<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/NCT02993068</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0298</org_study_id>
    <secondary_id>NCI-2017-01600</secondary_id>
    <secondary_id>2016-0298</secondary_id>
    <nct_id>NCT02993068</nct_id>
  </id_info>
  <brief_title>Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)</brief_title>
  <official_title>Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies how well online genetics educational video with or&#xD;
      without pre- and/or post-telephone genetics counseling works in assessing cancer-risk&#xD;
      distress in patients with triple negative breast cancer. Online genetic education and&#xD;
      telephone genetic counseling may help the doctors learn the stress a person feels about their&#xD;
      risk of cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To test the effects of online genetic education versus telephone genetic counseling on&#xD;
      cancer-risk distress.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To test the effects of online genetic education versus telephone genetic counseling on&#xD;
      testing completion rates.&#xD;
&#xD;
      II. To evaluate the role of psychological and social variables in women's reactions to&#xD;
      genetic testing for ovarian cancer risk with variable education strategies.&#xD;
&#xD;
      III. To consider the effects of variations of genetic education/counseling on genetic&#xD;
      knowledge, satisfaction with the decision to undergo testing, and family communication.&#xD;
&#xD;
      OUTLINE: Patients are randomized into 1 of 4 arms.&#xD;
&#xD;
      ARM A: Patients watch genetic testing online educational video and receive genetic testing&#xD;
      online test results report.&#xD;
&#xD;
      ARM B: Patients watch genetic testing online educational video, receive genetic testing&#xD;
      online test results report, and post-telephone genetic counseling.&#xD;
&#xD;
      ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic&#xD;
      counseling, genetic testing online test results report, and post-telephone genetic&#xD;
      counseling.&#xD;
&#xD;
      ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic&#xD;
      counseling, and genetic testing online test results report.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Anticipated">April 18, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 18, 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean cancer stress scores</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome.&#xD;
Subscales are summed to compute the total score.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">5200</enrollment>
  <condition>BARD1 Gene Mutation</condition>
  <condition>BRCA1 Gene Mutation</condition>
  <condition>BRCA2 Gene Mutation</condition>
  <condition>BRIP1 Gene Mutation</condition>
  <condition>Estrogen Receptor Negative</condition>
  <condition>HER2/Neu Negative</condition>
  <condition>MLH1 Gene Mutation</condition>
  <condition>MSH2 Gene Mutation</condition>
  <condition>MSH6 Gene Mutation</condition>
  <condition>PALB2 Gene Mutation</condition>
  <condition>PMS2 Gene Mutation</condition>
  <condition>Progesterone Receptor Negative</condition>
  <condition>RAD51C Gene Mutation</condition>
  <condition>RAD51D Gene Mutation</condition>
  <condition>Triple-Negative Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm A (online education)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients watch genetic testing online educational video and receive genetic testing online test results report.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (online education, post telephone counseling)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D (online education, pre-telephone counseling)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Watch genetic testing online educational video</description>
    <arm_group_label>Arm A (online education)</arm_group_label>
    <arm_group_label>Arm B (online education, post telephone counseling)</arm_group_label>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
    <arm_group_label>Arm D (online education, pre-telephone counseling)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Counseling</intervention_name>
    <description>Receive post-telephone genetic counseling</description>
    <arm_group_label>Arm B (online education, post telephone counseling)</arm_group_label>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Counseling</intervention_name>
    <description>Receive pre-telephone genetic counseling</description>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
    <arm_group_label>Arm D (online education, pre-telephone counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm A (online education)</arm_group_label>
    <arm_group_label>Arm B (online education, post telephone counseling)</arm_group_label>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
    <arm_group_label>Arm D (online education, pre-telephone counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (online education)</arm_group_label>
    <arm_group_label>Arm B (online education, post telephone counseling)</arm_group_label>
    <arm_group_label>Arm C (online education, pre- and post-telephone counselling)</arm_group_label>
    <arm_group_label>Arm D (online education, pre-telephone counseling)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30 or older. Note: Participants must meet each of Criteria 1-4.&#xD;
&#xD;
          -  Have access to a healthcare provider and be willing to share genetic results with that&#xD;
             provider&#xD;
&#xD;
          -  Have at least one ovary&#xD;
&#xD;
          -  Have a valid United States mailing address for receipt of saliva kit&#xD;
&#xD;
          -  Participants must meet any one of the following 6 criteria:&#xD;
&#xD;
          -  Diagnosed with breast cancer at age 45 or younger&#xD;
&#xD;
          -  Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor&#xD;
             and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60&#xD;
             or younger&#xD;
&#xD;
          -  Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D,&#xD;
             BARD1, MSH2, MSH6, MLH1, or PMS2&#xD;
&#xD;
          -  Have one relative with ovarian cancer&#xD;
&#xD;
          -  Have at least 2 relatives with breast cancer on the same side of the family, one of&#xD;
             which is =&lt; 50 years of age&#xD;
&#xD;
          -  Have one male relative with breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of ovarian cancer&#xD;
&#xD;
          -  Unable to read, speak, and understand English&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unwilling to complete baseline and follow-up questionnaires&#xD;
&#xD;
          -  Unable to access the internet&#xD;
&#xD;
          -  Previous genetic testing or counseling regarding cancer risk&#xD;
&#xD;
          -  Previous bone marrow transplant&#xD;
&#xD;
          -  Previous blood transfusion (7 days prior to genetic testing)&#xD;
&#xD;
          -  Active hematologic malignancy (cancer that begins in blood-forming tissue, such as&#xD;
             leukemia or lymphoma)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen H Lu</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen H. Lu, MD</last_name>
    <phone>713-745-7877</phone>
    <email>magenta@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen H. Lu</last_name>
      <phone>713-745-8902</phone>
    </contact>
    <investigator>
      <last_name>Karen H. Lu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth M. Swisher</last_name>
      <email>swishere@u.washington.edu</email>
    </contact>
    <investigator>
      <last_name>Elizabeth M. Swisher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://magenta.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02993068
org study id: 2016-0298
secondary id: NCI-2017-01600
secondary id: 2016-0298
nct id: NCT02993068
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized clinical trial studies how well online genetics educational video with or
      without pre- and/or post-telephone genetics counseling works in assessing cancer-risk
      distress in patients with triple negative breast cancer. Online genetic education and
      telephone genetic counseling may help the doctors learn the stress a person feels about their
      risk of cancer.
PRIMARY OBJECTIVES:

