Improving Clinical Trial Access and Support: A Practical e-Course Designed for Patient Navigators

Clinical trials and research play a critical role in improving outcomes and quality of life for patients with cancer by finding new ways to detect, prevent, and treat disease. Moreover, clinical trial participants have access to the latest therapies and treatment options and typically experience closer monitoring and more frequent check-ins from providers throughout the study.

Despite these benefits, only a small portion of eligible patients participate in clinical trials. For many, financial and logistical concerns are significant barriers to trial enrollment, especially for patients who don’t live near a trial site. Patient populations with historically lower financial resources, therefore, are severely underrepresented in clinical trials compared to patients with higher socioeconomic status. The downstream impacts of this disparity are concerning, as it enables a lack of data about the impact of certain therapies on these underrepresented patient populations. Another notable roadblock to trial participation is a lack of provider awareness of all current studies, both within and outside respective institutions, and difficulty initiating conversations about the benefits of clinical trials.

Recognizing the weight of these barriers to trial participation, Susan G. Komen partnered with breastcancertrials.org to develop a clinical trials navigation e-course designed to help patient navigators better support individuals in accessing trials. To learn more about this free, virtual on-demand training, ACCCBuzz interviewed Julie McMahon, MPH, director of community health programs at Susan G. Komen, and Sabrina Mayhew, PhD, RN, CN-BN, manager of access and diversity at breastcancertrials.org.

ACCCBuzz: Describe the mission of Susan G. Komen and breastcancertrials.org.

McMahon: The mission of Susan G. Komen is to ensure every patient with breast cancer gets the care they need, no matter where they live or who they are, so they achieve the best outcome. We prioritize health equity and addressing the most lethal and aggressive types of breast cancer through community health, research, and advocacy.

Dr. Mayhew: Breastcancertrials.org (BCT) is a program within a larger nonprofit called Quantum Leap Healthcare Collaborative. Our goal at BCT is to empower and educate individuals affected by breast cancer to consider clinical trials as a routine option for care.

ACCCBuzz: What prompted this partnership to create the clinical trials navigation e-course?

McMahon: There has been a lot of awareness building that there are disparities in access to clinical trials, that barriers exist, and that certain populations have been historically underrepresented in many clinical trials. But we have been trying to take it beyond that problem statement and dig into what we can do to actually address those issues and make traction.

We have a navigation training program at Komen through which we put tools in the hands of health care professionals to address barriers for patients. There has been a longstanding partnership between Komen and BCT, so when Sabrina and her team launched a new program for navigator training, it was natural for Komen to approach our partners and see how we could work together. BCT had all the right pieces to introduce a patient to the clinical trials process, while Komen had the dissemination power to reach thousands of navigators with that content.

Dr. Mayhew: Not everyone has equal access to clinical trials, and many patients don’t know that clinical trials exist, especially those from communities that have been historically left out of research. They don’t know that trials are an option for them or even how to find one. That’s where BCT comes in. We help patients find and join trials, and we offer matching tools for early-stage and metastatic breast cancer communities. Because Komen had this larger reach and navigation platform, we wanted to add to it with our expertise and technology.

ACCCBuzz: What did the course development process look like? How were topics chosen?

Dr. Mayhew: I incorporated a lot of content based on common questions I receive from patients in our navigation service program. Topics generally cover concerns that patients are likely to have and how navigators can address those concerns.

McMahon: Sabrina also trained patient navigators in our Patient Care Center, which was really helpful because it was a good gap assessment of what they needed to learn more about. It served as a way to pilot the kind of information other navigators outside of our organization would need and created a kind of real-life feedback loop. We also grounded our work in the existing professional oncology navigation standards.

ACCCBuzz: Who is the target audience for this training?

McMahon: It starts with professional patient navigators, who may be clinical, social work, or patient navigators who are not licensed clinicians. Our whole team at Komen has taken it and developed a workflow specifically to ensure we’re proactively bringing up the topic of clinical trials with patients. But the broader target audience is any kind of allied health professional who has a role in patient navigation. Navigation can be broad in that lots of professionals with different job titles do that kind of work. We’ve also seen patients take this training, along with advocates who are not professionals.

Dr. Mayhew: For this particular project, we had patient navigators in mind, but that also includes patients, caregivers, advocates, or anybody who is interested in clinical trials and wants to learn more about them.

ACCCBuzz: Can you speak to the broader issue of patient access to clinical trials and why this access is important in advancing cancer care?

