Nurses Are On the Frontlines of Clinical Trial Research in Breast Cancer

Bedside rapport is a crucial component of cancer care that the oncology nurse is uniquely poised to fill, according to Isabel Octaviano, RN.

“The bedside nurse is everything, they’re the first person the patients see [and] they’re the ones spending time with the patients,” Octaviano, a clinical research nurse at Baptist Health at the Miami Cancer in Florida, told Oncology Nursing News®.

Octaviano recently presented on clinical trial research during a CURE® Educated Patient Summit that was hosted at the 40th Annual Miami Breast Cancer Conference®. In an interview after the presentation, she discussed her own transition from an infusion nurse to a clinical research coordinator, the impact that nurses can wield during clinical trials. She also shared a case study of a patient she treated with triple-negative breast cancer (TNBC) in a clinical trial with pembrolizumab (Keytruda) prior to its indication for the disease.

Overall, she emphasized that the nurse can play a critical role in supporting clinical research.

“Sometimes, patients will have a visit with a physician and will tell the physician, X, Y, and Z, but then they come down to the infusion room and they tell you things that pertain to the research that they forgot to let the physician know, that’s very important,” Octaviano said.

“We all play a vital role and I encourage every nurse out there that if they have any interest in going into research or even if they don’t want to fully transition to it, there are so many other things that you can do to help with the conduction of research nationwide, most importantly to expand patients’ lives, cure of patients, and do all the wonderful things that we're here to do for them.”

Oncology Nursing News: What is unique about the nurses’ role in a clinical trial and how involved are they are when compared with the traditional oncologist?

Octaviano: We’re really the ones who have to study the protocol thoroughly and be able to answer questions. The way that I work with my physicians is we conduct clinic on daily. We do something called the prescreening, where I review everyone’s charts to see if they would be a possible candidate for the trials that we currently have available. Once I identify those patients, I review them with the oncologist and we briefly [review] the criteria and see whether they could participate.

From that point, the oncologist will approach the patient and offer the trial as another treatment option. A lot of times, they are offering them drugs that are not currently available for the type of breast cancer that the patient may be fighting [or] it may be available but [only] in a different setting. So that’s one of the beneficial things about enrolling them on a trial.

The nurse is very essential in the enrollment of the patient. During the time that the patient becomes active on study, we’re the ones conducting the visit alongside with the clinician, we really take care of all of the clinical aspects of the of the case, as the patient is on participating in a research clinical trial. Of course, we work under the direction of the oncologist, but our role is very essential.

How has the nurse’s role in clinical trials evolved over recent years?

At my institution, here in South Florida, the clinical research coordinator, called the CRC, does not come with a clinical background like nurses do. [I] was a chemotherapy infusion nurse prior to transitioning to research and that [has had] a huge contribution to the work that I do with my patients [and] the way that I’m able to identify things in a clinical setting based on my past expertise and experience.

The CRC takes care mostly of the administrative part that needs to take place with enrolling and maintaining patients on protocol. The research nurse conducts the clinical aspect [at] the time that the patient is enrolled. It’s great to combine both roles. The CRCs usually have a little bit more knowledge of the research rules of conducting a protocol [and] the clinical nurse brings a lot of expertise from a clinical setting, and that is vital to the success of a good research program.

What has your experience with clinical trials been?

My own experience with clinical research, going back to when I was in the chemotherapy infusion room, has been positive. I started [as] a chemotherapy research nurse that was administering the drugs and then I became the research nurse from a clinical aspect.

I still can remember my first patient in research—she was a patient with triple-negative disease.

This patient came to us under the care of Charles Vogel, MD, FACP. She came to us in a wheelchair recommended from an outside community oncologist that had told her that he was sending her to hospice, that there was nothing left for him to do for her. At the time, she was still in her 50s and was very down and thought that was ‘it’ for her.

We had that trial, we got genetic testing, [and] she was a match for a drug that’s now approved for [TNBC]—pembrolizumab. Pembrolizumab targeted the tumor that had [PD-L1 expression] within the genetic testing conducted and we kept her on protocol for 2 years. She did amazing. There were adverse effects related to this drug that have been experienced by many patients all over the world, but we were able to manage those, which gave us complete control of her disease systemically.

Even though at a certain point we had to stop the drug, it still brought her life [back to her]. She was able to go on other treatment regimens after with an amazing quality of life, she was traveling everywhere, [including] going to Europe and I’m still in touch with her. That is the beauty of research and because of the research that we conducted on her and many others, pembrolizumab is now an FDA-approved treatment for TNBC, which is incredible.

I have patients who have received the regimen [from] KEYNOTE-522 [NCT03036488], which is another protocol with pembrolizumab for triple-negative disease. That’s the regimen that is used now by [NCCN] guidelines where pembrolizumab is incorporated with other chemotherapies to treat patients with TNBC. That right there makes research amazing and beautiful.