The Nurses’ Role in a Clinical Trial: Everyone Is Involved

By Kristie L. Kahl

Nurses can serve in a variety of roles when it comes to clinical trials — from being a research nurse or a vital piece of the multidisciplinary team, according to Maria Hendricks, MSN, RN.

“Each and every one of you is involved in the care of a research patient. Your role is integral in the success of how we treat our patients moving forward,” Hendricks, director, clinical research operations, Abramson Cancer Center, Clinical Research Unity, University of Pennsylvania in Philadelphia, said during a presentation at the 3rd Annual School of Nursing Oncology.

Clinical Trials

Clinical trials are designed to study new drugs that are not yet approved by the FDA; new uses of drugs that are already FDA approved; new ways to administer the drugs; use of alternative medicines; new tests to find and track different cancer types; and drugs or procedures that alleviate symptoms.

Phase I studies are intended to find a safe dose of the drug, to decide how the new treatment should be given, and to see how the new treatment affects the patient and treats their respective cancer. This phase of studies typically includes 15 to 30 patients.

Phase II studies determine if the new treatment has an effect on a certain type of cancer. They also evaluate how the new treatment affects the individual and their disease. This phase typically involves less than 100 patients.

Lastly, phase III trials are designed to compare the new treatment, or new use of said treatment, with the current standard treatment, with or without placebo. This phase involves anywhere from 100 to several thousand patients.

The multidisciplinary care team on a clinical trial includes a physician (principal investigator or sub-investigator) and an advances practice provider, including:

  • Nurse Practitioner (NP)
  • Physician Assistant (PA)
  • Clinical Research Nurse (RN)
  • Clinical Research Coordinator (CRC)
  • Pharmacist/Pharmacy Technician
  • Biospecimen Coordinator
  • Regulatory Coordinator
  • Research Assistant (RA)

Clinical Research Nursing

As it includes all advanced practice competencies, clinical research nursing involves decision making and concrete thinking.

“It is a key focus of study management, human subject protection, care coordination — which is very complex when it comes to trials. Overall, it contributes to science in addition to using baseline clinical practice knowledge for the support and care of an oncology patient,” Hendricks explained.

In particular, there is a difference between a research nurse and a nurse researcher — roles that often get confused with one another. A clinical research nurse contributes to science with a focus on the care of the research participant and the coordination of research activities in a research practice setting, Hendricks explained. Meanwhile, a nurse researcher provides a significant body of knowledge to advance nursing practice, shape health policy, and impact the health of patients, she added.

The role of the research nurse includes determining consent and screening; eligibility criteria; treatment; grade and attributing toxicities; dose modification; concomitant medications; disease response; and deviation reporting.

“The research team of nurses is a key piece to be aware of. There is some additional training that is required. There is some education around what it is to do good clinical practice when it comes to the care of a research patient,” Hendricks said.

“It is taking a look at financial disclosures. It is making sure there is appropriate training about what happens on the study,” she added.

FirstHealth OK’s Cancer Center Project

October 23, 2020
by Laura Douglass

FirstHealth new cancer center FirstHealth of the Carolinas has approved a key step toward beginning its $68 million cancer center, finalizing interior architectural plans.

The facility, to be built across the street from its campus on Page Road, features a four-story building and adjoining parking deck across the street from Moore Regional’s main hospital campus in Pinehurst.

“The development of the FirstHealth Comprehensive Cancer Center on the Moore Regional campus is a major step forward for patients and families in our community and surrounding areas who are facing a cancer diagnosis,” said Sherwood Blackwood, chairman of FirstHealth’s Board of Directors.

While FirstHealth has a long-standing history of providing exceptional cancer services, the current facilities have been forced to grow and expand to meet the cancer care needs of the community in a less-than-ideal fashion.

“The cancer center will bring together all outpatient cancer treatments and support services into one state-of-the-art facility offering our community the highest quality and patient-centered cancer care right here at home. On behalf of the FirstHealth Board of Directors, we’re thrilled to support this worthwhile project to allow FirstHealth to advance cancer services in our region and continue to fulfill its core purpose to care for people,” he added. “I’d like to thank the many people; staff, volunteers and donors who have helped make this dream a reality. This facility is a game changer for the thousands of people who are affected by cancer.”

