When asked how she balances work as both a clinician and researcher, Nicole Fleege, MD, doesn’t hesitate: her patients always come first.

Now, two prestigious career development awards will help her advance this commitment. The Robert A. Winn Excellence in Clinical Trials Award Program recently selected Fleege for its fifth annual Winn Career Development Award (Winn CDA) cohort for her project, “Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response.” The second award, a VISN23 Career Development Award from the Veterans Administration, will allow Fleege to investigate “Advance Directive Documentation in Veterans with Cancer: A Mixed Methods Analysis.”

“Both of these awards reflect my interest in supportive care research and learning how more underrepresented patients can be represented in research,” said Fleege.

Reaching underserved communities through clinical research
Fleege’s drive to improve cancer care for Iowans developed during her training. She earned her undergraduate degree at the University of Iowa, followed by medical school and residency training at the Carver College of Medicine. Apart from her fellowship at the University of Michigan Health System, she has spent her entire medical career at UI Health Care, where she now serves as a breast oncologist in the Division of Hematology, Oncology, and Blood & Marrow Transplantation.

This long-standing commitment to Iowa patients has directed her research pursuit in the Winn CDA program. The two-year, $240,000 award will support her efforts to expand breast cancer research while increasing clinical trial access for rural Iowans and other underrepresented patients. All the while, Fleege will continue serving patients at home.

Through her Winn CDA project, Fleege aims to identify biomarkers that can predict which patients will benefit from Paclitaxel, a commonly used chemotherapy. Pre-determining treatment effectiveness could spare patients from experiencing unnecessary side effects and allow providers to opt for alternative therapies sooner.

“One of the things I love about breast oncology is how the field has expanded what treatment options are available, and we have worked to help patients live longer with those treatment options—even in the stage four cancer setting,” Fleege said. “But because of that, I think we need to pay attention to helping patients live better, not just longer.”

The Winn CDA program also supports community-engaged research and requires awardees to develop a second project aimed at increasing clinical trial participation. Its mission is to support providers who want to make clinical trials more inclusive, ensuring future therapies reflect the needs of all patients—especially communities historically underrepresented in research. For Fleege, this means focusing on rural Iowans.

“We all see patients at the University of Iowa who travel four hours one way just to come get care—whether that’s because the treatment they need isn’t available elsewhere, or they want to enroll in a clinical trial that’s only offered here,” she said. “I think about those patients when I’m driving even an hour and a half, and the patients that can’t make the trip at all.”

She identifies a few groups of rural Iowans. One rural cohort can travel far distances while the other—limited by finances, transportation, or work schedules—cannot. Some rural patients also prefer to receive care within their communities. Fleege hopes to find new approaches that bring clinical trials closer to rural areas through the Winn program’s curriculum in community engagement. Her work as a program liaison for Holden Comprehensive Cancer Center’s Community Outreach and Engagement team, as well as her involvement in the Iowa Cancer Affiliate Network (I-CAN), provide a strong foundation for expanding research access beyond urban medical centers.

Addressing a critical gap for veterans with cancer
Fleege’s second award will allow her to focus on a different element of cancer care. The Veterans Administration selected her for the VISN23 Career Development Award for her proposal to help veterans with cancer document their wishes for end-of-life care.

As Fleege cared for patients with metastatic (stage four) breast cancer, she noticed that many had no advanced directive—a legal document that details someone’s care preferences if they become too ill to communicate them. An advanced directive also provides surrogate decision-makers a necessary guide for making decisions on a patient’s behalf.

When she began reviewing available data, Fleege found an even greater cause for concern: while only an estimated 30% of Americans have an advanced directive, there is no documented rate for veterans with cancer. Fleege said that existing literature shows discussions about advanced care planning occur as rarely as 5% of the time within the VA system.

“It just made me think—are we really missing that many opportunities to talk with veterans about what they want?” she said. “The first step is understanding whether the gap truly exists and what the real rate looks like. Because in cancer care, I don’t think there’s anything more important than having a document that reflects what a patient wants. It ensures that care stays aligned with a patient’s goals if they reach a point where they cannot make decisions for themselves.”

Fleege’s mixed-methods study will analyze how often advanced directives are completed among veterans with cancer. She will also examine how social determinants of health, such as race, rural residence, or financial insecurity, affect access to this care.

Patient-centered research, rooted in Iowa
Whether working to expand clinical trial or end-of-life planning access, Fleege emphasized that her patients fuel her motivation as a researcher.

“My research is always about the patient. It matters because of them,” Fleege said. “What I see in clinic—the symptoms, the challenges, the stress the caregivers feel—that is what motivates me to find better solutions.”

She also credits her colleagues at the University of Iowa and the Holden Comprehensive Cancer Center for providing the support necessary to pursue investigator-initiated research early in her career. Fleege shared that when her previous grant had run out, UI Health Care ensured she had protected time to develop new proposals, believing in the importance of her work and her ability to bring it to fruition.

As she advances new projects focused on overlooked needs in cancer care, Fleege remains driven by the same principle that has guided her from the beginning: patients come first.

“These awards allow me to serve the people who inspire me,” she said. “If what I learn can make their lives better, then it’s worth every ounce of the effort.”

Acknowledgements
Fleege credits her success to the guidance and encouragement of her mentors at the University of Iowa, including Mark Burkard, MD, PhD; Sneha Phadke, DO; Bryant Howren, PhD, MPH; Aaron Seaman, PhD;Mary Charlton, PhD; and Ingrid Lizarraga, MBBS, FACS.