Communicating Objective Risk for Personalized Decision Making About Mammography

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01686360
First received: August 28, 2012
Last updated: September 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: Communicating Objective Risk for Personalized Decision Making About Mammography

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Behavioral intentions to get a mammogram [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.


Secondary Outcome Measures:
  • Attitude about mammography [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)


Other Outcome Measures:
  • Injunctive and descriptive norms about mammography [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    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.

  • Decisional satisfaction [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    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."

  • Risk perception [ Time Frame: immediately before and after intervention (time 0) ] [ Designated as safety issue: No ]
    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)."

  • Clarity of the information being presented [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.

  • Credibility of the information [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    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?"

  • Emotional reactions [ Time Frame: immediately following intervention (time 0) ] [ Designated as safety issue: No ]
    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?"


Estimated Enrollment: 1600
Study Start Date: September 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686360

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Joseph N Cappella, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01686360     History of Changes
Other Study ID Numbers: 816186
Study First Received: August 28, 2012
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014