Clinical trial NCT01686360: Communicating Objective Risk for Personalized Decision Making About Mammography
Official title: Communicating Objective Risk for Personalized Decision Making About Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 1560
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Behavioral intentions to get a mammogram
timeFrame: immediately following intervention (time 0)
Secondary outcomes:
measure: Attitude about mammography
timeFrame: immediately following intervention (time 0)
Other outcomes:
measure: Injunctive and descriptive norms about mammography
timeFrame: immediately following intervention (time 0)
measure: Decisional satisfaction
timeFrame: immediately following intervention (time 0)
measure: Risk perception
timeFrame: immediately before and after intervention (time 0)
measure: Clarity of the information being presented
timeFrame: immediately following intervention (time 0)
measure: Credibility of the information
timeFrame: immediately following intervention (time 0)
measure: Emotional reactions
timeFrame: immediately following intervention (time 0)
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Joseph N Cappella, PhD
role: PRINCIPAL_INVESTIGATOR
References: