Purpose: To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure.
Patients and methods: Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire.
Results: The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower.
Conclusion: Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.
© 2014 by American Society of Clinical Oncology.