Cancer Clinical Trials: The Navigator’s Role in Ensuring Inclusivity

AONN+ 2020 Conference Highlights Special Feature —January 4, 2021

Touching every area of society, issues of race are complex and deeply embedded. Cancer clinical trials are no exception. An examination of the demographic makeup of cancer clinical trial participants reveals most are white, well-educated, and have private health insurance. This seems counterintuitive, as cancer research provides medically underserved, underinsured, or uninsured patients access to cutting-edge treatments that they would not otherwise be able to obtain.

“We really need to reach out and include others,” asserted Linda Burhansstipanov, MSPH, DrPH, who identified herself as a member of the Cherokee Nation. “If we’re not included, then we don’t have the chance to influence the protocols used for the clinical trials.”

She went on to explain that Native Americans are an example of an underrepresented group in clinical trials, and one that has received inferior care compared with other races.

“Their life expectancies are actually quite a bit lower,” Daniel Petereit, MD, FASTRO, said of residents of Pine Ridge Indian Reservation in South Dakota.

Indeed, their life expectancy is the lowest in the United States, at 48 years for males and 52 years for females. With high rates of high-risk health behaviors and comorbidities resulting from social stressors, as well as low screening rates because of the lack of resources, trust, access, and health literacy, it is no wonder Native Americans are more likely to have advanced-stage cancer at diagnosis and are less likely to receive cancer-directed therapies after diagnosis compared with their non-Hispanic, white counterparts.

One need only look at the benefits of clinical trials to understand the importance of making them more inclusive, Dr Burhansstipanov said. Treatments validated in clinical trials have improved patient outcomes. In addition, new approaches to treating once-untreatable cancers have come from clinical trials. In some studies, patients may receive more careful and regular medical attention than received with standard treatment. It has also been shown that healthcare providers involved with clinical trials typically offer higher-quality care and access to the most recent validated treatments.

Multiple barriers stand in the way of underrepresented patients participating in clinical trials. Poverty and its accompanying pitfalls can affect compliance with trial protocols. Also, a trial could be considered lower in priority than other life issues that may be more pressing.

Cultural perspectives also play a role. Some minority groups feel disenfranchised and have feelings of distrust toward the medical establishment. Accordingly, many see clinical trials as only beneficial to the researchers, not providing enhanced access for their communities. These and other beliefs may deter underrepresented individuals from taking part.

“We do have a lack of sense of ownership of the research,” Dr Burhansstipanov said. “We hear comments: ‘It’s only for white people,’ or ‘It’s only for rich people.’”

Providers contribute to the issue in their own ways. Implicit or explicit biases may prevent them from referring underrepresented populations to clinical trials. For example, even African American doctors are less likely to refer African American patients to clinical trials. Also contributing is the perception that people from minority groups are less likely to comply with trial protocols. Sometimes, providers are simply too busy to explain clinical trial opportunities to patients, or are unaware of available resources, including transportation or lodging, that could help improve retention.

The oncology navigator’s dynamic role should include educating patients about clinical trial enrollment opportunities, according to Linda Krebs, PhD, RN, AOCN, FAAN.

“We try to allay some of the fears people might have,” said Dr Krebs, adding that patients often express that they don’t want to serve as “guinea pigs” and education can help. “You may want to help create community programs.”

Along with Dr Burhansstipanov and others, Dr Krebs did just that, co-founding the Colorado Blueprint, a program to increase clinical trial enrollment among underrepresented populations; the 7Cs, the Colorado Culturally Competent Clinical Cancer Care Curriculum; and Clinical Trials Education for Native Americans.

Dr Petereit is also leading the charge toward making clinical trials more inclusive. As principal investigator of Walking Forward, a community-based research program funded by the National Cancer Institute (NCI) to address high cancer mortality rates among Native Americans in Western South Dakota, he is well-versed in the need for building a foundation of trust in a community to foster greater participation in clinical trials.

“From the NCI’s perspective, they want 2 things: They want patients in clinical trials and they want manuscripts. That’s the icing on the cake for us,” he said, adding, “I really think the core of what we’ve done in our patient navigation program is establish trust within the communities. We often say Walking Forward is a research program with a service component.”

To find cancer clinical trials, visit the National Cancer Institute website ( or call 800-4CANCER.

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Last modified: January 20, 2021

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