Cancer clinical trials offer patients an opportunity to receive new and innovative treatment, as well as contribute to the future of cancer care. Enrollment onto clinical trials also may lead to better care and outcomes; however, few adult patients with cancer and even fewer ethnic and racial minority patients participate.
AT A GLANCE
- To address the known facilitators and barriers, multilevel approaches are needed.
- The authors present a case example of interventions to address and improve barriers to clinical trial enrollment at an urban National Cancer Institute–designated comprehensive cancer center.
- As frontline providers in cancer care, nurses are in a unique position to address barriers to clinical trial enrollment, particularly through interpersonal communication with their patients.
Participation in clinical trials is associated with improved one-year survival, increased quality of life, and psychological benefit; although many pediatric patients with cancer enroll on clinical trials, less than 5% of adult patients with cancer do so (Hallquist Viale, 2016; Unger et al., 2014; Weber et al., 2015). Participation in cancer clinical trials is even lower for racial and ethnic minorities and other groups, such as older adults, low-income patients, and those living in rural areas (Kwiatkowski, Coe, Bailar, & Swanson, 2013). This may be a factor contributing to the poorer survival and differences in other health-related outcomes that have been reported in these groups.
Much effort has been dedicated to studying barriers and facilitators to clinical trial participation, specifically in minority and underserved populations (see Table 1). Common themes often are grouped into trial-, provider-, and patient-specific barriers. Another way of depicting barriers is by system-, individual-, and interpersonal-level factors that may contribute to barriers to clinical trial enrollment and, therefore, disparities in participation and patient outcomes (see Figure 1).
National Community Oncology Research Program
The National Cancer Institute (NCI) created the NCI Community Oncology Research Program (NCORP) “to bring cancer clinical trials and cancer care delivery research to people in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities” (NCI, n.d., p. 1). Forty-six NCORP community sites accrue patients and participants to NCI-approved cancer clinical trials and research studies, including treatment, cancer control, prevention, and cancer care delivery. Of high interest is integration of disparities research within the network.
The NCORP network not only provides these community and minority-underserved (MU) sites with access to clinical trials, but also includes these sites in national discussions about cancer trials. For example, an NCI-led committee focuses on understanding and improving diversity among clinical trial participants. This initiative includes close examination of cancer clinical trials to ensure that appropriate eligibility criteria will promote the enrollment of a diverse group of participants. Other efforts include ensuring that appropriate translated materials, such as consents, patient-reported information surveys, and assessment tools, are available whenever possible. The aim is for patients to be eligible for trials regardless of race, ethnic group, gender, or age, unless science supports the limitation.
Local Institutional Strategic Approach
The Herbert Irving Comprehensive Cancer Center at Columbia University Irving Medical Center (CUIMC) in New York participates in the NCORP network as an MU-NCORP (Brooks et al., 2015). This MU title requires that at least 30% of the catchment area is of a racial or ethnic minority. The CUIMC MU-NCORP is intervening at the systemic, individual, and interpersonal level to understand, address, and establish interventions to reduce barriers to clinical trial enrollment for minority patient populations in the New York City area.
The CUIMC MU-NCORP has undertaken an initiative to understand the current local landscape, or multilevel factors, that may be barriers to clinical trial enrollment at a site. Survey instruments were developed to explore the knowledge, attitudes, and beliefs of providers, research staff, and patients related to clinical trial participation. Survey results identified areas for intervention for the CUIMC patient population, including specific strategies to improve access to clinical trials for minority and underserved patients with cancer. These include providing culturally sensitive materials adequately translated into the patient’s preferred language, providing professionally trained interpreters who can effectively translate the complexities of cancer treatment and clinical trials, and ensuring that all staff and providers who interact with patients are aware of culturally sensitive topics and have received adequate training to communicate about clinical trials and answer any questions or refer patients appropriately.
With clinical research coordinators, nurses, and navigators as the frontline faces of clinical trials, CUIMC MU-NCORP realized the need to focus on the behind-the-scenes infrastructures. A team of research staff members, including research coordinators, research nurses, nurse practitioners, educators, and a local patient advocate, are dedicated to developing outreach materials for potential and actual clinical trial participants. These include pamphlets with frequently asked questions about clinical trials and visuals, such as posters about clinical trials, which are hung in the patient waiting areas. These materials are culturally appropriate and written in plain language.
CUIMC MU-NCORP also uses patient navigators to help overcome individual, interpersonal, and system barriers to clinical trial participation. Patient navigation, which is a well-established intervention to help improve access to care in many settings, may offer improvement for access to clinical trials (Fouad et al., 2016). Patient navigators can help identify individual patient factors and address interpersonal factors leading to clinical trial enrollment barriers. Patient navigators help provide communication, guidance, and clarification for patients in areas of care that may pose challenges. Navigators help traverse the systemic barriers by helping individuals access cancer care and clinical trials. In addition, as expert communicators, navigators are well positioned to reduce the interpersonal and individual barriers to clinical trial participation by addressing culturally sensitive topics and offering guidance to improve patient–provider communication. CUIMC MU-NCORP uses lay and nurse navigators. Lay navigators were involved in an important cancer screening trial, S1204, and their expertise with the unique patient population resulted in CUIMC MU-NCORP being one of the highest-accruing NCORPs to this trial (Ramsey et al., 2018).
In addition to the internal strategies that the CUIMC MU-NCORP team has developed to improve access to clinical trials for minority patients, the CUIMC MU-NCORP team, specifically Gary K. Schwartz, MD, principal investigator for this grant, has spent time working with local community health organizations and church and religious leaders to understand the interpersonal factors related to clinical trial participation. By engaging the local community, the CUIMC MU-NCORP team members have identified groups that are unaware of or mistrusting of clinical trials and have opened up a dialogue to understand the local perspectives. These conversations are integral to engaging with the community, and the CUIMC MU-NCORP team anticipates building on the existing relationships and identifying new areas for growth.
Understanding the barriers to clinical trial enrollment informs current and future interventions to improve awareness and accrual to these important studies. Conceptual models that map the barriers to clinical trial enrollment offer many potential targets for interventions to reduce or eliminate those barriers. Although specific interventions have been identified for each level, a multilevel interventional approach likely will result in the greatest impact.
At the systemic level, clinical trials should continue to be rigorously developed by interprofessional teams, taking into consideration of the needs of underserved populations. This will lead to improvement of the detection, diagnosis, treatment, and management of cancer across multicultural populations. On the provider level, nursing education should include training on the importance of clinical trials and cultural competency when communicating with vulnerable populations about research. Finally, patient-reported information should be considered and elicited to ensure that adequate communication occurs between patients and their providers. Effective strategies will improve clinical trial involvement from underserved communities.
About the Author(s)
Melissa Beauchemin, MPhil, MSN, is a pediatric nurse practitioner at the Columbia University Irving Medical Center (CUIMC) in New York, NY, the program administrator for the CUIMC Minority Underserved National Cancer Institute (NCI) Community Oncology Research Program, and a predoctoral student in the School of Nursing at Columbia University; Grace Hillyer, EdD, MPH, is an assistant professor in the Mailman School of Public Health and director of the Executive MS in Epidemiology program in the Department of Epidemiology at Columbia University; and Diane St. Germain, RN, MS, is a nurse consultant in the Division of Cancer Prevention at the NCI in Bethesda, MD. The authors take full responsibility for this content. This study was supported by a grant (UGI-CA189960) from the National Cancer Institute of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Beauchemin can be reached at email@example.com, with copy to CJONEditor@ons.org.
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