CHER Awardee Tests the Role of Communication in Minority Women’s Enrollment in Clinical Trials
By Stephanie Zeller
To some patients, a clinical trial immediately sounds like a bad idea. Why would you want to be the proverbial guinea pig when you could just stick to tried-and-true methods of healing? Clinical trials sound uncertain and maybe even dangerous, but in reality, they could be instrumental in saving the lives of many who would not ordinarily be able to afford such treatments. But how do we most effectively describe the relative risks and benefits of clinical trials to understandably uncertain patients? One research team aims to find out.
An interdisciplinary team of researchers at Moody College of Communication and Dell Medical School were recently awarded a CHER grant to investigate both our fears and our mythologies surrounding clinical trials. The aim of the project (dubbed “The CARE Study: Communicating About Research with Empathy”) is to understand the reasons patients accept or reject participation in clinical trials. The project will focus on how communication and empathy between patient and provider may influence a patient’s decision regarding a trial.
The primary investigators are Dr. J Stuart Ferriss, MD, Assistant Professor of Gynecologic Oncology, Department of Women’s Health, Dell Medical School, along with co-investigator Anita Vangelisti, Professor of Communication Studies at the Moody College of Communication. They are assisted by Moody Communication Studies doctoral student Suzanne Burdick, and Stephanie Nutt, analyst in the Department of Women’s Health, Dell Medical School.
Perception
Enrollment in clinical trials is at a historic low, particularly in under-represented minority (URM) women, even in the face of increased efforts to raise enrollment rates.
A recent unaffiliated study investigated this issue by reviewing Gynecologic Oncology Group clinical trials between 1985 and 2013. Nearly 45,000 patients were represented over the course of 169 studies, and the results were clear: 83% of participants were white/non-Hispanic, 8% African American, and 9% other. According to the Centers for Disease Control, this URM statistic is up to 15 times less than what should have been expected.
Why is there such a staggering difference in demographic enrollment, and why are overall rates continuing to fall?
The issue is multi-faceted. There is a gap in patient-provider communication that can be attributed to a number of factors, including difference in education, perceived power differentials, and rushed appointments. There are also more basic communication barriers such as language and culture differences. These issues in combination with widespread, multigenerational misconceptions about the clinical trial process have put a veritable ocean between a patient and their doctor.
“Many times people feel, even unconsciously, inhibited from sort of ‘asking the stupid question,’” said Burdick. “Both groups are trying their best to be empathetic...but there is always an opportunity for miscommunication.”
“I am particularly interested in those gaps in understanding and the creation of those myths for something like clinical trials. Here’s what is actually happening, and here’s what people think is happening,” said Vangelisti. “It’s not only that there’s a gap, but that gap is creating big problems for people. And in this case, that gap might mean some people live and some people die.”
Such myths are not completely unfounded. In the past, clinical trials were often much riskier, and subsequently garnered distrust from the public.
“We have done a really poor job of communicating with our patients about how regulated and regimented trials can be. But at the same time, we need to acknowledge that it hasn’t always been this way, and for a really long time it was done really badly,” said Ferris. “So, we have to acknowledge that history and…try to make sure that never happens again.”
Cancer and the Under-Represented Population
Clinical trials are vital to clinical progress. According to Ferris, almost all of our major findings, specifically in cancer studies, come through clinical research. Unfortunately, medication and other treatments can take up to 10 years to obtain FDA approval and are oftentimes incredibly expensive.
“The reality is that there are medicines right now that we know are active in our cancers, but are not FDA approved, so therefore insurance companies are not paying for them,” said Ferriss. “Patients who are on public insurance programs—they have no access to that kind of medication. But, through a clinical trial, they would.”
Dropping clinical trial enrollment rates could mean a longer “gestation” period for drugs on the road to the mass market. It also means a less diverse testing population.
“One of the biggest problems we have in clinical research is that it doesn’t always reflect the patients that we are taking care of,” said Ferriss. In other words, clinical trials experience enrollment in only a few main demographic groups, as demonstrated by the Gynecologic Oncology Group study.
