Nurses play a key role in addressing the barriers associated with patients with cancer entering a clinical trial, according to Maria Hendricks, MSN, RN.
“One of the most important things is considerations for subject participation. That is why we all do what we do every day,” Hendricks, director, clinical research operations, Abramson Cancer Center, Clinical Research Unity, University of Pennsylvania in Philadelphia, said during a presentation at the 3rd Annual School of Nursing Oncology, held August 2-3 in San Diego.
Barriers to Cancer Clinical Trials
The first barrier Hendricks mentioned was stringent eligibility criteria that may not be meeting the endpoints of the study and could potentially exclude some patients who would otherwise enroll.
Similar to barriers with standard of care, financial toxicity and time constraints make up a large barrier to clinical trial participation.
“Not everything is paid for on the study, especially in cancer trials, unlike other trials. That does sometimes get lost in translation,” she said, adding that while clinical trials do offer patients access to the latest available interventions, such access often comes with a cost.
“With that sometimes is additional evaluations, increased return visits than would be from standard of care,” explained Hendricks. “So, someone who is working or at home as a stay-at-home mom, regardless of the scenarios, time is of value, too.”
In addition, clinical trial access is a barrier, as is trials competing for enrollment for the same tumor type. So, nurses need to carefully pick which trials to pursue.
Lastly, aspects like knowledge, education, and training; stress and fear; language barriers and literacy; and cultural barriers – while not only applicable to cancer clinical trials – are important to ensure patients are appropriately informed and aware of what their options are and is on an ongoing basis.
How Nurses Can Help
First, it is important to explain to patients about the routine care costs during a clinical trial. Of note, some insurance plans will pay for these costs, while others will not – this varies by state and health insurance. Typically, Medicare covers the payments of routine costs.
Hendricks explained that some insurance companies will pay for routine costs if:
- The trial is medically needed
- The costs are about the same as standard care
- There is no standard care for that disease
- The trial is funded by the National Cancer Institute (NCI).
To help with the costs of clinical trials, the American Society of Clinical Oncology (ASCO) issued the prospective reimbursement analysis (PRA), which involves a member of an institution’s billing compliance office who will review the clinical trial protocol with a clinical staff member.
“So, the key part to the PRA is being able to identify and work with the supporting group–whether it is an industry sponsor, NIH partner or philanthropic fund–to determine if those elements will be covered,” Hendricks explained, adding that nurses should be aware of this key piece of the puzzle.
“I encourage you to be aware of when you are meeting or have a patient that is on a trial to participate in the collaborative care of that patient,” she said. “There are people to ask these questions when the patients have a ton, and they are thinking, ‘Hey, am I supposed to be charged for this?’ It is important to reference your research team, and they will help support you in that direction.”
To enhance patient access to clinical trials, and to find more referral options, nurses should utilize sources such as NCI-designated cancer centers and the NCI Community Oncology Research Program (NCORP), which have been essential to providing access and funding, especially in underserved and minority communities throughout the United States, Hendricks said.
In addition, the American College of Oncology Surgeons Commission on Cancer is important in maintaining accreditation in community centers.
“There is a minimum percent accrual to trials that your institution needs to meet and that is met against your total number of new diagnoses and cancer patients,” explained Hendricks. “So, because of that, it is really important to identify which trials best match your patient population to ensure you have the available therapy options for your patients as well as the right portfolio to utilize resources to enhance your accrual opportunities.”