Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
2022年7月21日 更新者：Case Comprehensive Cancer Center
The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants.
It also evaluates participants' knowledge about prostate cancer screening and to improve understanding.
Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge.
This may increase confidence in participants' decisions.
Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.
研究概览
地位
终止
条件
详细说明
PRIMARY OBJECTIVES:
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
研究类型
介入性
注册 (实际的)
319
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、44106-5065
- Cleveland Clinic Taussig Cancer Institute, 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
19年 及以上 (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:
- Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
- Educational component: men over the age of 18
- Screening component: men over age 40
Exclusion Criteria:
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
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：放映
- 分配：非随机化
- 介入模型：并行分配
- 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：Men over 40: Screening with intervention
Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
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Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
其他名称：
Undergo digital rectal exam by a licensed healthcare professional.
The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal.
This is considered standard of care for prostate cancer screening
其他名称：
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
其他名称：
Survey will be administered at the end of the program for participants to assess their experience
其他名称：
PSA levels will be drawn and run as per institutional Laboratory standards.
Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
其他名称：
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
其他名称：
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实验性的：Men 18-39: Educational intervention
Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
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Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
其他名称：
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
其他名称：
Survey will be administered at the end of the program for participants to assess their experience
其他名称：
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
其他名称：
|
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 |
|---|---|---|
|
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
大体时间：Up to 1 year
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Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire.
The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.
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Up to 1 year
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Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions
大体时间：Up to 1 year
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Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.
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Up to 1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Proportion of participants who choose to enter the clinical trial
大体时间：Up to 1 year
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Up to 1 year
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Proportion of participants who choose screening after educational intervention
大体时间：Up to 1 year
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Up to 1 year
|
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10-year expected mortality based on USCF 10-year Mortality Index for all participants
大体时间：Up to 1 year
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Up to 1 year
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Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
大体时间：Up to 1 year
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Up to 1 year
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Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
大体时间：Up to 1 year
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Up to 1 year
|
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Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
大体时间：Up to 1 year
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Up to 1 year
|
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Proportion of participants with family history of prostate cancer
大体时间：Up to 1 year
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Up to 1 year
|
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Proportion of participants referred to a primary care physician who did not previously have a primary care physician
大体时间：Up to 1 year
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Up to 1 year
|
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Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
大体时间：Up to 1 year
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Up to 1 year
|
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Proportion of participants who expressed satisfied with this proposed informed consent and education model
大体时间：Up to 1 year
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Up to 1 year
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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：Samir Abraksia, MD、Cleveland Clinic Taussig Cancer Institute, 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)
2015年6月1日
初级完成 (实际的)
2021年10月1日
研究完成 (实际的)
2022年7月1日
研究注册日期
首次提交
2015年4月14日
首先提交符合 QC 标准的
2015年4月14日
首次发布 (估计)
2015年4月17日
研究记录更新
最后更新发布 (实际的)
2022年7月25日
上次提交的符合 QC 标准的更新
2022年7月21日
最后验证
2022年7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.