Faster, Easier, and More Anxiety-Inducing: Are DHTs Harming Patients' Mental Health?
By Emily Epstein, patient advocate and mental health activist
Digital health technology (DHT) is no longer the future; it is the now. Innovations in the past decade have included the rise of telemedicine, the growth of wearable devices, the development of mobile health apps, the adoption of electronic health records (EHRs), and the use of artificial intelligence (AI) and machine learning (ML). Within clinical research, electronic data capture systems are more widely used, telemedicine is more prevalent, and mobile devices and wearable technologies can facilitate the collection of real-time data, enable remote monitoring of trial participants, and improve communication between trial staff and participants. Decentralized, remote, virtual, and hybrid clinical trials also have the potential to diversify studies, increase participation and access, and reduce costs.
With social distancing and lockdowns in place, COVID-19 presented the unprecedented need for the swift and immediate implementation of these technological advances to adapt healthcare delivery. Digital technology and tools filled the communication gap created by physical distance during the pandemic, but have we created more space between participant and provider as we increasingly introduce and rely upon technology?
The prevalence of technological tools has made data easier to record and immediately share with participants without any involvement of healthcare professionals, but has this lack of involvement and support created isolation and a breeding ground for stress and anxiety among those in a trial? The widening gap between participant and provider is a disconnect that must be accounted for and addressed to maximize a participant’s mental and physical well-being and, in turn, a study's success.
DHTs Expedite Patients’ Results — And Amplify Their Anxieties
As a patient with Hereditary Breast and Ovarian Cancer Syndrome (HBOC) caused by the BRCA2 genetic mutation, I have benefited from the technological advancements in healthcare and experienced its accompanying challenges. A few years following the death of my father, who was adopted, I used a direct-to-consumer genetic test to discover my ethnic background. The test informed me that I am 99.8% Eastern European — exactly 99.4% Ashkenazi Jewish and 0.2% North African. My saliva sample, taken at home and sent back in the included return envelope, not only identified my heritage but found that my genetic makeup carried a high risk of cancer.
This life-changing information received via an app and later confirmed with my provider armed me with the knowledge and ability to be proactive in my care. In short, technology enabled me to save my own life. I have undergone a preventive bilateral mastectomy, which lowered my risk of breast cancer from 80% to 1%-3%, and a preventive bilateral salpingo-oopherectomy, which reduced my risk of ovarian cancer from 60% to 1%-3%. I schedule my many screenings in the patient portal and can view the results of pathology and scans for melanoma and pancreatic cancer, blood tests for CA-125 levels, and transvaginal ultrasounds. Living as a "previvor" is physically and mentally challenging. While I have lowered my physical risks significantly, there are constant mental and emotional hurdles that I must address on my own. My incisions were expertly sutured through each surgery, yet my fear remained an open wound. My EHR confirmed no evidence of cancer; however, the multiplying "cells" of anxiety went undetected.
In clinical trials and healthcare, acknowledging and addressing the psychological symptoms brought on by the diagnosis, prognosis, and treatment of many conditions is vital. When a provider overlooks the anxiety that accompanies the stress of managing physical symptoms, a disservice is done to the mental well-being of the patients and participants, which can have adverse effects on the trial itself.1 Several recent studies have examined the importance of communication in clinical trials to facilitate understanding requirements and build trusting relationships. If remote trials lack two-way communication between participants and researchers, there is a threat to patient engagement, compliance, and retention. For remote trials, studies have concluded that in-home treatment, “familiar” technology, and in-person interaction with a provider are essential reasons for trial participation and satisfaction. Though technology can ease stressors, such as time and travel, is it adding to the mental burden for participants? Some participants and mental health providers believe so.
I spoke recently with Nicole Loperena, who has participated in both in-person and remote clinical trials for breast cancer and lymphedema. She said, “I think clinical trials, in general, can be stressful… you become a data point.” Regarding questionnaires about her quality of life and body image since her double mastectomy, Nicole imparted that “the [remote] trials, in particular, feel particularly isolating. The questions were triggering and anxiety-provoking, asking about such a personal matter and something traumatic without a clinician or fellow discussing it. I don't feel like the purpose of the trials is to give patients' care so much as to gather information. It is dehumanizing when I'm answering 50 multiple-choice, very personal questions on an iPad or device.”
