Communicating Objective Risk for Personalized Decision Making About Mammography

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01686360
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-08-28
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Primary Completion: 2012-12-18
• Study Completion: 2012-12-18
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1560

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Behavioral intentions to get a mammogram	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.

Secondary Outcome Measures

Name	Time	Method
Attitude about mammography	immediately following intervention (time 0)	Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States