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Clinical Trials at VCU Health Community Memorial Hospital

Adriane Holloway, RN, OCN, CCRP and Vice President of Patient Care Services Mary Hardin, MSN, RN, OCN, NE-BC.

Having access to high-quality health care close to home is important. Having access to clinical trials is something expected in a metropolitan area. But here in rural South Hill, VCU Health Community Memorial Hospital (VCU Health CMH) is currently participating in clinical trials, giving patients access to advanced medical treatments before they are widely available.

Oncology Clinical Trials through VCU Massey Cancer Center

When VCU Health CMH affiliated with VCU Massey Cancer Center in 2012, that not only opened access to award-winning oncology care, but access to one of the largest selections of cancer clinical trials in the state. In addition, VCU Massey Cancer Center is one of only 14 grantees in the country with the National Cancer Institute Community Oncology Research Program for Minority/Underserved (NCORP-MU) community sites. Patients that fit the criteria in South Hill can participate in these trials locally and usually do not have to travel to Richmond.

Currently VCU Health CMH has 31 patients participating in 20 different national oncology studies: early stage and metastatic breast cancer, early stage and metastatic lung cancer, colorectal cancer, urinary cancers and chronic leukemia. The process is highly regulated and involves many pages of paperwork and approvals to ensure patient safety. Treatments range from a few weeks to one year and follow-up can continue for up to 15 years depending on the study.

Massey Cancer Center is currently conducting two studies that are available to VCU Health CMH patients, one on radiation treatment for breast cancer that reduces the number of treatments by half (available in South Hill) and another for breast cancer with the benefits of chemotherapy and immunotherapy before surgery that does require the beginning treatment in Richmond, but then can be completed in South Hill.

Adriane Holloway, RN, OCN, CCRP, is the Clinical Research Nurse Site Manager for VCU Massey Cancer Center. She’s been employed at VCU Health CMH for five years and has 10 years prior experience with administering trials for a Duke affiliate in Henderson, North Carolina. She resides in Franklinton near Wake Forest, North Carolina. Her daily duties include screening patients, consenting, ensuring study visits are scheduled according to the protocol, obtaining study drugs, conducting study labs, performing data entry and maintaining the research chart that is audited by the study groups periodically.

Cancer patients can’t just walk in and say they want to be in a study; it is so much more complicated than that. A large percentage of patients don’t qualify. Adriane meets with a physician each day to review the following day’s patients to see who may be eligible for a study. Some eligibility criteria can be several pages long. Once they find eligible patients, they approach them to gauge interest, obtain informed consent that can be several pages long, and get approval from the VCU Massey Cancer Center clinical trial office research team for that specific study, and then the patient can be enrolled.

During the consent process, Adriane discusses with patients why they were chosen, what other choices they have, risks associated with the study, benefits to their participation, procedures and tests that are required (sometimes including an extra biopsy), side effects and timing of treatments. The process seems daunting, but it gives patients access to drugs, tests and treatment they might not otherwise get.

“For example, one study we are getting ready to begin is the effects of chemo on the heart in breast cancer patients,” Adriane said. Some breast cancer patients experience debilitating fatigue and sometimes are unable to go back to work after completing treatment. “A patient in this study has access to three cardiac MRIs over the course of two years at no charge to them, a test that is not normally done in a standard course of treatment.”

Sometimes the patients in studies have access to new immunotherapies that don’t have the damaging side effects that chemo has. Immunotherapies are drugs that activate the immune system to fight the cancer. VCU Massey Cancer Center has seen great responses in some patients who received immunotherapy, with a few going from stage 4 into remission, and other patients who had an extended period that their cancer remained stable. 

“It’s true that a lot of patients come to us with advanced stage cancer and sometimes trials are good options when all other treatments have been exhausted,” said Adriane. “There are also some treatment trials for early-stage cancer patients, and a few that focus on prevention, wellness, health disparities, distress and reproductive health. Some patients see trials as an extra insurance policy, knowing that they did everything that was available to hopefully prevent the cancer from returning. While patients are helping us to find a cure, the goal is to see patients have beneficial outcomes. Some of the patients make the statement that ‘Even if this doesn’t help me, I hope that it will help somebody in the future.’  All of the cancer treatments we have available today have been possible because patients participated in clinical trials over the years.”

Learn more about oncology clinical trials at MasseyCancerCenter.org or visit VCU-CMH.org for more information about the CMH Cancer Center.

Other clinical trials through the C. Kenneth and Dianne Wright Center for Clinical and Translational Research

Outside of the oncology service line, clinical trials go through the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. VCU Health CMH recently teamed up with the Wright Center to create a monthly Protocol Review and Oversight Committee (PROC). The expert committee reviews current trials and determine which studies are feasible for the rural Southside patient population. Members of this committee include professionals from medical affairs, medical staff, clinical research, laboratory, pharmacy, imaging and nursing.

Vice President of Patient Care Services Mary Hardin serves as the chair of this committee. “We have initiated the oversight committee and are in the infancy of conducting clinical trials in the inpatient setting. We have reviewed several studies on convalescent plasma for COVID patients, Vitamin C for COVID patients and a cardiology trial,” Mary said. “The convalescent plasma was approved for use before we could initiate the trials at VCU Health CMH. Unfortunately, VCU Health CMH could not feasibly implement the Vitamin C trial due to limited nursing resources for the requirements of the trial.”

One Southside resident and COVID-19 survivor, Rebecca Jennings, told her story to VCU Health last summer. She participated in one of the first trials that arrived at VCU Health CMH. “You're not going to get anywhere with cures if you don't have clinical trials,” she told VCU Health.

The cardiology study is currently under review. Mary Hardin said, “One of our main goals is to ensure appropriate personnel resources are available for the safe, compliant, and successful conduct of clinical research projects. We have protocols in place to align with VCU Health’s Institutional Review Board for compliance with the Office for Human Research Protections.”

The clinical trial landscape is constantly changing, and new studies are reviewed each month. VCU Health CMH will continue to review appropriate studies and keep the community informed of the latest news.

In 2020, Virginia Commonwealth University was awarded $335 million for sponsored programs in research. VCU Health CMH is proud to be included in the breakthrough studies made available to residents of southern Virginia and northern North Carolina.

Learn more about clinical trials at C. Kenneth and Dianne Wright Center for Clinical and Translational Research or visit VCU-CMH.org for more information about VCU Health CMH.