In 2019, researchers at Wake Forest University School of Medicine received a 6-year, $25 million grant from the National Cancer Institute’s Community Oncology Research Program (NCORP) to continue and expand practice-changing cancer research to improve patient outcomes.
The Wake Forest NCORP research base is 1 of only 7 in the country, and those research bases partner with the 46 NCORP community and minority underserved community sites across the country. Researchers work to develop, implement and manage various research studies relating to cancer care delivery and detecting, treating and preventing cancer-related symptoms. Since 2019, the Wake Forest NCORP research base has had an average of eight studies running at any given time, with a maximum of 11 simultaneous studies.
Not even the changes brought on by 2020 and the COVID-19 pandemic could stand in their way. Slow some things down and necessitate changes in their processes? Yes. Stop their progress? Not a chance.
|“We’re interested in the problems our patients face and solutions to those problems. And we’ll look at drugs, at devices, at other approaches and at health system-type changes. We’re willing to look broadly to find solutions.” - Glenn Lesser, MD, professor of Hematology and Oncology|
Kathryn Weaver, PhD, professor of Social Sciences and Health Policy at the School of Medicine and co-principal investigator and cancer care delivery research lead for the Wake Forest NCORP research base, reported that by the first quarter of 2023, they have recruited nearly 2,000 oncology patients to 12 different research studies. These enrolled patients come from 173 locations and represent 48 states and Puerto Rico.
“There has been a fundamental and seismic shift and change in how clinical trials are perceived and carried out,” said Glenn Lesser, MD, the Louise McMichael Miracle Professor in Oncology at Wake Forest University School of Medicine and co-principal investigator for the research base. “The successes we’ve had in that setting and its challenges is a pretty important accomplishment.”
Lesser and Weaver credit the entire Wake Forest NCORP team for both the work accomplished and the conditions in which they’ve done so for the past three years. Through a myriad of challenges, Weaver pointed out that, like everything else, research had to find alternate ways to gather information and deliver interventions. Those included completing questionnaires online, signing consent electronically, examining what biospecimens were truly necessary and developing protocols for safe collection.
“Many of those pivots or changes can create new issues or concerns that might not have been present when a patient was seen in a doctor’s office,” said Lesser. “The use of technology has been wonderful but not everyone has access and not everybody is comfortable with it, so some of the disparity issues that we are researching might be exacerbated by these kinds of pandemic-induced changes and a shift to virtual care. Every solution engenders new questions and new issues to be dealt with.”
As well as challenges brought on by the global pandemic, the past four years have produced many highlights for the research teams. One example is the Optimizing Lung Screening (OaSiS) trial, which was published in the CHEST journal in March 2023. OaSiS evaluated opportunities and strategies for implementing smoking cessation support to patients who receive lung cancer screening. Offering such support is a Centers for Medicare and Medicaid Services requirement, but it’s difficult to implement and to know how well strategies succeed. The Wake Forest NCORP worked closely with 26 sites to test a package of strategies, analyze the workflow in the clinics, look at the resources available and then see what worked.
“We took an idea – about implementation of guidelines that are known to work but not done effectively or efficiently – and developed a novel set of implementation strategies, then went out to sites and worked with them,” said Lesser. “I think that's the lifecycle of what we do: have an important idea, then do it relatively quickly and well.”
Importantly, said Weaver, investigators didn't stop at publishing a paper in a high-impact journal and getting the word out to academics.
“They really did a beautiful job of distilling what we learned to the end users and making sure that information was widely available,” she said. “They created a toolkit for community oncology practices, and they put it out on a publicly available website, and I give them enormous credit for doing that.”
Other key highlights include two cardio-oncology studies looking at the incidents, implications and physiology of cardiovascular toxicity from breast cancer therapy. One was a cohort study looking at cardiac MRI and cardiopulmonary exercise testing to examine underlying mechanisms of fatigue as well as the cardiac damage that breast cancer patients may or may not get from their therapies. The second was an intervention to see if a statin, one of the common lipid-lowering drugs, could eliminate or minimize known cardiotoxic effects of a class of chemotherapy called anthracyclines. Results from both studies have been published in numerous journals, including the New England Journal of Medicine Advances.
|“When we design something – a study, an intervention, an approach for oncology care delivery – that ultimately will be broadly accessible, we include the providers from those diverse community settings and get input from them all along the way. The result is, hopefully, that we come up with good answers that can be rapidly taken and used in actual practice.” – Kathryn Weaver, PhD, professor of Social Sciences and Health Policy|
Lesser also mentioned a study examining what effects, good or bad, acupuncture has on xerostomia, or dry mouth, caused by radiation for head and neck cancer. Although results have not yet been published, he says the study underscores the nature of what the Wake Forest NCORP research base does.
“We’re interested in the problems our patients face and solutions to those problems,” Lesser said. “And we’ll look at drugs, at devices, at other approaches and at health system-type changes. We’re willing to look broadly to find solutions.”
Embodying the academic learning health system
That flexibility is crucial to a vital aspect of Wake Forest NCORP’s work: being functional and “real-world applicable” in the communities where patients are treated.
Lesser said about 85% of cancer patients are cared for in a community setting instead of a large academic or comprehensive center, and that includes people in rural and urban settings, of all ages, socioeconomic brackets and ethnicity, and who are in varying stages or every kind of cancer.
“What is really unique is we take the ultimate recipients of our research into consideration from the very beginning, and we include them,” said Weaver. “By including the communities and patients from the beginning, we can move more rapidly through all the cycles of translation.
“When we design something – a study, an intervention, an approach for oncology care delivery – that ultimately will be broadly accessible, we include the providers from those diverse community settings and get input from them all along the way,” she said. “The result is, hopefully, that we come up with good answers that can be rapidly taken and used in actual practice.”
And that input doesn’t stop once the study is activated, said Lesser. All the studies have regular calls with community sites to discuss what’s going well or not, feasibility issues, real-world feedback and, when necessary, how to amend the study to make it more applicable and functional. He likens it to a learning health system in practice.
“The ideas we get come from the clinics, patients and providers,” he said. “If we can run trials and identify things that work (or don’t) in the community setting, the translation is pretty straightforward. It can be generalized, and relatively quickly, to affect the experience of cancer patients throughout the country.”
Expanding the pool of researchers
By nature – and design – these research studies are collaborative. And as part of Atrium Health and the newly formed Advocate Health, the Wake Forest NCORP research base has even more opportunities to form investigative partnerships.
“We’re beginning to collaborate with investigators at Levine Cancer Institute in Charlotte and wrapping them into several of our studies and trying to expand that interaction,” said Lesser. “And there's at least one NCORP community site within the Advocate Health network, the Aurora NCORP (with locations in Wisconsin and Illinois) that we've worked with for many years.”
Closer to home, the Wake Forest NCORP research base is growing the next generation of researchers. A recent competitive grant supplement enabled them to execute a successful boot camp for investigators who are new or new to NCORP. The grant focused on diversity, equity, inclusion and accessibility mentoring, and boot camp participants could positively contribute to the diversity of investigators in cancer research.
On the horizon
Meanwhile, grass is not growing under the feet of Lesser, Weaver or any of the other researchers. New studies are continuously being proposed and started while others are in progress or wrapping up. One that recently opened will look at how to improve the delivery of radiation therapy for brain metastasis to patients don’t experience severe side effects that affect their cognition. A proposed study would focus on cancer caregivers and the challenges they face, how to better meet those needs and how to connect them with resources in a way that doesn’t overwhelm those resources.
“You ask a question, not only do you get the answer to that question but you get to ask many, many more questions from the information you collect,” said Lesser.