Cutting edge yet close to home: cancer research in the community.

Mr. A is a 67-year-old retired "big city" police officer, now living in a rural area. He was originally diagnosed with prostate cancer four years ago after his nurse practitioner noted rising prostate-specific antigen levels and an enlarged prostate. He underwent a radical prostatectomy with good surgical outcomes at that time. He recently began complaining of upper back pain, and a bone scan revealed multiple lesions on the spine and posterior ribs, consistent with metastatic disease. Mr. A's son, who still resides in a large metropolitan area, urged his father to move back to the city to receive the latest treatments.

[ILLUSTRATION OMITTED]

Mr. A says, "I told him, 'Son, I moved out here to get away from the big city, and my doctor tells me that I can get a lot of the same treatments here as part of a clinical trial. I can even get that new medicine for prostate cancer you sent me an e-mail about right here in town. I'm staying put!'"

Bringing New Treatments to the Community

Patients with cancer want to receive the best possible therapies for their disease. Until every patient can be cured with minimal adverse effects, we cannot be satisfied with the currently available treatments and must continually conduct clinical research trials to test and refine new therapies. However, not all patients are able to travel to large, academic medical centers to participate in studies. Fortunately, community-based research networks can be found throughout the country, offering patients access to new treatment options no matter where they live.

ONS member Lora Wilson, RN, BSN, OCN[R], a research nurse at Oregon Health and Sciences Cancer Institute, has extensive experience in the community setting and can speak to the benefits of providing access to clinical trials to patients outside the academic setting.

"Travel is a significant hardship for folks," Wilson says. "Treatment often takes an entire day, if not two, necessitating hotel costs. And we all know the cost of gas these days! Beyond that, traveling to a far-away facility removes many patients from the support network they desperately need when in the throes of advanced disease. In general, the closer to home patients can be, the better."

Some of the major activities of a research nurse involve connecting physicians and patients with clinical trial options at the right time, offering education about the study to ensure informed consent, and managing patients' clinical needs according to the parameters of the protocol and regulatory requirements.

[ILLUSTRATION OMITTED]

Meeting the Challenges of Community Research

According to Wilson, conducting research in the community (versus academic) setting presents unique challenges. Community-based research nurses frequently oversee activities at multiple physician offices, infusion centers, and hospitals. Being in the right place at the right time can be tough.

"In academic settings," Wilson says, "research staff can usually walk across the street or take the elevator down a few floors to see patients and physicians in person. When working in the community setting, I have made it a priority to attend cancer conferences at different sites whenever possible. Difficult cases are often discussed, and the research nurse may be able to suggest a study."

It's not just the physicians who need to be involved in the research process--the entire clinic staff needs to communicate with the off-site research team for patient safety.

"Reporting adverse events and making dose modifications per protocol is critical to patient safety and research integrity. Because nurses cannot be in several clinics at once, we rely on study sites to report information to us in real time, but this does not always happen. Research staff often learn too late that a dose modification was needed on the day of treatment, or a protocol-driven test was not ordered, potentially jeopardizing patient safety. It is difficult to appropriately monitor protocol activity when sites lack on-site research personnel. Good communication is essential," Wilson says.

[ILLUSTRATION OMITTED]

Programs to Increase Participation

To increase access to clinical trials in the community, the National Cancer Institute (NCI) has developed the NCI Community Cancer Centers Program (NCCCP). This program builds on the 20 years of success of the NCI Community Clinical Oncology Program and is specifically focused on community hospitals. ONS member Kathy Wilkinson, RN, BSN, OCN[R], manager of cancer research at the Billings Cancer Center, an NCCCP site in Montana, notes that her program has grown significantly over time.

"We have grown our program from 40 clinical trial patients in 2003 to 169 patients enrolled last year," Wilkinson says. "We have been doing some phase I trials that have been very challenging, where we have many patients calling and wanting to enroll. Usually you have to go out and search for patients, so we have had to develop a process for handling that aspect."

Participating as an NCCCP site has benefited the Billings Cancer Center in several ways. "It helped us to increase our tracking of patient information in ways we really had not done," Wilkinson says. "When collecting this baseline data, we focused especially on our outreach patient population (the center's oncologists routinely travel to nine rural hospital sites, which are located 120-300 miles away, each month for clinic sessions) to see how we can increase this group's accruals to studies. We've also started using telemedicine for visits where a study requires a physician visit but no physician is available on that clinic day."

[ILLUSTRATION OMITTED]

Some challenges that Wilkinson's team has encountered relate to finances, such as special clinical trials billing issues as well as reluctance on the part of local insurance companies to pay for services for patients participating in a study.

"Medicare requires some special coding, so we must be careful to not charge patients for a drug or something that is provided by the study. This required developing new processes with our billing department. Another barrier has been insurance in Montana--we have more and more patients unable to participate because their insurance denies coverage for clinical trials. We are working with the companies at the state level and are supporting the legislation currently in the Senate (S. 2999)."

Today Mr. A is enrolled in a clinical trial at his local oncologist's office with a new drug provided to him free of charge through a cooperative group study. He notes, "Not only am I feeling great, I'm really happy that I can teach my grown son a thing or two. I can't wait until he comes to visit so I can say 'I told you so' a few more times!"

Types of National Cancer Institute-Designated Clinical Programs

The Community Clinical Oncology Program is a large network that enables participation in clinical trials around the United States. Typical participants include community hospitals and private practices.

The Community Cancer Centers Program is a three-year pilot program targeting community hospital-based cancer centers that offer multispecialty cancer care (medical, surgical, and radiation oncology) under one administrative, medical structure.

Cancer centers generally conduct basic, population sciences, and clinical research and are encouraged to stimulate collaborative research involving more than one field of study.

Comprehensive cancer centers must demonstrate expertise in three areas--laboratory, clinical, and behavioral and population-based research--by conducting early-phase, innovative clinical trials. They also must conduct activities in outreach and education.

Contributing Editor Kristen L. Fessele, RN, MSN, APN-C, AOCN[R], is the associate director for Human Research Services and an advanced practice nurse in the Breast Service at the Cancer Institute of New Jersey in New Brunswick.

[By Kristen L. Fessele, RN, MSN, APN-C, AOCN[R], Contributing Editor]