Inpatient Hem/Onc Unit Adds Phase I Clinical Trial Program

ORLANDO—When an adjacent hospital closed its research unit with cancer trials pending, the Arthur G. James Cancer Hospital, Ohio State Univesity, Columbus, successfully added a clinical study component to an existing hematology-oncology unit, to ensure that patients could enroll in phase I trials and receive the care they need during their enrollment. Since March 2004, the unit has admitted an average of five study patients each week. Melinda Kiser, RN, MSN, OCN, nurse manager, described the implementation of the program at the Oncology Nursing Society 30th Annual Congress (abstract 228).

The nursing leadership at the James organized a multidisciplinary team to determine patient flow and educate staff about study protocols. The management team meets with nurses before each trial to ensure they understand the study intervention and the laboratory work, monitoring, documentation, and other requirements of the trial (see Table). Each clinical trial patient is assigned a nursing acuity rating based on the study protocol. Care hours include only those times when the nurse is giving medication or drawing follow-up lab work. For the most part, phase I clinical trial patients require one-on-one nursing care during the initial 8 to 12 hours after starting the study. Incorporating the trials into the inpatient unit required the addition of one full-time nurse.

Ms. Kiser's coauthors from the James nursing staff were Kimberly Catania, Susan Schaefer, Donna Madlener, Karen Kuhns, Polly James, and Kris Kipp.