Clinical Trial Catalyst: The Navigator’s Role in Clinical Trials

August 2024 Vol 15, No 8
Kendra Paabo, BSN, RN
Manager of Patient Navigation, Brain Tumor Network
Jennifer West, BSN, RN, CCRC, ONN-CG
Clinical Trial Nurse Navigator, University of Florida
Navigator Tools

Key Takeaways

Clinical trials are crucial for advancing cancer treatment and offering hope for better health outcomes for millions of people diagnosed with cancer worldwide. However, navigating the many complexities of trial participation can be an intimidating option for patients to pursue. This is where navigators play a pivotal role. We act as a bridge between patients and the often overwhelming world of clinical research, ensuring our patients have the information and support they need to make an informed decision about the next step in their cancer journey.

As navigators, we have the honor of walking alongside patients through their cancer experience, from initial diagnosis to survivorship, and beyond. This affords us with opportunities to engage patients in conversations about clinical trials early. A primary responsibility of navigators is to empower patients with comprehensive education about clinical trials. We help demystify the identification and enrollment process, address misconceptions, help overcome barriers, and explain the benefits and risks involved. Our support enables patients to ask informed questions and participate actively in their treatment discussion and decisions.

Remember that you most likely have a better idea of what a patient’s overall cancer journey will look like, and as navigators we can help them prepare for the unknown obstacles ahead. There are certain time points when patients are eligible to enroll in a clinical trial, including initial diagnosis, when standard of care is no longer effective, when progression of disease has been noted on their restaging scan, and even when they enter survivorship. Understanding these time points early on may help patients understand the full scope of their available treatment options. This is why assessing the patient’s readiness to engage in conversations about clinical research is important from the beginning of care and prior to initiating any discussions. This will happen by building trust and a rapport with your patients. By engaging in open, transparent, and informative conversations about clinical trials, we can help alleviate patient fears and mistrust. And educating ourselves allows us to empower our patients to become active participants in their cancer care from the early stages.

Navigators are integral in streamlining access to clinical trials. Whether you work in an academic center, private practice, or rural community, we can be a catalyst for clinical trial enrollment and participation. To provide comprehensive cancer care, we need to be aware of clinical trials being offered within our specialized disease processes, whether they are at our facility or within our community at large. Identifying clinical trials early on can allow the nurse navigator to assess potential barriers and challenges that may arise and hinder enrollment of a trial participant.

Scientist at computer

In the next Clinical Trial Catalyst, in the September issue of JONS, we will discuss how molecular profiling can influence clinical trial options and how to locate trials for your patients.

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Another way navigators can take an active role in being their patient’s advocate is by discussing the possible role of a clinical trial for a patient’s care plan at tumor boards or multidisciplinary conferences. Be proactive and introduce the conversation with the providers so they are aware the patient is open to exploring all available options. Many physicians may be reluctant to discuss participation in a clinical trial with their patient due to their lack of knowledge, clinic support, or treatment preference. For this reason, patients many times are referred too late to qualify for a specific study or are never given the opportunity.

Improving diversity in clinical trial participation is another significant area where navigators can make a difference. We play a key role in reaching out to and establishing relationships with underrepresented populations, educating them about the risks and benefits of clinical trials, potential opportunities for participation, and addressing specific barriers these groups might face. Taking the time to build trust within their communities, whether through outreach events, educational offerings, or media awareness, is vital. Through these efforts we can help ensure that clinical research reflects a broader, more inclusive patient population, ultimately leading to more accessible healthcare solutions.

Along with these efforts to bridge the gap to enrollment on a clinical trial also comes the challenge of retention, keeping the patient on a trial once enrolled. Many of these barriers include financial concerns, scheduling conflicts, poor compliance, fear of the side effects, etc. Keeping the patient engaged with the clinical trial team will help lower the chances of a patient coming off study prematurely. Patient navigators can be an important part of this process by staying in touch with the patient during this time, continuing to offer support and education of the clinical trial process, and being a compassionate and active listener. By addressing their concerns as they arise and bringing them to the attention of the clinical trial team, we can greatly add to the experience of the patient on a trial.

According to the National Institutes of Health, there are an estimated 2 million new cancer diagnoses in the United States, over 20,000 clinical trial opportunities, and less than 8% of patients actually qualify and enroll.

Navigators are essential in bridging the surprisingly wide gap between patients and clinical trials. Through education, logistical support, and personalized care, we empower patients to explore all available treatment options, including experimental therapy through clinical trials. The data collected and outcomes interpreted from clinical research are critical for advancing our medical knowledge. Through our close interaction with patients, navigators can contribute to this process by gathering detailed information that can be invaluable for research purposes.

Our efforts not only enhance the patient experience, but contribute significantly to the advancement of oncology care. As the role of the navigator evolves and expands, our impact on clinical trials will undoubtedly continue to grow.

Sources

  • Dobrea L, Gansauer L. The navigator’s role in supporting clinical trials. Journal of Oncology Navigation & Survivorship. 2018;9(8):324-325.
  • Johnson County Education Research Triangle. Nurse Navigators Light the Way To Clinical Trials. Johnson County Kansas. 2020. www.jocogov.org/johnson-county-education-research-triangle/blog/2020-blog-entries/nurse-navigators-light-way-clinical-trials
  • Unger MJ, Vaidya R, Hersman DL, et al. Systemic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111:245-255.
  • National Institutes of Health. Implicit Bias. https://diversity.nih.gov/general-page/implicit-bias

Unsure About Joining a Clinical Trial?

Exploring the possibility of participating in a clinical trial can be daunting, especially on the heels of a new cancer diagnosis. From understanding the process to weighing the risks and benefits, this article features key considerations that can help you make an informed decision about how clinical trials factor into your care journey.

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