GU Oncology Trial Logistics: Nursing Insights from Dana-Farber

Simone Payette-Capone, a research nurse on the Genitourinary Oncology team at Dana-Farber Cancer Institute, operates at the intersection of rigorous trial protocols and compassionate, real-world patient care. In the complex landscape of GU oncology, managing trial logistics is a high-stakes balancing act, ranging from coordinating timed pharmacokinetic blood draws to navigating tight scheduling windows for imaging and scans.

In this interview with Oncology Nursing News, she discusses her role as a clinical "detective," parsing out complex side effects in novel combination therapies, and shares personal strategies for improving patient adherence to daily treatment diaries. She also offers valuable insights into how research nurses collaborate with community oncology teams to ensure seamless care across institutions. This perspective highlights the essential competencies — and the importance of asking the right questions — needed to drive successful clinical trials while keeping the patient as the primary driver of care.

As a research nurse for the GU team, you sit at the intersection of strict trial protocol and real-world patient care. What do the day-to-day logistics of managing these trials look like for a nurse, and how do you balance rigorous protocol adherence with compassionate, patient-centered care?

In general, patient care is always going to come first. There are times where we have to balance between what the protocol wants and what's best for the patient in that moment. We're frequently going into visits with patients, so we see our patients with the provider in the visit, and so we're often helping the provider come up with a plan of care that satisfies both things, and then helping to decide if there's a situation where, for example, we want a patient to have an extended drug hold for a particular reason, or if the protocol requires a certain lab to be done at a certain interval, and we want to see if we can get around that for, say, a big life event coming up, or things like that, where we're wanting to prioritize not only their cancer care but also them as a whole, thinking about what ways we can get approvals from the sponsor for different things to make sure that , at the end of the day, focusing on the patient as the first and foremost driver of their care.

Clinical trials, especially in complex GU cancers, often involve highly synchronized logistics, from timed pharmacokinetic blood draws to specific imaging windows. What are the biggest operational or coordination hurdles oncology nurses face when executing these tight timelines?

For the things that happen the day of treatment, so that can be PKs, EKGs, vital signs, certain observation times, especially if we're administering multiple drugs, it can become a lot. And so, we work with our infusion nurses and with our trial coordinators to create flow sheets and spreadsheets for our schedulers and we film different in-services for the infusion nurses to review before they administer the drugs, just to give them the best possible overview and set them up as best as possible to be able to have all of those things happen.

And then, in terms of scheduling, it definitely can become difficult getting everything done within the protocol-specified window, especially scheduling things like scans and echoes and things that we have to book further out, and so sometimes if the protocol allows something to be done locally, we might be working with a local oncology team to see if they have earlier availability to get something done within that window, or not just looking at Dana-Farber but looking at different Brigham facilities and trying to be creative when we need to, to make sure that we can get things done within that specified timeline. And then, if and when we have to make exceptions, things that are a couple days off here and there, being in communication with the sponsor and with the patient's provider to make sure that, safety-wise, that's OK for that patient, and then being in communication with the sponsor, if we do have to do something slightly out of window. That's definitely come up recently with scans and when we have an MRI machine down or something that's being serviced and now things get shifted all over the place, and so it definitely takes a lot of collaboration between all of the different groups and the people that are involved to get all of that done.

With the rise of combination therapies such as linking immune checkpoint inhibitors with targeted TKIs or utilizing ADCs, side effect profiles can become deeply complex. How does your role as a research nurse shift when managing the unique or unexpected toxicities associated with investigational agents?

