Nurse Practitioners in Cancer Research: Recruitment, Protocols, and Documentation

Referring to protocol and documenting adverse events (AEs) are best practices when working in clinical trials, according to an oncology nurse practitioner who works in multiple myeloma (MM) research at the University of California San Francisco (UCSF).

Samantha Shenoy, NP, MSN, spoke with Oncology Nursing News® about the role of oncology nurse practitioners (NP) in clinical research. As an expert with 16 years of experience as an NP and 4 years of experience in MM research, Shenoy shared that keeping close track of patients’ disease progression as well as adherence to inclusion and exclusion criteria for known trials can enhance and expedite patient recruitment.

Additionally, Shenoy shared that referencing trial protocol is a staple of working in research as an oncology NP. While relying on protocol may be an adjustment for NPs, Shenoy added, it is important to do so in order to avoid prohibited medications and know when AEs have reached unallowable toxicity.

She added that “it is important to do so in order to understand the protocol study design, schedule of events, adverse events, toxicity management, the medications that are prohibited, and other important aspects of protocol.”

Documenting AEs is one of the most important parts of an NP’s role in cancer research, according to Shenoy. Using tools such as AE tables and collaborating with clinical research coordinators aid in ensuring that toxicities are properly documented.

Transcript

My name is Samantha Shenoy, and I’m a nurse practitioner at UCSF in San Francisco, California. I transitioned to this research position about four-and-a-half years ago, where I’m the research nurse practitioner for patients with hematologic malignancies on clinical trials.

With each patient, I’m either doing follow-up post-CAR [T-cell] therapy, or I’m approving—basically evaluating [patients] to make sure it’s safe for them to get their subsequent bispecific antibody therapy or other type of therapy.

My job is to do an exam, evaluate [patients’ lab results], manage any other issues that are occurring, such as cytopenias, [intravenous immunoglobulin replacement therapy], infection management, and so on.

[I’m] doing all of those things within a visit because, as you know, there are a lot of complications that can come with immunotherapy, specifically [CAR T-cell therapy] and bispecific antibody therapy. So I manage all of that.

Our new director of research for multiple myeloma specifically has this great model where he wants to identify patients early on so that we have a list of patients going who are potential candidates for trial. Once they’ve met criteria for progression, then we already have a trial that’s ready for them to go [on to].

Part of my role now is keeping a list of patients who are impending progressors. We’re starting to see their light chains rise, or their M proteins rise. I add them to a list, and I continue to monitor their labs every week.

While I’m doing that, I keep track of all the trials we have for myeloma and all the inclusion and exclusion [criteria], and so I already have an idea of what trial I think would be a good match for them so that when they actually officially meet the criteria for progression, we already have a trial ready to go, and we already know about the patient. It’s been a really great way to recruit patients for clinical trials.

Your protocols are your go-to, and I’d say to know that protocol. Know to always reference that protocol, because everything you need to know is in the protocol.

That was one of the toughest transitions, having not worked in research before, is that you need to always access the protocol. For example, if you want to prescribe a new medication, you need to make sure that that’s not on the prohibited medication list. Or if there’s a toxicity, some type of toxicity, some adverse event—you always need to look at the protocol to make sure that the grade is allowable for treatment.

For example, a lot of grade 3 or grade 4 AEs may not be allowable for a patient to continue treatment.…I’d say that that’s the number 1 thing: to know that protocol well and to access it regularly.

Documentation is so important in research, so I think that was another thing that I really have learned throughout this role, especially when you have—I mean, any clinical trial—but especially phase 1.

The data is so important, so coming up with a good way to capture the data—and we’ve really transitioned to doing AE tables—and so keeping track of the data is really important, and checking in with [clinical research coordinators] to make sure data is submitted in a timely manner. And so that’s another really important part of research, the documentation.

This transcript has been edited for clarity and conciseness.