PERSONAL PATIENT PROFILE PROSTATE (P4) - A RANDOMIZED, MULTI-SITE TRIAL

前列腺患者个人资料 (P4) - 随机、多部位试验

• 批准号: 7718748
• 负责人: Gregory J Swanson
• 金额: --
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718748
• 关键词: Area; Biopsy; Characteristics; Clinic; Clip; Communities; Computer Retrieval of Information on Scientific Projects Database; Computers; Conflict (Psychology); Control Groups; Data; Decision Making; Decision Support Systems; Diagnosis; Diagnostic Neoplasm Staging; Ethnic Origin; Funding; Grant; Home environment; Influentials; Institution; Internet; Intervention; Link; Localized; Malignant neoplasm of prostate; Measures; Modeling; Names; Outcome; Participant; Patient Education; Patients; Preparation; Printing; Probability; Prostate; Public Health Informatics; Randomized; Reading; Research; Research Personnel; Resources; Sample Size; Sampling; Score; Services; Side; Site; Source; Symptoms; Technology; Time; United States National Institutes of Health; Upper arm; Urologic Cancer; Work; base; cancer therapy; clinically relevant; computerized; follow-up; interest; men; preference; programs; satisfaction; statistics

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: To compare the primary decisional outcomes in men receiving traditional patient education strategies plus the P4 Program vs. traditional patient education strategies alone at one and six months in a diverse sample of men with localized prostate cancer with regard to: decisional conflict measured by the Decisional Conflict Scale, perceived preparation for the treatment decision measured by the Satisfaction with Preparation for Decision-Making Scale and decisional satisfaction measured by the Satisfaction with Decision Scale. RESEARCH PLAN: Men with a biopsy-proven diagnosis of prostate cancer, Stage I or II within the last six months who have not begun therapy will be invited to take part in the study at the time the are given the diagnosis of prostate cancer. They will be given a choice of accessing the P4 program from their home computer or from a private area on the GCRC. The subject has the opportunity to view video clips modeling interactions of his informtaion priorities ranking, read about level of participation in the decision, read about potential complications and link to reliable, outside Internet resources. The results of the information priorities, the control preference and the influential factors summary are automatically printed for him. The Control group program ends with an on-screen and print-available list of two websites, thank-you's and team names after the query component is concluded. Both groups receive follow-up questions occurring at 1 and 6 months. METHODS: Assuming a two-sided type I error probability of 0.05, a sample size of 214 subjects per arm will give us power at 90% to detect a significant difference between intervention and control group scores. Participant demographic data for both groups will be summarized with descriptive statistics and examined for group comparability. Statistical significance will be considered p<.05. We will explore the differences between the groups with regard to change in decisional control preferences from pre-decision to post-treatment measured by a modified Control Preferences Scale. Resource utilization as measured by the Amount of Clinician Contact query will be compared between groups. Selected sociodemographic characteristics will not only be used to describe the sample, but will be used as vairables along with influential factors and symptoms. Based on our preliminary work we anticipate that the data will indicate significant correlations between influential personal factors, sociodemographic characteristics and other outcome vairables of interest. Additionally, the information sources used may vary by ethnicity. CLINICAL RELEVANCE: This new program provides a fresh approach to patient education and support with a) the understanding and computerized assessment of influential personal factors involved in the decisions; and b) computerized decisional control and information preference assessment. Combining the power of current health informatics technology to instantaneously synthesize input and generate a tailored intervention with the accessibility of Internet access both at the point-of-service in a urologic cancer clinic and in the community, this unique decision support system could transform localized prostate cancer treatment decision making.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 目的：在不同的局限性前列腺癌男性样本中，比较接受传统患者教育策略加 P4 计划与仅接受传统患者教育策略的男性在 1 个月和 6 个月时的主要决策结果：通过决策冲突量表测量的决策冲突、通过决策准备量表满意度测量的治疗决策感知准备情况以及通过决策满意度量表测量的决策满意度。 研究计划：过去六个月内经活检证实诊断为 I 期或 II 期前列腺癌但尚未开始治疗的男性将被邀请在诊断出前列腺癌时参加研究。 他们可以选择从家庭计算机或 GCRC 上的私人区域访问 P4 程序。 受试者有机会观看视频剪辑，该视频剪辑模拟了其信息优先级排名的交互，了解决策的参与程度，了解潜在的复杂性并链接到可靠的外部互联网资源。 自动打印信息优先级、控制偏好和影响因素汇总的结果。 查询部分结束后，控制组程序以屏幕上和可打印的两个网站、致谢和团队名称的列表结束。 两组在 1 个月和 6 个月时都会收到后续问题。 方法：假设双边 I 型错误概率为 0.05，每组 214 名受试者的样本量将使我们有 90% 的能力检测干预组和对照组分数之间的显着差异。 两组的参与者人口统计数据将通过描述性统计进行总结，并检查组的可比性。 p<.05 将被认为具有统计显着性。 我们将探讨各组之间在决策控制偏好变化方面的差异，从决策前到治疗后，通过修改后的控制偏好量表进行测量。 将在组之间比较通过临床医生联系查询数量衡量的资源利用率。 选定的社会人口特征不仅将用于描述样本，还将与影响因素和症状一起用作变量。 根据我们的初步工作，我们预计数据将表明有影响力的个人因素、社会人口特征和其他感兴趣的结果变量之间的显着相关性。 此外，所使用的信息来源可能因种族而异。 临床相关性：这项新计划提供了一种新的患者教育和支持方法，包括：a) 对决策中影响个人因素的理解和计算机化评估； b) 计算机化决策控制和信息偏好评估。 这种独特的决策支持系统结合了当前健康信息技术的力量，可以在泌尿科癌症诊所和社区的服务点和社区中通过互联网接入即时综合输入并生成量身定制的干预措施，可以改变局部前列腺癌治疗决策。