Oncologist-Reported Barriers and Facilitators to Enrolling Patients in Optimization Trials That Test Less Intense Cancer Treatment

Abstract

PURPOSE: 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 affect accrual to optimization clinical trials and the generalizability of future findings. METHODS: We conducted a qualitative study with semistructured 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 used a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists highlighted specific reasons to consider optimization trials. These 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. Oncologists also identified accrual barriers, such as tumor-specific biology, individual (host) factors, prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support enrollment in optimization trials. CONCLUSION: Although oncologists are generally willing to enroll patients on optimization clinical trials, barriers affect their acceptance. A scientific focus on overcoming these barriers is needed to support future enrollment on trials tailoring therapy on the basis of risk and potential benefit to allow true personalization of treatment.

“Clinical trials are space travel”: Factors of psychological response to recurrence among oncologists enrolling patients in treatment optimization trials

“…Interviews were conducted by a breast medical oncologist (GR) via Zoom or telephone using a semi‐structured interview guide developed utilizing an a priori model‐based Norton and colleague's De‐implementation Framework 7 and aligned with patient interview guides from a prior study focused on patient perspectives of optimization trials 2 . The full interview guide has previously been published along with overarching barriers and facilitators that oncologists perceived to enrolling breast cancer patients in optimization trials 6 . This analysis delves deeper into a subsection of the interview where oncologists were asked how they would feel if a patient recurred after participating in an optimization trial.…”

“…Purposive sampling techniques were utilized to identify a balanced convenience sample of oncologists according to setting, gender, ethnicity, age, years of experience, and geographic location. In‐depth sample methodology and oncologist characteristics are described elsewhere 6 . Briefly, physicians from different US practices were identified through working relationships with the oncologists, engagement with the ECOG‐ACRIN Breast Committee, or referral from previous participants.…”

“…2 The full interview guide has previously been published along with overarching barriers and facilitators that oncologists perceived to enrolling breast cancer patients in optimization trials. 6 This analysis delves deeper into a subsection of the interview where oncologists were asked how they would feel if a patient recurred after participating in an optimization trial. The interviewer probed specifically to determine (1) whether negative psychological responses on the part of the oncologist occurred after patient recurrence;…”

The REthinking Clinical Trials Program Retreat 2023: Creating Partnerships to Optimize Quality Cancer Care

“…There is often difficulty in obtaining funding for dose-finding studies despite these studies saving more money than they cost [ 38 ]. There is also difficulty in enrolment as patients and physicians fear the potential impact on treatment benefits [ 39 , 40 ]. Despite positive dose optimization trials, there is a low rate of implementation of low-dose strategies [ 41 , 42 ].…”

Optimizing the doses of cancer drugs after usual dose finding

“…80 Oncologists are increasingly willing to enroll patients in trials that seek lower toxicity, cost, and patient burden. 81 Oncologists are willing to discuss flexible approaches to dosing that may better balance toxicity and efficacy, particularly in metastatic disease. 21 Given the rising recognition of nondrug treatment toxicites, 56,82,83 less frequent dosing could conceivably increase a drug’s market share, albeit at the risk that fee-for-service prescribers and treating facilities lose drug administration revenues.…”