The Role of Navigators, Patients, and Community Members in Accruing for Clinical Trials

May 2021 Vol 12, No 5


Clinical Trials

When it comes to identifying cancer clinical trial opportunities for patients, the role of the oncology navigator is crucial, according to Linda U. Krebs, PhD, RN, AOCN, FAAN, associate professor emerita at the University of Colorado College of Nursing. However, it is not solely up to the navigator to facilitate patient enrollment on one of these potentially lifesaving trials. At the AONN+ 11th Annual Navigation & Survivorship Conference, Dr Krebs discussed the roles, responsibilities, and knowledge needs of the navigator, the patient, and members of the community in working together to accrue participants for cancer clinical trials.

Clinical trials for cancer are research studies conducted on people (not animals) that compare the most effective known treatment for a specific type/stage of cancer with a new approach that researchers think might be even more effective. This can be a new drug, a combination of drugs, or a different way of using common therapies. It is important to know that the people who participate in cancer clinical trials are not “guinea pigs,” and they are never given a placebo in place of a potentially effective treatment.

Information from studies with diverse populations is important when developing new treatments, so it is vital that the individuals participating in a clinical trial come from distinct backgrounds. This is where the navigator can play an important role in accruing for these trials.

What the Navigator Needs to Know

To provide information about clinical trials to their patients, navigators must first start with their own education.

“You need to know the basics of that clinical trial, and the ethical principles behind the research,” she said. “You need to know that the trial is valid, that it has social and clinical value, and that patients are selected fairly, so when you talk with your patients about clinical trials, you’re able to share that information with them.”

Navigators should also be aware of trial components like background, procedures, eligibility, and informed consent, as well as trial monitoring practices and procedures, and any potential for adverse events.

It is also important to know where trials are actually taking place: is it a local, regional, national, or international trial? “You also need to know how to access the trial information,” she said. “That might be from the Internet, a pharmaceutical company, a local cancer center, or even social media.”

If a patient is considering a clinical trial, it is helpful to have decision aids on hand to guide informed decisions. To avoid stepping on anyone’s toes, be aware of each community’s “politics of care,” she advised, as well as that community’s distinct cultural and social norms.

“In terms of advocacy, you obviously need to know your patient, and no one knows their patients better than patient navigators,” she said. “But within a clinical trial discussion, you need to know who makes decisions (the individual? the family?), how those decisions are made, and what principles underlie the decisions that a family may make.” Before talking about clinical trials with a patient, consider whether the patient wants to include their family/caregiver/spouse in that discussion.

Next, anticipate and plan for any potential and real barriers and find appropriate resources for patients. “One of the most important things that we do is promote safety and plan in advance for adverse events,” she noted. “And then of course, adhering to the protocol with timely referrals, adhering to trial monitoring processes, and making sure your navigation plans fit in with the protocol.”

Communication is extremely important for a navigator, not only in terms of being aware of one’s own communication skills, but also being able to facilitate interpersonal communication between invested parties (eg, between patient and family or navigator and family).

Knowing how the patient will be accessing important trial materials is another crucial aspect of communication; this includes understanding generational and geographical barriers to communication, as well as Internet/smartphone availability and use.

“Think about your communication skills in all of these areas; are you sending out communication to your patient with a big logo that says ‘Cancer Center,’ when your patient doesn’t want anyone in the community to know that they have cancer? Think about using identifying information that will make the patient much more comfortable,” she advised.

Finally, the navigator must be able to collaborate when it comes to guiding their patient through a clinical trial. Roles and responsibilities will vary by position and location, but the navigator must be part of the team, keeping in mind that the clinical trials team may be different from their regular team. The navigator should not only know who is on that team, but also what his or her role is with each of those individuals.

Other aspects of effective collaboration in terms of clinical trials are very much in the navigator’s wheelhouse: acting as a resource to the patient’s healthcare team; working across service boundaries to provide timely, culturally appropriate high-quality care; and facilitating the timely submission of samples/referrals/appointments/follow-up. “These are obviously things that navigators do constantly and do well,” said Dr Krebs.

What Patients and Families Need to Know

First, patients and their families should be provided with education. The patient should be aware of available clinical trials and should know the status of their eligibility to participate in them. Patients should also be able to verbalize their attitudes and beliefs about clinical research and their feelings about taking part in it.

“Do they have a lot of misconceptions? Many patients will say they don’t want to be a guinea pig, and we always tell people that guinea pigs don’t have choices, whereas people do,” she said. “So we try to help allay some of those fears.” The patient should also be completely educated on his or her treatment plan and should be able to make an informed decision or an informed refusal; decision tools can help with this process.

“A person should really understand why they may want to take part in a clinical trial and should be able to make the decision whether or not to take part,” she added. “And the navigator should be part of that discussion.”

In terms of advocacy, the navigator should be helping the patient to secure any appropriate cultural resources that they might need—ensuring privacy and confidentiality as well as safety (early recognition of barriers/adverse events)—throughout the whole process.

Finances are a huge issue for many patients when it comes to clinical trials (ie, out-of-pocket costs for transportation, lodging, childcare, etc), and the navigator is invaluable in helping the patient to figure these things out.

Patients should be educated on informed consent processes (and should recognize that they can take part or drop out without their care being affected), and they should always be encouraged to ask questions. The navigator should also identify general and specific support services for each patient, always maintaining their privacy while encouraging interactions (many synchronous online support groups allow for typed anonymous comments).

The navigator should be aware of how well a patient is able to communicate their needs and wishes to their family, their care team, and their clinical trials team, and the patient’s role in community events, religious activities, and work/personal obligations should be made clear to avoid any scheduling conflicts. The patient should always feel that their navigator is supporting their participation in a clinical trial.

How the Community Can Help

Members of a community should be made aware of what clinical trials are, how they are accessed, and the reasons that patients may have for participating in them. Creating educational community programs can be incredibly helpful in informing community members about cancer trials, she said.

Advocacy efforts needed within the community are similar to those necessary on an individual patient level: raising awareness of clinical trials as a potential option for care, providing accurate information, dispelling myths and misconceptions, and promoting informed decision-making.

Finally, the navigator should be able to share their perspective on clinical trials with the community and should be available to answer questions. They should also be sensitive to community diversity in language and literacy, providing information in more than one format, and partnering and collaborating with the community by taking part in cancer awareness events.

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Last modified: August 10, 2023

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