One of the fun things about being a research nurse is that we get to be a detective in those situations. Especially in situations where it's a really novel agent or first in human, we don't have a ton of data. There are certain things that they can check in rats and dogs, but a dog can't tell you if they're feeling something. And so frequently we'll have patients report symptoms that we aren't sure if that's related to the study drug, and so working with the sponsor and the medical monitor to see if they've had any incidences of that before, and if they have any resources that they can provide, and then also working with the patient's MD. For example, we have a number of studies that we're combining immunotherapy with a TKI, and so if a patient's reporting diarrhea, that could be from either the immunotherapy or the TKI, and the way that we treat those would be very different. And so, trying to do different testing and parsing out as best we can what we think is the culprit, and then a trial and error. So, if we think it's the immunotherapy, we try a steroid for a couple days. If it doesn't make any difference, then we know it's definitely not the immunotherapy. And so, working through different lines and trial and error, figuring out what works best for treating that particular side effect.

Many GU clinical trials require extensive oral therapies taken at home, along with detailed patient diaries. What strategies do you rely on to ensure patient adherence to rigorous protocols over long periods, and how do you proactively troubleshoot any compliance issues?

The diaries, we try to make them as user friendly as possible. Sometimes they ask for a lot of information, which then can become difficult for the patient, just day-to-day remembering to write down everything, and so usually simplifying as much as we can to make sure that it makes the most sense and that it's laid out in a way that that makes sense and makes it easy for the patient to be doing that on a daily basis.

And then, one of the things that has been an interesting experience for me is I have ADHD, and so I have struggled with remembering to take my medication every day, and have had to come up with different strategies to remind myself. And so, getting to share that experience with some of my patients who are who are struggling and figuring out what's the best way for you to remember not only to take the medication, but then to also remember to document it in your diary, whether that's a specific space that you go to every morning where you take the medication, you immediately write it in the diary, whether it's you put the diary on your refrigerator, so first thing in the morning when you go to open your fridge and get breakfast you know, “Oh, OK, I've got to do this,” setting different timers, all kinds of different strategies that we can try and come up with and work with the patient to figure out what the best situation is for them, and making sure that, of course we want FDA compliance, but also we want to make sure that the patient's taking the drug regularly because that's treating their cancer, and so working with them around whatever those obstacles are to help come up with good strategies.

How has the role of oncology research nurse evolved at a place like Dana-Farber as trial designs become more personalized and biomarker driven, and what specific logistical skills or competencies do you find are most vital for nurses entering this this space today?

We have a number of trials that will have specific requirements for different testing of their tumor or certain genetic markers, and so part of that is us being able to read these reports. When I first started in this position, that was not something that I was able to just see this report and know exactly what I was looking for, and so I think, especially as things are changing and we have different studies that will come up that have these different requirements, or we're seeing new things, using our PIs and our providers as a resource has been incredibly helpful. One of the wonderful things about Dana-Farber is our physicians. We're also a teaching hospital, and so many of our physicians are really people who like to teach, and so getting their perspective and having those things explained has been very helpful to me.

I would say in general, with skills and competencies, I think the biggest skill is just knowing when you don't know something and knowing who to ask and when to ask to have those things explained to you, especially going into research nursing from perhaps as a regular oncology nurse, there are going to be things that you don't know. There were plenty of things that I didn't know, but knowing when to ask questions and being not afraid to ask questions and using our PIs who know all the science behind these studies, using them as a resource when the protocol language or the report that you're looking at is just looking like gibberish to you, having them help to explain it has been very helpful.

Many patients transition between major academic research centers and local community clinics for parts of their care. What insights or advice can you share with community oncology nurses regarding the best ways to collaborate on trial logistics and keep patient care as seamless as possible?

The biggest thing is just having an open line of communication. Frequently, we'll have email chains going with local teams or having a direct line to be speaking back and forth, so that when we're trying to coordinate something, instead of going through all of these different people, just being able to communicate nurse to nurse is always really helpful. And then I would say, if you're working as a local nurse navigator you might be sending a patient to a bigger institution to be on a study, I would say feel free to ask the research nurses questions, and if there are things that are coming up with a patient where they're calling the local oncology office and reporting symptoms, not being afraid to send that over to us or ask us questions, use us as a resource. I certainly can say for Dana-Farber that we're always more than more than happy to be collaborating in that way.