Nurses at Tampa, Fla.’s H. Lee Moffitt Cancer Center & Research Institute care for ill patients, but in the process they also are helping to expand medicine’s knowledge base as part of a research team striving to find effective oncology treatments.Studies rely on nurse researchers, such as Sem Bastien, RN, left, and Karen Maynard, RN, for timely, accurate blood tests.
“When you come to Moffitt, you realize everyone in the hospital is involved in research,” says Karen Maynard, RN, BSN, a staff nurse at Moffitt Institute who has long been interested in scientific study but shied away from becoming a researcher because she enjoys caring for people directly.
As part of the hospital’s mission, all nurses have a stake in advancing medicine’s understanding and treatment of cancer. “Working at a large teaching and research institution gives you the feeling you are involved in changing the standard of care, and that makes you feel very empowered,” says Anna Spanolios, RN, BSN, OCN, a patient care manager at Moffitt Institute.
Hundreds of Moffitt Institute outpatients have enrolled in clinical trials, but some studies require patients be admitted for close observation and frequent blood testing. In the past, these patients were scattered throughout the 162-bed facility, but earlier this year, Moffitt Institute began providing nurses on a hematology/oncology unit with additional education about trials and admitting study participants to that floor.
“It’s exciting, interesting, and a little more demanding,” Spanolios says. “We change staffing as needed if there are a lot of observations. We’ll do one-on-one nursing care with these patients.”
Jeannie Vaughn, RN, MS, OCN, research clinical nurse specialist, has organized the inpatient clinical trial program at Moffitt Institute. She aims to help nurses become more expert in scientific pursuits. Eventually she hopes the hospital develops an inpatient staff committee to review clinical trials before they begin and make recommendations about staffing, which would encourage ownership of the studies and could help in the finance department’s negotiations with trial sponsors.
Preparing nurses to care for clinical trial participants, hospital educators and researchers present sessions about the basics of research involving human subjects. They cover everything from ethical considerations and informed consent to the need for precise adherence to the protocols.
“In the long run, that is necessary to get decent results,” Spanolios explains.
All new hires take a human subjects class as part of their orientation. Vaughn expects current nurses working throughout the facility will have completed it within the next year or so. Research nurses must repeat it annually.
In addition to the general information, Moffitt Institute research coordinators hold in-services to teach nurses, floor pharmacists, and anyone else involved in patient care about the specific protocols for a trial in which a patient will be admitted.
The research nurse provides copies of the chemotherapy order forms and discusses all of the resources that will be needed to manage the patient. The research lab will deliver tubes labeled for the patient in a basket, with the tubes in the order they should be used. If the specimen must be placed in ice, the lab will bring up an ice chest. “They try to provide anything the nurse needs to be able to take care of that patient and do the extra research requirements,” Vaughn says.
The research team also provides a “cheat sheet” — a single piece of paper outlining required nursing care, such as taking vital signs every eight hours for five days, and time points for lab draws.
“It may be a month in between receiving patients for the same trial,” says Vaughn, explaining the need for the quick reference tool. “In the interim, they may have had patients on a different trial.”
Types of trials
All of Moffitt Institute’s current inpatient trials involve pharmaceuticals. Some agents may be completely new. In addition, Food and Drug Administration-approved drugs are tested on different types of cancers. Depending on the trial, patients may stay in-house for as long as six weeks.
Most of the trials involve phase 1 research, which aims to find the maximum tolerated dose for an agent and will typically last a year or less. Vaughn says these trials often try a drug on a small number of patients with a solid tumor, such as those associated with breast, lung, or colon cancer.
“These first studies in people evaluate how a new drug should be given — by mouth, injected into the blood, or injected into the muscle; how often; and what dose is safe,” Vaughn says.
A phase 2 study is more disease-specific than phase 1 and begins to evaluate how well the new agent works. “In phase 2 cancer studies, all patients receive at least the standard of care,” Vaughn says. Patients may get the standard regimen and a randomly selected cohort will also receive the new agent.
Phase 3 trials determine if a new drug or a new combination of drugs is effective. Patients are randomized to receive the standard of care or the new agent or combination to see which works best and has the fewest side effects.
“If they have the same outcome with different drugs, but quality of life is better [with one of the regimens], then that is what you want to start using as the standard,” Vaughn explains.
Phase 2 and 3 trials could stay open four or five years until the last patient has received the treatment and met the outcome measurement. Then researchers analyze the data.
