DESCRIPTION (investigator's abstract): 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
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