The COVID-19 pandemic transformed the world, and nowhere more so than in the health-care arena. Significant changes happened almost overnight in the delivery of medical care to focus on the safety and convenience of patients, staff, and providers. Although pilot efforts to integrate telemedicine had begun prior to the pandemic, the immediacy of the response to the crisis forced our clinicians, staff, and patients to adopt new technology and learn to connect in different ways, with an emphasis on social distancing and remote work for safety.
Locally, the uptake of telehealth service was explosive in the Yale New Haven Health System, increasing from 316 telehealth visits conducted in 2019 to more than 500,000 virtual encounters in 2020. At Yale/Smilow Cancer Hospital, in the spring of 2020, more than 50% of patient encounters were via telemedicine compared with less than 1% previously. Our patients came to the hospital for bloodwork and infusions, but other visits that did not require physical contact were often performed remotely by video conferencing or phone.
Anne Chiang, MD, PhD
Roy S. Herbst, MD, PhD, FACP, FASCO
Some patients very much appreciated avoiding contact and travel. Some even commented that it was nice to have doctors looking directly at them without a mask during the telehealth visit as opposed to clinic encounters requiring masks. Video visits allowed limited but critical assessment of overall appearance, distress level, rate of breathing, skin changes (such as rash or bruising), and cognition. Physicians and staff remarked that video visits allowed a more intimate glimpse into the home environment of the patient, with caregivers and sometimes even pets nearby.
Assessing the Pros and Cons of Telemedicine
A national survey of almost 800 health-care providers on their perspectives of telemedicine for patients with cancer was conducted by the National Comprehensive Cancer Network. Many respondents said there was no difference between video and in-person visits to explain malignancy-related clinical data; they said that video visits were better for follow-up surveillance or for explaining reassuring data, whereas in-person visits were better to assess complications of therapy and to establish a personal connection with their physicians.1
The survey respondents noted that barriers to telehealth uptake included patients’ access to technology, inefficient workflows, the need for a physical exam or laboratory tests, and reimbursement. A total of 93% of respondents reported that an adverse outcome never or rarely arose due to a telemedicine visit compared with an in-person visit. Finally, the averaged response of participants indicated that “absent financial implications,” 33% of patients could be seen via video visits after resolution of the pandemic.1
During the early days of the pandemic, the volume of COVID-19 patients overwhelmed hospital systems and reduced the ability to provide nonemergent care. Some institutions, including ours, even had to shut down accrual to clinical studies. In response to the pandemic, the National Cancer Institute’s (NCI’s) National Clinical Trials Network adapted policies to allow telemedicine or delayed study visits, laboratory or imaging tests, or even treatment or biospecimen collections as minor deviations, provided patient safety and study integrity were not compromised.2
The NCI’s central institutional review board supported “remote” informed consent, for instance, by telephone discussion with a witness and written signature on the document. Quality-of-life questionnaires could also be done over the phone. Patient care could be transferred to different study sites, and local health-care physicians could provide treatment, exam and assessments, tests, and imaging with oversight by the responsible investigator.
The flexibility in standard clinical trial processes during this pandemic hopefully opens the door to sustaining patient-centric changes. We advocate for the continuation of these policies in the future.
Making Clinical Trials More Accessible and Equitable
Most of our patients enrolled in clinical trials were seen in person during the early pandemic for treatment and toxicity evaluation, but many were also able to benefit from telemedicine for nontreatment visits. It became clear that the advantages of using telehealth for clinical practice extended to patients participating in cancer trials, for example, by avoiding the inconvenience of travel and time off from work for multiple visits by patients and caregivers.
Zoom visits also offered the opportunity to include caregivers or family members from different parts of the country, as well as clinical trial staff who were working remotely, assuring that everyone was able to participate in clinic or educational visits.
Ideally, such an approach could help increase future participation in clinical trials by saving patients travel time for routine clinic checkups or even tissue screening consents. This could even allow more patients from different geographic areas, including rural ones, to access trials that are not locally available.
