Purpose and Benefits of Early Phase Cancer Trials: What Do Oncologists Say? What Do Patients Hear?

Abstract

Cancer patients overestimate benefits of early phase trials but studies have not reported what oncologists say to patients about trials. We audiotaped oncologists talking to cancer patients about Phase I or II trials and interviewed patients about the purpose and expected outcomes of trials presented to them. Oncologists gave mixed messages, saying Phase I trials measure safety and dosing, yet referring to trials as treatment with uncertain therapeutic effects. Seventeen percent of Phase I respondents said the trials purpose related to safety/dosing (p = 0.017); 17% of Phase I respondents said the purpose was “to cure my cancer.” Patients may find it important to believe trials offer significant benefit. Oncologists, while respecting patients' hopes, should be precise in their language, particularly regarding Phase I trials, distinguishing early stages of research from treatment.

Keywords

cancer ethics research informed consent Phase I Phase II therapeutic misconception

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