Informed Decision Making Regarding PSA Screening

关于 PSA 筛查的知情决策

• 批准号: 7020722
• 负责人: Roshan Bastani
• 金额: $ 44.31万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-13 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7020722
• 关键词: Hispanic Americans; behavioral /social science research tag; cancer prevention; clinical research; clinical trials; decision making; health behavior; health care service utilization; health disparity; human subject; interview; longitudinal human study; male; medically underserved population; patient care personnel relations; patient oriented research; prostate neoplasms; racial /ethnic difference

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.

描述（由申请人提供）：关于基于人群的PSA筛查无症状男性的价值以及对筛查疾病的积极治疗的疗效，医学界存在严重分歧。在这一争议中，专业团体越来越多地提倡完全告知男人筛查的利弊，并允许他们就是否进行筛查做出个人决定。尽管知情的决策正在迅速成为该领域的“护理标准”，但关于如何在现实世界环境中制定筛查决策以及促进知情决定的最佳方法的信息很少。对于少数民族男性，这些信息差距尤其急剧，他们尚未对前列腺癌筛查进行系统的研究。因此，我们建议进行一项随机临床试验，以评估旨在增加西班牙裔男性社区样本中有关前列腺癌筛查的知情决策的干预措施的影响。西班牙裔构成了洛杉矶和加利福尼亚州人群的大量，前列腺癌是癌症的最常见形式，也是该组癌症死亡的第二大原因。 我们将招募来自洛杉矶地区多个基于社区组织的900名西班牙裔男子，并进行面对面的基线访谈。之后，受试者将被随机分为两个研究组。干预组（n = 450）将被邀请参加一个小组讨论会议，旨在向男人告知前列腺癌的性质，筛查的优缺点，围绕早期疾病治疗的争议，以及做出积极而知情的决定，就获得PSA [PROSTATE特定特异性抗原]测试的重要性。他们还将收到量身定制的印刷材料，总结了干预会议中提供的信息。对照组（n = 450）将被给予先前存在的公开小册子，该小册子提到了前列腺癌的筛查测试的可用性，但不包括有关筛查的利弊或干预措施的其他元素的详细信息。两组的受试者将在基准后重新接触12个月，并进行电话访谈以评估我们的干预措施的影响。这两个主要结果将包括一个知情决策的综合度量（多维结构，包括对前列腺癌的知识以及筛查的利弊，与医师或其他人有关筛查以及积极参与筛查决策的沟通）以及在过去的12个月中收到PSA。