Dr. Mayhew: Individuals of all different races, ethnicities, and backgrounds respond differently to treatment. If clinical trials only include a narrow slice of the population, we can’t be sure that the treatment will work for everyone. Diversity is essential in clinical research because it makes research better, safer, and more effective for everyone. A lot of the time, patients enroll in clinical trials when they’re treated at a large academic center. Individuals being treated in smaller community clinics, however, may not have access to trials. Navigation then opens the door and can make these diverse communities feel more supported and included in research.

McMahon: In our space, we talk a lot about democratizing access to clinical trials, because often patients are limited by what their provider has the time, awareness, opportunity, and forethought to bring up in an appointment. There’s so much happening so fast in cancer research that providers may not even know the trials at their own institution, much less if they’re at a community clinic, and don’t have a whole department or initiative dedicated to clinical trial enrollment. Therefore, patients in nonacademic settings don’t typically have the same access to trials, or they’re limited to trials that happen to be available at their institution.

That’s the bottleneck we’re targeting with our e-course, by providing patients with a tool they can use to see which trials are out there that could be an option for them. Learning that they’re eligible for a trial at a hospital an hour away can totally change a patient’s outcome.

ACCCBuzz: How does your training aim to address these issues?

Dr. Mayhew: We want health care professionals to feel more comfortable talking about trials and recommending them to their patients. A lot of people are still afraid of research, and many of them don’t know they can join a trial at the very beginning of their treatment planning. The information in our training gives patients the ability to make more informed treatment decisions.

McMahon: An important component of this training is assessing the readiness of a patient to have a conversation about clinical trials that is fluid throughout their treatment. Some patients aren’t ready to talk about trials at an early stage, and many of them don’t realize that there are opportunities to participate in trials early on in their cancer journey. There are many points in the continuum of care where patients are eligible, so it’s important to us that patients understand they can drive that conversation with their provider. Our e-course ultimately aims to provide patients with the research skills and the language to understand their pathology and eligibility criteria.

ACCCBuzz: Describe the content areas this e-course covers. What information/skills will learners walk away with?

Dr. Mayhew: The course includes 4 modules. The first provides an introduction to clinical trials and how to navigate them, along with basic information such as who can participate in trials, informed consent, and the role of the navigator in supporting patients. The second module focuses on BCT and how patients can use it to find a trial. It touches on inclusion and exclusion criteria, the importance of knowing your biomarkers, and how to have conversations with your provider after you’ve found a trial you’re interested in. The third module explores the most common barriers to clinical trials and how navigators can support patients in overcoming them, and the fourth is dedicated to health equity and the importance of enrolling diverse populations in trials.

ACCCBuzz: What has the response/uptake been like so far?

McMahon: The reviews we’ve received have been great. People are really appreciative of the content, saying that it’s practical information that they haven’t already gotten somewhere else. This has been particularly gratifying because it goes back to our original purpose, which wasn’t to just restate a problem, but to arm health care professionals and patients with functional tools to improve clinical trial navigation. We are also constantly monitoring the user experience and evaluating how much time users spend completing the e-course, and we’ve already made some tweaks based on feedback we've received.

Now, our goal is to disseminate this training as widely as possible so we can reach the people who can benefit from it. It was released in December 2024, and our plan is to embed it in our required training at Komen because it does align with the standards of what navigators should be equipped to do. We anticipate high enrollment this summer, and after our navigation summit in September, which will include a dedicated session on clinical trials. The course has definitely been effective, based on our data and the survey responses we’ve seen. Now it’s just a matter of making sure people know about it and getting it into their hands.

ACCCBuzz: Are there any other resources available to address the diversity gap in clinical trials?

McMahon: ShareForCures is a breast cancer research registry that allows individuals who have been diagnosed with breast cancer to contribute their health data to fuel scientific discovery. By expanding participation beyond a narrow subset of patients, ShareForCures ensures that research better reflects the full diversity of those affected by breast cancer. The platform was designed to reduce barriers—making it easier for anyone, regardless of background, to contribute to research.

Dr. Mayhew: Led by Quantum Leap Health Care Collaborative, the I-SPY ACCESS program focuses on expanding access to the I-SPY family of clinical trials for historically underrepresented populations. The program intentionally partners with safety net hospitals, county hospitals, HBCU-affiliated institutions, Hispanic-serving hospitals, and rural and community cancer centers. By investing in infrastructure and providing support for both sites and patients, I-SPY ACCESS is making groundbreaking trials more inclusive and representative of the people who need them most.

The e-course “Navigating Clinical Trials” is available here. New users will need to create an account. For assistance, please contact navigationnation@komen.org.