Ethnically and Language Concordant Clinical Trial Educational Intervention to Increase Diversity in Cancer Clinical Trial Participation
Tuesday, November 21, 2023
We recognize that there is a great discrepancy in the participation rates of minority patients compared to their proportion of the general population. For example, in the Dallas, Collin, Tarrant, & Denton counties, Hispanics make up approximately 31 percent of the general population, yet they make up only roughly 6 percent of our patient population.
All patient populations benefit from clinical trial participation. The immediate patient receives hope that their cancer may be positively impacted by the therapy, while their participation helps to advance a potentially life-saving new treatment towards FDA approval for future cancer patients. Unfortunately, however, a vast disparity exists in the trial participation of different ethnic groups. Equitable access to healthcare necessarily includes participation in clinical trials by underrepresented patient populations who would benefit from such participation.
We identified two main factors inhibiting participant enrollment to clinical trials. First, there is a distrust of the medical community, particularly when it comes to clinical trials and medical research. Second, a language barrier prohibits education of and communication with non-native speakers of the English language.
We attempted to mitigate these barriers by building trust with, increasing clinical trial awareness in, and providing clinical trial education for our local Spanish-speaking cancer community. We hope that our efforts will increase the percentage of Hispanic cancer patients who enroll onto a clinical trial.
We hosted a two-hour clinical trials educational event entitled “Ensayos clínicos en Cáncer” on the morning of November 12, 2022 in Dallas, TX. The meeting was attended by 17 Hispanic cancer patients and their family and friends who were interested in learning more about clinical trials. We utilized a voluntary and anonymous pre-meeting and post-meeting questionnaire to assess the impact of the educational intervention.
“Ensayos clínicos en Cáncer” was completely conducted in Spanish. The event was led by our investigator, clinical research nurse, clinical trial manager, and clinical social worker. We also had representation from Genentech’s Patient Inclusion & Health Equity team. The 17-slide presentation covered the phases of clinical research, a patient’s journey on a clinical trial, psychosocial resources available at MCCR, and commonly asked questions and answers about clinical trial participation. Additional content included the “¿Qué es un estudio de investigación clínica?” educational video and our patient testimony.
We developed a questionnaire to assess whether we were addressing the proposed barriers to clinical trial participation. In addition, we asked the following sociodemographic questions: gender, if attendee was diagnosed with cancer, if attendee was offered a clinical trial, and insurance status. Identical surveys were distributed pre-meeting and post-meeting for voluntary completion.
A comparison of the pre-/post-meeting survey means showed improvement in the attendees’ clinical trial knowledge and willingness to participate in clinical trials. However, there was not an improvement in trust when asked the question “Medical researchers do not tell people everything they really need to know about being in a research study”.
The FDA has provided guidance to increase the enrollment of underrepresented populations in clinical trials. As we are dedicated to cancer clinical research and are located in the South Central region of the U.S., we decided to focus our outreach on the Hispanic cancer community.
We determined that there are two main factors that inhibit Hispanic cancer patient enrollment to clinical trials: distrust of the clinical research community and a language barrier prohibiting education of and communication with Spanish-speaking cancer patients.
Survey results demonstrated that we were able to improve the attendees’ clinical trial knowledge and willingness to participate in a clinical trial. We attribute this improvement to successfully educating the attendees in their native language. We were surprised to find that we did not fully overcome the barrier of mistrust despite having an ethnically concordant team of clinical researchers present. These results suggest that additional interventions are necessary to garner the Hispanic cancer community’s trust.
The survey results also revealed that the majority of attendees were uninsured or underinsured. Despite the attendees’ willingness to participate in a clinical trial, the financial burdens of cancer treatment and associated with cancer clinical trials may deter the cancer patient from actually enrolling onto a cancer clinical trial.
This clinical trial educational invention was a pilot session. With only 17 attendees, we understand the results may not be representative of the entire Hispanic cancer population in the DFW metroplex. We hope to conduct future Hispanic-focused sessions to gather more data for significant analyses. Additionally, we are interested in piloting a clinical trial educational invention for the local African American cancer community. Long term, we are excited to see how the concentrations of racial and ethnic minority patients change in our patient population.