur concluded by saying the “secret ingredients in this success” included existing prior infrastructure for clinical trials, a hospital-based practice, local hospital and medical community support, strong national network support, NCCCP participation, expanded infrastructure through benchmarking and use of the best practice tools, and a dedicated local team and shared passion for clinical trials.
The Saint Francis Medical Center is a 200-bed regional referral center offering a wide array of specialty services, including a cancer treatment center that serves more than 600 patients newly diagnosed with cancer each year with an additional 21,000 clinic visits. The primary service area is home to 40,595 women and 40,381 men in four counties, Copur said, with a tertiary market that stretches from South Dakota to Kansas and west into the Nebraska panhandle. The majority of Saint Francis’s service area is rural and more than 20% of one of the counties served is Hispanic, 80% of whom have an annual household income of less than $25,000.