Communicating Objective Risk for Personalized Decision Making About Mammography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Communicating Objective Risk for Personalized Decision Making About Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Decision Aid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group 1: pre/post-test<br>Group receives pre and post test questions only. | |
| Experimental: Control group 2: tool and pre/post-test<br>Group receives decision tool without personalized information. (Behavioral: Decision Aid) | Behavioral: Decision Aid<br> <br> |
| Experimental: Gail score in a percentage format<br>Group receives Gail score in a percentage format. (Behavioral: Decision Aid) | Behavioral: Decision Aid<br> <br> |
| Experimental: Gail score in a frequency format<br>Group receives Gail score in a frequency format. (Behavioral: Decision Aid) | Behavioral: Decision Aid<br> <br> |
| Experimental: Frequency + Average 50 year old<br>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) | Behavioral: Decision Aid<br> <br> |
| Experimental: Frequency + Mammography Data<br>Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid) | Behavioral: Decision Aid<br> <br> |
| Experimental: Frequency + Mortality Data<br>Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid) | Behavioral: Decision Aid<br> <br> |
| Experimental: Frequency + Avg 50 year old + Mamm Data + Mortality Data<br>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) | Behavioral: Decision Aid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral intentions to get a mammogram | All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50. | immediately following intervention (time 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitude about mammography | Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.) | immediately following intervention (time 0) |