<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01686360</url>
  </required_header>
  <id_info>
    <org_study_id>816186</org_study_id>
    <nct_id>NCT01686360</nct_id>
  </id_info>
  <brief_title>Communicating Objective Risk for Personalized Decision Making About Mammography</brief_title>
  <official_title>Communicating Objective Risk for Personalized Decision Making About Mammography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effects of objective risk information about breast&#xD;
      cancer and mammography outcomes using a randomized control trial. Women between the ages of&#xD;
      35 and 49 will receive information about their personal risk for breast cancer and be&#xD;
      randomly assigned to receive data about a woman who should be screened, data about the&#xD;
      potential outcomes of screening, or data about breast cancer deaths. Two presentation formats&#xD;
      will be tested and compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will compare alternative strategies for the presentation of individualized&#xD;
      information about the risks and benefits of mammography screening. The purpose of this study&#xD;
      is to understand how objective risk information influences outcomes including behavioral&#xD;
      intentions, attitudes about mammography, and emotional responses.&#xD;
&#xD;
      After participants view objective risk information, a post-test survey will measure outcome&#xD;
      variables including behavioral intentions, knowledge, and emotional responses.&#xD;
&#xD;
      After reading information based on their condition, study participants will be asked to&#xD;
      complete a series of questions to measure their reactions based on their condition.&#xD;
      Specifically, the investigators will be measuring the following dependent variables (primary&#xD;
      outcomes): behavioral intentions to receive mammograms, attitudes about mammography,&#xD;
      subjective norms about mammography and breast cancer screening, knowledge about mammography&#xD;
      outcomes and screening recommendations, and emotional responses to the material including&#xD;
      psychological reactance. These outcomes will be measured using self-reported questionnaire&#xD;
      items.&#xD;
&#xD;
      In this project, the investigators will compare alternative communication strategies to&#xD;
      determine which strategy or strategies result in the greatest level of understanding. The&#xD;
      investigators also will examine if the various strategies differentially affect the primary&#xD;
      outcomes listed above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 18, 2012</completion_date>
  <primary_completion_date type="Actual">December 18, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral intentions to get a mammogram</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attitude about mammography</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Injunctive and descriptive norms about mammography</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional satisfaction</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided. Items include, &quot;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.&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk perception</measure>
    <time_frame>immediately before and after intervention (time 0)</time_frame>
    <description>This variable includes perceived severity and perceived susceptibility of breast cancer. Items include, &quot;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).&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Clarity of the information being presented</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.</description>
  </other_outcome>
  <other_outcome>
    <measure>Credibility of the information</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid. Items include, &quot;How credible did you find the information presented in the decision aid?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional reactions</measure>
    <time_frame>immediately following intervention (time 0)</time_frame>
    <description>The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid. Items include, &quot;How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?&quot;</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">1560</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Control group 1: pre/post-test</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group receives pre and post test questions only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group 2: tool and pre/post-test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives decision tool without personalized information. (Behavioral: Decision Aid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gail score in a percentage format</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives Gail score in a percentage format. (Behavioral: Decision Aid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gail score in a frequency format</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives Gail score in a frequency format. (Behavioral: Decision Aid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency + Average 50 year old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency + Mammography Data</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency + Mortality Data</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency + Avg 50 year old + Mamm Data + Mortality Data</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <arm_group_label>Control group 2: tool and pre/post-test</arm_group_label>
    <arm_group_label>Frequency + Average 50 year old</arm_group_label>
    <arm_group_label>Frequency + Avg 50 year old + Mamm Data + Mortality Data</arm_group_label>
    <arm_group_label>Frequency + Mammography Data</arm_group_label>
    <arm_group_label>Frequency + Mortality Data</arm_group_label>
    <arm_group_label>Gail score in a frequency format</arm_group_label>
    <arm_group_label>Gail score in a percentage format</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women between the ages of 35 and 49 will be invited to participate in this&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have been previously diagnosed with breast cancer or have tested positive&#xD;
             for the breast cancer gene will not be included.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph N Cappella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>July 20, 2017</last_update_submitted>
  <last_update_submitted_qc>July 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686360
org study id: 816186
nct id: NCT01686360
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Single (Participant)
measure: Behavioral intentions to get a mammogram
time frame: immediately following intervention (time 0)
description: All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
measure: Attitude about mammography
time frame: immediately following intervention (time 0)
description: Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
measure: Injunctive and descriptive norms about mammography
time frame: immediately following intervention (time 0)
description: 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.
measure: Decisional satisfaction
time frame: immediately following intervention (time 0)
description: 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."
measure: Risk perception
time frame: immediately before and after intervention (time 0)
description: 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)."
measure: Clarity of the information being presented
time frame: immediately following intervention (time 0)
description: These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
measure: Credibility of the information
time frame: immediately following intervention (time 0)
description: 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?"
measure: Emotional reactions
time frame: immediately following intervention (time 0)
description: 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?"
arm group label: Control group 1: pre/post-test
arm group type: No Intervention
description: Group receives pre and post test questions only.
arm group label: Control group 2: tool and pre/post-test
arm group type: Experimental
description: Group receives decision tool without personalized information. (Behavioral: Decision Aid)
arm group label: Gail score in a percentage format
arm group type: Experimental
description: Group receives Gail score in a percentage format. (Behavioral: Decision Aid)
arm group label: Gail score in a frequency format
arm group type: Experimental
description: Group receives Gail score in a frequency format. (Behavioral: Decision Aid)
arm group label: Frequency + Average 50 year old
arm group type: Experimental
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)
arm group label: Frequency + Mammography Data
arm group type: Experimental
description: Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)
arm group label: Frequency + Mortality Data
arm group type: Experimental
description: Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)
arm group label: Frequency + Avg 50 year old + Mamm Data + Mortality Data
arm group type: Experimental
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)
intervention type: Behavioral
intervention name: Decision Aid
arm group label: Control group 2: tool and pre/post-test
arm group label: Frequency + Average 50 year old
arm group label: Frequency + Avg 50 year old + Mamm Data + Mortality Data
arm group label: Frequency + Mammography Data
arm group label: Frequency + Mortality Data
arm group label: Gail score in a frequency format
arm group label: Gail score in a percentage format
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph N Cappella, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor