The Clinical Trial and Navigator Connection

Clinical trials involve more than new cancer drugs; they also encompass a wide range of research areas, including new surgery techniques; radiation therapy approaches; new ways to identify, diagnose and measure diseases; as well as potential prevention strategies. Clinical trial participation calls for a trusting relationship between the patient and the healthcare system, thus navigation is an inside track for the patient to use on this journey. All types of oncology navigators play essential roles in clinical trials, from outreach through survivorship continuum of care, to positively promote the culture of research for the patient.

Navigators significantly impact clinical trials by enhancing patient awareness, access, and understanding, ultimately leading to increased participation. They function as a bridge between patients and the complexities of the healthcare system, addressing barriers to trial enrollment, and ensuring patients receive the necessary information and support. Misconceptions that start in the community can be addressed with correct information, and backing this up with logistics of getting to a cancer center with trials improves the overall patient experience and promotes a positive attitude toward clinical trials.

This publication has consistently shared the value of navigation in clinical trials as best stated in the NCCN Clinical Practice Guidelines in Oncology—“the best management of any patient with cancer is in a clinical trial.”¹ Navigators educate patients and families about the benefits of clinical trials and how they contribute to advancements in cancer care.² They help patients understand and overcome fears or misconceptions about clinical trials and provide unbiased information, empowering patients to make informed choices about participating in trials.³ Navigators work with oncologists and research staff to identify patients who may be suitable for clinical trials and to connect them with relevant trials.⁴ They help patients locate and understand appropriate clinical trials, ensuring they are informed about eligibility criteria and potential benefits, and they make the enrollment process smoother as the patient is proactively prepared for the extensive consent forms.⁵

The bottom line is that patient navigators are an enrichment to clinical trials as they increase trial participation, improve patient outcomes by helping patients access potentially life-saving or life-extending treatments, ensuring that patients from underserved communities have equal access to clinical trials with the latest cancer treatments. By coordinating care and providing ongoing support, navigators can help patients navigate the complexities of cancer treatment, including clinical trials, and to adhere to treatment protocols and follow-up appointments.

References

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines. Distress Management. Version 1.2021. www.researchgate.net/publication/349992750_NCCN_Clinical_Practice_Guidelines_in_Oncology_NCCN_Guidelines_R_Distress_Management_Continue_NCCNorg_NCCN_Guidelines_for_Patients_R_available_at_wwwnccnorgpatients#pf3
2. Paabo K, West J. Clinical trial catalyst. The navigator’s role in clinical trials. Journal of Oncology Navigation & Survivorship. 2024;15(8):233-235.
3. Michaels M, Szumita L. Improving diversity in cancer trials: the role of the nurse navigator. Journal of Oncology Navigation & Survivorship. 2024;15(1):16-19.
4. Preparing Patients for Cancer Clinical Trials. https://jons-online.com/issues/2024/july-2024-vol-15-no-7/preparing- patients-for-cancer-clinical-trials
5. James TA. Barriers to patient enrollment in therapeutic clinical trials for cancer: a landscape report. Journal of Oncology Navigation & Survivorship. 2018;9(10):412-413.