ABSTRACT
Background: Since the onset of COVID-19, oncology practices across the U.S. have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. However, the extent of provider experience and comfort with TM/RPM in treatment trials is unknown. In this study, we surveyed oncology researchers to assess experience and comfort with TM/RPM. Method(s): Between April 10 and June 1, 2022, we distributed email surveys to U.S.-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated an interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, and workplace characteristics, as well as frequency and impression of TM/RPM use across trial components in phase 1, phase 2/3, and post-treatment trials. TM/RPM was defined as clinical trial-related health care and monitoring for patients geographically separated from the site administering the clinical trial. Result(s): There were 141 respondents. 53% identified as female. 39% were under 45 years old, and 25% were over 60. 70% identified as White. 90% were site or study PIs. 98% practiced in a non-rural site. Most respondents had enrolled patients on industry-sponsored trials (97%), NCI-sponsored trials (84%), and investigator- initiated trials (83%), across Phase 1 (92%), Phase 2/3 (100%), and post-approval trials (75%). About 41% of respondents had >20 years of trial experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. For Phase 2/3 trials, while > 75% of respondents expressed comfort (C) using TM/RPM for some trial components, the corresponding experience (E) in these areas was lower. Specifically for Phase 2/3 trials, comfort levels exceeded experience for prescreening (C = 91% vs. E = 47%), education and counseling (C = 95% vs. E = 52%), informed consent (C = 79% vs. E = 30%), routine lab testing (C = 81% vs. E = 37%), symptom monitoring for adverse events (C = 88% vs. E = 55%), PROs in real time (C = 87% vs. E = 20%), PROs as a study endpoint (C = 89% vs. E = 27%), and long-term outcome monitoring (C = 90% vs. E = 47%). Notably, 60% of respondents ranked patient access as the top advantage of providing TM/RPM in treatment trials. Top disadvantages included limited ability to monitor patients (34%) and disparities in patient technology access (23%). More than a quarter of respondents identified the top barrier to use of TM/ TPM as trial regulations (29%) or cross-state licensure challenges (27%). Conclusion(s): COVID-19 spurred the rise of TM/RPM in cancer treatment trials. Among oncology researchers, higher levels of comfort compared to real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.
ABSTRACT
Background: During the COVID-19 pandemic, remote cancer care, and video communication in particular, has become increasingly common in the context of routine visits and clinical trials. Though this medium has the potential to augment patient-provider communication, telehealth also raises concerns about the digital divide promoting disparities in access to cancer care. In this study, we surveyed oncology patients who declined to participate in a pilot study looking at a one-time pharmacist-led video visit for patients initiating oral anti-cancer medications to evaluate their primary reason for declining the intervention. Method(s): Between June 2021 and June 2022, we conducted a prospective survey among adult oncology patients at Columbia University Medical Center (CUMC) who declined a pilot study looking at a video visit intervention for patients initiating oral anti-cancer medications to assess the primary barriers to participation. The survey categorized specific reasons for decline into telehealth- related barriers (no access to electronic device, inability to navigate video visits specifically, patient preference for in person care) and trial-related barriers (patient too tired/unwell, no time to participate, not interested in this study specifically, not interested in clinical trial participation in general), and patients were asked to select the primary reason for declining among the list of options. Result(s): Twenty-three patients completed the survey (82% completion rate). Among 23 respondents, 9 patients (39%) described a technology-related barrier to participation, including 7 (30%) who owned a mobile device with video capacity, but did not know how to use video technology well enough for the visit, 1 (4%) who did not own a device with video capacity, and 1 (4%) who preferred in person visits. Fourteen respondents cited a reason unrelated to telehealth for declining participation, including 7 (30%) who did not feel the study would benefit them, 3 (13%) who did not have time, 2 (9%) who were too tired to participate in a study, and 2 (9%) who were not interested in participating in any kind of clinical trial. Conclusion(s): Video-based telehealth visits have become increasingly common in routine cancer care and clinical trials. Among oncology patients who declined participation in a pilot study looking at a pharmacist-led video consultation, over a third cited telehealth-related barriers to participation, the majority of whom had a mobile device, but did not know how to use video technology well enough to participate. Focusing efforts on training patients to use technology, particularly video communication, may help address the digital divide in cancer care.
ABSTRACT
Background: We sought to describe factors associated with treatment delay among cancer patients with COVID-19. Methods: We conducted a retrospective analysis of de-identified data from the ASCO COVID-19 Cancer Data Registry, a longitudinal cohort study launched in April 2020 with 60 community and academic practices. We evaluated all patients who were documented as having therapy (anticancer drug therapy, surgery or radiation therapy) scheduled at the time of entry into the registry due to a positive SARS-CoV-2 test result. Treatment delay were defined based on length of delay: on schedule or within 14 days, and delay > 14 days or discontinued entirely. The latter is defined as “delay in care”. We used univariate and multivariate logistic analyses to address these questions. Results: At the time of data analysis, 3028 patients were included in the registry, of which 2103 had scheduled drug therapy, 125 had scheduled surgery, and 202 had scheduled radiation. 46% of patients had a drug delay or discontinuation of care. A multivariable logistic regression found that delays were higher among Black patients relative to white patients (OR 1.73, 95%CI 1.27, 2.35), and Hispanic or Latino patients compared to non-Hispanic or Latino patients (OR 1.95, 95%CI 1.36, 2.80). Compared with patients with 0-1 comorbidities, having 2 or more comorbidities was associated with delay in treatment (OR 1.26, 95%CI 1.01, 1.56). Having metastatic disease, rather than local or regional disease (OR 1.61, 95%CI 1.28, 2.04), and having any COVID-19 complications compared to none (OR 1.49, 95%CI 1.22, 1.83) were associated with delay. Relative to the initial outbreak of the pandemic from March-June 2020, having a COVID-19 diagnosis later in the pandemic was associated with lower likelihood of delay (OR 0.45, 95%CI 0.26, 0.74). 47% (95/202) of patients had a radiation delay or discontinuation of care. Factors associated with radiation delay included having 2 or more comorbidities (OR 2.78, 95%CI 1.22, 6.53). 71% (89/125) of patients had a surgical delay or discontinuation care. Factors associated with surgical delay included female sex (OR 6.05, 95%CI 1.34, 34.6), being in the South compared with being in the Midwest (OR 9.00, 95%CI 1.97, 49.0). Counter-intuitively, having 2 or more comorbidities was associated with a lower likelihood of delay (OR 0.27, 95%CI 0.09, 0.90). Being diagnosed with COVID-19 in July-Sept 2020 was associated with lower likelihood of delay (OR 0.07, 95%CI 0.01, 0.49). Conclusions: Previous data has shown persistent disparities in COVID-19-related outcomes in subgroups of disadvantaged and minority patients and populations. Data from our study shows that another disparity borne of treatment delays for chronic disease in the setting of a positive SARS-CoV2 test may also contribute to overall poor outcomes in these vulnerable populations.