Mental Health Support Doesn’t Have To Be Complicated
During clinical trials focusing on physical symptoms and treatment, is there a way to minimize the psychosocial and emotional effects that participants like Nicole feel? As the physical distance between participants, providers, and researchers grows, there is a loss of connection and interaction with the study population. Lindsey Matt, Ph.D., a mental health provider who has also participated in clinical trials, suggests that easing the feelings of mental stress, anxiety, and isolation could be quite simple. For example, she suggests adding a chatbox feature to an app or website platform. Matt advises, “When we experience stress, we all have less mental bandwidth. Imagine, while completing assessments for a trial, you have a concern. Rather than having to stop what you are doing and fumble through various emails about the trial, you instead have a chatbox available on every page, similar to those we encounter while doing our shopping or banking online. The chatbox might utilize auto-replies to direct a curious participant back to a trial overview, support a concerned participant in sending a message to their provider, or allow a participant feeling anxious to access a mental health resource list with just a few clicks.” The method of delivering and receiving information does not have to change, but remote patients should have other ways besides a site visit to feel supported. Knowing what to expect or that support is just a click away can make a remote participant feel less isolated.
There are many conversations and questions about adding mental health support to clinical trials and how to execute it. With a focus on empathy toward patients, another solution may be rethinking how information is delivered. Examining the wording of survey questions and adding a more human or empathetic tone where appropriate can help patients feel less anxious and isolated. In some cases, informing the participant that they may encounter intimate questions throughout the trial could also lower the subsequent anxiety. A remote participant like Nicole may not anticipate having to answer personal questions about their body image throughout a clinical trial for breast cancer and therefore may be blindsided, surprised, or frustrated when they unexpectedly encounter them outside of a provider’s office.
Dr. Melissa Frey is an assistant professor of obstetrics and gynecology in the gynecologic oncology division at New York-Presbyterian/Weill Cornell Medical Center. In both her medical practice and her research in genetics and genomics in gynecological cancer, Frey has noticed the positive and negative aspects of delivering medical information via web-based platforms. "I love that I can message a patient at 3 a.m. that their CA-125 is normal, but it makes it harder for a patient to say, ‘That test makes me anxious' or ask further questions." Patients or participants often feel burdensome or anticipate difficulty reaching out to their providers or study coordinators when a non-urgent question arises.
For me, rarely does a provider share results in person or over the phone; most times a notification alerts me to confusing and hard to understand reports in my EHR. Because I have my health data just a single click away, I often end up consulting “Dr. Google” in an attempt to decode the information until I can get hold of my provider. In one instance, several days had passed before I could confirm the scary red exclamation point flagging my “HBSAb” as “reactive” and in the “nonstandard range.” It turns out the result meant that I had received a mandatory, protective, and important vaccine. As a possible solution, Frey and I discussed how adding links to clearer explanations of tests could prevent an anxiety-induced web search for information. Another beneficial addition would be to add a single line to the written delivery of results that reads, “Would you like a call back from your provider?”, to remind patients that live avenues of communication still exist.
Humanizing DHTs Starts With Empathy
Although accessible technology has changed the face of healthcare, it has placed an invisible barrier between patients and providers that can breed anxiety and stress. By acknowledging the isolation and dehumanizing loss of intimacy and individuality that can result from the loss of in-person care and taking small steps to fix it, we can begin to strengthen the provider-patient relationship and improve patient mental health. Mental health support in clinical trials can exist in many ways and may not be as difficult as some think.
"It first starts with understanding what mental health is and what mental health support really means, and a realization that it is not complicated," says Esther Howard, founder and CEO of Bezyl, a data and digital mental health company. "It's as simple as first thinking about the patient as a human, then providing tools that simplify the life of a patient in their day-to-day lives, thus decreasing anxiety and worry. When a patient has less to worry about, they are able to embark on their journey with more mental strength." By looking at the delivery of care and information through a more empathetic lens, we can change the patient experience and increase the future success of clinical trials.
References:
- Coyle, J., Rogers, A., Copland, R. et al. A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs). Trials 23, 614 (2022). https://doi.org/10.1186/s13063-022-06521-4
About The Author:
Emily Epstein is a patient advocate and activist for the inclusion of mental health support and improved patient support in clinical research and medical settings. When her 30-year career as a professional actress was paused by the Broadway shutdown during COVID-19, she began pursuing her passion for mental health full time. A graduate of NYU-Tisch and an MSW candidate at Fordham Graduate School of Social Services, Emily has been referred to as an “empathy advisor.” In her continued work as a psychosocial advisor, she helps healthcare providers and researchers to work with more empathy when interacting with their patients. As a peer navigator, Emily provides support to patients and their families. Through her journey with the BRCA2 mutation and utilizing her skills as a social worker, Emily brings knowledge, awareness, and perspective to panels, advisory boards, and support groups.