About every two minutes a woman is diagnosed with breast cancer in the United States, making it the second most common cancer in American women. Breast cancer clinical trials – and cancer clinical trials in general – are an integral part of the research process and the best way to translate new research into clinical practice, ultimately improving patient care.
“The ultimate goal of conducting clinical trials is to find better therapies for cancer,” said Dr. Alexandra Thomas, Williams Family Chair in Breast Oncology and professor of hematology and oncology, who leads the project at Atrium Health Wake Forest Baptist Medical Center’s Comprehensive Cancer Center. “But those trials aren't going to work if the patients enrolling in the trials don't match the populations we ultimately treat with these therapies.”
With funding from the National Cancer Institute (NCI), researchers at Wake Forest University School of Medicine, the academic core of Atrium Health, are bringing the best new treatments for breast and other cancers to patients where they live and receive care. The Comprehensive Cancer Center is one of only eight NCI-designated cancer centers in the U.S. to receive an NCI grant entitled CATCH-UP (Create Access to Targeted Cancer Therapy for Underserved Populations). This grant funding helps researchers bring clinical trials closer to where people live and addressing barriers with minority and underserved populations that may prevent participation.
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Exceeding goals
The CATCH-UP award is congressionally mandated funding to help address disparities in clinical trial enrollment that have existed for decades. Institutions that receive the one-year grant can participate in trials of potentially life-changing targeted cancer therapies administered by the NCI’s Experimental Therapeutics Clinical Trials Network(ETCTN).
“The CATCH-UP grant aligns with the Cancer Center’s commitment to improve cancer outcomes for ALL patients,” Thomas said. “It gave us the resources to buttress some of the efforts already in place to focus on diversifying the patients enrolled in these trials.”
Cancer Center researchers selected 17 ETCTN clinical trials to offer to cancer patients. While the CATCH-UP grant required institutions to enroll at least 24 patients in ETCTN trials during the first year, Wake Forest Baptist researchers went above and beyond by accruing 33 patients, 14 of whom were from underserved populations.
“This grant helped give us a purposeful goal to reach more underserved populations by intentionally working toward tackling barriers,” said Dr. Jimmy Ruiz, associate professor of hematology and oncology, co-principal investigator for the project and assistant director for clinical research at the Cancer Center. “It also showed us that we can meet the needs of our diverse communities by encouraging and educating them on the importance of clinical trials.”
Location is key
Clinical trial location was one important barrier that the researchers addressed through this grant. Thanks to the grant, researchers are making it easier for racial and ethnic minorities and underserved patients in North Carolina, Virginia and West Virginia to access the latest cancer treatments through clinical trials.
“People in underserved populations often live some distance away from the Cancer Center, and clinical trials typically require more clinical visits than traditional therapies,” said Ruiz. “This can create a significant barrier for clinical trial participation.”
Instead of having patients come to the Cancer Center in Winston-Salem, the researchers worked to implement clinical trials in community-based practices that served minority and underserved populations. In some cases, this meant co-managing patients.
For instance, a breast cancer patient of Thomas’ was recently able to come to her clinic when they were first starting a new clinical study and then was able to complete their remaining visits at a doctor’s office closer to home for the rest of their visits. This co-management setup not only gave this patient access to a breast cancer clinical trial, it also allowed them the convenience of staying closer to home during much of their treatment.
Building trust
Cultural barriers that affect participation in a clinical trial can be complex, so it often takes a personal approach to build trust and fill in knowledge gaps about how trials work. To do this, the researchers drew on several programs already in place at the Cancer Center. One is the Center’s Population Health Navigator Program, which uses culturally and linguistically concordant navigators to address the social needs of cancer patients. There are specific navigators for African American, Hispanic and rural patients.
“In addition to addressing social needs, these navigators promote participation in cancer research studies to their patients,” said Ronny Bell, professor of social sciences and health policy, who directs the Cancer Center’s office of Cancer Health Equity. “Because they work with these communities every day and understand their needs and concerns, we've seen a very big increase in cancer study participation from underserved groups since we've had this program.”
The Cancer Center also has a program called Advocates of Research and Medicine that trains cancer survivor volunteers to be advocates for cancer research by teaching them about cancer research and the importance that all groups are represented in these studies. These advocates provide another resource to patients who might be considering a cancer trial.
The CATCH-UP grant researchers also designated specific disease-orientated team champions to review clinical trials and evaluate progress in accruing minority and underserved populations.
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Looking to the future
“The CATCH-UP study required a direct investment in working to understand why we have a deficit in representation in trials,” said Bell. “We plan to make sure that what we learn gets incorporated into the strategy that we use in the future for recruitment and retention in cancer therapy trials.”
Some of the new knowledge is already being implemented. For example, clinical trials outside of the ETCTN network are now increasingly being offered at community-based practices. Many of the studies that were initially made available through the CATCH-UP grant are also still enrolling patients thanks to funding from the Cancer Center.
Bell adds that as the Cancer Center integrates with the Atrium Health enterprise, it will open even more opportunities to address disparities.
“Atrium Health’s Levine Cancer Institute reaches a large number of patients, including a very large urban area in Charlotte,” said Bell. “We will continue to think about ways to continue our efforts to diversify our clinical trial offerings, keeping in mind this new strategic alliance.”
Please visit the Comprehensive Cancer Center or Levine Cancer Institute to learn more about participating in a clinical trial.
