Navigator program for breast cancer trial recruitment and enrollment at a county hospital

598 Background: Only a small fraction of patients with breast cancer are enrolled on clinical trials, fewer from minority and underserved populations. Limited resources in county hospitals accentuate barriers to accrual. Methods: We designed a Patient Navigator program at the Breast Clinic at Parkland Hospital in Dallas, which serves a primarily Hispanic and African American population. Patients were identified at first diagnosis of breast cancer or at the time of recurrence. Demographic and clinical details were entered into a database and appropriate queries and secondary screening were performed to identify candidates to several open trials. At subsequent clinic visits, patients were systematically approached by study coordinators and faculty physicians. The number of eligible candidates, number of patients enrolled and reasons for not enrolling were recorded. Results: The Navigator program was fully implemented in October 2003 and data through October 2004 are presented. A total of 373 patients were screened. Racial/ethnic distribution was African American 45.6%, Hispanic 27.6%, White 20.1% and Asian 4.3%; 38.1% of patients were under age 50 and 5.4% were over 70. Of 373 patients, 308 episodes of eligibility were found (more than one for some patients) and 35 enrollments occurred. Neo-adjuvant trials are a special focus of the research program, and 79 patients were eligible, with 10 patients (12.7%) enrolled. Reasons for not enrolling included patient declining due to study procedures (20%), non-English speaking (21%), patient choice of mastectomy (18%), physician choice of alternate protocol (13%), co-morbidities (10%) and risk of non-compliance (10%). Only 1 eligible patient was not approached. For a node-negative cooperative group trial, 34 candidates were identified and 3 were enrolled (9%), with similar patterns of reasons for not enrolling. Data on additional trials and results by demographic variables will be presented. Conclusions: Implementing a Navigator program results in early identification of clinical trial candidates and can potentially increase enrollment onto clinical studies in a county hospital setting serving minority and underserved populations. Additional educational tools are needed. No significant financial relationships to disclose.