Informed Decision Making Regarding PSA Screening

描述(由申请人提供)：医学界对基于人群的无症状男性PSA筛查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严重分歧。在这场争议中，专业团体越来越主张充分告知男性筛查的利弊，并允许他们就是否进行筛查做出个人决定。尽管知情决策正在迅速成为这一领域的“关怀标准”，但关于在现实世界中如何做出筛选决策以及促进知情决策的最佳方式的信息很少。这一信息差距对于少数民族男性来说尤其严重，他们还没有得到关于前列腺癌筛查的系统研究。因此，我们建议进行一项随机临床试验，以评估一项干预措施的效果，该干预措施旨在增加社区拉美裔男性样本对前列腺癌筛查的知情决策。拉美裔在洛杉矶和加利福尼亚州的人口中占很大比例，前列腺癌是这一群体中最常见的癌症形式和第二大癌症死亡原因。 我们将从洛杉矶地区的多个社区组织招募900名拉美裔男性，并进行面对面的基线面试。之后，受试者将被随机分配到两个研究小组。干预组(N=450)将被邀请参加一个小组讨论会，目的是让男性了解前列腺癌的性质、筛查的利弊、围绕早期疾病治疗的争议，以及就获得PSA(前列腺特异性抗原)测试做出积极和知情决定的重要性。他们还将收到为文化量身定做的印刷材料，其中概述了干预会议上介绍的信息。控制组(N=450)将收到一份预先存在的、可公开获得的小册子，其中提到了前列腺癌筛查测试的可用性，但不包括关于筛查的利弊或干预措施的其他要素的细节。两组的受试者将在基线后12个月再次联系，并进行电话采访，以评估我们干预的影响。两个主要结果将包括对过去12个月知情决策(多维结构，包括前列腺癌知识和筛查的利弊，与医生或其他人就筛查进行沟通，以及积极参与筛查决定)和接受PSA的综合衡量。

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.