Telehealth utilization in gynecologic oncology clinical trials (295)

ABSTRACT

Objectives: In light of the COVID-19 pandemic, the Society of Gynecologic Oncology (SGO), National Cancer Institute, and Food and Drug Administration published clinical practice statements encouraging the use of telemedicine in clinical trials, which had previously been prohibited. Our study aimed to assess the feasibility and safety of telehealth utilization in clinical trials for gynecologic malignancies. Methods: A retrospective cohort study was performed. Patients who were enrolled in a gynecologic oncology clinical trial at the University of Pennsylvania Health System from March 16, 2020, to August 30, 2020, were included. Receipt of care during the telehealth period (March 16, 2020, to August 30, 2020) was compared to the pre-telehealth period (September 30, 2019, to March 15, 2020). Pairwise comparisons of clinical trial outcomes were performed between the two time periods, using paired t-test, Wilcoxon signed-rank test, simple linear regression, Chi-square, and ANOVA. Results: Thirty-one patients met the inclusion criteria. The mean age was 63.7 years (SD 10.3);84% were non-Hispanic White. The median distance from home zip code to study center was 25.2 miles (IQR 16-46, range 1.9-170). Most patients had high-grade serous ovarian carcinoma (84%) and had the disease at an advanced stage (Stage III 48%, Stage IV 38.7%). Trial drugs included 22.6% (n=7) intravenous only, 29% (n=9) oral only, and 48.4% (n=15) combination oral/intravenous therapies. The median duration of enrollment was similar between pre-telehealth (5.2 months, IQR 3.2-5.6) and telehealth periods (5.6 months, IQR 3.8-5.6), (p=0.682). During the TELEHEALTH period, significantly more virtual provider visits (p <0.001) and remote laboratory testing (p=0.015) occurred, with similar rates of remote imaging (p=0.551). Delayed provider visits (p = 0.965), laboratory testing (p = 0.989) and imaging (p = 0.999) occurred infrequently in both timeframes. The number of patient touchpoints (portal messages and phone calls) per month did not increase (p = 0.147). Patients who lived farther from the study center were more likely to use remote imaging (p = 0.013);however, the distance was not associated with the use of virtual provider visits (p = 0.309) or remote laboratory testing (p = 0.821). Number of dose reductions (p = 0.112) and toxicity-related treatment delays (p = 0.888) were similar. Increased need for extra imaging was noted in the telehealth period (p=0.007) and was not associated with disease progression (p=0.614). Extra provider visits, emergency department visits, and hospital admissions were infrequent and similar in both timeframes (Table 1). The total number of deviations was increased (p=0.010);however, when adjusted for minor deviations documenting telehealth use or deferment of research-related laboratory testing given the pandemic precautions, there was no difference between timeframes (p = 0.468). The total number of adverse events and severe adverse events did not increase in the telehealth period (p=0.494 and p=0.601, respectively). Conclusions: Utilizing telehealth in clinical trials for gynecologic oncology patients did not increase clinical workload or adverse patient outcomes. Documentation of telehealth use and pause of research-related laboratory collections resulted in a higher number of protocol deviations during the telehealth period. Telehealth should be incorporated into future clinical trials as it appears safe and feasible and may facilitate access for remote, rural, and under-served populations.