Spiritual beliefs and a historically based distrust of clinical research may influence Black patients’ decisions about whether to participate in cancer trials, according to new findings presented by Gomez et al at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 215) and simultaneously published in the International Journal of Radiation Oncology • Biology • Physics.
Background
Clinical trials in the United States have historically been populated almost exclusively by White, male participants. In 1993, Congress directed the National Institutes of Health to establish guidelines for the inclusion of women and minority populations in all government-funded clinical research so that study populations would more accurately reflect real-world populations.
Despite these mandates, inclusion of racial and ethnic minority populations in cancer trials has remained low. Prior research has shown that among the cancer clinical trials reporting race, only 7.2% of the participants identified as Black, even though Black patients make up 14% of new cancer diagnoses. More recently, research has revealed that the gap in participation between Black and White patients grew wider among those diagnosed with cancer during the COVID-19 pandemic. Underrepresentation of diverse populations in clinical research can have consequences.
“When you offer someone participation in a clinical trial, the conversation has to go beyond the consent form,” explained lead study author Charlyn Gomez, BS, a medical student at the University of Maryland School of Medicine. “If we want to improve recruitment of underrepresented [patients] in clinical research, we cannot just talk about trial goals. We have to look beyond that to understand where the patient is coming from and what their priorities are,” she continued.
Study Methods and Results
In the new cross-sectional, descriptive study, researchers asked patients who underwent definitive radiation treatment for curative gastrointestinal, thoracic, gynecologic, and head and neck cancers at two Baltimore medical centers to complete a questionnaire developed from two previously validated surveys. Between October 2023 and February 2024, 97 patients—30% of whom were Black—were asked if they would participate in a clinical trial and to fill out surveys describing the factors they might consider when making this decision. They were asked to complete the surveys while waiting to see their cancer physicians. The researchers sought to identify the key psychosocial factors that may be contributing to the growing underrepresentation of Black patients in cancer trials and identify strategies to improve recruitment efforts so the results can be generalizable to more diverse populations.
There were no differences in insurance coverage, education, employment status, cancer stage, or cancer treatments between the Black and non-Black participants. Within both groups, at least 90% of the participants stated that they trusted their cancer physicians.
Despite their self-reported trust in their cancer medical teams, the researchers found lingering distrust in clinical research among Black patients. Compared with the non-Black patients, the Black patients were more than five times as likely to agree with statements that death or illnesses were determined by God’s will (55.5% vs 10%, P = .001) and that God, not research, determined wellness (59.1% vs 11.6%, P < .001). Further, 20% of Black patients reported they agreed that research harmed minority populations compared with 0% among non-Black patients (P < .001).
The researchers discovered that about 33% of Black patients felt that research would provide information about their health they would rather not know about compared with 4% among non-Black patients (P = .037). Black participants were also 10 times more likely than their non-Black peers to state that they felt they, individually, (20% vs 2%, P = .038) and their community (40% vs 6%, P = .031) had nothing to gain from participating in clinical research.
The researchers suggested that at least some of that distrust may stem from historically unethical research practices that harmed Black patients. From 1932 to 1972, the U.S. Public Health Service failed to obtain informed consent or explain the risks of a study of untreated syphilis among Black men in Tuskegee, Alabama. Researchers withheld penicillin treatment from the 399 study participants with syphilis when it became available in 1945, causing preventable illness and death among study participants and their family members. This led to the creation of the Belmont report, establishing ethical principles and guidelines for the protection of human research participants.
“Our research has identified some really important themes that should be discussed with patients as part of the recruitment process, such as spirituality or faith, as well as recognizing … a justifiable mistrust stemming from structural racism and historical practices in clinical trial programs,” Ms. Gomez stressed. “[O]n the positive side, we also found there is trust in the medical care team, and perhaps we can build from there,” she added.
Conclusions
The researchers emphasized that overcoming that justifiable and deeply embedded distrust is imperative to developing cancer treatments that can benefit Black patients.
“Physicians need to be more intentional in their efforts to gain the trust of Black patients, so they may be better represented in clinical trials. Unfortunately, [because of] a host of issues such as systemic racism and fewer access points into the health-care system, we are seeing that Black patients tend to experience poor outcomes with certain cancers. This reality should raise a lot of alarms, because if we're trying to develop new treatments, and the patients who need them the most aren't part of the clinical trials testing them, then we're missing a big group of important [patients],” Ms. Gomez underlined.
The researchers hope their findings can guide the development of training programs for researchers and physicians to help with recruitment efforts. In light of the weight given to religious and spiritual beliefs, the researchers noted that it may also be critical to include family and community members in discussions about the potential benefit and importance of participating in clinical trials.
“Sometimes, patients seek out guidance to help them make [a] choice, alongside their family and other community members, and it becomes a shared decision-making process. I think it would be well-received if physicians were trained to address these issues and perhaps incorporate these discussions into their protocols,” Ms. Gomez underscored.
Future studies may also be needed to further explore the factors that may impede participation in clinical research among underrepresented groups.
“It's crucial for us to improve the recruitment of Black patients into cancer clinical trials, [b]ut to do that, we have to understand the values and priorities of patients in this underserved population,” Ms. Gomez concluded.
Disclosure: For full disclosures of the study authors, visit astro2024.eventscribe.net and redjournal.org.
