Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies

Psychooncology. 2011 Apr;20(4):361-8. doi: 10.1002/pon.1748. Epub 2010 Apr 7.

Abstract

Purpose: Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies.

Patients and methods: Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies.

Results: Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences.

Conclusions: Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Clinical Trials, Phase I as Topic*
  • Communication*
  • Female
  • Humans
  • Informed Consent*
  • Male
  • Medical Oncology / standards
  • Middle Aged
  • Neoplasms / psychology
  • Neoplasms / therapy
  • Patient Selection
  • Physician-Patient Relations*
  • Physicians
  • United States