Communicating Objective Risk for Personalized Decision Making About Mammography

University of Pennsylvania

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT01686360

816186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,560 patients

Sex: Female

Ages: 35 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

1,560 participants in 8 patient groups

Control group 1: pre/post-test

No Intervention group

Description:

Group receives pre and post test questions only.

Control group 2: tool and pre/post-test

Experimental group

Description:

Group receives decision tool without personalized information. (Behavioral: Decision Aid)

Treatment:

Behavioral: Decision Aid

Gail score in a percentage format

Experimental group

Description:

Group receives Gail score in a percentage format. (Behavioral: Decision Aid)

Treatment:

Behavioral: Decision Aid

Gail score in a frequency format

Experimental group

Description:

Group receives Gail score in a frequency format. (Behavioral: Decision Aid)

Treatment:

Behavioral: Decision Aid

Frequency + Average 50 year old

Experimental group

Description:

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)

Treatment:

Behavioral: Decision Aid

Frequency + Mammography Data

Experimental group

Description:

Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)

Treatment:

Behavioral: Decision Aid

Frequency + Mortality Data

Experimental group

Description:

Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)

Treatment:

Behavioral: Decision Aid

Frequency + Avg 50 year old + Mamm Data + Mortality Data

Experimental group

Description:

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)

Treatment:

Behavioral: Decision Aid