Oncology Nurses Are Playing Key Roles in Clinical Trials

NEW YORK—With ever more new therapeutic agents in development, more practitioners are needed to shepherd patients through clinical trials—coordinating the trials, developing standardized treatment orders, managing symptoms, providing patient education and advocacy, facilitating informed consent, and accruing more patients.

During a Cancer Care Inc. teleconference for health care professionals, a group of nurses who work with patients enrolled in trials discussed the important role that oncology nurses play in the clinical trials setting.

Phase I Trials

Rita Zamek, RN, MSN, CS, a nurse practitioner specializing in oncology, works specifically with patients enrolled in phase I trials at the Cancer Institute of New Jersey, New Brunswick. Since most patients enrolled in phase I trials have had disease progression and symptoms, it is crucial to be able to distinguish between baseline symptoms and side effects from investigational drugs, she pointed out.

Because of her expanded role as nurse practitioner, Ms. Zamek said, she can take a history, do a physical examination, and order diagnostic and laboratory tests and medications. “These capabilities place me in an ideal position not only to assess whether the patients’ experiences are related to a drug toxicity but also to follow through and help the patient deal with the symptoms they are experiencing,” she said.

Patient education starts at or before the first visit to the Cancer Institute. “Once the patient is scheduled to see us, I send the patient a pamphlet that, in general terms, describes phase I trials,” she said. “This gives them the opportunity to become familiar with trials and to start formulating questions.”

At the first visit, the patient meets the physician and the nurse practitioner and, after the history and physical, is given a consent form for the study. The patient returns to the nurse practitioner for follow-up, setting the stage for her to be the main follow-up person in the educational and consent process, which, Ms. Zamek noted, continues throughout the study.

She also works with other members of the phase I team, such as the data coordinator and the treatment nurse, to generate treatment calendars, instructions, and other materials.

Patients are seen weekly, more often if there are problems. “We err on the side of seeing patients more frequently,” Ms. Zamek said.

Patients remain on the study as long as therapy is effective. “If it becomes ineffective, then, many times, they will go on to another phase I study,” Ms. Zamek said. “Therefore, these patient are cared for by us over quite a long period of time, which allows for the development of a close relationship.”

This relationship becomes more important over time because, as patients go through phase I therapies, their options become fewer. “In the end, many of them enter hospice care, and we see them through the hospice program,” Ms. Zamek said. “We continue to strive for better treatments so that hopefully in the future this will not be the case.”

Support to Nurses in NSABP Trials

Jennifer Aikin, RN, MSN, AOCN, is director of the Clinical Coordinating Section of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Pittsburgh-based cooperative trials group. The Clinical Coordinating Section was established to provide support to nurses and clinical research associates who participate in NSABP clinical trials, Ms. Aikin said.

The support is provided via a toll-free line and an e-mail address for clinical questions about studies, and through the preparation of nursing guidelines that accompany each new protocol, as well as through the education of the participating nurses and clinical associates.

Clinical Trials Nursing Manual

The Oncology Nursing Society recently published a manual about clinical trials nursing (available by calling 412-921-7373). It represents the efforts of many nurses, Heidi Ehrenberger, RN, PhD, OCN, said at the Cancer Care teleconference. Dr. Ehrenberger is an oncology nurse and adjunct assistant professor, University of Tennessee School of Nursing, Knoxville.

“The manual is unique in that it is written from the philosophical orientation of the nursing discipline,” Dr. Ehrenberger commented. “It adds to the growing body of literature addressing the contribution of oncology nurses to clinical trials.”

With the demand far exceeding the supply of trained professionals to help patients through clinical trials, she said, “industry and academia, individually and jointly, are beginning to recognize the need to initiate training and internship programs that will create a pipeline of individuals who will take on the challenges.”

“Over the past few years, nurses have become part of the protocol development process,” Ms. Aikin said. “For each new protocol that is developed, a nurse from the Clinical Coordinating Section participates as a member of the protocol team. We bring to this process our understanding of how clinical trials are carried out at the local level as well as our experience as oncology nurses. The nurses also bring their desire to make a protocol document as user friendly as possible and to ensure that the protocol logistics are really feasible in the clinical setting.”

Clinical Coordinating nurses also assist in writing the consent forms, she added. “Our experience in educating patients helps us to communicate risk information as well as the protocol logistics in lay language,” Ms. Aikin said, “and that, in turn, facilitates the informed consent process.”

Once a protocol is developed, the nurse who worked on the protocol team develops a companion document of nursing guidelines. These guidelines outline the practical information that nurses and clinical research associates need as they work with the new protocol.

The guidelines generally include drug specimen collection and shipping. “The focus of the guidelines is symptom management strategies for the symptoms that are most often associated with the protocol agents,” Ms. Aikin said.

Clinical Coordinating nurses also develop patient tools such as patient diaries, calendars, and educational books that outline administration issues, side effects of the agents, and self-care for patients to help them cope with common side effects. And because the nurses take part in the protocol development process, they are able to serve as a clearinghouse of information about symptom management strategies and clinical practice, which they share on the 800 line or by e-mail.

The nurses are also the “first line” in helping participating institutions to sort through adverse reporting requirements, Ms. Aikin said. When more urgent reporting is involved, the reports are referred to nurses in the NSABP’s biostatistical section.