Interviews revealed that patients often did not remember being offered participation in a clinical trial. All treatment discussions, whether experimental or standard, seemed to stream together in their minds as they recounted struggles to keep up with information, appointments, bills, families and jobs. Patients at this safety net hospital generally, and hence many interviewees, lived in single occupancy hotels or other substandard housing, lacked health insurance, often spoke little English, and were usually grateful for the care they had received since their diagnosis. Many recounted financial difficulties including the need to pay rent, hold down a job while managing appointment scheduling and exhaustion from therapy, and pressure to send remittances to family in countries of origin. Stress stemming from unstable living situations and multiple family responsibilities including parenting challenges were also common themes. In light of these many competing priorities, the expectation that patients acquire the specialist knowledge necessary to recount and make assessments of research versus treatment, the basis for informed consent to participate in research, was particularly challenging.
One of the oncologists in the clinic (Dr. Lee)a staunchly believed this, and invoked a social justice ethic of inclusion and research access to explain her approach to clinical trial recruitment. She stated, "It’s a matter of justice. We need patients like ours represented in these studies. It’s our job to make sure they know about studies and how important it is for them to participate." In response to my comment that few patients interviewed remembered being offered a trial, she said, "ah, that means we’re doing our job." In other words, clinic providers were making research participation a normal part of cancer care. Dr. Lee expressed her strong belief that clinic patients should be represented in the production of evidence and treatment innovation to new oncology fellows when they rotated onto the service. She also discussed the importance of clear communication about clinical trials and the need to be aware of differing literacy levels and cultural orientations. When discussing research participation with breast cancer patients, she explained that the way we know how to provide treatment is because other women participated in early studies, thus invoking a ‘public good’ or ‘gift to other women’ rationale.
In the following I describe a consultation this oncologist had with a monolingual Spanish-speaking patient regarding clinical trial participation. The excerpt, similar to other trial recruitment discussions I observed, highlights challenges to clear communication, differing perspectives on appropriate information, and struggles to both conflate and distinguish research and care. It also highlights the role of actors not present in bioethical debates about therapeutic misconception–but present in the care of underserved patients–and their potential influences on clinical trial recruitment and decision-making. In this safety net hospital, additional influential actors include medical interpreters and patient navigators. Lastly, this field note excerpt illustrates the importance of expanding notions of ethical consent beyond discussion of the consent form to the initial introduction of the possibility of research participation.
Ethnographic Field note
It was a busy day in clinic. There were few providers – an expected Fellow failed to arrive – and a stack of charts with patients waiting in the waiting room. Dr. Lee, seated at a desk in the middle of the hallway, discussed Millie’s chart with the resident who had been in to see her to determine if she was eligible for an ongoing chemotherapy trial. Since this was a teaching clinic, small exam rooms often accommodated students and attending physicians as well as patients and, sometimes, family members or patient navigators. This crowd sometimes increased when trials were to be discussed, contributing a feeling of gravitas to the discussion. In this case, Millie and her brother watched as Dr. Lee, the navigator, the clinical trials coordinator, the resident, and the anthropologist all filed in.
Dr. Lee started off explaining that Millie needed to start chemotherapy. She then said that one of the things she wanted to talk about with Millie was the possibility of participating in a study on how best to give chemotherapy. Dr. Lee explained that one of the ways they can find out the best way to give chemotherapy is by asking women with breast cancer to help them figure it out. Millie asked, "What do they do in those studies?" The navigator interpreted as Dr. Lee explained that this particular study was a chemotherapy study that looks at a couple of old drugs, plus one new drug; half of the women get the "regular stuff" and the other half get the additional knew drug. The navigator stopped interpreting, turned to Dr. Lee and asked, "Is this a randomized trial"? Dr. Lee turned to the navigator and responded "yes." The navigator translated this response as "we wouldn’t know if you…which one you would get because it is basically a lottery." Dr. Lee turned to the navigator and asked, "How did you say that exactly?" Her tone indicated annoyance despite the smile on her face. The resident, who also spoke Spanish, answered that the navigator had said, "It is basically a lottery." "The point is," Dr. Lee said, "You don’t decide, I don’t decide. The computer decides who gets which; that’s in order for it to be completely fair." The resident translated this response. Millie then asked "But the two medicines that they gave before worked?" The resident translated again. Dr. Lee answered "yes." Millie started to ask a question regarding the number of medications she would receive. Dr. Lee interrupted, saying that the new medication also works, because it has been tested in women with breast cancer before. The navigator interpreted, saying, "It would only be three medications, two are the normal medication plus the new medication which they have tested by itself and it has proven to work, but they want to know if it works best…" Dr. Lee said, "We haven’t described the trial quite correctly, but that’s okay," to which the navigator responded that Millie was asking if she was going to get the two plus three more medications. Dr. Lee said no, that the medication in both cases were known to work, and one of the questions they have is which one works better. The navigator responded that she was trying to explain that to Millie, but Millie wanted to know if she would receive more than three medications, to which Dr. Lee responded "no." The navigator interpreted, "It will always be the two that they offered before." The doctor said, "That is the part where you are not quite right, but that’s okay." The navigator asked for clarification, to which Dr. Lee responded that it was not important to explain it; what was important was to say that in both cases the medicines are known to work and the only question is which one works better than the other. Dr. Lee said, "don’t discuss the numbers." The navigator responded, "but she wants to know the number, if there are going to be three or five medications." "There are no more than three," Dr. Lee said.
Millie asked "The two that work, they add one more, isn’t that too strong for the person?" Dr. Lee answered, "It is not about muy fuerte" and added that the secondary effects are different, but about the same. Millie asked, "When they give three medicines, is the dose less?" The resident again interjected, stating that the doses have been established in previous parts of the experiment. The navigator responded, but "she wanted to know if she is going to get the same number of doses," to which Dr. Lee responded that this was more detail than was necessary at this point; what they really wanted to ask was if Millie would think about the possibility of being part of the study, and that the details would be explained later if she decided to do it. The question was about the principle of whether or not she would be interested in being part of a research study.