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Completed

NCT Number: NCT01686360

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decision aid

Behavioral

Primary outcomes

  1. Behavioral intentions to get a mammogram

    Time frame: 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 outcomes

  1. Attitude about mammography

    Time frame: immediately following intervention (time 0)

    Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)

Other outcomes

  1. Injunctive and descriptive norms about mammography

    Time frame: immediately following intervention (time 0)

    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.

  2. Decisional satisfaction

    Time frame: immediately following intervention (time 0)

    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."

  3. Risk perception

    Time frame: immediately before and after intervention (time 0)

    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)."

  4. Clarity of the information being presented

    Time frame: immediately following intervention (time 0)

    These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.

  5. Credibility of the information

    Time frame: immediately following intervention (time 0)

    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?"

  6. Emotional reactions

    Time frame: immediately following intervention (time 0)

    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?"

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 18, 2012
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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