Congress Abstracts 2006

61

DEVELOPMENT OF AN ONCOLOGY SPECIFIC CLINICAL RESEARCH CENTER. Teresa Mazeika, RN, BSN, OCN^®, and Jennifer Guglia, RN, BSN, OCN^®, Dana-Farber Cancer Institute, Boston, MA.

Conducting Phase-1 clinical trials (Ph1CTs) in ambulatory oncology is challenging because they are complex and time intensive. They often require intensive monitoring and pharmacokinetic blood sample collection as frequently as every five-minutes. Oncology nurses provide the care and conduct the tests required during the Ph1CT. By necessity, the care needs of all the patients in a unit take precedence over the data collection needs of the Ph1CT making it difficult to complete the requirements of the trial. Innovative ways of managing Ph1CTs in the ambulatory setting are needed.

The purpose of this abstract is to describe the development of an ambulatory oncology clinical research center (CRC).

Because nurses did not have dedicated time to review the intricate details of the protocol, and pharmacokinetic draws were being missed, the Dana-Farber Cancer Institute (DFCI) opened a CRC. The unit is open 13-hours/day and there are 35-50 Ph1CTs being managed at one time. The nurse-patient ratio is 1:RN to 2:patients; more complex trials may require a 1:1 staffing ratio. Oncology nurses have developed an expertise in the care of patients during Ph1CT. These nurses are skilled in chemotherapy-administration as well as patient- assessment, time-management, and attention-to-detail. Due to the risk of serious side effects, from novel medications, each nurse is ACLS-certified. The nurses work out a pharmacokinetic blood draw schedule for each patient, to coincide with a clinical assistant/runner that transports the specimens to the lab. Weekly multidisciplinary meetings are held with the nursing staff and research teams to discuss patients and operational issues.

Enrollment to these trials has been steady from 596 in 2003 to 598 in 2005. Significant improvement has been seen in the accuracy of data collection. In 2003, research blood samples were often missed on a daily basis. Since opening the CRC, blood samples are missed on average once a month.

Accurate data collection is crucial to the development of new agents to treat cancer. Because oncology nurses are integral in this process, providing nurses with the necessary resources in a designated CRC significantly improves their ability to meet the needs of patients and the research needs of Ph1CTs.