PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk

Study Overview
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Brief Summary
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In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool will be pilot tested, and then implemented and tested in nine primary care and OB/GYN practices within the University of Pennsylvania Health System.

Detailed Description
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In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool incorporates questions about a women's personal history of breast cancer and compares her to the average women her age in terms of breast cancer risk. The tool helps the women to understand the benefits and risks of breast cancer screening. This tool will be pilot tested using SSI to help develop the final version of the decision aid tool. The decision aid tool will then be implemented and tested in nine general internal medicine, family medicine, and OB/GYN practices within the University of Pennsylvania Health System.

Official Title
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PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Breast Cancer Screening Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 39-48 Patient of one of the nine primary care or OB/GYN practices that are participating in the study Must have had an appointment at one of these locations in the past 24 months Must have an appointment during the study period Woman has not yet initiated breast cancer screening (no prior mammogram) No history of breast cancer Exclusion Criteria: Prior diagnosis of breast cancer Major comorbidity that substantially affects their 10 year mortality Non-English speaker

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 48 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid<br>Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid. | Behavioral: Breast Cancer Screening Decision Aid<br>* The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.<br>|
| No Intervention: Standard of Care<br>Those in the standard of care arm will not be given access to the decision aid. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammography Use Correlated to Personal Risk of Breast Cancer | Medical charts of women in both the intervention and control groups of the study will be analyzed to determine if these women initiated breast cancer screening (mammography) correlated to their personal risk of breast cancer as displayed by the decision aid. | One year post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception | Six weeks after a women's appointment with their primary care or OB/GYN provider, they will receive a post-intervention survey which will assess knowledge, worry, satisfaction, numeracy, behavior, etc. | 6 weeks post-intervention |