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Clinical Trials for Cancer
Oncology nurses juggle ethical considerations in clinical trial work.
Posted on:
February 7, 2011
With researchers furiously developing new therapeutic agents for cancer, the role of the nurse in clinical trials is growing in equal proportion.
According to data from the Oncology Nursing Society, as of October 2009, the National Cancer Institute Physician Data Query includes abstracts of more than 8,000 clinical trials that are open and active for patient accrual. This extensive list includes trials for cancer treatment, genetics, diagnosis, supportive care, screening and prevention.
For Katy Bortel, MS, RN, CCRP, clinical research supervisor at Central DuPage Hospital in Winfield, IL, it's a thrill to see today's educated patient come to a meeting with a printout of possible studies from the NIH website http://www.clinicaltrial.gov/.
Even when working with an informed patient, the complexities of clinical trial work are magnified in oncology. This patient population tends to be sicker than those enrolled in the average sleep study. Side effects are a given and don't necessarily occur right away. For many oncology patients, the clinical trial accompanies radiation or chemotherapy and it's often hard to attribute the side effects.
 Because clinical trials can take 10-15 years to complete, nurses develop relationships with patients throughout the course of their treatment regimen. Negative outcomes can be devastating in this line of work, but many nurses report the hope for a cure is the best motivation.
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Ethical Considerations
Any discussion of clinical trials and ethics conjures memories of the Tuskegee syphilis experiment. Today's clinical trial nurses say their ethical conflicts are much less dramatic, but equally sad.
Darilyn Greenhow, BSN, RN, OCN, has been working on clinical trials at Chicago's Rush University Medical Center since 2006. Today, she's involved in a study testing the effectiveness of a vaccine for stage IV melanoma. Her responsibilities include educating patients about the vaccine, coordinating care and ordering study-required procedures.
Though Greenhow feels better able to concentrate on individual patient care than when she worked on an oncology unit, she's also struggled emotionally about her role.
"It's hardest when you're working on a trial with a control arm," Greenhow explained. "Sometimes both the patient and I know they're getting the control. It can be really disappointing when they're hoping to get a new drug. My main conflict is giving treatments that may or may not be the real thing."
For Bortel, most heartache occurs in ensuring it's the patient, not the family, who wants to participate in the clinical trial.
"I've learned to do the consenting process over three or four stages," she said. "The doctor and I always talk to the patients alone and say we know the family's wishes and ask if it's what they want, too."
At any facility, patients always have the option of quitting the trial and pursuing other forms of treatment. If the disease progresses or new side effects appear, the patients are immediately removed from the trial.
Not So Happy Endings
While no clinician would knowingly recruit for a clinical trial that doesn't suit the patient's needs, many still feel a sense of responsibility for involving patients in treatments that could impact the lifespan.
Michele Britto, MS, RN, OCN, CCRP, works at the Kellogg Cancer Center at NorthShore University HealthSystem. Her first during college was at the NIH and she's been involved with clinical trials now for 15 years.
Several years ago, Britto coordinated a melanoma trial at NorthShore that was randomized between a vaccine and interferon. While NorthShore patients were seeing positive outcomes, the trial ended early because patients on the standard arm were having better results. When the NorthShore team called about the disconnect, they learned their findings didn't support the national data.
"We would never give patients an ineffective treatment, but there have been trials where we discovered later that the new drug or treatment under consideration was less effective than standard treatment," Britto said.
NorthShore mostly works in phase II or phase III trials and Britto is a strong believer in the effectiveness of clinical trials as a whole.
"My goal is to learn and understand as much as I can about a trial before proceeding in an effort to provide the best possible care for patients," Britto said.
Changing Cancer Care
In her experience, Britto has been fortunate to see how clinical trials can change the way physicians and nurses practice medicine.
"Some patients participate in clinical trials because it will help and others for altruistic reasons. When I tell them they've changed the standard of care in breast cancer treatment, for example, the look on their faces is one of astonishment."
Robin Hocevar is senior regional editor at ADVANCE.
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