Abstract P6-09-04: Oncologist-reported Barriers and Facilitators to enrolling patients in optimization trials that test less intense cancer treatment
Authors: Rocque Gabrielle B. , Courtney Andrews , Frazier Rachel M. , Valerie Lawhon , Ingram Stacey A. , Smith Mary Lou , Wagner Lynne I. , Zubkoff Lisa , Tung Nadine , Wallner Lauren P. , Wolff Antonio C. 
Published: March 2023

Abstract
Background: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could impact accrual to optimization clinical trials and about the generalizability of future findings. Methods: We conducted a qualitative study with semi-structured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. Results: Forty-six physicians were approached from 3/31/21-11/5/21; 39 oncologists from different oncology practices across 17 states completed interviews, 7 either declined or did not respond to email requests. Physician characteristics were balanced: men vs. women (49% vs 51%) and community oncologist vs. academic oncologist (49% vs 51%); and time practicing as medical oncologist (31% 0-9 years; 33% 10-19 years; 36% 20+ years). All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists reported the need for treatment optimization, with one oncologist noting “historically, we’ve given way too much treatment to patients.” Oncologists highlighted specific reasons to consider optimization trials. They included quality of life improvement by reducing toxicity; reduction in financial toxicity; fertility preservation; ability to avoid chemotherapy; minimization of overtreatment in patients with comorbid conditions; personalized treatment; opportunities to test novel therapies; and leveraging the availability of targeted therapies. At the same time, there was hesitancy amongst some oncologists with this approach, “All my life I’ve worked to try to improve things and so I am not totally philosophically comfortable with the notion that I’m going to be happy with a result that says, we haven’t improved it but we can get by with less.” In addition, oncologists also identified accrual barriers, like tumor-specific biology, individual (host) factors (e.g. disease characteristics, patient demographics, patient psychological state, patient preferences), prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support communication about and enrollment in optimization trials. Conclusions: While optimization clinical trials are generally accepted to be beneficial by oncologists, barriers impact their acceptance. Scientifically robust design and education to overcome barriers are needed to support future enrollment on trials tailoring therapy based on risk and potential benefit to allow true personalization of treatment.
Citation Format: Gabrielle B. Rocque, Andrews Courtney, Rachel M. Frazier, Lawhon Valerie, Stacey A. Ingram, Mary Lou Smith, Lynne I. Wagner, Lisa Zubkoff, Nadine Tung, Lauren P. Wallner, Antonio C. Wolff. Oncologist-reported Barriers and Facilitators to enrolling patients in optimization trials that test less intense cancer treatment [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-09-04.