In an interview format at the AONN+ 9th Annual Navigation & Survivorship Conference, Lavinia Dobrea, RN, MS, OCN, Manager of the Oncology Research and Biospecimen Program at St. Joseph Hospital/Center for Cancer Prevention and Treatment in Orange, CA; Lucy J. Gansauer, MSN, RN, OCN, CCRP, Director of Cancer Care Delivery Research at Spartanburg Medical Center, SC; and Karen Winkfield, MD, PhD, Associate Professor of Radiation Oncology at Wake Forest School of Medicine, revealed insight on how navigators can mitigate care barriers and support clinical trial participation among underserved and minority populations.
“We know minorities have a higher morbidity and mortality rate. But the problem is, nationwide, only about 3% to 10% of patients participate in clinical trials, and of that small percentage, less than 10% come from African American, Latino, and Asian populations,” said Ms Dobrea. “This means that most drugs are tested on Caucasian populations, underlining the need for minority and barrier population participation in clinical trials.”
“If we don’t move that number, we’re treating patients with drugs and protocols that have never been tested in their population,” added Ms Gansauer. “That’s unethical, and it’s basically immoral. We’ve got to do a better job in this country.”
Ms Dobrea: Dr Winkfield, can you address the myths and the beliefs that influence the [lack of clinical trial participation] among underserved populations?
Dr Winkfield: They’re afraid of being a guinea pig. We’ve all heard that word, right? The other thing that people don’t understand about cancer clinical trials is that they’ll never get a placebo. They’ll always get current standard of care plus or minus [a drug]. People also think that once they’re on a clinical trial they’re locked in, but if they decide that they don’t want to participate anymore, they can just say so.
Ms Dobrea: In your experience, are minorities and underserved populations willing to participate in clinical trials?
Dr Winkfield: Absolutely. That is such a myth, that they’re unwilling to participate. While there’s some fear and trepidation, I think it’s important to make sure people understand what a clinical trial is. For the African American population, that word “trial” in itself can be a little bit nerve-racking. So, a lot of times using a different terminology can smooth over some of those worries.
Ms Dobrea: What about the motivators for clinical trials?
Dr Winkfield: Most of my published research is in the African American community. Helping their community is a big driver for people. They think that their participation can help—maybe not themselves—but a future generation.
Ms Gansauer: What we’ve observed at our institution—and I think that’s where I latched onto the term “normalization”—is the trust that the navigator has with the patient and family. Her access for following up with their questions makes them comfortable and makes them willing to sign up for a clinical trial. And then she’s able to help them with any barriers, such as transportation.
Ms Dobrea: What barriers to clinical trials have your navigators seen?
Ms Gansauer: It’s a lot of the same barriers you see with every patient: transportation, health literacy, lack of education, lack of insurance, out-of-pocket expenses, and life responsibilities. If they have a job, they’re worried about missing 1 extra day, and sometimes clinical trials require extra visits. Navigators can reach out to their employers and explain some of the demands on them for treatment. There are also specific barriers that we’ve found with clinical trials—number 1—lack of awareness. And part of lack of awareness is that they may not remember that the doctor offered it to them during a consult visit. But if a navigator knows that it was part of the discussion, she can bring that awareness back.
Also, this perception around randomization, being treated as a guinea pig, and some basic mistrust with providers and research. Communication is the most important. For patients, this is the first time they’ve met that medical oncologist; they don’t know how to communicate with him or her. And if the navigator can bridge the gap between the patient and the provider, that’s going to help patients accrue to clinical trials.
There are also a few specifics with minorities: language, cultural differences, and the lack of translated informed consent documents. And there’s always the legacy of racism and oppression. One of the things we noticed at our institution is that we had research staff that viewed minorities and underserved populations as more difficult to accrue to clinical trials, and they found it was burdening their jobs. So, we have to monitor that.
Ms Dobrea: Dr Winkfield, is there research demonstrating the benefit of having navigators participate in that clinical trial discussion with minority patients?
Dr Winkfield: Literature definitely suggests that having navigation as part of the clinical trial discussion is critical. In our institution, we have a Hispanic patient navigator, Maria. Just her presence alone in having these discussions with patients really makes people comfortable. And because she understands the Hispanic population, she’s shown that with the patients she navigates, 51% of them actually enroll in clinical trials. So there has been a 30% increase in enrollment in that population.
Ms Gansauer: Navigators can provide that personalized patient support that will make the difference between a patient being able to go on a trial or not.
Ms Dobrea: Dr Winkfield, can you give us specific examples of how you discuss strategies with the African American population?
Dr Winkfield: Let me start by saying, I don’t like the term “African American.” I’m black; I am not African. So, I think one of the things that points out is that you have to know your population and your community. When I was in Boston, I had a growing immigrant population: lots of Haitians, lots of Dominicans, and lots of Africans. Now that I’m in North Carolina, it’s a whole different ball game. So that community assessment that I did about perceptions of cancer care and clinical trials, I’ve got to redo it because I am in a new community.
That’s why navigators are so critical—many of you are from the community, know the community, understand the community, and understand how they refer to themselves.
There is also that mistrust of the medical system that we know African Americans have. One of the things that I’ve come to understand is the importance of the church. That can be a very helpful community- based organization that can help reach the African American population.
But that’s not the only one. In Boston, we used to have community conversations where we would go to the hair salon and close it down for a few hours on a Saturday and just have conversations. We’d bring in physicians, nurses, or pharmacists of color because we wanted to show the people in the black community that they looked like they did.
And really, outreach. Again, I’m highlighting Maria. The community sees her out there, so when they come to the hospital to see her again, she’s trusted because she’s in the community. That really makes a big difference.
Ms Gansauer: As Dr Winkfield said, knowing your community is most important. Our Hispanic and Latino community is growing in this country, but that is a very diverse community with very different beliefs and cultures. So, you have to know what Hispanic and Latino groups are in your community. For Hispanics, cancer is the leading cause of death; we have to start getting them on clinical trials. Often their families are very integral in decision-making. So, if those family members aren’t included, the patient is not going to make the decision to go on a clinical trial.
The National Cancer Institute suggests making sure that you have translated materials. Use images of that population in any of your print media, and then conduct community outreach. Go to their meetings. Don’t set up meetings for them to come to you. If I’m not aware of what the priorities are in their community, I’m not going to be able to serve them as well.
Dr Winkfield: We talk about cultural competency, but there’s no way anybody is ever going to be competent in somebody else’s culture, so let’s lay that to rest. But cultural literacy, or cultural humility, is really critical, particularly for the newly immigrant population.
Ms Dobrea: Would you identify some best practices that will help us make sure clinical trials are being offered to these underserved populations?
Dr Winkfield: I think the first thing is, again, making sure that we normalize clinical trials, and making sure that clinical trials are really, truly on the table for these folks. The other thing is making sure you have racially concordant or even population-concordant navigators.
Ms Gansauer: I think that the final tip I would give you is, you don’t have to have the answers, but you know where to get them; you connect the dots and connect the patient. Use that trust level you have with your patients to help them achieve their best outcome.
Ms Dobrea: What about the cost of clinical trials?
Ms Gansauer: Clinical trials are not free. Someone does have to pay for them, but the majority of the time it’s not the patient. I think patients get confused because they have to pay for standard of care and all of the copays that are associated with that. So, it’s important to explain that, and the patient can get specific information from the research nurse on what is paid by the study and what’s not.