Communicating Objective Risk for Personalized Decision Making About Mammography

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Decision Aid

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 Type: Interventional
• Enrollment (Actual): 1560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injunctive and descriptive norms about mammography	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.	immediately following intervention (time 0)
Decisional satisfaction	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."	immediately following intervention (time 0)
Risk perception	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)."	immediately before and after intervention (time 0)
Clarity of the information being presented	These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.	immediately following intervention (time 0)
Credibility of the information	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?"	immediately following intervention (time 0)
Emotional reactions	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?"	immediately following intervention (time 0)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Joseph N Cappella, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 18, 2012
• Study Completion (Actual): December 18, 2012

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 816186