Communicating Objective Risk for Personalized Decision Making About Mammography
研究概览
详细说明
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Exclusion Criteria:
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
学习计划
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：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control group 1: pre/post-test
Group receives pre and post test questions only.
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实验性的：Control group 2: tool and pre/post-test
Group receives decision tool without personalized information.
(Behavioral: Decision Aid)
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实验性的：Gail score in a percentage format
Group receives Gail score in a percentage format.
(Behavioral: Decision Aid)
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实验性的：Gail score in a frequency format
Group receives Gail score in a frequency format.
(Behavioral: Decision Aid)
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实验性的：Frequency + Average 50 year old
Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman.
(Behavioral: Decision Aid)
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实验性的：Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography.
(Behavioral: Decision Aid)
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实验性的：Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography.
(Behavioral:Decision Aid)
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实验性的：Frequency + Avg 50 year old + Mamm Data + Mortality Data
Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography.
(Behavioral: Decision Aid)
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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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Behavioral intentions to get a mammogram
大体时间：immediately following intervention (time 0)
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All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
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immediately following intervention (time 0)
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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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Attitude about mammography
大体时间：immediately following intervention (time 0)
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Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
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immediately following intervention (time 0)
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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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Injunctive and descriptive norms about mammography
大体时间：immediately following intervention (time 0)
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Participants will be asked to report their perceived norms about mammography, what they think important others would expect them to do and what they think other women their age or older are doing.
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immediately following intervention (time 0)
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Decisional satisfaction
大体时间：immediately following intervention (time 0)
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This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided.
Items include, "The information in the decision aid made me feel the choice to get a mammogram is being taken away from me by the groups that make screening recommendations."
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immediately following intervention (time 0)
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Risk perception
大体时间：immediately before and after intervention (time 0)
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This variable includes perceived severity and perceived susceptibility of breast cancer.
Items include, "What is the chance that an average 40-49 year old woman will develop breast cancer in the next 10 years?
Please choose a number between 0 (no chance of breast cancer) and 100 (definitely will get breast cancer)."
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immediately before and after intervention (time 0)
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Clarity of the information being presented
大体时间：immediately following intervention (time 0)
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These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
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immediately following intervention (time 0)
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Credibility of the information
大体时间：immediately following intervention (time 0)
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These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid.
Items include, "How credible did you find the information presented in the decision aid?"
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immediately following intervention (time 0)
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Emotional reactions
大体时间：immediately following intervention (time 0)
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The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid.
Items include, "How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?"
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immediately following intervention (time 0)
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合作者和调查者
调查人员
- 首席研究员：Joseph N Cappella, PhD、University of Pennsylvania
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 816186
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.
决策辅助的临床试验
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Fondazione Poliambulanza Istituto Ospedaliero完全的
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University of Alabama at BirminghamNational Cancer Institute (NCI)招聘中
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Butler HospitalBrown University; University of Rhode Island邀请报名