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临床试验/NCT01686360
NCT01686360已完成不适用

Communicating Objective Risk for Personalized Decision Making About Mammography

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 1,560 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,560
试验地点
2
主要终点
Behavioral intentions to get a mammogram

研究概览

简要总结

The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women between the ages of 35 and 49 will be invited to participate in this study.

排除标准

  • Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.

研究组 & 干预措施

Control group 1: pre/post-test

No Intervention

Group receives pre and post test questions only.

Control group 2: tool and pre/post-test

Experimental

Group receives decision tool without personalized information. (Behavioral: Decision Aid)

干预措施: Decision Aid (Behavioral)

Gail score in a percentage format

Experimental

Group receives Gail score in a percentage format. (Behavioral: Decision Aid)

干预措施: Decision Aid (Behavioral)

Gail score in a frequency format

Experimental

Group receives Gail score in a frequency format. (Behavioral: Decision Aid)

干预措施: Decision Aid (Behavioral)

Frequency + Average 50 year old

Experimental

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)

干预措施: Decision Aid (Behavioral)

Frequency + Mammography Data

Experimental

Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)

干预措施: Decision Aid (Behavioral)

Frequency + Mortality Data

Experimental

Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)

干预措施: Decision Aid (Behavioral)

Frequency + Avg 50 year old + Mamm Data + Mortality Data

Experimental

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)

干预措施: Decision Aid (Behavioral)

结局指标

主要结局

Behavioral intentions to get a mammogram

时间窗: immediately following intervention (time 0)

All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.

次要结局

  • Attitude about mammography(immediately following intervention (time 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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