"Scientists, Educators, Patient Advocates... Clinical Trial Nurses Play Many Roles " (ONS News, Volume 15, Number 4: http://www.ons.org/xp6/ONS/News.xml/ONS_News.xml/April_2000.xml/Scientists_Educators_Patient_Advocates_Clinical_Trial_Nurses_Play_Many_Roles.xml)

In the 27 years since the signing of the National Cancer Act that established the 'War on Cancer,' there have been innumerable fundamental discoveries about how cancer develops and progresses. These findings provide the blueprint for completely new therapies that exploit the characteristic molecular abnormalities of cancer cells."

--ONS Position on Cancer Research and Cancer Clinical Trials

The U.S. Food and Drug Administration (FDA) estimates that it takes an average of eight-and-a-half years for a new medication to be approved. This time includes laboratory and animal testing, three phases of human clinical trials, and the application process. Although the process is long, it ensures that only "beneficial drugs with acceptable side effects" will be approved.

Barriers other than a lengthy FDA process prevent new cancer treatments from being approved. According to the American Society of Clinical Oncologists (ASCO), "inadequate financial support for data managers and research nurses" is among the top-three barriers that oncologists face when participating in clinical trials. ASCO also reported that only 9% of pharmaceutical clinical trials are devoted to oncology, whereas cardiology clinical trials represent 25% of the research industry.

Oncology nurses also face many challenges. Rita Zamek, RN, MSN, CS, OCN®, is a nurse practitioner in a phase I trial clinic at the Cancer Institute of New Jersey. "Reimbursement and practice issues are still unresolved in New Jersey and impact our practice daily. It is also a challenge to help patients and their families negotiate through a chronic illness in the context of the current healthcare system," Zamek said. "New Jersey is the first state in which insurers have voluntarily agreed to cover the cost of clinical trials," Zamek said. A New Jersey working group issued a report containing three key reasons why the law needed to be passed.

1.  Clinical trials do not cost much more than standard care and, in many cases, cost less.

2.  Patients with life-threatening illnesses deserve increased choices for their care.

3.  If more patients participated in clinical trials, the studies could be completed more quickly, leading to improved care for all patients.

"Another current issue I face is the paucity of patients referred for clinical trials. In our phase I clinic, we see patients after they have received sometimes four or five treatment regimens. By this time, the patient is laden with symptoms related not only to the disease but also as a sequelae of numerous treatments," Zamek said. "Because some of the new therapies utilize a novel approach or are designed specifically to overcome tumor resistance, there is the hope that even for resistant tumors there may be control and/or palliation of symptoms."

ASCO reported that "while it is estimated that 20% of patients are eligible, only about half of those are approached by oncologists to participate in clinical trials and less than half of those (approximately 3%) are actually enrolled."

With such a low percentage of patients with cancer enrolled in clinical trials, programs have been initiated to increase accessibility and to ensure diversity among clinical trial participants. The National Cancer Institute implemented the Community Clinical Oncology Program (CCOP) with the goal of making clinical trials available in communities throughout the United States. Marge Good, RN, BSN, OCN®, is manager of the Wichita, Kansas CCOP. Good said that the patients she works with like the continuity of care they receive as clinical trial participants. "They feel more secure knowing they have a doctor, a research nurse, and a group of national experts reviewing their care and response."

Although many clinical trials study cancer treatment, other types exist. These may or may not include patients with cancer. Cancer prevention, early detection, and quality-of-life clinical trials are also part of cancer research. The nurses at the Wichita CCOP enroll patients in both treatment and prevention clinical trials. According to Good, "the challenge with prevention trials is that we are working out in the community. Some STAR (Study of Tamoxifen and Raloxifene) clinical trial sites have clinics where they see patients, but we go out into the community, mainly to primary-care physicians? offices."

Recruiting potential participants, determining eligibility, and enrolling participants are just a few of the responsibilities oncology nurses have when working with clinical trials. Some clinical trial nurses administer study medications, whereas others do not. Other duties are as varied as obtaining informed consent and monitoring and analyzing data to determine responses and toxicities.

