TREATMENT DECISIONS AND PATIENT REPORTED OUTCOMES IN LOW RISK PROSTATE CANCER

描述（由申请人提供）：20世纪80年代末前列腺特异性抗原（PSA）检测的出现导致前列腺癌（PCa）发病率急剧上升。这是一个重大的公共卫生问题，因为35-40%的新发前列腺癌进展风险低，不太可能从治疗中获益，每年有超过75，000名美国男性。鉴于有证据表明PCa的过度诊断和过度治疗，人们越来越关注主动监测（AS）作为手术和放疗的主动治疗（AT）的替代方案。AS已被提出作为一种合法的方法，以尽量减少由于治疗低风险PCa（定义为PSA水平< 10，Gleason评分< 6，和早期疾病）而对生活质量（QOL）和疾病相关功能的损害。虽然AS现在被国家综合癌症网络和美国泌尿外科协会推荐用于低风险PCa，但AS被认为在低风险疾病男性中未得到充分利用。然而，很少有研究探讨影响AS使用的非临床因素，这是一个重要的问题，因为对PCa治疗的公共卫生影响。我们的具体目标是在低风险PCa患者中进行纵向前瞻性研究，其中我们将：1。评估a）AS与AT的初始治疗决策和B）继续AS与转换为AT的临床、医生和患者相关预测因素。2.比较选择AS与AT的患者在基线、6个月和24个月评估时患者报告结局（QOL、疾病特异性功能、治疗满意度）的纵向变化。我们将在Kaiser Permanente北方加州（KPNC）HMO内进行研究，该HMO提供了明确定义的人群、实时病例确定、治疗前收集的全面患者报告数据和易于访问的EMR系统的显著实际优势。来自2010年美国人口普查的证据表明，15-21%（N > 4100万）的被保险人口参加了类似于KPNC的团体模型HMO，另外3%（N = 800万）接受VA的护理，这表明拟议的研究将在代表美国医疗保健市场的重要部分的环境中进行。我们将入组1465例新诊断的低风险PCa患者，并在诊断后1个月内进行基线电话访谈，并在基线后6个月和24个月进行两次随访评估。创新中心包括3个数据来源：决策和心理病人的结果，医生的实践模式，生物医学和利用EMR数据，以充分评估男性的治疗决策和病人报告的结果的重要因素。我们的研究还解决了国际移民组织关于比较有效性研究报告的5个最优先条件之一。最后，该队列的建立将很容易使其自身适合于未来比较长期临床终点、整体卫生服务利用以及旨在改善可能最终减少低风险PCa过度治疗的决策的医生和患者针对性干预措施的开发。 公共卫生相关性：每年有超过75，000名美国男性面临低风险前列腺癌（PCa）过度治疗的风险。这导致人们对主动监测（AS）作为低风险PCa（定义为基于PSA、Gleason评分和疾病分期，疾病进展可能性较低的PCa）手术和放疗的替代方案的兴趣增加。然而，AS在患有低风险疾病的男性中未得到充分利用。很少有研究检查非临床因素（例如，患者相关的决策和心理因素，以及医生的实践模式），影响治疗选择和男性随后的生活质量。鉴于减少低风险PCa过度治疗对公共卫生的影响，这些都是重要的问题。

DESCRIPTION (provided by applicant): The advent of prostate-specific antigen (PSA) testing in the late 1980s has led to a dramatic rise in prostate cancer (PCa) incidence. This is a significant public health problem, as 35-40% of new prostate cancers have a low risk for progression and are unlikely to benefit from treatment, which translates into more than 75,000 U.S. men each year. In light of evidence indicating overdiagnosis and overtreatment of PCa, there has been increasing interest in active surveillance (AS) as an alternative to the active treatments (AT) of surgery and radiotherapy. AS has been proposed as a legitimate approach to minimizing the harms to quality of life (QOL) and disease-related function due to treatment of low-risk PCa (defined by PSA level < 10, Gleason score < 6, and early stage disease). Although AS is now recommended for low-risk PCa by the National Comprehensive Cancer Network and the American Urological Association, AS is considered to be underutilized among men with low-risk disease. However, there has been very little research examining non-clinical factors that affect use of AS, an important question given the public health implications for the treatment of PCa. Our specific aims are to conduct a longitudinal, prospective study among low-risk PCa patients in which we will: 1. Assess the clinical, physician- and patient-related predictors of a) the initial treatment decision of AS vs. AT and b) remaining on AS vs. switching to an AT. 2. Compare longitudinal changes in patient reported outcomes (QOL, disease specific function, treatment satisfaction) at the baseline, 6-, and 24-month assessments among those who chose AS vs. AT. We will conduct the study within the Kaiser Permanente Northern California (KPNC) HMO, which provides the significant practical advantages of a well-defined population, real-time case ascertainment, comprehensive patient reported data collected pre-treatment, and a readily accessible EMR system. Evidence from the 2010 U.S. Census indicates that 15-21% (N > 41 million) of the insured population is enrolled in a group model HMO similar to KPNC and an additional 3% (N = 8 million) receive care from the VA, indicating that the proposed study will be conducted in a setting that represents a substantial segment of the US healthcare market. We will enroll 1465 newly diagnosed, low-risk PCa patients and conduct a baseline telephone interview within 1 month post-diagnosis and two follow-up assessments at 6- and 24 -months post- baseline. Innovation centers on the inclusion of 3 sources of data: decisional and psychological patient outcomes, physician practice patterns, and biomedical and utilization EMR data, in order to fully assess the factors important to men's treatment decisions and patient reported outcomes. Our study also addresses one of the 5 top priority conditions of the IOM's report on comparative effectiveness research. Finally, the establishment of this cohort will easily lend itself to future comparisons of longer term clinical endpoints, overall health services utilization, and the development of physician- and patient-targeted interventions designed to improve decisions that may ultimately reduce the overtreatment of low-risk PCa. PUBLIC HEALTH RELEVANCE: More than 75,000 U.S. men are at risk for overtreatment each year for low-risk prostate cancer (PCa). This has resulted in an increased interest in active surveillance (AS) as an alternative to surgery and radiotherapy of low-risk PCa (defined as PCa that has a low likelihood of disease progression, based on PSA, Gleason score, and disease stage). However, AS is underutilized among men with low-risk disease. There has been very little research examining non-clinical factors (e.g., patient-related decisional and psychological factors, and physician practice patterns) that affect treatment choice and men's subsequent quality of life. These are important questions given the public health implications for reducing overtreatment of low-risk PCa.