FirstHealth of the Carolinas serves 15-counties in central North Carolina. While the region’s population has grown, so too has the cancer rate.

“We feel this is a good time to build a comprehensive cancer center,” said Firsthealth CEO Mickey Foster. “This brings everything together under one roof. It also gives us the space to give multidisciplinary care for our patients.”

Land clearing is already underway for the parking deck and work should be completed in May. Construction of the center itself will begin about that same time frame and should wrap up in late 2022.

Dr. Daniel Barnes, president of FirstHealth Physicians Group presented the final design to hospital trustees on Tuesday.

“This is one of the most significant things FirstHealth has done since the Reid Heart Center and FirstHealth Moore Regional-Hoke campus were built,” Barnes said. “We are starting to see the project evolve and everyone along the way is excited and looking forward to the future and what we can offer.”

To help refine the Cancer Center’s initial design, CPL: Architecture erected to-scale versions of various clinical spaces inside an Aberdeen warehouse. This “cardboard city,” as it was nicknamed, let medical providers, staff and FirstHealth trustees walk-through different parts of the proposed building to better assess the functionality of each space before construction begins.

“It allowed us to come up with innovative ideas,” Barnes said. “We had a significant amount of input through the cardboard city. It helped move along the design process even further. The design really is a compilation of the input of all the various stakeholders in the process.”

The life-sized mock-up should also provide substantial cost-savings over time, he added, as fewer change orders are anticipated. The cardboard rooms were detailed all the way down to where electrical outlets would be installed.

“It is a different approach to design. We’d rather make any small changes now rather than later,” said FirstHealth’s project manager, Cindy Hetzler.

Robin Washco of CPL: Architecture said the to-scale model allowed different departments to better understand how the building would flow from one section to another.

“It is easier to envision the space this way,” she said. “Another goal was also to standardize the spaces, such as exam rooms. That works better from an operational standpoint and a budget standpoint as well.”

Foster said developing plans through the use of a cardboard city model is new for FirstHealth, but considered best practice for a modern, large construction project.

“This has to be one of the most well-thought out plans I’ve seen in my cancer center career,” Foster said.

Laura Kuzma, FirstHealth’s director for oncology support services and patient navigation, also worked closely with the architectural team and surveyed 80 FirstHealth cancer patients to help ensure the final design is also patient-friendly.

The Cancer Center’s healing garden will serve as the building’s focal centerpiece. The infusion chemotherapy area, where many patients spend long periods undergoing treatment, received particular attention. The large open-space includes private, semi-private and communal areas — most within view of an expansive glass window overlooking the healing garden.

“We wanted to create a place that met everyone’s needs, no matter where they are in their (cancer) journey,” Kuzma said.

Foster said the uniqueness of the fourth floor — set aside for patient support services — also differentiates the facility.

“There is an exercise gym for patients, a meditation space, massage spaces, community classrooms where support groups will meet, a patient resource room, palliative care, and this where the nurse navigators will be. They have one of the most important roles in cancer care.”

As a matter of convenience, the four-story adjacent parking garage will provide 500 parking spots with a drop-off area for patients. On the first floor, the new center will have a bistro cafe with healthy drinks, smoothies and other food options for patients and visitors.

Importantly, the new comprehensive cancer center will house FirstHealth’s clinical trials and research program. Initiated first in the early 1990s, the program has expanded with most trials focused primarily on breast cancer, lung cancer, colon cancer and prostate cancer.

Last year, FirstHealth made history twice: enrolling the first patient into a worldwide trial testing the efficacy and safety of immune therapies designed to battle cervical cancer, and as the first health care system in the nation to participate in a clinical study with Intuitive Surgical’s ion endoluminal system, a catheter-based, robotic-assisted technology.

In recent weeks, Moore Regional Hospital made history again as the first site to enroll a patient into a clinical trial for a new regimen to treat COVID-19 patients. Results from the study could be available by the end of the year, according to Dr. Gretchen Arnoczy, an infectious diseases physician with FirstHealth.

