Imagine being handed a map to a building with hundreds of doors, no labels, no directory, and a meter running on your parking spot the whole time you’re trying to figure out which door is right for you. That’s what enrolling in a cancer clinical trial can feel like for many patients, except the stakes are your health, and the “parking meter” might mean hotel bills, gas money, missed paychecks, and days away from home.
Researchers in the Public Health Sciences Division at Fred Hutchinson Cancer Center wanted to make that maze easier to navigate. In a new study published in Cancer Causes & Control, a team led by Dr. Kristine Karvonen and Dr. Jason Mendoza interviewed 20 patients and 20 healthcare providers to design a program called GUIDE (Guiding participation toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials). The idea was to pair patients with a dedicated “Guide” who can help them navigate trial logistics and, just as importantly, reimburse them for the often-overlooked costs of participating.
Only about 8% of cancer patients ever enroll in a clinical trial, even though these trials are how new treatments are discovered and approved. Some of the reasons are medical, as not every patient is eligible for every study. But many of the biggest barriers have nothing to do with biology at all. They’re about money, time, and logistics. The Fred Hutch team calls these “health-related social needs,” (HRSN): things like housing, food, and transportation. And for patients who live far from Seattle, these needs can become dealbreakers fast.
The stories patients shared painted a vivid picture. One patient described driving to Fred Hutch from a town six hours away, and on bad traffic days, the round trip stretched to seven or eight hours. Another patient, who lived out of state, had to relocate to Seattle for six weeks for a trial and noted that the cost of doing so meant “most of the people that go through the clinical trials are locals.”
Even patients whose insurance covered their medical care found themselves stuck with travel, lodging, and food costs that added up. And asking for help with these costs wasn’t easy. “We’re not wealthy people. We have enough,” one patient explained. “And so, there’s a sense of pride. We don’t want to ask for help.” That patient went on to describe how difficult it feels to request money “when you’re dealing with a life and death situation,” even when the need is real.
Beyond the financial side, patients also said they wanted a single point of contact, someone who could help them understand confusing medical terminology, explain what a clinical trial actually involves, and answer questions as they came up. One patient summed up the appeal of having a continuous point of contact “whenever questions arise after the fact or while they’re engaged in the clinical trial, instead of having someone different each time.” Several others echoed the same wish: one less unfamiliar face to navigate, one more person who already knows their situation.
The clinicians, nurses, social workers, and patient navigators interviewed were unanimously supportive of the GUIDE concept. “I think [the GUIDE program] would be wonderful,” said one clinical nurse coordinator, recalling patients who never started a trial simply because they lived too far away and couldn’t afford the trips. Many providers said the program filled a real gap; while Fred Hutch already has patient navigators and social workers, no single team member is specifically responsible for connecting clinical trial-related financial needs with the resources to address them. Providers also raised practical questions. Some oncologists wondered how a new “Guide” role might overlap with existing staff, but patient navigators and social workers themselves saw the role as complementary, not redundant, and suggested the Guide work closely alongside their teams. One patient navigator pointed out that the need is especially acute for patients who don’t speak English or whose families expect younger relatives to handle medical matters, leaving older patients “a much more difficult time navigating the system.”
Based on these conversations, the research team developed three core recommendations for the program. First, the Guide should screen patients for health-related social needs repeatedly, not just at enrollment, since financial strain can shift throughout treatment, and connect patients to relevant resources, whether that’s reimbursement, transportation help, or a referral to social work. Second, the program needs clear infrastructure for reimbursement; because financial assistance for trial-related costs isn’t yet standard practice, GUIDE will need defined rules about what expenses are covered, how quickly people get reimbursed, and how the process minimizes paperwork burden on patients. Third, the Guide should be woven into the existing care team rather than created as a freestanding role, working alongside oncologists, nurses, social workers, and patient navigators with clearly defined responsibilities so nothing falls through the cracks. “This work highlights stakeholder priorities that we thought critical to understand prior to finalizing the design of GUIDE,” said Dr. Karvonen. “We wanted to make sure we were listening to patients and providers before building the program.”
GUIDE represents a concrete, patient-informed step toward closing the gap between who could benefit from a clinical trial and who actually gets the chance to enroll. Fred Hutch researchers are now working to tailor the program for regional sites that serve more diverse patient populations. But for Dr. Karvonen, some of the most important questions are still ahead. “What I find most exciting about these findings is that they contribute to our knowledge of what key components are necessary for a program to improve clinical trial access,” she said. “We still have a lot to learn about what the perfect ‘recipe’ is for a successful clinical trial navigation program to ensure that every patient who is interested in a clinical trial can participate, and whether this recipe needs to be personalized for each patient.” With that goal in sight, the hope is that a friendlier map, and someone to walk it with you, can help more patients find their way through the door.
Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium Members Drs. Hannah Linden, Ajay K. Gopal, Evan Yyu, and Jay Mendoza contributed to this research.
This research was supported by the Andy Hill Cancer Research Endowment (CARE) Fund, with additional support for the study's lead author provided through the Robert A. Winn Excellence in Clinical Trials Career Development Award.
Karvonen, K. A., McDougall, J. A., Hohl, S. D., Carosso, E. A., Burrows, T., Mecham, S. H., Stohr, E., Devine, A., Linden, H., Gopal, A. K., Yu, E. Y., Cowan, A. J., & Mendoza, J. A. 2026. Perspectives on GUIDE (Guiding participation toward understanding, inclusion, diversity, and equity for cancer trials): a clinical trial access intervention. Cancer Causes & Control. doi: 10.1007/s10552-025-02098-w.
Science Spotlight writer Darya Moosavi is a postdoctoral research fellow within Johanna Lampe's research group at Fred Hutch. Darya studies the nuanced connections between diet, gut epithelium, and gut microbiome in relation to colorectal cancer using high-dimensional approaches.