Decisions to Enter Phase I Oncology Clinical Trials: Effectual and Ethical Informed Consent

Decisions to Enter Phase I Oncology Clinical Trials: Effectual and Ethical Informed Consent
Stephanie Solomon Cargill, Natalie Hardy
Patient Education and Counseling, April 2023
Abstract
When faced with advanced stage cancer, patients consider participating in Phase I oncology clinical research trials. The likelihood of patients benefiting from trial interventions is low (5%). Although scholarship has found that participants overestimate the benefit interventions, research has failed to assess the social context that may influence how potential participants evaluate their decision to participate. This understanding is critical for ethical informed consent procedures. Thus, the aim of this pilot project was to examine oncology patients’ decisions to enroll in Phase 1 trials. In-depth interviews were conducted with eight adults who were invited to participate in Phase 1 oncology clinical trials. Analysis was guided by Problematic Integration Theory (PI, e.g., Babrow, 2001), providing a framework for understanding tensions among desires and expectations, particularly when faced with uncertainty. Researchers took an iterative analytical approach shifting between respondents’ viewpoints and PI theory. Analysis revealed that participants understood that when invited to the trial, their current treatments were ineffective. In facing the tension between the likelihood of benefitting from the trial intervention with the hope that the intervention would be successful (and incur few negative side effects), participants faced an ambivalent situation. Thus, participants entered conversations with research coordinators anticipating to enter the trial with few uncertainties. Participants expressed a desire for more information about the chances the trial would effectively treat their cancer, but trust that the medical team was acting in their best interest, providing hope.