Prospective evaluation of patient perceptions and willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials

Abstract

6587 Background: Increasing numbers of clinical trials include optional or mandatory pharmaco-dynamic and -kinetic assays. Since little is known about patients’ (pts) perceived willingness to undergo specific tests and the number of tests pts would tolerate on a single trial, this study was conducted. Secondary purposes included correlating test number and type with demographics, prior test experience, coverage, and inconvenience. Methods: Exploratory correlative study using a multi-item self-report questionnaire to measure pts willingness (0–10 scale, 0 = not willing, 10 = very willing) to undergo imaging (e.g., MRI, ECHO), invasive (e.g., tumor, skin biopsies [bx]) and less invasive tests (e.g., blood, urine). 61 pts (22 female, 39 male) with advanced malignancies participating in phase I or II trials at one institution were enrolled from June 2008-December 2008. Descriptive and non-parametric statistics were used. Results: Statistically significant (p < 0.01) inverse relationships were found between the number of imaging studies (e.g., CT, ECHO), tests required (e.g., tumor, skin bx, blood draws) and pts reported willingness to undergo these tests. Pts were least willing to undergo tumor bx (median 5.5, interquartile range [IQR] 3.5–10), skin bx (6.8, 3.1–10), and unexpectedly MRIs (8, 4–10) (all p < 0.01). Surprisingly, inconvenience and prior negative experiences for the more invasive tests (e.g., skin bx) did not negatively affect willingness to undergo these tests in the future as opposed to most imaging studies. College-educated were more willing to undergo tests than non-college educated. Few pts were unwilling to undergo tests/procedures at all, if mandatory for enrollment. Conclusions: Results provide improved understanding of pts willingness to undergo trial requirements and suggest that adequate explanation (e.g., MRI) and test rationale may affect willingness to undergo tests. Findings can be used to improve study design and consent procedures to minimize patient discomfort and inconvenience. The overall willingness of advanced stage cancer pts to undergo study specific tests/procedures is high. No significant financial relationships to disclose.