Welcome back to Navigation Refresh, a recurring, informative feature for novice and seasoned patient navigators alike. In this issue, we cover the imperative role of patient navigators in oncology clinical trials.
Clinical trials are research studies that investigate new ways to prevent, diagnose, and treat cancer. There are different kinds of clinical trials. There are prevention trials that explore ways to reduce the risk of getting cancer. There are screening trials that aim to find new ways to detect cancer early. There are treatment trials that test new medicines, surgical procedures, or novel therapeutic methods. There are supportive care trials that aim to improve quality of life for people affected by cancer.
The gold standard for clinical trials is the randomized controlled trial, in which participants are randomized to get experimental treatment or the current standard of care. The experimental treatment will always aim to be better than the current standard of care. These trials are done so that, as a field, we can make improvements to therapies by increasing effectiveness, improving outcomes, reducing side effects, and/or reducing risks of current therapies.
When a person enrolls in a clinical trial, there may be costs associated with the trial, such as costs getting to extra appointments. However, whatever is being tested (ie, the experimental portion of the treatment) is sponsored by the funder of the trial and should never be a cost to the patient. The patient may retain costs for standard-of-care elements of the intervention (ie, parts of the trial that are not experimental and are typically needed by patients with a certain diagnosis and prognosis).1
Clinical trials provide valuable data that lead to a better understanding of cancer, new cancer treatments, improved treatment strategies, and evidence-based supportive care interventions. Historically, only about 7% of adult cancer patients participated in clinical trials, but a recent study showed that approximately 21.9% of cancer patients participated in trials for the period 2013 to 2017.2 This is great progress! Greater clinical trial participation leads to more rapid development and improvement of cancer treatments and supportive care interventions.
It is important that participants in clinical trials reflect the diversity and lived experience of the people who could benefit from the tested therapy. By including people with a range of lived experiences, including diverse racial, ethnic, and cultural backgrounds, as well as sexual and gender minorities, trialists will be able to detect potential differences in risks and outcomes for different groups of people. If the trial is effective for people of many different backgrounds, that means it is more generalizable (effective for the population at large).3
Every clinical trial has risks and benefits.
Risks: The new treatment being tested may not work as well as other treatments or may result in worse side effects. Trials may require patients to attend more clinical visits and undergo more tests than they would otherwise.
Benefits: Alternatively, the new treatment may be more effective than the current standard-of-care treatments. The trial may help doctors learn information that helps many future patients. Trial participants may be the first to access and benefit from a new treatment. In addition, the research team pays particular attention to potential side effects of experimental therapy and may check in with patients more frequently to be sure that all is going well.
Patient navigators can raise awareness about clinical trials and help address barriers to clinical trial enrollment, particularly for populations that are currently less well represented in trials. Each clinical trial is different and has different criteria for eligibility and participation. Patient navigators can let patients know that clinical trials are available, and why they are important. The assessment of the patient’s eligibility and ultimate enrollment in a trial should be done by a clinical research team member.
Patient navigators can help patients enrolled in clinical trials identify potential barriers to participation, such as transportation, cost, caregiver burden, time requirements, language constraints, understanding of information, and medical distrust. While patient navigators cannot solve every potential barrier, they can break down possible challenges to clinical trial participation and work with the patient to find solutions.
Patient navigators can also help educate patients about their rights in a trial. Participation in a clinical trial is always voluntary and can always be stopped if the patient is no longer comfortable participating.1
This edition of Navigation Refresh aligns with standards 16 and 19 of the Professional Oncology Navigation Task Force (PONT) standards: All navigators should advocate for patient participation in clinical trials (Standard 16). Clinical nurse navigators should use knowledge of clinical trial processes, requirements, and the specific treatment regimen to guide, direct, and support patients in their decision-making and informed consent about clinical trials (Standard 19).
National Cancer Institute. Cancer Clinical Trial Information for Patients and Caregivers. www.cancer.gov/research/participate/clinical-trials
CISCRP. Center for Information and Study on Clinical Research Participation. www.ciscrp.org/
GW Oncology Patient Navigator Training 2025 Guide. https://bit.ly/PN-Guide2025
GW Oncology Patient Navigator Training. The Fundamentals: http://bit.ly/PNTraining
National Institutes of Health: https://clinicaltrials.gov/
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