The Institute of Medicine recommends that providing """"""""access to high quality clinical trials"""""""" and """"""""policies to ensure full disclosure of information about appropriate treatment options"""""""" could improve clinical care. This revised application addresses these areas by investigating patient (PT) and physician (MD) communication behaviors and their relationship to treatment decisions, generally, and participating in a clinical trial, specifically. Previous work by the principal investigator has demonstrated that PT-MD communication is linked to patient decisions about treatment choices (i.e. whether to participate in a clinical trial) and that significant variability and problems exist in the ways physicians explain clinical trials and treatment options to patients and their families. The objective of this study is to demonstrate the role of PT-MD communication on treatment decision-making while considering predisposing factors of the patient (including sociodemographic variables, coping style, preference for information, perceived life expectancy), predisposing factors of the physician (sociodemographic and attitudinal), the features of the protocol and the impact of the presence of a key family member (usually a spouse) on the interaction. The central hypothesis is that the PT-MD interaction mediates the predisposing factors of the PT, MD and protocol and is therefore the important element in understanding and explaining cancer PT's decisions about treatment options. In addition, it is hypothesized that the presence and participation of a family member significantly increases the complexity of the interaction and needs to be systematically assessed to better understand how PTs make treatment decisions and how communication with MDs can be improved. The encounter in which a clinical trial is discussed is the observational unit. At Time 1, self-reported data on predisposing variables will be collected from 260 adult cancer patients (eligible for a Phase II or Phase III clinical trial and who have a key family member with them), and 50-68 MDs at two sites, the Moffit Cancer Center (Tampa) and the Cancer Center at the Albany Medical Center (Albany NY). At Time 2, the PT-MD interaction in (the presentation and discussion of the option to enroll in a clinical trial) will be videotaped. These data will be coded using the Moffit Accrual Analysis System (MAAS). Interactions between the family member and the MD also will be videotaped, coded and analyzed. At Time 3, an interview will be conducted with the patients to assess their decision, perceptions of factors leading to the decision, comfort level with the decision and the process, their sense of therapeutic alliance with the MD, and the role of the key family member in the decision-making process.