Earlier this year, Moore Regional Hospital was named in the top five of the state’s best hospitals, climbing from an 11th place ranking just one year ago. Perhaps more importantly, the flagship facility of FirstHealth of the Carolinas, along with Moore Regional Hospital-Hoke and Richmond campuses, was also recently ranked No. 4 for “patient picks” according to Business North Carolina magazine.

For more information about cancer clinical trials in your area, click HERE

The Pandemic of COVID-19 and its Effect on Clinical Trials in the Community

James Adkins, SCOR co-principal investigator

James N. Atkins, MD Bon Secours Cancer Institute at St. Mary’s & Co-Principal Investigator, SCOR NCORP, Richmond, VA

This story is part of The Cancer Letter’s ongoing coverage of  COVID-19’s impact on oncology. 

This pandemic has affected a lot of people, both physicians and patients, physically as well as emotionally.

There are patients who have become afraid to come into the office to see the staff for fear that they would contract the virus. Our patients seem to have more depression, which may stem from a lack of social interaction.

We have all had our practices turned upside-down, we have gone from face-to-face visits, which we love, to computer-to-computer, or phone-to-phone visits. We have seen physician reimbursement plummet and colleagues stress about their ability to run a private practice.

Physicians have been concerned about their ability to pay the bills as well as their own mortality from this invisible enemy.

We are seeing PTSD in practitioners.

This virus, like cancer, has turned a lot of lives upside-down, and perhaps has shown us what our patients face on a daily basis.

Some patients whom I have seen have been treated on clinical trials in large cities and have been told that they cannot come back to the city for therapy due to the COVID lockdown. They have been referred to our communities to get their clinical trial therapy.

We are treating patients on clinical trials, but they are on trials that we do not have open. This would have been unheard of a few weeks ago. It would be a major protocol deviation, but should it be?  What can we learn—and what should we learn—from this pandemic when it comes to clinical trials and audit time?

Getting patients in to be seen on time (as per protocol) has been more difficult due to patients’ fear about going to the hospital, a doctor’s office or the concerns about social distancing on the way to or in the office.

In the past, we could get tests done when we wanted them—within a day or two. Now, a CT scan will have to be classified as STAT in order to get it done on a certain date.

We would never had ordered it STAT in the past, as it may cost more; but now we have to. With COVID, the x-ray departments have changed their protocols so as to have more time available for COVID patients and to conserve supplies. So our patients who need x-rays are delayed.

Some of our nursing staff may have been furloughed or redeployed due the pandemic as the hospitals are losing money and they are trying to maintain a balance sheet that is already negative.

One of the offices in our NCORP have had their staff furloughed, with just a manager left behind, 6 of 19 offices are trying to do 75% to 90% of their work remotely, and 10 of 19 continue to work in-house.

There has been a significant decline in NCTN accruals to clinical trials over the past month nationally. It also seems that there has been a significant decrease in new cancers over the past month as well. The decrease in cancers is probably due to people being afraid to come to see a doctor—or the procedures to diagnose the cancer is considered elective.

Some of the practitioners, doctors included, are afraid to see patients for fear that they may get the virus from the patients and then get sick or die. We are seeing more patients with virtual visits, and this is good in that it does decrease the exposure of our patients to others. However, this makes documenting for clinical trials more difficult.

Those of us treating patients worry about deviations from protocols and the protocol violations that then occur.

The good thing is that there are people in the clinical trial organizations and the NCI who do understand what’s going on. We believe that the problems of the pandemic will be considered when it is audit time.

We are having problems getting procedures done like colonoscopies for iron deficiency in the older population, and needle biopsies of lung lesions when we need them. We have found that we have to be more insistent on what we want and when we want it, as others may not understand.

I had a patient who needed a lung biopsy after her third cycles of therapy, and radiology was not very happy, because we already had a diagnosis of lung cancer, we had not been clear enough in our request.

We are also having problems getting tests done within the eligibility time window, just getting pulmonary function tests or a Cardiac Echo may take time.

What can we learn from this pandemic? What can we do to make changes that will improve clinical trials in America? Can we have a system where physicians are approved by some organization as being physicians that have demonstrated good practice with clinical trials and those so designated be allowed to work across trials from different sites?

It seems like we have seen a significant drop in accrual to clinical trials over the past year or two, as trials became more precision-based. COVID has just made this worse.

