NEW YORKWith ever more new therapeutic agents in development,
more practitioners are needed to shepherd patients through clinical
trialscoordinating 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
The manual is unique in that it is written from the
With the demand far exceeding the supply of trained professionals to
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
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 NSABPs biostatistical section.