Cancer trial subjects define burdens, benefits
Symptoms, economic concerns play role
When reviewing cancer clinical trials, IRBs must weigh the risks and benefits to potential participants. But it's not always clear what participants themselves consider to be a risk or a benefit of their enrollment in a study.
A new survey of cancer patients explored that topic in detail, asking open-ended questions to let participants themselves define those terms.
Connie Ulrich, PhD, RN, FAAN, an associate professor of bioethics and nursing at the University of Pennsylvania School of Nursing, says the idea of participants' perceptions came to her when she was a post-doctoral fellow at the National Institutes of Health.
"I started thinking about this issue of respondent burden and what did it really mean," she says. "And there wasn't much in the literature to help us understand that particular concept."
So her study team recruited 32 cancer patients taking part in Phase I, II and III trials. They asked them to describe their experiences, what they saw as benefits and burdens, and how they weighed the two in making a decision to enroll.
The resulting study was published in a recent issue of the American Journal of Bioethics Primary Research.
Some of the results were unsurprising. Participants complained of nausea, fatigue and other physical symptoms of the treatments they were receiving. They discussed the personal inconveniences associated with a trial, including travel and time away from work, as well as the burden of paperwork, particularly informed consent. Benefits included a sense of accomplishment and control over their situation, as well as free care and close monitoring of their condition.
Participants talked about the influence of their families and their doctors on their decisions to enroll, and many described spirituality as an important component of their decision-making.
But the results also raised some new questions for researchers: Do some patients rely too much on their doctors' opinions? More than a third of those asked expected some benefit from their participation — are too many patients confused about the essential fact that they are participating in research?
Ulrich says this survey begins to scratch the surface of what goes into a participant's decision.
Influence of physicians, cost of care
"There are so many concepts that came out of the study that need much more exploration, which is terrific, but that doesn't give us a definite answer at this point," she says. "It's exciting from that standpoint, but I would also like to know."
For example, she notes that two-thirds of the respondents described their physician as either "moderately" to "extremely" influential in their health care decision-making, including decisions about research participation.
"I came away from this trying to have a better understanding of what the role is of trust with regards to patients understanding the risks and benefits," Ulrich says. "There's a lot now in the literature about shared decision-making, but I'm not convinced how much control patients want to have over the decisions that they make related to their research participation."
Another area that raised red flags was the economic burden of health care, and the effect that may have on patients' deciding to enroll in a trial.
One patient interviewed about this subject told researchers, "To be honest, part of being in a clinical trial — I don't have to pay my co-pay. Is that awful?"
"Economic burden was a major factor that came out in our study," Ulrich says. "People were worried about the cost of cancer care. We need to further explore that."
The team also was concerned about responses that pointed to possible therapeutic misconception. Because the survey was open-ended, there were no questions specifically attempting to measure this element, but Ulrich hopes to receive a grant soon that will allow her to go into this and other issues in greater detail.
Role of spirituality
She says the issue of spirituality "jumped out" at researchers as they looked at the responses to the survey. Seventy-four percent of respondents said spirituality was very important to them, with some saying that it helped them deal with the uncertainty of the cancer diagnosis and treatment.
"So they had trust in a higher being, so to speak, but they also had trust in their physician/researcher, so both of them could coexist at the same time," Ulrich says. "There's been some literature to suggest that spirituality is associated with quality of life in cancer patients. We probably need a better understanding of what exactly is the role of spirituality in cancer clinical trials — how that helps patients cope with their illness and also the research participation aspect of the trial."
Ulrich, who serves on her institution's IRB, says these results raise interesting questions about the role of the IRB, particularly in situations where participants seem not to be truly weighing both benefits and burdens of research participation. One respondent candidly said, "I didn't look at the burdens at all — I just looked at the benefits."
"I think we [on the IRB] will just probably continue to be vigilant in looking at those risks and benefits, and how we think about weighing those risks and benefits for the particular population under study."
She says she hopes information from this and future research will inform strategies to help patients who are considering enrolling in trials.
"We know that less than 5% of [eligible] adults actually participate in cancer clinical trials," Ulrich says. "Maybe this will help us better help patients who are considering enrolling in a trial to know what the issues are that might be relevant for them."
Reference
Ulrich CM, Knafl KA, Ratcliff SJ et al. Developing a Model of the Benefits and Burdens of Research Participation in Cancer Clinical Trials. AJOB Prim Res 2012 3:2(10-23).
When reviewing cancer clinical trials, IRBs must weigh the risks and benefits to potential participants. But it's not always clear what participants themselves consider to be a risk or a benefit of their enrollment in a study.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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