“Our patient populations, depending on where you practice, could be very different,” said Ferriss. “The more we learn about specific cancer treatments…your genetic background matters more and more, especially as we get these treatments that are more targeted.”
If minorities are under-represented in trials, the treatments will reflect it. In this project, with funding from the CHER grant, the team will look for ways to better reach these minority populations, as well as methods to garner more trust and therefore increased participation in clinical trials that could, ultimately, be vastly beneficial.
Methodology
There are two principal aims: one primary and one secondary. The primary aim is to identify themes that distinguish women who agree to participate in clinical trials from those who decline. The secondary aim is to investigate how these themes differ among English- and Spanish-speaking women.
The communications research team will work with the clinical research group, based in the cancer clinic, to obtain a list of women who were approached to participate in a clinical trial within the last 6 months. These women will constitute the research cohort. They will be invited to attend a 60-90-minute focus group, which will provide a comfortable, non-clinical environment that encourages open discussion. Each group will have 5-8 members.
To address the primary aim, researchers will separate the focus groups by those who agreed to participate in a trial and those who declined. To address the secondary aim, the groups will be further divided based on whether patients are primarily English- or Spanish-speaking.
Transcripts of the focus groups will be coded for themes and perceptions in order to identify the differences between the acceptance and the rejection groups, as well as the English and Spanish groups. Following this initial analysis, one-on-one interviews will be conducted with patients to explore identified themes in greater depth.
Future Steps
Another recent study surveyed women at an urban, academic hospital in order to identify general perceptions of clinical trials. Using a validated survey tool from the National Institute of Health (NIH), researchers found low rates of interest (28%) in clinical trials amongst patients. However, when presented with educational materials concerning clinical trials, interest rose to 61%. These statistics illustrate the value in a vital component of clinical communication: education.
The results of this study will provide both a comprehensive assessment of focus group research and an educational tool for physicians, aimed at increasing enrollment of URM women in clinical trials. Once this tool is validated, it could be used in other populations and clinical settings outside of cancer treatment.
“Lots of the concerns we will discover will probably just be human concerns,” predicts Burdick. “They won’t be specific to women with cancer who speak Spanish, they’re going to be human concerns that we can generalize to a larger population.”
The team hopes to use this project as a springboard for future studies that could shed more light on low trial enrollment in all areas of medicine.
“If we could take this to its biggest conclusion with unlimited resources, it would be a curriculum for medical providers rooted in the patient’s voice,” said Ferriss. “We want to level that field, to bring down those barriers that we are not yet familiar with between patients and their doctors.”
“The bottom line is creating a space where patients will be able to make an informed choice, rather than one rooted in misunderstandings or mythologies,” Vangelisti added.
The team advocates for, in addition to educational materials, a “negotiator” or a mediator—a communication specialist that can be there with the doctor and the patient to translate between the two and to help correct misconceptions.
“We need teams of people in the clinics to help,” said Ferriss. “I think that we are more successful as a team than as individuals. And if the patient can feel like we are all going to be part of a team together, then we will be more successful.”
The Center for Health Communication is as a joint academic center of both Moody College of Communication and Dell Medical School at the University of Texas at Austin. It was established in 2014 to bring together researchers and experts from diverse backgrounds of health communication into one organizational unit where they can collaborate, share ideas and innovations, and advance their scholarship. It is an interdisciplinary group whose goal lies in improving health through evidence-based communication research, thereby advancing the health of people and populations.
About the Author
Stephanie Zeller is a rising senior at the University of Texas at Austin studying Public Relations in the Moody College of Communication, Studio Art in Fine Arts, and McCombs School of Business foundations certificate. Stephanie has a special interest in health, as well as in astronomy and biology and will begin to marry her varied interests during a public affairs internship with NASA in the summer of 2018. She hopes to build a career around writing and creating visual works to bridge what she views as an unnecessary gap between the arts and the sciences.