Communicating Objective Risk for Personalized Decision Making About Mammography

Breast Cancer Clinical Trial

Official title:

Communicating Objective Risk for Personalized Decision Making About Mammography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686360
• Other study ID #: 816186
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: July 20, 2017
• Start date: September 2012
• Est. completion date: December 18, 2012

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1560
• Est. completion date: December 18, 2012
• Est. primary completion date: December 18, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Decision Aid

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)