Clinical Research Nurses

Dedicated Advocates for Patients on Clinical Trials

June 24, 2009

	Research nurse Sara Simeone manages David Dugan's care while he's on a clinical trial for lung cancer.

When Sara Simeone, RN, talks to a patient about entering a clinical trial, she has one overriding concern—the patient's well-being. "A patient advocate, that's primarily how I describe myself," asserts Simeone, who's one of a special coterie of research nurses at Norris Cotton Cancer Center who manage the care of patients on clinical trials.

"The research nurse is really the person who is the advocate for patients as they go through their research experience," explains Cheryl Carlson, RN, BSN, who oversees many of the research nurses and is a research nurse for patients on neuro-oncology trials. A clinical trial is one of the final steps in cancer research that can result in medical advances for patients, such as a new drug, or a new approach to surgery or radiation therapy. "The only way to increase cure rates is though new therapies," says Marc Pipas, MD, immediate past Medical Director of the Office of Clinical Research. "The clinical trials process is the only way to achieve this goal."

Making the Decision

The backbone of clinical trials is the patients who volunteer. The job of a research nurse is to make sure trials run smoothly and are conducted in the best interests of these patients. David Dugan hadn't smoked in 22 years when he was diagnosed with non-small cell lung cancer in 2007. He was interested in clinical trials from the beginning, and his medical oncologist, Konstantin Dragnev, MD, suggested two. "We were looking at all the possibilities," explains Dugan.

As a research nurse for lung cancer patients, Sara Simeone worked with Dugan from the beginning. "Everyone here has been terrific," he says, "but Sara's the person I see the most." Simeone made sure Dugan and his wife, Margaret, understood what was involved with the trial—the types of drugs, the schedule of treatments, the possible side effects—before he agreed to participate. "Patients hear new information, new words, and they're reeling," says Simeone. "I feel it's really important to give the patient a lot of space to make the decision to join a clinical trial."

After explaining carefully in plain terms the purpose, benefits, and risks of a trial—what's called "informed consent"—Simeone encourages patients to go home and think about it. She wants them to fully understand what they're taking on. Although she has never had a patient withdraw from a trial, she's always clear that's an option.

It Takes A Village

Dugan chose a clinical trial in which two standard drugs were combined with a new one to boost effectiveness, what Simeone calls "making what's already good better." It's one of the most common types of clinical trials. Once patients are on a trial, the research nurse becomes the point person working on the their behalf. Research nurses coordinate communication between a myriad of medical personnel—nurses, oncologists, pharmacists, primary care physicians, researchers, data entry specialists, and social workers. Simeone checks in with Dugan every time he has chemotherapy and is his go-to person when he has a problem related to treatment. When he felt lousy after chemotherapy, she arranged for him to receive fluids at a hospital close to his home near New London. "Sarah's been terrific," says Dugan.

"It takes a village to do a clinical trial," says another research nurse. Research nurses coordinate the sometimes complicated research protocols that define patient care plans. A protocol may involve a complex combination of drugs or a special schedule of treatments. Patients may experience symptoms that are severe or be on a treatment that is their last, best hope. In a single day a research nurse may act as a treatment coordinator, patient advocate, budget analyst, sympathetic listener, and gofer. She or he may even walk down to the special pharmacy where the research drugs are dispensed and hand carry them to a patient. At the same time, the research nurse is constantly making sure the patient maintains a good quality of life. All the research nurses encourage their patients to call whenever they have a concern, however small or inconsequential it might seem at first. "I tell them to call me no matter what, even if it sounds silly," says one of the research nurses.

Simeone enthusiastically agrees. "I'd rather a patient call me and let me be the one to decide if something is a big deal, rather than worrying. I want to know every little thing," she says. Simeone was a triage nurse before "jumping at the opportunity" to apply her skills to research. She manages the care for 50 lung and esophageal cancer patients, half of whom are on active clinical trials. The other half have completed trials but she continues to follow up with them regularly.

A Team of Experts

The Cancer Center offers close to 150 clinical trials that range from chemotherapy regimes and drug combinations to the effects of lack of sleep on cancer patients. Each research nurse is an expert on the trials in his or her specific medical area. Jeanne Popielarz, RN, who has 30 years of experience with research trials, manages follow-up care for clinical trials patients at Norris Cotton Cancer Center at Catholic Medical Center in Manchester, New Hampshire. The expanded Manchester location allows clinical trial patients in the southern part of the state to receive care closer to home.

"I'm very privileged to be given the opportunity to enter these patients' lives at this time," says Simeone, who expresses a common sentiment among the research nurses. "The transformation you can see is remarkable. The strength that they have, I really admire."

—This article was originally printed in Focus (Spring 2008), the newsletter for Norris Cotton Cancer Center.