Informed Consent Issues for Patients With Advanced Cancer in Phase I Trials


Key Points

  • Oncologists discussed phase I trial purpose in 40% of encounters and alternatives to trial participation in 47%.
  • Patients were more likely to subsequently correctly identify the purpose of the trial when it was disclosed by oncologists during discussions. 

As reported by Hlubocky et al in the Journal of Oncology Practice, oncologists may not provide patients with advanced cancer participating in phase I clinical trials with sufficient information about prognosis and purposes of phase I testing during enrollment discussions.

Study Details

The study involved recorded discussions during enrollment into phase I trials between 101 patients with advanced cancer and 29 oncologists (18 principal investigators and 11 fellows) at 3 U.S. medical institutions. The discussions were analyzed for informed consent components using the Roter Interactional Analysis System, and patients completed follow-up questionnaires to assess recall of informed consent components.

Oncologist Disclosure and Patient Recall

Principal investigators discussed phase I clinical trial purpose in 40% of encounters; specific physical risks in 60%; potential specific benefits offered by trial participation (eg, disease stabilization) in 48.2%; and alternatives to trial participation in 47.1%, including palliative care information in 1.1% and hospice information in 2.3%. Patient-specific prognosis was brought up in 29.0% of encounters, with the terms “death” and “terminal” used in 4.7% and 1.2%, respectively.

Overall, 26% of patients correctly reported trial purpose as safety, 7% reported that major adverse effects (eg, organ damage) could result from participation, 55% recalled discussion of prognosis, and 76% recalled alternatives to participation. Significantly more patients identified the trial purpose as identification of dosage and toxicities when oncologists did vs did not identify the specific purpose during discussion (85% vs 13%, P < .05).

The investigators concluded, “Many oncologists provide incomplete disclosures about phase I trials to [advanced cancer patients]. When disclosure of certain elements of [informed consent] occurs, it seems to be associated with better recall, especially with regard to the research purpose of phase I trials.”

The study was supported by grants from the National Institute of Allergy and Infectious Diseases and National Cancer Institute.

Fay J. Hlubocky, PhD, of the University of Chicago Medicine, is the corresponding author for the Journal of Oncology Practice article. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.