Initiative to standardize a clinical trial educational program.

535 Inconsistencies in how clinical trial information is disseminated and what information is given can adversely affect the number of patients enrolled (Avis, Smith, Link, Hortobagyi, & Rivera, 2006; Cox, 2002; Cox & McGarry, 2003; Ellis, Butow, & Tattersall, 2002; Ellis, Butow, Tattersall, Dunn, & Houssami, 2001; Hutchison & Campbell, 2002; Stevens & Ahmedzai, 2004; Wright et al., 2004), patient compliance with trial expectations (Kornblith et al., 2002; McTiernan, 2003; Oppenheim, Geoerger, & Hartmann, 2005; Stevens & Ahmedzai, 2004), and the validity of trial results (Beskow, Sandler, Millikan, & Weinberger, 2005). Additionally, inconsistencies can compromise patients’ ability to make informed decisions about whether to participate in clinical trials (Barrett, 2005; Menikoff, 2005; Weinfurt et al., 2005). Providing clinical trial information at a major comprehensive cancer center can be a challenge. At the start of the project described in this article, the University of Texas MD Anderson Cancer Center had few clinical trial educational resources, no standard clinical trial education program, and no systematic way to communicate such information to patients, staff, and the public. Patients reported being offered clinical trials as treatment options but having no tools to help them make decisions. In this article, the authors describe a needs assessment and a process survey to determine the clinical trial education needs of patients and the education practices of nursing research staff. The authors then discuss how a standard clinical trial education program was developed and implemented.