Despite Showing Interest, Vulnerable Populations Lack Sufficient Clinical Trial Information
Kristie L. Kahl
Despite showing an interest in clinical trials and biobanking, underserved populations appear to be unclear on how to learn about them, while community physicians reported lacking appropriate information to give them, according to data to be presented at the American Association for Cancer Research (AACR) Annual Meeting.
Vulnerable populations – those who experience cancer health disparities such as racial and ethnic minority groups, individuals with low socioeconomic status and those who live in rural areas – are often underrepresented in clinical trials and biobanking. For example, less than 5 percent of patients with cancer are enrolled in a clinical trial, of which less than 10 percent are minorities.
“We must have diverse participation to identify how specific drugs and treatments are most useful for different people,” Terry C. Davis, Ph.D., professor of Medicine and Pediatrics at Louisiana State University Health Sciences Center and the Feist-Weiller Cancer Center, said during the AACR Annual Meeting media preview webinar. “Effective strategies are needed to help unrepresented populations get understandable information and see the value in participating in clinical trials.”
Davis, who is also the director of the Health Literacy Core of the Louisiana Clinical & Translational Science Center, attributed this problem to widening gaps in communication and knowledge.
“There is a communication problem,” she added. “Precision medicine and genomic testing initiatives are creating a widening gap in the novel space of researchers, community providers and patients and the public. Researchers often assume that patients and community providers know more than they do about clinical trials and understand all of our jargon.”
Davis and colleagues conducted 14 focus groups and seven individual interviews to identify awareness, understanding, trust and acceptance of clinical trials, while also trying to elicit input in crafting clear, culturally appropriate messages and recruitment strategies for patients. These focus groups and interviews included rural and urban patients and providers in safety-net primary care and oncology settings, and also patients in social, faith-based and support groups.
In total 103 individuals from Louisiana participated, including 78 clinic patient and community participants and 25 providers. Of the 78 community participants, 24 percent lived in rural areas, 78 percent were African-American and 70 percent reported having low incomes. Of the providers, 10 were physicians, seven were clinical research associates, five were nurse practitioners and three were behavioral health professionals.
Discrepancies between terminology appeared to be a recurring problem among participants. For example, researchers say clinical trials, whereas the participants simply called them studies. Similarly, researchers say biobanking, whereas those surveyed better understood saying, “your blood or tissue will be stored in a bank.”
When researchers mentioned the term “genomics,” participants felt that it sounded intimidating and alarming, and the term did not resonate or mean anything to most.
African American participants reported that messages regarding these trials and biobanks needed to convey the incorporation of all races and ethnicities. For example, rather than a message saying, “Minorities are needed in clinical trials – most treatments based on studies with majority of white participants,” they would rather hear, “All people are needed for studies to improve treatments and find cures.” The difference between the wording of both messages raised suspicions in these individuals.
In particular, individuals wanted to know the following: What are you going to do with my blood sample; how much information about ‘me’ are you going to keep; and what is it going to be used for?
Despite being told of protection and confidentiality, some participants still raised concerns around patient privacy, in particular, because it could become a barrier to jobs or insurance.
Overall, almost all of the participants stated they were open to participating in clinical trials and biobanking, especially in learning about studies focused on a disease they or their family had. Interestingly, low income and minority patients said were open to these options even if it would not benefit them directly.
However, only two patients with cancer reported they were previously asked about participating in a clinical trial by their physician.
The researchers noted that community participants were less trusting of clinical trials than patients were. All of the participants said that information and recommendations for clinical trials and biobanking would be most effective and actionable if it came from a trusted physician.
Participants also reported that transportation to academic centers was a barrier to their involvement in clinical trials and biobanking, but “mobile health vans could enhance participation,” Davis said.
Urban and rural providers also showed an interest in being more involved in clinical trials, but admitted they lacked the time it takes to identify trials and explain them to patients.
As a result, providers said that receiving brief, plain language handouts with talking points and a card to give patients to call for more information would be helpful in increasing participation.
Lastly, very few patients, caregivers or providers said they looked for clinical trials on the internet or social media.
“Communication needs to be easy to get your hands on. It needs to be honest and transparent. It needs to be easy to understand and actionable. What is it that we want patients to know and do?” said Davis.
Since this study was only conducted in Louisiana among select underserved populations, Davis noted additional studies are needed where researchers also speak with individuals from more diverse communities, such as additional rural areas and those in Hispanic and non-English speaking communities.
At the end of the presentation, AACR President Michael Caligiuri, M.D., President and Physician-in-Chief at City of Hope National Medical Center, commended the study, highlighting that “this is a very complex issue in terms of the barriers that really contribute to us not providing equal access, and therefore, in many cases, equal care to these underserved groups.”