http://www.ncbi.nlm.nih.gov/pubmed/23091107

J Clin Oncol. 2012 Oct 22. [Epub ahead of print]

Research Participants' High Expectations of Benefit in Early-Phase Oncology Trials: Are We Asking the Right Question?

Weinfurt KP, Seils DM, Lin L, Sulmasy DP, Astrow AB, Hurwitz HI, Cohen RB, Meropol NJ.

Source

Kevin P. Weinfurt, Damon M. Seils, Li Lin, and Herbert I. Hurwitz, Duke University, Durham, NC; Daniel P. Sulmasy, MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL; Alan B. Astrow, Maimonides Medical Center, Brooklyn, NY; Roger B. Cohen, Fox Chase Cancer Center, Philadelphia, PA; and Neal J. Meropol, University Hospitals Seidman Cancer Center and Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH.

Abstract

PURPOSE

To determine whether patients' expectations of benefit in early-phase oncology trials depend on how patients are queried and to explore whether expectations are associated with patient characteristics. 

PATIENTS AND METHODS

Participants were 171 patients in phase I or II oncology trials in the United States. After providing informed consent for a trial but before receiving the investigational therapy, participants answered questions about expectations of benefit. We randomly assigned participants to one of three groups corresponding to three queries about expectations: frequency type, belief type, or both. Main outcomes were differences in expectations by question type and the extent to which expectations were associated with demographic characteristics, numeracy, dispositional optimism, religiousness/spirituality, understanding of research, and other measures.

Results

The belief-type group had a higher mean expectation of benefit (64.4 of 100) than the combination group (51.6; P = .01) and the frequency-type group (43.1; P < .001). Mean expectations in the combination and frequency groups were not significantly different (P = .06). Belief-type expectations were associated with a preference for nonquantitative information (r = -0.19; 95% CI, -0.19 to -0.36), knowledge about research (r = -0.21; 95% CI, -0.38 to -0.03), dispositional optimism (r = 0.20; 95% CI, 0.01 to 0.37), and spirituality (r = 0.22; 95% CI, 0.03 to 0.38). Frequency-type expectations were associated with knowledge about clinical research (r = -0.27; 95% CI, -0.27 to -0.51). 

CONCLUSION

In early-phase oncology trials, patients' reported expectations of benefit differed according to how patients were queried and were associated with patient characteristics. These findings have implications for how informed consent is obtained and assessed.