Prostate Cancer Screening: Fostering Informed Decisions

描述(由申请人提供)：2002年，预计将有189,000名男性被诊断为前列腺癌(PCA)，并将导致美国30,200人死亡。尽管前列腺癌带来了巨大的疾病负担，但筛查无症状男性的效用仍然存在争议，因为尚未有随机试验证明，早期诊断和治疗前列腺癌可以降低与疾病相关的死亡率。这项拟议研究的主要目标既不是鼓励也不是阻止PCA筛查，而是评估一种患者教育方法，旨在提供详细的筛查和治疗相关信息，并澄清患者的偏好和价值观，最终帮助男性做出知情的筛查决定。这项教育干预的目标人群将是在免费的大规模筛查计划中注册接受PCA筛查的男性。虽然乍一看，这似乎是一个以教育干预为目标的非典型群体，但我们提供的信息表明，这一群体代表着一个庞大的、穿制服的群体，对他们来说，有效和廉价的教育方法至关重要。参与者是注册参加乔治敦大学和霍华德大学举行的一年一度的PCA大规模筛查项目的男性。在2004年和2005年的筛查计划中，我们将总共招募770名男性(385名非裔美国人男性，385名高加索男性)。男性将在筛选前至少3-6周打电话登记参加筛选，然后我们将打电话给男性进一步描述该项目，并招募那些希望参与的人。在登记和基线访谈后，参与者将被随机分配到四组中的一组：1)在预定的筛查日期前一周收到的信息加决策辅助(IDA-HOME)；2)在筛查当天收到的信息加决策辅助(IDA-CLUSIC)；3)在预定的筛查日期前一周收到的常规护理信息(UC-HOME)；或4)在筛查当天收到的常规护理信息(UC-诊所)。后续评估将在筛查后、筛查后结果和干预后一年进行，以衡量知识、决策冲突、决策满意度和实际筛查决定。我们将使用2(IDA/UC)X 2(家庭(临床))重复测量协方差分析和多元回归来评估这些结果的组间差异。如果被发现是有效的，这项研究计划的长期目标是将这种信息决策辅助传播到全美的大规模筛查计划中。

DESCRIPTION (provided by applicant): In 2002 it is expected that prostate cancer (PCa) will be diagnosed in 189,000 men and will be responsible for 30,200 deaths in the U.S. In spite of the significant disease burden presented by PCa, the utility of screening asymptomatic men remains controversial, as it has not yet been demonstrated by a randomized trial that early diagnosis and treatment of PCa reduces disease-related mortality. The primary goal of the proposed study is neither to encourage nor discourage PCa screening, but to evaluate a method of patient education that is designed to provide detailed screening and treatment-related information and to clarify patient preferences and values, ultimately assisting men in making an informed screening decision. The target population for this educational intervention will be men who have registered to undergo PCa screening within a free, mass screening program. Although at first this may appear to be an atypical group to target for an educational intervention, we present information suggesting that this population represents a large and uniformed group for whom effective and inexpensive methods of education are of critical importance. Participants are men who register for the annual PCa mass screening programs held at Georgetown University and at Howard University. During the 2004 and 2005 screening programs, we will accrue a total of 770 men (385 African American men, 385 Caucasian men). Men will call to register for screening at least 3-6 weeks prior to screening, and we will then call men to describe the project further and to enroll those who wish to participate. Following enrollment and the baseline interview, participants will be randomly assigned to one of four groups: 1) Information plus Decision Aid received one week prior to the scheduled screening date (IDA-home); 2) Information plus Decision Aid received on the day of screening (IDA-clinic); 3) Usual Care information received one week prior to the scheduled screening date (UC-home); or 4) Usual Care information received on the day of the screening (UC-clinic). Follow-up assessments will be conducted post-screening, post-screening results, and one-year post-intervention, to measure knowledge, decisional conflict, decisional satisfaction, and the actual screening decision. We will utilize a 2 (IDA/UC) X 2 (Home (Clinic) repeated measures analysis of covariance and multiple regression to assess for group differences on these outcomes. If found to be effective, the long-term goal of this research program is to disseminate this informational decision aid to mass screening programs throughout the United States.