I fear that we are getting down much closer to 1% of adults going on trials not the 3% of the past. Should a patient be able to go 200-400 miles away to get started on a trial and then be allowed to get some or all of their follow-up treatment closer to home if it is agreeable with all the providers?

I think it is worth considering.

The easier we make it for a patient to go on a clinical trial and the easier we make it for their follow-up, the better we will do with accrual and changing the therapy for cancer.

If this is a time for change, then we need to re-evaluate the barriers for patients going on trial.

These may range from a lack of clinical trial training in our training programs, to physician apathy and burnout, ability to open trials due to lack of staff, patient trust, and financial support just to name a few.

We have to decide how important it is and whether we want to try to fix it—or whether the status quo is acceptable.

Copyright (c) 2020 The Cancer Letter Inc.

Dynamic Duo in Pinehurst Appreciates Opportunity to Participate in Clinical Trial

Ken & Betty Hill cancer clinical trial FirstHealth CarolinasPINEHURST– While FirstHealth of the Carolinas has earned widespread acclaim as a national leader in community health, Sandhills residents may not know of a superpower within the system that offers opportunities for patients in the region and worldwide: its extensive clinical trials program.

“FirstHealth offers a wide array of clinical trials that far exceeds the average for regional medical centers,” said Charles S. Kuzma, M.D., institutional principal investigator of clinical trials at FirstHealth of the Carolinas. “Patients who choose to participate in a research treatment opportunity at FirstHealth gain access to new, state-of-the-art treatments before they are widely available to the public. On a broader level, the advances in medicine we enjoy worldwide today are thanks in part to clinical trials as part of medical research.”

In January of 2012, removal of a melanoma from Ken Hill’s skin revealed an additional and different kind of cancer: chronic lymphocytic leukemia (CLL). “When the melanoma was removed, the leukemia cells were attracted to the incision like little Pac-Men,” said Hill, a retired salesperson with Union Carbide and father of three. “I’m lucky I had the melanoma so the CLL was found.”

Between then and 2015, Hill did not undergo treatment for CLL, a type of cancer of the blood and bone marrow, because everything was stable. However, a scan in 2015 discovered otherwise; his blood was 80 to 90 percent saturated with cancerous cells. To fight infection that could happen as a result of a weakened immune system brought on by the CLL, he started infusions of a blood product called intravenous immunoglobulin (IVIg) every 28 days.

His oncologist, Charles Kuzma, M.D., of the FirstHealth Outpatient Cancer Center in Pinehurst, told Hill and his wife Betty of a treatment clinical trial that he might want to consider adding to his IVIg infusions. The clinical trial’s purpose was to determine the efficacy of combining two drugs – a non-chemotherapy drug called ibrutinib taken orally each day and rituximab, a drug administered by infusion.

Ken and Betty determined this would be a good course of action and Ken started the trial. He took ibrutinib every day for a month. Then he added eight infusions of rituximab — one each week for four weeks and then one each month for four months. The rituximab was incorporated into his regular IVIg infusion regimen. Eight months after the last rituximab infusion, a bone marrow scan showed that cancer cell saturation in his blood had reduced to 40 to 50 percent. Now 27 months later his saturation level is 20 to 30 percent. He continues his daily dose of ibrutinib and infusions of IVIg every 28 days, and he will maintain this regimen until his condition changes or the end of the clinical trial in 2025.

“We don’t know the results of the clinical trial, but something is working for him,” says Betty, 80, of her 81-year-old husband.

“We feel blessed that this clinical trial was available in Pinehurst and that Ken was chosen for it,” said Betty, a dynamic partner in Ken’s health. The sponsor of the trial, Alliance for Clinical Trials in Oncology, funded the cost of the ibrutinib.

“When Dr. Kuzma recommended this clinical trial, Betty and I read all the research and I knew it would be good for me,” said Ken. “We’re now advocates for others to participate in a trial.” He and Betty are training to serve on FirstHealth Cancer Services’ Cancer Advocacy Advisory Board, a peer support group sponsored by the Southeast Clinical Oncology Research Consortium.

“We want to be an encouragement for others,” said Betty.


Patients and their families seeking more information about clinical trials at FirstHealth of the Carolinas can visit or talk with the patient’s physician.