Moffitt Institute has four inpatient trials under way: two for hematologic malignancies, one for myelodysplastic disease, and one for any progressive metastatic malignancy.
The Tampa cancer center is participating in an open-label, phase 1 and 2, multi-center dose escalation study of zosuquidar, daunorubicin (Cerubidine), and cytarabine (Cytosar-U) in patients ages 55 years to 75 years with newly diagnosed acute myeloid leukemia.
The first phase, now complete, aimed to identify dose schedules. Half the patients randomly and blindly received the agent, and the other half did not.
“None of the nurses knew who was getting it,” Maynard said. “In phase 2, everybody gets the drug.” That second phase, now under way, will determine the complete remission rate. Scientists think zosuquidar may help the other two agents kill cancer cells.
For patients with advanced hematologic malignancies, Moffitt Institute is conducting a phase 1 study to determine the safety of CPX-351 and to examine how the body handles this formulation of cytarabine and daunorubicin. In animal studies, CPX-351 was found more active than combinations of the conventional formulations of the two drugs. The trial will determine the maximum tolerated dose and, as secondary measures, evaluate the safety, toxicity, pharmacokinetic parameters, and preliminary efficacy of the agent.
In a phase 1 study of ALT-801, a recombinant fusion protein with an interleukin-2 component, Moffitt Institute is evaluating the clinical anti-tumor response of the agent in patients with progressive metastatic malignancies. The study focuses on safety and toxicity, but secondary measures include tumor and immune response. Interleukin-2 has been found to play a role in tumor control. Patients are admitted to the hospital for two treatment cycles, spaced 10 days apart, and are typically discharged the day after the last infusion.
A phase 2 trial is assessing the mechanism and response of antithymocyte globulin (Thymoglobulin) in patients with myelodysplastic syndrome, a rare, serious bone marrow disease in which the marrow stops making healthy blood cells, producing instead malformed immature cells.
“Thymoglobulin is thought to work by blocking the immune system so that normal cells can grow,” Vaughn says.
Patients receive daily thymoglobulin injections during a four-day hospitalization. They are given oral prednisone two days before hospitalization, throughout their stay, and for 14 days after discharge to limit side effects. Patients are followed up monthly to evaluate medication response.
To understand how the agent is working in the body, nurses must draw blood at exact times, often hourly, after giving the agent. “When you work on a floor as a nurse, you usually have a little leeway,” says Vaughn, explaining that if the pharmacokinetics call for lab work at, say, 9:05, the blood must be drawn at that time, not 10 minutes later, hence the need for one-on-one staffing.
Nurses also must carefully assess their patients and note any possible side effects. “You might be giving a drug for the first time, so every observation becomes imperative,” Spanolios says.
If a patient experiences a bad reaction to the trial agent, the nurse notifies the physician leading the study and participates in finding a solution to the problem.
For example, when a recent patient developed chills and a 104-degree temperature, the team gave the patient the option of withdrawing, which he preferred not to do. The doctor changed the medication given before the test agent, and the patient was able to successfully continue with the trial.
“A lot of times, if they have a reaction to the protocol, they probably go off the protocol,” Spanolios says. “Making sure we save the patient’s life and get him or her back to a stable state is more important [than the study].” Vaughn agrees, saying that Moffitt Institute will not jeopardize patient safety.
After the trial
“This is interesting, watching how people respond and new drugs come to light,” Maynard says. “We haven’t had a lot of new drugs in oncology. We’re basically using the same thing in different doses and combinations. It’s neat. Learning new things makes your work interesting.”
It takes years before an investigative drug passes all the regulatory hurdles for use in clinical practice. Nurses involved in trials often wonder what happened to the agent. The Food and Drug Administration requires an annual review of trials by the Institutional Review Board. Therefore, Moffitt Institute’s research team learns, at least annually, what is happening with the study, but passing that information on to nurses has been spotty.
Not knowing the outcomes is nurses’ main complaint about participating in studies, Vaughn says. To remedy that, Vaughn shares information during annual competency fairs, when all nurses demonstrate their skills, and posts a summary.
Research coordinators attend staff meetings and give nurses updates about whether particular trials are still wending their way through the process or if they were discontinued. The hope that an agent the team has worked with will prove beneficial keeps nurses’ interest up.
“Eventually some of these drugs will change the standard of care,” Spanolios says. “It is an empowering feeling to be part of the advancement in the medical field.”
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