Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct:177:103-108.
doi: 10.1016/j.ygyno.2023.08.011. Epub 2023 Aug 31.

Telehealth utilization in gynecologic oncology clinical trials

Leslie Andriani  1 , Jinhee Oh  2 , Erin McMinn  3 , Emily Gleason  4 , Nathanael C Koelper  5 , Jesse Chittams  5 , Fiona Simpkins  1 , Emily M Ko  6
Affiliations

Telehealth utilization in gynecologic oncology clinical trials

Leslie Andriani et al. Gynecol Oncol. 2023 Oct.

Abstract

Objective: Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic.

Methods: Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control.

Results: Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods.

Conclusions: Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic.

Keywords: Clinical trial protocol; Clinical trials; Decentralization of clinical trial; Gynecologic cancer; Telehealth; Telemedicine.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

    1. Zon Robin T et al. “Telehealth in Oncology: ASCO Standards and Practice Recommendations.” JCO oncology practice vol. 17,9 (2021): 546–564. doi:10.1200/OP.21.00438 - DOI - PubMed
    1. Pothuri Bhavana et al. “Anti-cancer therapy and clinical trial considerations for gynecologic oncology patients during the COVID-19 pandemic crisis.” Gynecologic oncology vol. 158,1 (2020): 16–24. doi:10.1016/j.ygyno.2020.04.694 - DOI - PMC - PubMed
    1. Williams Erin L et al. “Taking Tele Behind the Scenes: Remote Clinical Trial Monitoring Comes of Age During the COVID-19 Pandemic.” JCO oncology practice vol. 17,9 (2021): 577–579. doi:10.1200/OP.21.00524 - DOI - PMC - PubMed
    1. Tolaney Sara M et al. “The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute.” Journal of the National Cancer Institute vol. 113,11 (2021): 1453–1459. doi:10.1093/jnci/djaa144 - DOI - PMC - PubMed
    1. Li Guanqiao et al. “Digitalized Adaptation of Oncology Trials during and after COVID-19.” Cancer cell vol. 38,2 (2020): 148–149. doi:10.1016/j.ccell.2020.06.018 - DOI - PMC - PubMed

Publication types

LinkOut - more resources