In 2021, ASCO published its Road to Recovery Report, which outlined lessons learned from the COVID-19 experience to improve cancer care and clinical research.3 The report emphasized specific goals to ensure equity and access to clinical trials, the design of more pragmatic clinical trials, and ways to reduce regulatory burdens on research sites as well as recommendations to provide patients access to high-quality cancer care via telemedicine.
Patient-Centric Approach to Clinical Trials
Our collective pandemic experience at Yale Cancer Center has taught us that we are capable of nimble change and innovation to focus on patient safety and care. We need to translate that experience into simpler pragmatic research protocols that not only allow telemedicine for nontreatment visits and tissue consents, but also require fewer laboratory tests and imaging studies that may burden patients with extra visits and reduce the regulatory burden for research staff as well. It is important to specify that patient visits and/or consents can be conducted remotely in the protocol.
In addition to innovation in clinical trial design, a patient-centric approach toward clinical research needs to explore decentralized virtual remote assessments. A recent article by Sessa et al described new approaches to oncology clinical trials, including the use of electronic patient consent forms and medical updates, local laboratories for blood tests, home nursing visits for blood draws or infusions, and electronic patient-reported outcomes. It also stressed the importance of working together with local doctors, direct-to-patient drug delivery, and remote monitoring to increase patient convenience.4
Although this new approach sounds daunting, the united response of our medical community to the COVID pandemic gives us inspiration to implement bold changes in the future that will reduce patient burden and transform clinical research. This way, cancer care may become more accessible and equitable for all our patients.
Dr. Chiang is Associate Professor at Yale Cancer Center and Chief Integration Officer and Deputy Chief Medical Officer at Smilow Cancer Hospital. Dr. Herbst is Ensign Professor of Medicine, Deputy Director for Clinical Affairs, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, and Assistant Dean for Translational Research at Yale School of Medicine.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
DISCLOSURE: Dr. Chiang has received research funding from Bristol Myers Squibb, AstraZeneca, AbbVie, Amgen, and Genentech and has served as an advisor or consultant to AstraZeneca, Regeneron/Sanofi, and Genentech. Dr. Herbst is on the boards of Immunocore and Junshi Pharmaceuticals; has received consulting fees from Junshi Pharmaceuticals, AstraZeneca, Bolt Biotherapeutics, Bristol Myers Squibb, Cancel Therapeutics, Checkpoint Therapeutics, Cybrexa Therapeutics, DynamiCure Biotechnology, eFFECTOR Therapeutics, Eli Lilly and Company, EMD Serono, Genentech, Gilead, HiberCell, I-Mab Biopharma, Immune-Onc Therapeutics, Immunocore, Janssen, Johnson and Johnson, Loxo Oncology, Merck and Company, Mirati Therapeutics, NexCure, Novartis, Ocean Biomedical, Oncocyte Corp, Oncternal Therapeutics, Pfizer, Regeneron Pharmaceuticals, Revelar Biotherapeutics, Ribbon Therapeutics, Roche, Sanofi, and Zencor; and has received research funding from AstraZeneca, Eli Lilly and Company, Genentech/Roche, and Merck and Company.
REFERENCES
1. Tevaarwerk AJ, Chandereng T, Osterman T, et al: Oncologist perspectives on telemedicine for patients with cancer: A National Comprehensive Cancer Network survey. JCO Oncol Pract 17:e1318-e1326, 2021.
2. National Cancer Institute: Cancer Therapy Evaluation Program. Coronavirus Guidance. Last updated January 31, 2022. Available at https://ctep.cancer.gov/investigatorResources/corona_virus_guidance.htm. Accessed December 7, 2022.
3. Pennell NA, Dillmon M, Levit LA, et al: American Society of Clinical Oncology Road to Recovery Report: Learning from the COVID-19 experience to improve clinical research and cancer care. J Clin Oncol 39:155-169, 2021.
4. Sessa C, Cortes J, Conte P, et al: The impact of COVID-19 on cancer care and oncology clinical research: An experts’ perspective. ESMO Open 7:100339, 2022.
