“Why is my disease less important than COVID?” Donna asked me toward the end of our phone call.
Two years ago, after celebrating her 65th birthday, she was diagnosed with acute myeloid leukemia—an aggressive type of blood cancer—which turned out to be refractory to conventional chemotherapy. After spending hundreds of hours with doctors and social workers, she was scheduled to enroll in a clinical trial in May 2020. But COVID-19 postponed it.
She is angry, devastated, and heartbroken.
Many patients are echoing similar sentiments as COVID-19 has temporarily halted enrollment in clinical trials. Furthermore, with an uncertain end to the pandemic alongside testing capacity constraints in the United States, there is no clear end in sight leading patients to feel like ticking time bombs, robbed of a second chance at life. In addition to the impact on their physical health, the mental health consequences have been immense.
As studies were suspended out of safety concerns, new patients entering trials dipped by nearly 65 percent in March 2020. Despite understanding the need for precautions, people feel concerned that the natural course of their diseases may claim their lives before COVID-19. Among some of my very sick patients, this sense of vulnerability has engendered severe resentment toward healthcare, public health, and government stakeholders who they feel have prioritized COVID-19 over their conditions. Additionally, patients like Donna are worried that their disease may worsen, making them ineligible to participate in the future.
But patients awaiting enrollment aren’t the only ones in despair. Subjects in ongoing trials feel similarly unsettled.
With some exceptions, in-person site visits have been canceled, and patient monitoring moved to remote platforms. An obvious downside has been the inability to perform blood draws and imaging studies to monitor therapeutic effects (if any). This has been especially devastating for patients who rely on trials as their source of care.
Technology access and literacy have also been challenging. Not every patient has a smart device or access to high-speed internet. Additionally, older patients who are not necessarily technology-savvy and would otherwise rely on someone for help with a virtual encounter can’t do so as others are self-isolating to minimize transmission risks to elders.
Importantly, the psychological toll has been immense. Being part of a clinical trial is more than just receiving a pill or an infusion; it is an all-encompassing experience. Patients interface with so many people at their research sites—entire teams that are constantly encouraging them to keep going, providing assurance, giving hugs, and doing other small gestures to demonstrate that they truly care—that goes a long way for their mental health and well-being.
As an example, Nathan (name changed), a man in his mid-forties, was diagnosed with a progressive neurological disorder called amyotrophic lateral sclerosis (ALS), for which no treatments currently exist. His family moved cross-country to New York City to enroll in a clinical trial that my sister helps coordinate. During so many of his visits, when he broke down in tears, my sister’s hug, or a pat in the back went a long way. With the site currently closed, he finds it hard to stay positive. Knowing the emotional setbacks, my sister has prioritized going above and beyond to make him feel supported through phone calls and text messages. The deep human connection in these moments of vulnerability makes such a difference in the lives of research participants—making their final stretch more bearable, poignant, and human. Sitting in front of a computer screen, talking to a grid of faces just doesn’t emulate the same experience.
With research sites being closed—due to health risks, shortage of personal protective equipment, and personnel being deployed to COVID-19 duty—many have worked alongside study sponsors to mail experimental drugs to patient’s homes. Trials requiring infusions have certainly been more challenging. But few sites have offered professional mental health support to these participants. Donna says that she is left on her own to find support through an online community.
It would be remiss to say that research sites and study sponsors are unaware of the physical and mental health impacts of trial disruptions on participants. However, in addition to mailing pills and virtually discussing side-effects—reducing the trial experience to a merely biochemical one—they should consider providing resources for mental health support to help patients during these tough times. In doing so, we can continue advancing science for the benefit of mankind, while respecting every individual’s sacrifice in good times and in bad.
Lala Tanmoy Das is a medical student.
Image credit: Shutterstock.com