Fear about side effects hinder trial participation
Fear about side effects hinder trial participation
Oncologists underestimated impact
Physicians discussing clinical trials with their patients may not realize the importance of patients’ fears about side effects in making a decision about whether to participate.
That’s the conclusion of a survey of oncologists and cancer patients that looked at their attitudes about various psychosocial barriers to clinical trial participation.
Neal J. Meropol, MD, a medical oncologist at Fox Chase Cancer Center in Philadelphia, studies decision making and communication regarding research. His group presented their findings in May to the American Society of Clinical Oncology’s annual meeting in Orlando.
Importance of informed consent discussions
Meropol says IRBs reviewing the protocols should keep patients’ concerns about side effects in mind when looking over informed consent documents.
"I think that special care has to be taken in the informed consent process to strike an appropriate balance between complete disclosure of potential side effects and overweighting of potential harm," he says.
Meropol says in the past five years, there has been a lot of interest in determining the importance of barriers to research participation, both among patients and doctors. He says much of the previous focus has been on practical barriers to doctors’ participation, including lack of access to trials, not enough office time, not enough staff or reimbursement.
"The conclusion from that research has been that we have to improve access to clinical trials — we have to make the eligibility criteria looser to make more people eligible, and we’ve got to get people comfortable talking about them and we have to get doctors to recommend them. That’s what will influence patients," Meropol explains.
He says his group came at the question from another angle, looking at the psychosocial barriers that patients experience and how those barriers influence decisions to participate or not participate in research.
Methodology
Using a grant from the state of Pennsylvania, researchers mailed out a survey to every oncologist in the state, receiving 137 surveys back. Each physician also was given a package of 10 patient surveys that they could either distribute themselves or could leave in their offices for patients to pick up. There were 170 patient responses to those surveys, Meropol reports.
Each group was asked about patients’ attitudes toward research — how they would rank the following psychosocial barriers to research participation:
- uncomfortable with random assignment;
- don’t trust the medical establishment and fear of being a guinea pig;
- fear of receiving a placebo;
- don’t understand what clinical trials are;
- fear of side effects.
Meropol says both the oncologists and the patients were interested in clinical trials, particularly for advanced stages of disease, after standard treatments had failed. Eighty-four percent of the cancer patients had heard of clinical trials, with white patients and more educated patients being more likely to have knowledge about trials.
Differences were striking
When asked whether patients would benefit from participating in clinical trials, 79% of doctors agreed, but only 57% of patients said yes.
When asked specifically about the barriers to participation, the difference in the doctors’ responses and the patients’ responses was striking.
Doctors, on average, ranked fear of side effects as the least important psychosocial barrier to participation in a clinical trial. Meanwhile, more than a third of patients ranked it as the most important barrier — the highest ranking of all the barriers cited in the survey.
Meropol says this result, while surprising, is consistent with previous studies of patients that showed they care as much about the quality of their lives as the remaining length of their lives.
"In a previous study of 328 patients considering Phase 1 studies, 96% of people ranked quality of life as at least as important as length of life," he says. "I don’t think doctors realize this. That even people who are in the most desperate straits — everything’s failed, they’re thinking about a Phase 1 study — believe quality of life is still really important."
Fears overlooked
Meropol says doctors may be so focused on the possibility that clinical trials could extend patients’ lives that they underestimate the patients’ fear of side effects from treatment.
While there were few demographic differences in patients’ rankings, he says oncologists from academic medical centers seemed to recognize a fear of side effects as more of a barrier than oncologists from community or nonacademic medical centers.
Conversely, Meropol says, doctors perceived lack of trust in the medical establishment as one of the most important barriers to participation, while patients ranked it as one of the least important.
"It may be that just the patients who filled out the survey are more trusting," he says. "But it does raise a concern that the doctors don’t understand where the patients are coming from."
Meropol says doctors may be overly hesitant to suggest clinical trials, believing that they must overcome severe trust issues that aren’t really that severe.
Meropol did note that some of the patients had difficulty answering the ranking questions. "A ranking question is tough for some people to understand," he says.
In responding to patients’ concerns about the possibility of side effects, Meropol says IRBs need to strike an appropriate balance of ensuring patients get the information they need during informed consent while making sure that information is put in the proper context.
A long laundry list of possible side effects "can freak people out," he says. "In the consent process, it’s important to stratify those side effects by both severity and their likelihood of occurrence. The challenge for those involved in consent is to devote the time necessary to really put in perspective the potential for harm and the potential for benefit."
Meropol says he wants to confirm these findings in a larger group of patients and doctors, as well as develop tailored delivery of information to patients that can address the specific concerns they have about research.
"We need to identify who the patient is you’re dealing with and tailor your presentation to that individual, to their particular decision-making calculus," he says. "That’s the major thrust of my research."
Physicians discussing clinical trials with their patients may not realize the importance of patients fears about side effects in making a decision about whether to participate.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.