An exploration of the experiences, motivations and expectations of patients with advanced cancer, without any standard options, during phase-I trials.

Abstract

Title: Patients’ experiences, motivations and expectations during oncological phase-I trials

Background: Patients who enroll in a phase-I clinical trial, may have therapeutic misconception, therapeutic optimism and are often motivated by other people, like their family and doctor. Despite side effects these patients continue to participate. Little is known about the experiences, motivations and expectations when they continue participation in these trials.

Aim: To explore the experiences, motivations and expectations of patients with advanced cancer, without treatment options, during phase-I trial participation.

Methods: A generic qualitative study in which ten semi-structured interviews were thematically analyzed according to Braun and Clarke methodology.

Results: While most participants were pleased they could perform their daily activities again, they also experienced side-effects and burden. Burden such as being confronted with the fact that they have no regular treatment options and experiencing mental and physical fatigue. All participants got their motivation from controlling the outcome, to do good for one another and living in harmony. Participants who just enrolled only tended to look into the future in the short term, while participants who had several tumor evaluations dared to look further into the future.

Conclusion: Participating in phase-I trial is a great uncertainty. Participating creates the feeling that they tried everything and they are treated to the limit. This not only gives the motivation to continue participating but also a sense of altruism. Family and friends, hope, realism, optimism and helping to develop a new drug also provide motivation. Despite different burdens, side-effects and the feeling of being a test-subject, the participants will not easily choose to stop participation, in order to prevent to say afterwards: "If only I had".

Recommendation: It is recommended to discuss end-of-life care, burdens and motivations during phase-I trial.