When Stephanie L. Walker, RN, was diagnosed with metastatic breast cancer in 2015, she was not given information about an appropriate clinical trial or help navigating her way through the financial difficulties she was having after a stroke from complications of the cancer forced her to leave her job as a hospice nurse. With no income and no health insurance, Ms. Walker started researching organizations offering financial aid for patients with breast cancer. She ultimately found support at Living Beyond Breast Cancer (lbbc.org), a founding member of the Metastatic Breast Cancer (MBC) Alliance (www.mbcalliance.org/about/), and a career as a patient advocate, especially for Black women diagnosed with metastatic breast cancer.
In her new role, Ms. Walker discovered that Black individuals are often not represented in leadership positions within breast cancer organizations and are often left out of participation in clinical trials. She was determined to change both dynamics.
In 2021, Ms. Walker became Chair of the MBC Alliance’s BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) Initiative and is the Project Lead on the BECOME Initiative study. The objectives of the initiative, which was launched in 2019, are to understand the barriers to cancer clinical trial participation by Black patients with metastatic breast cancer and to identify actions to increase enrollment.
Studies have shown that although Black patients account for 12% of new breast cancer cases in the United States, just 3% of those patients participated in breast cancer clinical trials that were led by U.S. Food and Drug Administration approvals between 2008 and 2018.1 Black women are also more likely to be diagnosed with more advanced-stage breast cancer and be diagnosed at a younger age than White women with breast cancer.2
Understanding Black Patients’ Concerns About Clinical Trials
To conduct the BECOME study, the researchers first reviewed 34 articles related to Black patient participation in clinical trials. They then conducted 31 virtual interviews, including with patients who are living with metastatic breast cancer and clinicians involved in breast cancer treatments or are hospital administrators (among others), to identify relevant issues, concerns, motivations, and barriers dealing with the disease. The information gleaned from the literature review and interviews were then used to compose survey questions sent to patients with metastatic breast cancer. Of the 424 respondents to the survey, 102 (24%) self-identified as Black.
“I believe that being offered a clinical trial should be a standard of care for patients with advanced breast cancer.”— Stephanie L. Walker, RN
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During the 2022 ASCO Annual Meeting in Chicago, Ms. Walker presented the results of the survey. An overwhelming majority of Black respondents, 83%, said they were somewhat or very likely to consider participation in a clinical trial. However, nearly half, 40%, of those respondents said they had never been informed by the health-care team about the opportunity to enroll in a trial, compared with 33% of non-Black respondents.3
Additionally, Black respondents:
- Had a high level of trust and satisfaction in their medical team, 90%
- Were more likely than non-Black respondents to believe that unstudied treatments may be harmful (57% vs 31%)
- Were less likely than non-Black respondents to trust trials (73% vs 91%) and to trust that people of all races and ethnicities received fair treatment in clinical trials (32% vs 56%)
- Were more likely than non-Black respondents to value receiving trial information from someone of the same racial/ethnic identity (67% vs 10%), who had breast cancer (73% vs 44%) or metastatic breast cancer (73% vs 51%), or who had participated in a trial (72% vs 48%)
- Were more likely than non-Black respondents to be motivated to participate in clinical trials to ensure people with their racial or ethnic identity would benefit (83% vs 51%).
The ASCO Post talked with Ms. Walker about the BECOME Initiative survey results, how clinicians can increase trial participation by Black patients, and the Initiative’s next steps.
Determining Why Few Black Patients Enroll in Clinical Trials
Among the most startling results from the BECOME study is that 40% of Black patients with metastatic breast cancer were never given information about an appropriate clinical trial compared with their White counterparts (33%). Why do you think there was such a discrepancy in providing information to Black patients compared with White patients, when an overwhelming majority of Black respondents, 83%, said they would consider enrolling in a clinical trial?
I think the reasons for the discrepancy are multifactorial. Is it because clinicians and oncology teams have limited time to spend with each patient, and explaining clinical trial information can take hours, or because the hospital does not have the infrastructure to support clinical trials? Is institutional and/or physician bias a reason?
There is research suggesting that physicians with a strong implicit bias may view their minority patients as unlikely to comply with the trial requirements and may not be good candidates for a trial.4 They also may think minority patients are financially strapped and will not be able to complete the trial.
There are many reasons why clinicians may hesitate to ask Black patients and other minority patients to participate in a cancer clinical trial.
