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Professionals in the field of oncology are faced daily with evidence of how little is known about controlling or eliminating cancer. We see younger women diagnosed with breast cancer, patients with no family history and few symptoms diagnosed with late-stage cancer, and many cancers defying all known treatment. It’s for these reasons many oncology specialists, including oncology research nurses like me, support the merits of clinical trials.

Problems with clinical trials arise, however, because these studies happen in “real life” among cancer patients in hospitals and physicians’ offices and not in a laboratory. The reality of conducting clinical trials places a very heavy demand on physicians who may have to prescribe medications, monitor responses to treatment, and document processes according to very specific, often unfamiliar and time-consuming protocols. The challenge for a research oncology nurse who coordinates clinical trials involves an ongoing process of problem identification and resolution: to permit the continuation of the clinical trial in accordance with its requirements — as long as the best interests of the patient are served.

Most physicians are willing to recommend a patient’s enrollment in a clinical trial if they feel it will support the patient’s treatment. As an oncology research nurse, in coordination with the physician, I take on a large share of record-keeping responsibilities and work closely with physicians to complete required documentation.

It has been challenging to work with physicians to avert problems that might occur following unexpected, nonroutine trial requirements. For example, at Englewood Hospital and Medical Center, Englewood, N.J., we have a patient with inflammatory breast cancer enrolled as a study participant. According to the protocol requirements of the trial in which this patient is enrolled, a blood specimen needs to be drawn both before and after chemotherapy. This requirement could be overlooked because it departs from standard protocol. It’s my responsibility to work with the physician to ensure that the test is prescribed and done on time. This is far from a minor detail. Lack of compliance or sloppy records may result in bad marks and a facility’s being barred from participation by the National Cancer Institute and other sponsors of clinical trials. A detailed schedule is an essential tool for the practical implementation of clinical studies. With this charting, I know which treatments are appropriate for which patients, and when. Compliance also involves a great deal of legwork; I stay in contact with nurses and physicians to make sure things are done correctly.

Directly related to participation in the trial are realistic concerns about the known and unknown side effects. For example, a patient may experience an allergic reaction like anaphylaxis. Other reactions may include problems with cardiac function as a result of receiving chemotherapy, or the patient may experience neuropathy in which the sensation of swelling, numbness, and tingling of the extremities becomes a major health risk. Potential side effects and all other aspects of a trial are detailed in the consent form signed by patients.

Balancing possible adverse reactions with the hope that a new treatment will provide substantial benefit is an understandable cause of stress for patients. In addition, patients set their sights on a specific date for the completion of treatment. When delays occur because of a treatment reaction, their anxiety level is heightened. Besides accurate record-keeping, the research nurse has a relationship with patients enrolled in a trial and a responsibility to help them manage their anxiety.

To respond to the challenges associated with participation in clinical trials, I must forge cooperative relationships with physicians, maintain meticulous patient schedules and hands-on oversight of compliance with clinical protocols, and ensure precise data collection. Most important, I need to nurture patients with cancer as they face uncertainties with the progression of their illness and treatment.

Audrey Ades, RN, BSN, CCRP, is an oncology research nurse at Englewood Hospital and Medical Center, Englewood, N.J.