PERCEPTIONS OF CANCER-PATIENTS AND THEIR PHYSICIANS INVOLVED IN PHASE-I TRIALS

Purpose: In an attempt to understand some of the complex issues relate d to the participation of cancer patients in phase I trials, and the p erceptions of patients toward these trials, we conducted a pilot surve y study of 30 cancer patients who had given informed consent to partic ipate in a phase I trial at our institution. Concurrently, the oncolog ists identified by the surveyed patients as responsible for their care were surveyed as well. Patients and Methods: Twenty-seven of 30 conse cutive patients agreed to and completed the survey. Patients were surv eyed before they received any investigational agents. Eighteen oncolog ists participated in this survey study. Results: Eighty-five percent o f patients decided to participate in a phase I trial for reasons of po ssible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that th ey understood all (33%) or most (60%) of the information provided abou t the trials in which they had decided to participate. Only 33% were a ble to state the purpose of the trial in which they were participating , with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs reg arding expectations of possible benefits and toxicities for their pati ents participating in phase I trials. Conclusion: Cancer patients who participate in phase I trials are strongly motivated by the hope of th erapeutic benefit. Altruistic feelings appear to have a limited and in consequential role in motivating patients to participate in these tria ls. Cancer patients who participate in phase I trials appear to have a n adequate self-perceived knowledge of the risks of investigational ag ents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose -determination studies.