The Navigator’s Role in Supporting Clinical Trials

Patient navigators are increasingly recognized for their critical role in helping patients make their way through complex healthcare systems, all the way from screening to treatment adherence. Clinical trials are a vital part of high-quality cancer care, and navigators have become invaluable in facilitating patient awareness and access to trials, while also normalizing the clinical trial process and dispelling myths.

In an interview format at the AONN+ Midyear Conference, Lavinia Dobrea, RN, MS, BSN, OCN, Manager, Oncology Research and Biospecimen Repository Program, The Center for Cancer Prevention and Treatment, Orange County's St. Joseph Health, and Lucy Gansauer, MSN, RN, OCN, CCRP, Director of Cancer Care Delivery Research, Spartanburg Medical Center, SC, discussed the integration of cancer clinical trials into patient navigators' usual activities and revealed insight on how navigators can mitigate care barriers and support clinical trial participation.

Lavinia: Lucy, what are the treatment goals for patients at your cancer center?

Lucy: We want all patients to understand that clinical trials are an option for care, whether it's a treatment for their first diagnosis, a recurrence, or for symptom management, and to be considered for any available trial. We want to make sure that all staff is participating in education about clinical trials, but, more importantly, that the navigator is part of that conversation with the patient. We want every patient to be educated on all options in order to make an informed decision and to feel confident enough to ask, "Is there a trial for me?"

Lavinia: How can we facilitate this when we don't even have a research background?

Lucy: Start small. When the physician is explaining a patient's treatment options and brings up a clinical trial, the patient may be shocked to hear those words. After that initial consult, the navigator can break down what the patient doesn't understand and start filling in the gaps in the information. Navigators can really help the patient understand that this is part of good clinical cancer care and even help patients make a list of questions to ask about clinical trials.

Patients are often afraid to ask questions for fear of sounding unintelligent. The navigator, one-on-one with the patient or family, can help articulate those questions for the patient and get the answers.

Lavinia: How can navigators "normalize" clinical trials?

Lucy: Ask the patients what they've heard about clinical trials. It starts a dialogue. Based on what they've heard, you can start addressing those myths and fears with simple answers.

Lavinia: How might a navigator address those myths?

Lucy: I think one of the first myths patients have heard is that they're going to be randomized to something that's not good; that they'd be a guinea pig. One of the easiest things to do is use a positive analogy: "While this trial has multiple arms, we don't know which arm you're going to be on. It's like when you're having a baby and you don't know if it's going to be a boy or girl." You want to avoid things like "flip of a coin," because that implies a winner and a loser.

Placebo is another big fear that patients have. Explain that it's unethical to withhold effective treatments for any patient if there is an effective treatment available. Explain that in a clinical trial, a patient will either get standard of care or what is considered a superior addition to standard of care.

Lavinia: How would you explain the purpose of a clinical trial?

Lucy: We have to be very careful that we don't promise a superior outcome, because that's not ethical. But we can explain it by saying, "As a participant in a clinical trial, you can have early access to promising therapies before they are widely available," or "Clinical trials are designed to see if a new treatment will improve on current treatments…the hope is that it will."

Lavinia: What are additional ways navigators can support clinical trials?

Lucy: Quickly scheduling appointments for surgical and medical oncology consults as required by the study, arranging transportation for research appointments, and working around patients' school or work schedule are all extremely important; people worry about losing their jobs.

And stay in constant communication with other nurses and physicians. Navigators are often the first to be aware of adverse events, and it's important for the research staff to be able to capture those in the side effect profile for a new molecule, so be sure to communicate those to the research nurse.

Lavinia: What tips do you have for navigators when addressing clinical trial questions?

Lucy: You don't have to know all the answers, just know where to get them. The patients mainly want someone to have a dialogue with. They want to discuss this with someone who's not rushed, and the navigator has the time to actually make phone calls to other family members and reassure them about their loved one enrolling in a clinical trial.

They want to discuss this with someone they trust, and they trust you. You know a lot more than you think you know.