PSA TOOL for Prostate Cancer Screening Discussions
2018年5月9日 更新者：Case Comprehensive Cancer Center
Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings
The study team created a tool to help identify patients who may benefit from shared decision making in the primary care setting.
This tool is a guide to aid in decision making for prostate cancer screening.
The team proposes the topics to be discussed in the screening conversation include the risk for developing prostate cancer based upon age, race/ethnicity, family history of prostate cancer, history of previous digital rectal exam, and history of previous prostate specific antigen (PSA) as well as self-reported health status and preferences for treatment.
The team now proposes 1) testing this tool first for ease of use in primary care clinics 2) revising this tool based upon feedback from patients and providers, then 3) testing this tool for effectiveness in improving patient knowledge that they have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision.
研究概览
详细说明
Objectives:
- To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for usefulness and ease of use in primary care practices.
- To revise the PSA TOOL based upon provider and patient feedback.
- To assess patient knowledge about the option to be screened for prostate cancer and factors to consider in the prostate cancer screening decision before and after use of the tool.
Study Design:
This protocol is for field testing of a brief tool to improve prostate cancer screening discussions that occur at previously scheduled primary care outpatient visits.
研究类型
介入性
注册 (实际的)
95
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic, Case Comprehensive Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 69年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
Provider:
- Provider at selected primary care practices in the Cleveland Clinic Health System
- Willing to utilize a guide to aid in decision making for prostate cancer screening
Patient:
- Patient of participating Cleveland Clinic primary care provider who is scheduled for a routine appointment with the provider
Exclusion Criteria:
- Not a patient or provider of the Cleveland Clinic Health System
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Provider Field Test
15 providers will be given an initial version of the PSA TOOL, over a 4 week period, they will be able to provide feedback on the tool.
This will be used to revise the screening decision aid.
Informal interviews with providers will also be conducted by a member of the study team to obtain feedback about ease of use and usefulness of the tool.
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Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.
Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
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实验性的：Patient test of revised PSA TOOL
150 patients will be asked to use the revised PSA TOOL.
Pre- and Post-tests will be given to see if the tool changed the knowledge that patients have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision.
Informal interviews with patients who are exposed to the tool will also be conducted by a member of the study team to obtain feedback on issues addressed by the survey questions.
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Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
Patients will be given the revised PSA TOOL, after providers have given their initial feedback.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Score from Perceived Usefulness scale
大体时间：Up to 4 weeks after getting PSA TOOL
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scale will be summarized as means and standard deviations
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Up to 4 weeks after getting PSA TOOL
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Score from Perceived Ease of Use scale
大体时间：Up to 4 weeks after getting PSA TOOL
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scale will be summarized as means and standard deviations
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Up to 4 weeks after getting PSA TOOL
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Change in Score from Pre-Test to Post-Test
大体时间：Up to 30 minutes after Pre-Test
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The paired t-test will be used to compare the pre- and post- patient survey scores
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Up to 30 minutes after Pre-Test
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Informal Interview
大体时间：Up to 15 minutes after post test is performed
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Informal interviews will be done with patients and providers and assessed for themes
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Up to 15 minutes after post test is performed
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anita Misra-Hebert, MD, MPH、Cleveland Clinic, Case Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月2日
初级完成 (实际的)
2017年12月13日
研究完成 (实际的)
2018年4月23日
研究注册日期
首次提交
2017年4月27日
首先提交符合 QC 标准的
2017年4月27日
首次发布 (实际的)
2017年5月1日
研究记录更新
最后更新发布 (实际的)
2018年5月11日
上次提交的符合 QC 标准的更新
2018年5月9日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PSA TOOL的临床试验
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Necmettin Erbakan UniversityKonya City Hospital招聘中
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Karolinska InstitutetThe Swedish Research Council; Swedish Cancer Foundation主动，不招人
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St. Joseph's Hospital and Medical Center, Phoenix终止
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London Health Sciences Centre Research Institute...Zimmer Biomet招聘中