Patient Navigators: The Missing Link to Increasing Minority Participation in Cancer Clinical Trials
A study conducted by the University of Alabama at Birmingham (UAB) and funded by the National Institute on Minority Health and Health Disparities that promotes the inclusion of minorities in cancer clinical trials has been selected by the American Society of Clinical Oncology to be featured in Clinical Care Advances 2016, an annual review of major advances in clinical cancer research.
The study, led by Mona Fouad, M.D., MPH, director of the UAB Minority Health and Health Disparities Research Center, focuses on the use of patient navigators as a liaison between medical staff and patients, to inform and enroll eligible African American cancer patients into clinical trials.
Dr. Fouad stated this model came as a result of the staggering disparities in clinical cancer research, currently fewer than 10 percent of patients enrolled in cancer clinical trials are minorities.
To achieve accurate results, cancer clinical trials require participation of individuals from all cultural and ethnic backgrounds, however enrollment and retention of minority groups often proves challenging.
"We started with the patient navigation model to assist under-resourced patients in our cancer center," said Fouad. "We’ve been using patient advocates for the last two decades to promote cancer screening, but then we started thinking, ‘Well, what if they have a positive test?’ ‘How do we link them to the care needed to start treatment?’"
Patient advocates were trained to become patient navigators as a way to steer patients in the right direction to locate resources and enlist the best possible care to treat their cancer diagnosis.
"We were successful in providing this model to help patients comply and complete their cancer care, and when we accomplished that, the compliance rate was as high as 95 percent in low-income populations. So then we thought, why don’t we test this model to see not only if it helps patients to access care, but can it educate them about clinical trials as well," said Fouad.
Fouad admitted that while many patients were reluctant at first, they came around to the idea once it was explained in detail and resources were provided to make clinical trial involvement easier for them.
"What we found by doing this is that a lot of minority patients are scared about therapeutic trials. They believe that they are experiments, and some were reluctant due to the times they’d have to be available for the trials, so the navigators were able to help with those reservations," stated Fouad, explaining the navigators were trained to identify resources to aid trial participants.
"Navigators connected patients with social workers and did what they could to make sure all the patient had to focus on was their care and involvement in the clinical trial," said Fouad.
While it is generally the job of medical staff to offer clinical trials to every eligible patient, the study revealed that protocol is not always followed with minority or lower socioeconomic patients.
"Sometimes, even the physician, if they know there is a patient coming from a rural area or having difficulty traveling, they tend to just not offer them clinical trials because they don’t want to increase the burden on the patient or they think the patient is not going to be a compliant participant, so, unintentionally, they just won’t offer them the trials," said Fouad.
However, with the navigators acting as the link between the patient and healthcare provider, it has given providers needed assistance when it comes to patient education.
"We found that when the physicians knew they had the support of the navigators, they started to offer the trials to more patients," said Fouad. "So it helped the physicians and it helped the nurses, too, because they don’t always have enough time to sit and talk with every patient about clinical trials."
Fouad stated initially patient navigators were not welcomed among the UAB cancer center clinical staff, so they had to be incorporated gradually until the need for them was realized.
"As can be expected, we got pushback from the physicians and the nurses. They said, ‘We’re doing everything right, we offer the clinical trials. People don’t want to participate, and you are in our way.’ So we started by sending the navigators in to educate patients in the waiting areas while they were waiting to see their physician. The doctors were shocked by the outcomes because African American patients would come in and ask, ‘Do you have a clinical trial for me?’ and the doctors didn’t know how to answer because it came from the patient, so they were then persuaded to talk about clinical trials," said Fouad.
Fouad said unlike nurses, navigators have 24-hour accessibility, which helped boost clinical trial participation among African Americans. They could call the navigators directly from home should questions arise.
According to the study, between 2007 and 2014, of the 378 African Americans eligible for a clinical trial, 304 enrolled and 272 opted to receive patient navigation support. For those trial participants receiving navigation support, 75 percent completed the trial compared to 38 percent for trial participants not receiving navigation support. The difference in retention rates between the two groups proved statistically significant and the participation of African Americans in cancer clinical trials increased from 9 percent to 16 percent.
Fouad stated, initially the pilot study, funded by the National Cancer Institute, took about three years to get off the ground and to get medical staff on board with having the patient navigators. Navigators were only used in the breast cancer clinic before the study garnered a larger grant from NIMHD and the navigators were expanded to all cancer clinics within the UAB cancer center network.
"There was a system change with this study. Physicians, nurses and navigators became one team," said Fouad. Dr. Fouad said in the future, she hopes to incorporate other minority groups into more clinical trials, however she must convince other cancer centers to accept patient navigators and find ways to sustain the work that has already been done.
"At this time, we are trying to replicate this model in four other cancer centers. We have to convince the leaders of these cancer centers that this can increase minority participation in clinical trials," said Fouad. "And we require resources. Right now, we’re funding these navigators through grants, but we’re hoping when the grants end, we’ll be able to pay navigators for their time," said Fouad.
Fouad noted the study shows the need for a personalized approach to healthcare, as generalized care has not been working and will not work to address research and healthcare issues of minorities.
"The blame has always been put on the patient, that they don’t want to participate, but you can see from this model if you have the appropriate support, culturally, emotionally and time wise, minorities do participate in therapeutic clinical trials," said Fouad.
Posted July 20, 2016