Informed Decision Making Regarding PSA Screening

描述（由申请人提供）：医学界对于基于人群的PSA筛查对无症状男性的价值，以及对筛查发现的疾病进行积极治疗的有效性存在强烈分歧。在这场争论中，专业团体越来越多地提倡充分告知男性筛查的利弊，并允许他们就是否接受筛查做出个人决定。尽管知情决策正在迅速成为这一领域的“护理标准”，但关于在现实环境中如何做出筛查决策以及促进知情决策的最佳方式的信息却很少。这种信息差距对于少数民族男性来说尤其严重，他们还没有被系统地研究过前列腺癌筛查。因此，我们建议进行一项随机临床试验，以评估一项旨在增加西班牙裔男性社区样本中前列腺癌筛查知情决策的干预措施的效果。西班牙裔在洛杉矶和加州人口中占很大比例，前列腺癌是最常见的癌症，也是该群体癌症死亡的第二大原因。

DESCRIPTION (provided by applicant): There is intense disagreement in the medical community regarding the value of population based PSA screening for asymptomatic men, and the efficacy of aggressive treatment of screen-detected disease. In the midst of this controversy, professional groups are increasingly advocating fully informing men of the pros and cons of screening and allowing them to make a personal decision regarding whether to obtain screening. Although informed decision-making is rapidly becoming the "standard of care" in this area, there is a paucity of information regarding how screening decisions are made in real world settings, and the best ways to promote an informed decision. This information gap is especially acute for ethnic minority men, who have not been systematically studied with respect to prostate cancer screening. Therefore, we propose to conduct a randomized clinical trial to evaluate the effect of an intervention designed to increase informed decision-making regarding prostate cancer screening in a community sample of Hispanic men. Hispanics constitute very large proportions of the Los Angeles and California populations, and prostate cancer is the most common form of cancer and the second leading cause of cancer death in this group. We will recruit 900 Hispanic men from multiple community-based organizations in the Los Angeles area, and administer an in-person baseline interview. Following this, subjects will be randomized to the two study arms. The Intervention Group (N=450) will be invited to attend a small group discussion session aimed at informing men about the nature of prostate cancer, pros and cons of screening, the controversy surrounding treatment of early stage disease, and the importance of making an active and informed decision regarding obtaining a PSA [prostate-specific antigen] test. They will also receive culturally tailored print materials summarizing the information presented in the intervention session. The Control Group (N=450) will be given a pre-existing, publicly available pamphlet, that mentions the availability of screening tests for prostate cancer but does not include details regarding the pros and cons of screening, or other elements of the intervention. Subjects in both groups will be re-contacted 12-months post baseline and administered a telephone interview to assess the impact of our intervention. The two main outcomes will include a composite measure of informed decision making (multidimensional construct including knowledge of prostate cancer and the pros and cons of screening, communication with physician or others regarding screening, and active participation in the screening decision) and receipt of PSA in the past 12 months.