Surprising Survey Result
What surprised you about the survey results?
The number-one surprise for me was that such a high majority, 83%, of Black respondents said they were somewhat or very likely to consider participating in a clinical trial if they were asked. Patients cannot agree to be on a trial if the information is never presented to them.
Clinical trials evaluate the efficacy, safety, and effectiveness of experimental treatments in patients with cancer. To understand how these treatments affect patients from diverse racial and ethnic backgrounds, clinical trials must be inclusive. Minority patients need to be represented in clinical trials to ensure that the medications being investigated and approved by the U.S. Food and Drug Administration and prescribed are safe and effective.
Shouldn’t all patients with metastatic breast cancer be offered a clinical trial?
Yes, definitely. I believe that being offered a clinical trial should be a standard of care for patients with advanced breast cancer.
Removing the Barriers to Clinical Trial Participation
What must happen in oncology to change the dynamic of low clinical trial participation by Black patients with breast cancer or any type of cancer?
First and foremost, we must be asked by our physicians and medical team to enroll in a clinical trial. We also need more nurse navigators in community-based cancer centers to help guide patients through health-care systems with the resources they need for a good clinical outcome. In addition, patient navigation may help to eliminate health disparities and improve equity in cancer care.
We need pharma and other clinical trial sponsors to make access to cancer trials easier and to get rid of overburdensome eligibility requirements. Finally, we need patients to be involved in the process from the inception of the trial to the administration of the approved drug.
All stakeholders involved in the clinical trial process have a role to play in increasing minority participation in research studies.
Knowing Your Patients
What can oncologists do to ensure that they are informing all eligible patients about clinical trials?
They need to know their patients beyond what they learn in the short time they spend with them in an office visit. Clinicians need to know what happens to a patient when she goes home. Is she a single mother and/or taking care of multiple generations of family members and needs help paying for expenses related to clinical trial participation (eg, travel and child-care costs)? Then, clinicians need to deliver patient-friendly information in an unbiased way and work with patients to get them enrolled in a clinical trial if that is the best treatment option for them.
Building Trust in Minority Communities
What must happen in the Black community to raise awareness of the benefit of clinical trials?
We must come out of our comfort zone and openly talk about cancer and the potential benefit of enrolling in a clinical trial. As a Black woman, I can tell you that we are private people. If we have a problem, we keep it within the family, and we need to break out of that paradigm.
We need to educate ourselves about the benefits and risks of clinical trials, we need to be self-advocators, and we need to be more aware of our bodies and the importance of getting regular cancer screenings. And, most of all, we need to build trust with our physicians.
As a community, we need to support each other in this effort, whether it is through education messaging at the church, barber, and beauty shop or the grocery store.
Educating Health-Care Providers on Delivering Patient-Friendly Information
What are your next steps for the BECOME Initiative?
I would like to see this survey have a wider distribution in rural communities and in community-based cancer centers. I also want to see it expanded to include other minority populations, such as Latinx, Asian, and Pacific Islander patients with metastatic breast cancer.
In addition, the Metastatic Breast Cancer Alliance is partnering with Black Women Speak (https://bwspeak.org) to hold a symposium for health-care providers during the 2022 San Antonio Breast Cancer Symposium in December (www.sabcs.org). The goal of the symposium is to educate health-care providers on the language to use to help women understand what is involved in a clinical trial. Another goal is to increase the enrollment of Black patients into clinical trials.
We have come a long way since I started this effort 2 years ago, but we still have a long way to go.
DISCLOSURE: Ms. Walker reported no conflicts of interest.
REFERENCES
1. Loree JM, Anand S, Dasari A, et al: Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol 5:e191870, 2019.
2. Black Women’s Health Imperative: What You Need to Know About Breast Cancer Now…Part 1 of a 3 Part Series with Dr. Lisa Newman. Available at https://bwhi.org/2018/10/10/what-you-need-to-know-about-breast-cancer-nowpart-1-of-a-4-part-series-with-dr-lisa-newman/. Accessed August 9, 2022.
3. Walker S, Carlson M, White CB, et al: Increasing Black patient participation in metastatic breast cancer clinical trials: The BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project. 2022 ASCO Annual Meeting. Abstract 1014. Presented June 6, 2022.
4. Hamel LM, Penner LA, Albrecht TL, et al: Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control 23:327-337, 2016.
