Increasing Minority Participation in Clinical Trials
2017年9月7日 更新者：Consuelo H Wilkins、Vanderbilt University Medical Center
Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
This study will also determine the feasibility of implementing an office-based video educational program.
研究概览
详细说明
Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:
- Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
- Determine the feasibility of implementing an office-based video educational program.
研究类型
介入性
注册 (实际的)
63
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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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt Ingram Cancer Center, Vanderbilt University Medical 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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation
Exclusion Criteria:
- Previous history of clinical trial research participation
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：其他
- 分配：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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无干预：Standard care/control group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the standard of care group will be provided standard educational resources (booklet and DVD), with no additional instructions.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
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实验性的：Video viewing group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
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First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
其他名称：
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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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study feasibility
大体时间：12 months
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The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones.
An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases.
Three scores will be derived from the SIC measure.
The first score is the number of stages completed.
The second score is the time spent at each stage.
The third score is the proportion of activities completed at each stage.
Implementation of the SIC model poses no additional burden on study participants.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Clinical trial participation
大体时间：12 months
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Information on clinical trial participation will be collected by a team member by reviewing the participants' health record and by contacting the VICC clinical trial team.
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12 months
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Clinical trial knowledge survey
大体时间：7-10 days
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This survey consist of 22-items assessing a participants views on clinical trials on 5 domains (positive beliefs, safety, information needs, negative expectations, and patient involvement).
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7-10 days
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Likelihood to participate survey
大体时间：7-10 days
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This survey consist of 5-items assessing reasons for not participating in research, views about sources of research, views about sharing of research data, trust, and willingness to advise research teams.
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7-10 days
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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：Consuelo H. Wilkins, MD、Meharry-Vanderbilt Alliance, Vanderbilt University Medical 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)
2014年12月1日
初级完成 (实际的)
2017年6月28日
研究完成 (实际的)
2017年6月28日
研究注册日期
首次提交
2015年11月5日
首先提交符合 QC 标准的
2015年11月6日
首次发布 (估计)
2015年11月9日
研究记录更新
最后更新发布 (实际的)
2017年9月11日
上次提交的符合 QC 标准的更新
2017年9月7日
最后验证
2017年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 14117
- P30CA068485 (美国 NIH 拨款/合同)
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.