When the hope goes: Talking with patients after withdrawal from cancer clinical trials
Cancer clinical trials remain underutilized by patients as a means of acquiring experimental drugs, tests and/or procedures that they otherwise might not be able to obtain.
For some patients, access to these trials has been hampered by geographic location, systemic biases and racism, and language barriers.
Although work is underway to improve access and reduce disparities in clinical trial enrollment, less is known about individuals with cancer who are compelled to withdraw from participation.
“We often focus on recruitment, which is important in itself for beginning any research trial,” Connie M. Ulrich, PhD, MSN, RN, professor of nursing in the department of biobehavioral health sciences at Penn Nursing and professor of medical ethics and health policy at Perelman School of Medicine at University of Pennsylvania, said in an interview with Healio, “but less is known about the end of the trial and what is important to patients and families at that point in the research process — a critical time point we tend to forget.”
To better understand the experiences of trial participants at this important juncture in their cancer journeys, Ulrich and colleagues at University of Pennsylvania conducted a qualitative, descriptive study in which they interviewed 20 individuals with cancer who discontinued participation in clinical trials.
Ulrich spoke with Healio about the study’s findings, its future implications and the emotional challenges involved in letting go of what was once an important source of hope.
Healio: What inspired you to undertake this study?
Ulrich: As a nurse bioethicist, I have been interested in ethical issues related to research participation, especially recruitment and retention. Being diagnosed with cancer is a very stressful time for patients and their families. These patients have to make very difficult decisions about their care, and research is one option they may consider, although we know that less than 5% of adults participate in cancer clinical trials or clinical trials in general. This study was part of a larger study, one of the aims of which was to talk to participants who were withdrawn or who withdrew from their trials, to understand their experience.
Healio: What are some of the reasons a patient might withdraw or be withdrawn from a cancer clinical trial?
Ulrich: Sometimes people may have severe side effects and the burden may be too much. Another possibility is that the trial might not be benefiting them in terms of cancer markers or tumor reduction, so the research provider might discuss other avenues the patient could take.
Healio: How did the trial participants you surveyed feel about being in the trials?
Ulrich: In much of my work, patient participants and their families shared that they were hopeful that the trial would cure their disease, or they were deriving hope from doing something proactive. This was especially true of participants who were diagnosed with late-stage cancer and had indicated to us that they had few to limited options available. Many of them were just so hopeful that this would at least give them some quality of life, or perhaps allow them to share more time with their families. Many participants also said they appreciated the close monitoring that they received for their disease. They were thankful for the nurses and physicians involved in the trial.
Healio: Your study identified five themes that emerged from the survey responses. What were these?
Ulrich: The five themes were post-trial prognostic awareness, goals-of-care discussions, emotional coping, burden of adverse effects, and professional trust and support. We also identified subthemes, which included regrets or hindsight, urgency to start the next treatment, and weighing benefits and burdens of treatment. We found that some of them felt there was no clear path forward.
Healio: How did the patients feel about discontinuing their participation in the trial?
Ulrich: They were very, very disappointed that the trial did not work, but many of them still reported holding out hope that there might be something else available to them —some alternate routes they can take. Patients who perceived the benefits of the trial and viewed those benefits positively were more likely to remain in the trial. Those who experienced more of the burdens of being in a trial — for example, side effects from experimental drugs — were more likely to withdraw.
Healio: Do you think patients who withdraw from trials feel abandoned by the research community?
Ulrich: I believe we need much more research on this. It could certainly cause patients to feel abandoned, especially if this was their last option and they developed a close relationship with the research team. If it is determined that the experimental drug is not benefiting them or their tumors have not regressed, this can cause a feeling of being left behind. Communication is central to helping patients understand their research trajectory. We should continue to ascertain whether the trial reflects the patient’s preferences and goals, and this conversation should be ongoing throughout the trial. We should also begin talking about the support that might be available for patients after they withdraw from their trials, but we simply don’t have data yet to understand what exactly is happening. I hope my research is a start to try to understand what is happening not only at the front end of the trial with recruitment, but what is happening when they decide to withdraw or are withdrawn from their trials at trial exit.
I would also like to see more research toward understanding the disparities that continue to exist in clinical trials and especially cancer clinical trials, because we know that minority communities are disproportionately burdened by cancer and are often diagnosed at later stages of disease. Our data is a start, but we need more data that can help us understand what is important to different communities. My hope is that we will continue to listen to the voices of patients from a variety of different communities that participate in cancer research. It is these voices that will help us identify how and where we can improve the research, especially at trial exit, which we know so little about.
For more information:
Connie M. Ulrich, PhD, MSN, RN, can be reached at University of Pennsylvania School of Nursing, Claire M. Fagin Hall, 418 Curie Blvd., Philadelphia, PA 19104; email: culrich@nursing.upenn.edu.
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