Inclusivity Must Be Made A Priority in Clinical Trials and Cancer Care

Narjust Florez, MD

Bringing equality to cancer care remains a focus and building upon the foundation of guidelines to usher in a more inclusive environment for patients will require making appropriate modifications to care and the enrollment process of clinical trials,” according to Narjust Florez, MD.

“Cancer care equity means that regardless of your sexual orientation, your racial background, the language you speak, where you come from, or your socioeconomic status, you are receiving the standard of care that follows the guidelines,” she said. “ It [mean]s that we are able to provide equal care for everyone and also tailor to their needs as we are different, and our populations are different.”

Ahead of her presentation at the 40th Annual CFS® titled, “Cancer Care Equity & Survivorship” Florez spoke with Oncology Nursing News® to highlight key takeaways for the audience. These include addressing difficult situations that may arise at the clinic and how to handle them to give patients the best care. In our discussion, Florez, a thoracic medical oncologist and associate director of the Cancer Care Equity Program at Dana-Farber Cancer Institute, also noted that she will identify the 3 principles of cultural humility, how to apply them to everyday practice for all cancer diagnoses regardless of stage, and what steps oncologists can take to help create an environment where all patients are given the same care and opportunities to participate in clinical trials.

Cancer Survivorship and Equity

Although there are often misconceptions of what cancer survivorship means with the assumption that it’s the period after patients have completed treatments, Florez noted this definition excludes patients with metastatic disease. “Cancer survivorship establishes [patients] have a cancer diagnosis until the end of their journey or the moment of death,” she said.

In cancer care, the entire cancer continuum is affected by inequities. Education and fostering an understanding of these issues in the treatment paradigm are steps that can be taken to bridge the gap in knowledge, but there is also an intersection “between survivorship and equity,” which is often overlooked.

“We often talk about equity at moments of diagnosis [or with] biomarker testing, but we forget about the intricate parts of cancer survivorship and how certain populations can be discriminated or excluded from the health care system during their cancer survivorship,” Florez said.

“Everybody should be involved in cancer equity,” she added. “This is not taking away from the majority group of patients—it is that everybody deserves equal care. Race, socioeconomic status, or English proficiency shouldn’t affect that.”

Inequalities That are Prevalent in Care

Florez explained that the lack of inclusion in clinical trials reaches beyond racial and ethnic disparities, affecting subgroups including younger patients—who often have their experiences invalidated—as well as minorities, women, and older adults. Additionally, in lung cancer trials, women and older adults are often excluded.

“It’s unethical not to provide these patients the option to participate in a clinical trial. Drugs can take years to get approved or for patients to get access. Being part of a clinical trial allows those patients to get access to drugs early on, not only drugs, but drugs combinations,” Florez said.

In the United States, White men represent up a large percentage of clinical trial participants. However, when key groups of patients are not included, the efficacy data will not accurately reflect all patient populations. This results in unknown adverse events and complications with treatments for minority subgroups.

“It is like you’re trying to create a wedding dress that would fit every bride in the world—it is impossible,” Florez said. “We come in different ways, shapes, forms, and [with varying] metabolisms. A lack of inclusion of all these populations generates very homogeneous data that unfortunately drugs get approved and then we learn about [adverse] effects. We learn about lack of efficacy in these populations after the drug is approved and after we know they have worse outcomes.”

She noted, for example, that when the agent tamoxifen (Soltamox) was developed, most of the clinical trial participants were White women. The exclusion of Black women resulted in suboptimal outcomes after treatment. Although today oncologists recognize that the tolerability and metabolism of the drug affects different populations differently, many patients suffered from not being included in the clinical trials—a setback that could have been avoided.

“Racial minorities [such as] Black, Hispanic, Native American, Native Hawaiian, and Pacific Islander populations [represent] around 40% of the US population,” Florez said. When we ask for inclusion, we’re not asking to include a 1% subgroup, [we want] 40%. When you add women and older adults, over 50% of patients with cancer [belong to a minority group]. We’re excluding the majority instead of including them.”

Inclusivity in Care

Florez noted that a shift in terminology toward more compassionate language can go a long way. For example, saying “patients with lung cancer” rather than “lung cancer patients” emphasizes the patient first and helps avoid defining someone by their disease. Bringing inclusivity to care also encompasses the process of training new doctors and establishing clinical trials throughout the community and continuing to foster those community relationships. Additionally, certain exclusion criteria remain a challenge in ensuring that clinical trials are representative of the whole population, making it more critical that trials are brought to the community setting.

Embracing the concept of cultural humility by learning from peers is also a key step in understanding how others view healthcare. Florez noted that previously the term cultural competency was used to demonstrate understanding of another person’s culture, but it is difficult to truly be competent in another’s culture. Therefore, shifting to the mindset that every day you can learn from the people around you to better understand their cultural beliefs and practice being culturally humble, will help physicians also recognize how their patients view healthcare. According to Florez, it is key “to listen and follow our patients’ cultural beliefs and healthcare beliefs because that's what dictates health [and] how you see health in your own eyes.”

“Survivorship is seen with different lenses, and that cultural beliefs and healthcare believes affects our patient survivorship experience,” Florez said. “We need to listen and understand instead of judging; judging is no way to practice medicine. For some cultures complimentary medicine is part of survivorship, so having an open communication with your patients, we ensure that they let you know that they're taking any complimentary medicine what their goals in survivorship are.”

“Every day we have more and more survivors so it's important that we understand how each of them see cancer survivorship and their life moving forward,” she added.

Dana-Farber Cancer Institute’s Steps Toward Inclusion

“I’m in an ivory tower institution and at Dana-Farber and Harvard Medical School, we need to come down and get to meet our community partners. It is no longer you and the doctor, and this is what I do. We’re in this together,” Florez said.

In 2012, the Cancer Care Equity Program at Dana-Farber was established to expand access to treatments, clinical trials, and educational programs as well as facilitate community outreach. Patients are referred to the Dana-Farber clinics by a primary care physician when there is a possibility of a cancer diagnosis regardless of insurance and location of residence.

Florez described the program as a direction intervention where Dana-Farber oncologists treat and assist patients following referrals. She also highlighted the Patient Navigator Program that was created to assist patients with the health care system.

“It has been very successful; we have navigated, in the last year, over 170 patients to assure they have access to care. For example, [imagine] that you have a mutation, but you cannot afford the [targeted agent]? [Imagine] you survive your cancer, but you are not able to get the CT scans that require follow-up to see if the cancer is back? [It is important to] be there in the clinic to help [mitigate these issues] and continue to help with patient navigation.”

She concluded by noting that time-bound interventions may not be as effective for patients as long-lasting interventions. The long-lasting interventions allow oncologists to learn from the community and continue to be a part of the care process and time-bound interventions do not give the time necessary to foster a relationship with the community. She noted that there can be a lack of trust when patients see their doctors come in for a short span of time and leave, not remaining a part of care.