As an adult oncology clinical research coordinator, Denise Dearing, RN, BSN, OCN®, identified and recruited potential patients, obtained informed consent, developed physician order sheets for all arms of the study, administered the study drug, and documented on the case report forms. "Because our program was small, I was responsible for all aspects of the study and patient follow-up," Dearing said, adding that her responsibilities also included all of her administrative work.

Zamek collaborates with other members of a specially designated phase I clinical trials team. As a nurse practitioner within the group, she is involved in all aspects of protocol management, from review of the protocol during the scientific and institutional review processes to the closing of the study and the analysis of the clinical trial data. Zamek said that phase I protocols require close monitoring of patients for toxicity and frequent visits for pharmacokinetic samples. "If the patient presents to the clinic and nursing assessment reveals a problem, then I am called on to assess the patient. It is an advantage having a nurse practitioner because I can do the assessment, order the necessary diagnostic tests and medications, consult with members of the phase I team as necessary, and provide the necessary education to the patient and their family, with the intent of achieving adequate symptom management," Zamek said. "As a team, we provide efficient and safe care to the patient while, at the same time, keeping in mind the integrity of the clinical trial."

Clinical trials also can include nursing research. Heidi Ehrenberger, PhD, RN, adjunct assistant professor at the University of Tennessee-Knoxville, examined the barriers that prevent women from entering clinical trials. "Nursing research often is conducted as a companion study with a treatment trial and primarily looks at quality of life, support, and decision making," she said.

Educating patients and nurses about clinical trials is a key priority for many of the nurses in the ONS Clinical Trial Nurses Special Interest Group (SIG), according to Good, coordinator of the SIG.

Zamek said she would encourage all oncology nurses to become familiar with the concepts of clinical trials so they then can advocate for the inclusion of all treatment options for their patients, including clinical trials as a valid option. "Patients have many questions about participation in clinical trials," Zamek said. "Nurses are in an ideal position to give them clear, concise, and correct information."

In addition to educating other nurses and patients about clinical trials, Good is exploring other avenues. She is trying to encourage clinical trials education as part of the nursing-education programs in her community. She also helps to educate her local media about clinical trials. Good said she takes a proactive approach by contacting her local television station and newspaper when her program has something newsworthy to report. Good said that by relaying the information, she also is able to educate the media and the public about clinical trials.

The media presents varying opinions about clinical trials. The cover story of the October 11, 1999 issue of U.S. News and World Report was titled "Dying for a Cure." NCI responded to the article by pointing out all of the accomplishments of clinical trials and maintaining that the article "portrayed a few tragic cases without presenting a balanced picture of the true risks and rewards of cancer research."

Good said that although the story had little to no impact on her community, she and other nurses at the Wichita CCOP discussed how the article was biased and did not cover a lot of critical issues.

Dearing, an oncology nurse information specialist at the American Cancer Society, said that patients and family members frequently call after learning about a new medication on television news programs such as 20/20 and Dateline. "I acknowledge their need for education and provide them with reliable information about the medication and its stage in clinical trial development." In her role as a patient educator, Dearing educates patients about their specific type of cancer and its treatment, including clinical trials. "I refer people to the NCI Web site and walk them step by step through each page. I teach them how to read the abstracts and encourage them to discuss clinical trials with their healthcare team."

Despite the challenges nurses experience related to clinical trials, they agree that they also come with great rewards.

Zamek said that seeing hope return to the face of her patients and their families is a high point of her job. "Many of our patients come to us describing death sentences that they have been given. We work very hard to try to realistically describe the chance for control of their disease," she said. "With our therapies, we can sometimes provide control of their disease for up to a year. Even though many of my patients transition into hospice, they do so with the sense that they have tried everything."

All nurses play a critical role in clinical trials. As Dearing said, "nurses provide patients with information and are patient advocates and collaborators in the research process along with other scientists."

Editor's note. For responses to the previously mentioned U.S. News and World Report article from ONS President Roberta Strohl, RN, MN, AOCN¬Æ, and ONS President-Elect Paula Trahan Rieger, RN, MSN, OCN®, ANP, FAAN, visit ONS Online (www.ons.org).

Bibliography

http://www.fda.gov/fdac/special/newdrug/testtabl.html

http://cancertrials.nci.nih.gov/understanding/indepth/fda/index.html

http://www.asco.org/people/nr/html/99am/f_pressrelease99.htm