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Complementary and Alternative Medicine Among Advanced Cancer Patients Enrolled on Phase I Trials: A Study of Prognosis, Quality of Life, and Preferences for Decision Making

Fay J. Hlubocky, Mark J. Ratain, Ming Wen, Christopher K. Daugherty

From the Department of Medicine, Section of Hematology/Oncology, MacLean Center for Clinical Medical Ethics, the Cancer Research Center, The University of Chicago, Chicago, IL; and Department of Sociology, University of Utah, Salt Lake City, UT

Address reprint requests to Christopher K. Daugherty, MD, University of Chicago, 5841 S Maryland Ave, MC 2115, Chicago, IL 60637; e-mail: cdaugher{at}medicine.bsd.uchicago.edu

Purpose We sought to describe complementary and alternative medicine (CAM) usage among phase I trial participants and to describe these patients' treatment decision-making preferences, awareness of prognosis, survival, and quality of life.

Patients and Methods Advanced cancer patients enrolling onto phase I trials were surveyed regarding biologically based CAM use. Decision-making preferences and awareness of prognosis were assessed using validated and/or standardized instruments. The Functional Assessment of Cancer Therapy–General instrument was used to assess quality of life. Univariate and multivariate analyses were performed to detect differences between CAM users and nonusers.

Results Of 212 interviewed patients, 34% (n = 72) described taking biologically based CAM. Median age of those taking biologically based CAM was 55 years, compared with 62 years for nonusers (P < .005). There were no statistically significant differences found between CAM usage and preferences for degree of patient involvement in medical decision making. Those patients who acknowledged that their deaths were likely to occur within 1 year were more likely to admit to prior CAM use (70% v 34%; P = .02). CAM users had poorer overall quality of life compared with nonusers (87.0 ± 12.4 v 91.2 ± 14.7; P = .007). No differences in survival were identified.

Conclusion Prior CAM use among phase I cancer trial patients studied was common and associated with age, stated acknowledgment of prognosis, and quality of life. Patients enrolling onto early-phase trials should be questioned about CAM use. Additional study is needed to determine the frequency of use of those biologically based CAM agents that threaten the accuracy of early-phase cancer trial data.

Supported by grants from the Soros Foundation Project on Death in America (Faculty Scholar Program [C.K.D.] and the National Institutes of Health [C.K.D.; Grant No. RO1 CA 087605-01A1]).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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