Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies
Article first published online: 7 APR 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Volume 20, Issue 4, pages 361–368, April 2011
How to Cite
Brown, R., Bylund, C. L., Siminoff, L. A. and Slovin, S. F. (2011), Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies. Psycho-Oncology, 20: 361–368. doi: 10.1002/pon.1748
- Issue published online: 21 MAR 2011
- Article first published online: 7 APR 2010
- Manuscript Accepted: 1 MAR 2010
- Manuscript Revised: 25 FEB 2010
- Manuscript Received: 10 DEC 2009
- informed consent;
- physician–patient communication;
- Phase I clinical trials
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. Copyright © 2010 John Wiley & Sons, Ltd.