Congress Abstracts 2006

226

AN INNOVATIVE DESIGN FOR IMMEDIATE SUBJECT ACCRUAL FOR RESEARCH. Suzanne Lemler, RN, CCRP, Barbara Thompson, Anita Rush-Taylor, Vivian Murphy, Darlene Christmon, and Nicki Coleman, Indiana University, Indianapolis, IN.

The ability to recruit and conduct a study on a large number of subjects in a clinical trial in an efficient amount of time has been an ongoing challenge.

In order to evaluate the role of polymorphic differences in genes important in the angiogenesis pathway in breast cancer, 1000 women (500 women with history of breast cancer and 500 controls) were required. Although subjects with cancer can be recruited from clinic populations, recruitment of controls is challenging. We estimated total accrual would take months or years at great expense. To minimize resources and to optimize time, Indiana University's (IU) oncology nursing staff, supported by an oncology fellow and a patient advocate, coordinated to obtain subjects for the trial in a single day.

Not applicable.

A 5-page questionnaire (consisting of risk factors, medications, and demographic information) and a 9ml tube of blood (for future DNA extraction and genotyping) were required. Funding sources were recruited to obtain phlebotomy supplies, food for the volunteers, volunteer T-shirts, etc. Location and flow of the study were designed and mapped for the single day event, which took place 5 blocks from the Indianapolis Susan G. Komen Race for the Cure. Over 160 volunteers from a variety of disciplines were recruited to help conduct the trial. Several newsletters were created and an orientation session was presented for volunteer preparation.

On Saturday, April 16, 2005, a total of 855 subjects successfully completed the study over a 5.5-hour period. The majority of women enrolled did not have a history of breast cancer (ratio 7 to 1); therefore, recruitment to complete enrollment for breast cancer survivors continued in the clinics for 2 months with 389 additional subjects (average of 10 subjects per day) enrolled with a final count of 1244 subjects for the entire project.

In conclusion, IU's nursing staff created a model for collecting large groups of subjects in hours rather than months or years. With detailed logistical planning and effort by a committed group of volunteers, biologic samples from a large group of breast cancer survivors and controls can be collected within several hours.