How do late-stage cancer patients join an early phase clinical trial? A qualitative investigation of the process.

Abstract

60 Background: Late-stage cancer patients (LSCPs) face complex choices as they exhaust standard treatment options, including whether to seek enrollment in an early phase (EP) clinical trial and how they may engage palliative care. Existing research describes patient-level decisional motivations, but less is known about the process by which patients arrive at decisions and the institutional barriers or facilitators that shape it. We investigate this process and the key barriers and facilitators for initiating an EP trial. Methods: We collected longitudinal, ethnographic data on 96 LSCPs from breast, genitourinary, gastrointestinal, lung, gynecology, and melanoma clinics at two large academic medical centers. We used constant comparative analysis to inductively identify factors that shaped patients’ paths towards or away from EP trial initiation. Results: Four key factors shaped patients’ pathways and help explain why most patients did not join a trial. These arose during two distinct periods. The first, “Setting the Stage,” concerned achieving both (a) patient and (b) physician interest in and support for the patient’s involvement in an EP trial. These achievements depended on the patient’s knowledge and opinions of experimental research, the physician’s awareness of relevant EP trials, and whether the physician considered the patient a good EP candidate, among other influences. The second period, “Securing an Experimental Seat,” concerned aligning (c) the availability of a specific EP trial with (d) the patient meeting the trial’s eligibility requirements. Disease progression, type and timing of past treatments, and dynamic trial enrollment windows all complicated this alignment. Despite the complexity of Securing a Seat, our data suggest that Setting the Stage was the more consequential period in terms of when patients exited the EP trial pathway. Conclusions: Patients’ priorities and decision-making are only one part of a multi-level process. LSCPs’ paths onto an EP trial depend not only on their making a particular decision, but also on relational, clinical and system-level conditions. This suggests that boosting EP trials participation requires interventions on multiple levels.