Abstract Background: Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death. However, screening asymptomatic men remains controversial, as early diagnosis and treatment of PCa has not yet been definitively demonstrated to reduce disease-related mortality in a randomized trial. The primary question is whether PCa screening results in overdiagnosis, the detection and treatment of disease that would not otherwise result in increased morbidity or mortality. Ongoing trials are addressing this question, but the final results will not be available for several years. Further, if the trials do not provide a definitive recommendation for or against screening, the question will persist. The difficulty of making medical decisions prior to the availability of definitive outcome data has been a long-standing issue in cancer screening and is likely to become increasingly important as screening technology advances more rapidly than our ability to validate it. Thus, widely applicable approaches to health education are needed in order to facilitate informed decision making about the growing number of unproven treatment and screening technologies, of which PCa screening is a prime example. Despite the PCa screening controversy, the practice of screening asymptomatic men is increasing in the U.S. and men are increasingly committed to screening. Most men who undergo PCa screening are unaware of the controversy and believe that the medical community unequivocally accepts the benefits of screening. One approach to improving informed consent for PCa screening is the development, evaluation, and dissemination of patient education materials and decision aids. Abundant evidence documents the expanding role of the Internet in increasing access to and understanding of health information. However, systematic evaluations of Internet-based interventions are needed to address questions regarding the accessibility and efficacy of this mode of health education, particularly among older adults, persons without a college education, and minority participants. We conducted a randomized clinical trial to test the effectiveness of widely accessible and disseminable methods to assist men in making informed decisions about PCa screening. The goal of this research program is neither to encourage nor discourage PCa screening, but instead is designed to assist patients in making an informed decision until the definitive data on screening effectiveness are available. Method: This study included male outpatients aged 45 to 70 from two Washington, DC, area hospitals and an outpatient group practice (N = 1,893). Trial arms included: 1) print-based information and a decision aid (Print; N = 630), 2) web-based information plus an interactive decision aid (Web; N = 631), and 3) usual care (UC; N = 632). Subjects completed outcome assessments at baseline, one- and 13-months post-baseline. The primary outcomes of interest were knowledge, decisional conflict, decisional satisfaction, health-related quality of life, screening preferences, screening intentions, and screening behavior. Results: Participants were a mean age of 57, 40% were African American, and 70% had been screened for PCa within 12 months prior to the baseline assessment. We assessed the short-term (1-month) impact of the educational interventions on knowledge, decisional conflict, and decisional satisfaction. Multivariate analyses revealed a significant improvement in knowledge for the print and Web groups at the one-month assessment in comparison to the UC group (F (2,1630) = 119.4, p = .000). Regarding decisional conflict, the Web (OR = .449 (.341, .591)) and print (OR = .464 (.352, .611)) arms were less likely than the UC group to report high decisional conflict at the 1-month follow-up. There was no significant impact on satisfaction with the screening decision between the three study groups. We will also present findings on the short-term impact of the interventions on screening preferences and screening intentions, as well as the long-term (13-months) impact on prostate cancer screening behavior. Conclusions: Both the Print- and Web-based tools significantly impacted short-term outcomes by increasing knowledge and reducing decisional conflict relative to the UC arm. However, contrary to prediction, there were no group differences in decisional satisfaction. This was likely due to a ceiling effect, as all groups reported a very high level of decisional satisfaction at both assessments. We have developed and tested two methods of patient education that are easily disseminable in real-world settings. These methods are effective and could improve clinical care by providing an easily adaptable way to provide patients with the information needed to assist them in making an informed decision about PCa screening. The next step of this research is to conduct a dissemination trial to determine the most cost-effective method of educating large groups of men about PCa screening so that they may make the best screening decision for themselves, until there is a definitive recommendation either for or against screening. Citation Information: Cancer Prev Res 2010;3(12 Suppl):CN05-05.
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Jan 6, 2015
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Open Access