Purpose/Objectives: To reveal the decision-making process in patients considering participation in cancer phase I clinical trials.
Design: Grounded theory approach.
Setting: Cancer center in a metropolitan area of Tokyo, Japan.
Participants: 25 patients with cancer, including individuals who ultimately declined to participate in a phase I trial.
Methodologic Approach: Semistructured interviews and unstructured observations were conducted.
Main Research Variables: Patients' decision-making process and influencing factors.
Findings: The core category of patients' decision-making process was searching for a way to live to the end. The process consisted of four phases: only waiting for death to come if nothing is done, assessing the value of the phase I trial, finding decisive factors, and reminding oneself that this is the right decision. Factors influencing the process included patients' perceptions of physicians' explanations of the phase I trial, patients' perceptions of their families' attitudes toward the phase I trial, patients' experiences with past anticancer therapies, and patients' attitudes toward living with cancer.
Conclusions: Patient decision-making is a challenging process associated with issues about how to live at the end of life. The pattern of searching for a way to live to the end differed depending on the levels of the four factors that influenced patients' decision-making process.
Implications for Nursing: Nurses play pivotal roles in talking to patients about phase I trials, discussing what is important for the rest of their lives, and recognizing that patients made a satisfying decision for themselves.