Congress Abstracts 2005

80

CLINICAL VACCINE TRIALS: LESSONS FOR ONCOLOGY NURSES. Carol Hill, BSN, RN, OCN^®, Emory University, Atlanta, GA; and Karen Ann Anderson, PhD, MSN, RN, CDE, Janelle Bowersox, MSN, RN, and Kia Stokes, BSN, RN, Emory University, Winship Cancer Institute, Atlanta, GA.

For many years chemotherapy agents have been used to treat cancer after surgery or radiation therapy. Over the past several years vaccine therapy has emerged as a promising treatment for many different types of cancer such as melanoma, head and neck, pancreatic, lymphoma, renal cell, and prostate cancers. The rationale for the clinical trial development of vaccine therapy is to determine if the patient’s own immune system can be enhanced to trigger a response to help kill cancer cells. The clinical oncology nurse plays a key role in managing these clinical research trials.

This report discusses the unique challenges presented by vaccine therapy and nursing implications that are exceptionally dissimilar to that of chemotherapy. It is of critical importance to the well being of the patient for oncology nurses to understand how clinical trial vaccines are stored, prepared, administered, and documented.

Vaccines must be given within a strictly specified time after preparation, must be given subcutaneously or intradermally, and most must be given in a non-resected nodal basin. Timing of administration is critical to patient safety and includes frequent monitoring for as long as eight hours after administration. Clinical trial blood draws for pharmacokinetic studies may also be required and must be processed appropriately.

Detailed documentation is important since each vaccine is made specifically for each patient and side effects will vary from patient to patient. Finally, extensive post-vaccine patient education will also be an important part of the vaccine trial administration.

The oncology nurse brings clinical expertise and sound scientific knowledge to the clinical trials setting. The complicated features of a vaccine clinical trial create challenges that oncology nurses need to understand prior to assuming the responsibilities related to vaccine trials. Therefore, it is critical for nurses and nurse managers to avail themselves of educational opportunities that will best support their staff in preparation of vaccine clinical trials. Vaccine clinical trials will soon be a significant part of the oncology nurse experience.