Research and Scholarship

Management of Adverse Events in Early Clinical Trials by Advanced Practice Providers in the Outpatient Setting: The University of Texas MD Anderson Cancer Center Experience

Fedricker D. Barber (1), Erick Campbell (1), Yuko Yamamura (1), Clover J. Patterson (1), Audrey C. Hartnett (1), Holly Kinahan (1), Victoria A. Miller (1), Amanda L. Brink (1), Anna Poullard (1), Gabriele E. Urschel (1), Andre Brantley (1), Isabel G. Cepeda (1), Poonam Goswami (1), Sheena Charles (1), Shincy Philip (1), Sara Bresser (1), Sandra Musekiwa-Adjei (1), Nageli Perez (1), Hung Le (1), Penny Phillips (2), Vivek Subbiah (1), Funda Meric-Bernstam (1,3,4), and Ecaterina E. Dumbrava (1)

From (1)Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas; (2)Clinical Center for Targeted Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas; (3)Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas; (4)Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas

Authors’ disclosures of conflicts of interest are found at the end of this article.

Correspondence to: Fedricker D. Barber, PhD, ANP-BC, AOCNP®, FAANP, FAAN, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030 E-mail: dbarber@mdanderson.org


J Adv Pract Oncol 2022;13(7):664–672 | https://doi.org/10.6004/jadpro.2022.13.7.2 | © 2022 Harborside™


  

ABSTRACT

Background: Advanced practice providers (APPs) play important roles in enrolling, educating, and caring for patients in clinical trials. However, much remains unknown about the role of APPs in managing adverse events (AEs) in early (phase I to II) clinical trials. In this study, we assessed the outpatient management of grade 3 to 4 AEs by APPs in early trials and characterized the workflow of our APP Phase I to II Fast Track (FT) Clinic. Patients and Methods: We retrospectively reviewed records of patients with advanced or metastatic solid tumors enrolled in phase I to II clinical trials who were seen by APPs from September 2017 to August 2018 in the APP phase I to II FT clinic in the Department of Investigational Cancer Therapeutics. Results: A total of 808 patients enrolled in 159 clinical trials were seen in 2,697 visits (median 3 visits per patient; range 1–28) by 10 APPs. Treatment was interrupted in 6.9% of visits, and grade 3 to 4 AEs were seen in 5.4% of visits; however, patients from 1.4% of visits were sent to the emergency center (EC) and/or admitted. Patients referred to the EC and/or admitted were more likely to have baseline hypoalbuminemia, high lactate dehydrogenase, and poor Eastern Cooperative Oncology Group performance status (i.e., ECOG > 1; p < .001). There were no associations between EC referral and gender, APP years of experience, or type of treatment. Conclusions: The APP Phase I to II FT Clinic has an important role in the management of AEs by APPs in early clinical trials in the outpatient setting, potentially avoiding EC visits and admissions.




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