Talking About Trials: Overcoming Bottlenecks in Clinical Communication
Behind the often-quoted statistic that only about 3 to 5 percent of adult cancer patients participate in clinical trials is the fact that no one knows how many patients are actually offered the opportunity to enroll in one. Eligibility is one factor to consider, as only a minority of adult cancer patients are eligible for any given trial.
“But of those who are eligible, how many are asked to participate?” asked Dr. Neeraj Arora, program director in the Outcomes Research Branch of NCI’s Division of Cancer Control and Population Sciences. “Provider recommendation is one of the biggest predictors of use of many services—if your doctor recommends something, you’re likely to do it—but we really don’t know to what extent clinical trials are offered,” he added.
Dr. Arora is currently planning a study as part of the 10,000-patient Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) looking at differences in patients’ care experiences between participants who enrolled in a trial (about 5 percent in CanCORS) and those who did not.
In addition to comparing satisfaction with care between patients treated on and off trials, CanCORS investigators will track how patients heard about clinical trials, whether they discussed the option with their providers, the roles they felt they played in making decisions about participating in a clinical trial, and whether they chose to participate once offered enrollment.
Clues to the likely results from the CanCORS study come from work by Dr. Terrance Albrecht and her colleagues at the Barbara Ann Karmanos Cancer Institute in Detroit.
In 2008, the researchers published a study showing that when patients were explicitly offered participation in a clinical trial, 75 percent chose to enroll. However, out of 235 recorded patient–physician interactions reviewed during the study, explicit offers were made only 20 percent of the time. “Patient refusal rates may be less of a problem than low rates of trial offers,” wrote the authors.
Provider recommendation is one of the biggest predictors of use of many services—if your doctor recommends something, you’re likely to do it—but we really don’t know to what extent clinical trials are offered.
Patients who felt that their doctors communicated in a way that built alliances, provided support, and explained the trial in understandable language were more likely to choose to participate in a trial once offered.
“What it really came down to was, in situations where physicians made a clear offer of a trial, when the patients understood that they’d been offered a trial, and when the physicians were engaged in patient-centered communication and provided the necessary information, patients were entering these studies and they were entering them without a lot of second thoughts or serious doubts,” recounted Dr. Albrecht. “What we’re trying to do now is step back and ask why we don’t have more offers.”
A 2007 study from Fox Chase Cancer Center in Philadelphia found that, although most oncologists recognize the importance of clinical trials, some may face their own psychosocial barriers to referring patients. These barriers include concerns about patients’ willingness to be randomly assigned to treatment and physicians’ tendencies to favor clinical trials for patients with late-stage disease or disease that has not responded to standard treatment—patients who may actually be less likely to benefit from an experimental therapy.
But even for oncologists who want to offer trials to their patients, Dr. Albrecht believes that “maybe the system just isn’t set up effectively for doctors to have these conversations.” A large bottleneck is found at the institutional level, since doctors often do not have access to a system that would rapidly and effectively identify which patients are eligible for which trials.
Currently, Dr. Albrecht and her colleagues have a grant from NCI “to go back into the system and increase the number of offers by identifying eligible patients earlier in the process,” she explained. This includes providing tablet computers in clinical team meetings that would let oncology nurses match patients with clinical trials before doctors meet with patients, and better integrating the nursing team into the doctor–patient relationship to serve as an additional resource for information.
But doctors and treatment centers are only one side of the equation. If patients are unfamiliar or uncomfortable with the concept of clinical trials, both informed consent and informed refusal can be impeded.
Changing the Norm
“We believe the discussion about clinical trials should be initiated by the doctor, but if that’s not going to happen—and we can’t always expect for that to happen—then the conversation should be initiated by the patient: Is there a clinical trial for me? Why or why not?” said Margo Michaels, executive director and founder of the Education Network to Advance Cancer Clinical Trials (ENACCT).
ENACCT has developed training programs for communities, health care providers, and researchers with the goal of improving access to cancer clinical trials through education and collaboration with each of these groups. One of their programs trains local community leaders “to spread the word about clinical trials and normalize the concept of clinical trials in a community, which can do two things,” explained Michaels. “It makes it so the first time a patient hears about clinical trials is not at the time of diagnosis, and it can influence a loved one to encourage a patient to ask about clinical trials.”
As of early 2010, ENACCT has trained 85 local community trainers in 6 communities nationwide, who in turn have trained 1,500 of their peers in how to spread the word about the importance of cancer clinical trials. Those 1,500 community leaders have made informal or formal presentations to more than 7,000 community members about why clinical trials are important.
In a test of their Pilot Education Program (PEP) employing this concept, ENACCT used Emerging Med, a commercial clinical trials matching service, to track how many people attending their presentations went on to access additional information about clinical trials. They found that over 3,000 people accessed Emerging Med to learn more about clinical trials after attending community education sessions. In addition, PEP participants boosted the creation of new patient profiles for their geographic areas in the Emerging Med database by approximately 10 percent.
“The peer-to-peer discussions encouraged in our training programs are between equals and can foster familiarity and inquiry about clinical trials,” stated Michaels. “Lack of knowledge and misconceptions about clinical trials play a large part in barriers to participation, and if we can address the knowledge and attitudinal issues, we can help to change the social norms around the importance of clinical trials.”