Accepting to Participate in an Early-Phase Clinical Trial in Oncology: A Qualitative Study on the Patients' Experiences, Understanding, and Inner Motivations.

Abstract

Background: The clinical trial landscape in oncology has evolved, with shifting endpoints and increased emphasis on early-phase clinical trials (EPCTs) across European centers.

Aims: This study aimed to update knowledge on the experiences of patients enrolling in EPCTs, focusing on the individual/contextual factors influencing decision-making, and how to improve ethical and psycho-oncological support.

Methods: This qualitative single-center study was part of a broader multicenter project. Twenty-five patients with locally advanced or metastatic solid cancer, for whom standard therapies had failed, were interviewed face-to-face, at a French EPCT center. A reflexive thematic analysis of the transcripts was conducted, following Braun and Clarke's six-step approach.

Results: Four overarching themes emerged: "Experiencing the EPCT proposal", "Accepting the EPCT", "Ambivalent feelings" and "Coping strategies", and several subthemes. Decisions were often made quickly in crisis situations and perceived as the only option. While patients reported receiving adequate information, their understanding of the trial's aims varied. Emotional distress and time pressure likely hindered full comprehension. Patients relied on trust in clinicians and reframed trial participation as a constructive goal, drawing on coping strategies to manage uncertainty and restore a sense of coherence.

Conclusions: Patients were neither delusional nor misinformed, but their decisions were shaped by complex emotional and relational dynamics. The perception of being well informed does not ensure true understanding, especially in high-stress contexts. Ambivalent emotions, tensions between expectations and hopes, and constrained choices should be considered when tailoring supportive care. Evidence-based strategies are needed to enhance communication and shared decision-making in EPCT settings.