TREATMENT DECISIONS AND PATIENT REPORTED OUTCOMES IN LOW RISK PROSTATE CANCER

低风险前列腺癌的治疗决策和患者报告的结果

• 批准号: 8186005
• 负责人: Kathryn L Taylor
• 金额: $ 64.11万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8186005
• 关键词: Address; Adverse effects; Affect; American; Anxiety; Autopsy; Biopsy; California; Cancer Patient; Caring; Censuses; Characteristics; Clinical; Comorbidity; Computerized Medical Record; Data; Data Analyses; Data Reporting; Data Sources; Decision Making; Development; Diagnosis; Digital Rectal Examination; Disease; Disease Progression; Enrollment; Future; Gleason Grade for Prostate Cancer; Goals; Growth; Healthcare Market; Incidence; Indolent; Institution; Intervention; Intestines; Knowledge; Life; Light; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Modeling; Monitor; National Comprehensive Cancer Network; Newly Diagnosed; Observational Study; Operative Surgical Procedures; Outcome; Outcome Measure; Palliative Care; Patient Outcomes Assessments; Patient observation; Patients; Phase; Physician' s Practice Patterns; Physicians; Population; Prospective Studies; Prostate-Specific Antigen; Protocols documentation; Psychological Factors; Public Health; Quality of life; Radiation therapy; Reporting; Research; Risk; Sample Size; Staging; Surveys; System; Telephone Interviews; Testing; Time; Translating; Tumor Burden; Uncertainty; active method; alternative treatment; base; cancer risk; cohort; comparative effectiveness; cost; disease characteristic; disorder risk; effectiveness research; follow-up; health care service utilization; improved; innovation; interest; lifetime risk; men; mortality; preference; prospective; psychologic; randomized trial; satisfaction; therapy design; urinary; urologic

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.

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较低，不太可能从治疗中受益，这意味着每年有超过 75,000 名美国男性接受治疗。鉴于有证据表明前列腺癌的过度诊断和过度治疗，人们越来越关注主动监测（AS）作为手术和放疗主动治疗（AT）的替代方案。 AS 已被提议作为一种合理的方法，以最大限度地减少低风险 PCa 治疗（定义为 PSA 水平 < 10、格里森评分 < 6 和早期疾病）对生活质量 (QOL) 和疾病相关功能的损害。尽管国家综合癌症网络和美国泌尿外科协会现在推荐 AS 治疗低风险 PCa，但 AS 被认为在患有低风险疾病的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，考虑到治疗 PCa 的公共卫生影响，这是一个重要的问题。我们的具体目标是在低风险 PCa 患者中进行一项纵向、前瞻性研究，其中我们将： 1. 评估临床、医生和患者相关的预测因素：a) AS 与 AT 的初始治疗决策；b) 保留 AS 与转为 AT。 2. 比较选择 AS 与 AT 的患者在基线、6 个月和 24 个月评估时报告的结果（生活质量、疾病特异性功能、治疗满意度）的纵向变化。我们将在北加州凯撒医疗机构 (KPNC) HMO 内进行这项研究，该机构具有明确的人群、实时病例查明、治疗前收集的全面患者报告数据以及易于访问的 EMR 系统等显着的实际优势。 2010 年美国人口普查的证据表明，15-21%（N > 4100 万）的参保人口加入了类似于 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很大一部分的环境中进行。我们将招募 1465 名新诊断的低风险 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。创新的重点是纳入 3 个数据源：决策和心理患者结果、医生实践模式以及生物医学和利用 EMR 数据，以便充分评估对男性治疗决策和患者报告结果重要的因素。我们的研究还涉及 IOM 比较有效性研究报告中的 5 个最优先条件之一。最后，该队列的建立将很容易有助于未来对长期临床终点、整体卫生服务利用率以及针对医生和患者的干预措施的开发进行比较，这些干预措施旨在改进决策，最终可能减少低风险前列腺癌的过度治疗。 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。这导致人们越来越关注主动监测 (AS) 作为低风险 PCa（根据 PSA、格里森评分和疾病分期定义为疾病进展可能性较低的 PCa）手术和放疗的替代方案。然而，AS 在患有低风险疾病的男性中并未得到充分利用。很少有研究考察影响治疗选择和男性随后生活质量的非临床因素（例如，患者相关的决策和心理因素以及医生的实践模式）。考虑到减少低风险 PCa 过度治疗对公共卫生的影响，这些都是重要的问题。