      I. To test the effects of online genetic education versus telephone genetic counseling on
      cancer-risk distress.

      SECONDARY OBJECTIVES:

      I. To test the effects of online genetic education versus telephone genetic counseling on
      testing completion rates.

      II. To evaluate the role of psychological and social variables in women's reactions to
      genetic testing for ovarian cancer risk with variable education strategies.

      III. To consider the effects of variations of genetic education/counseling on genetic
      knowledge, satisfaction with the decision to undergo testing, and family communication.

      OUTLINE: Patients are randomized into 1 of 4 arms.

      ARM A: Patients watch genetic testing online educational video and receive genetic testing
      online test results report.

      ARM B: Patients watch genetic testing online educational video, receive genetic testing
      online test results report, and post-telephone genetic counseling.

      ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic
      counseling, genetic testing online test results report, and post-telephone genetic
      counseling.

      ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic
      counseling, and genetic testing online test results report.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean cancer stress scores
time frame: Up to 4 years
description: Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome.
Subscales are summed to compute the total score.
arm group label: Arm A (online education)
arm group type: Experimental
description: Patients watch genetic testing online educational video and receive genetic testing online test results report.
arm group label: Arm B (online education, post telephone counseling)
arm group type: Experimental
description: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
arm group label: Arm C (online education, pre- and post-telephone counselling)
arm group type: Active Comparator
description: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
arm group label: Arm D (online education, pre-telephone counseling)
arm group type: Experimental
description: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
intervention type: Other
intervention name: Educational Intervention
description: Watch genetic testing online educational video
arm group label: Arm A (online education)
arm group label: Arm B (online education, post telephone counseling)
arm group label: Arm C (online education, pre- and post-telephone counselling)
arm group label: Arm D (online education, pre-telephone counseling)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Genetic Counseling
description: Receive post-telephone genetic counseling
arm group label: Arm B (online education, post telephone counseling)
arm group label: Arm C (online education, pre- and post-telephone counselling)
intervention type: Other
intervention name: Genetic Counseling
description: Receive pre-telephone genetic counseling
arm group label: Arm C (online education, pre- and post-telephone counselling)
arm group label: Arm D (online education, pre-telephone counseling)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm A (online education)
arm group label: Arm B (online education, post telephone counseling)
arm group label: Arm C (online education, pre- and post-telephone counselling)
arm group label: Arm D (online education, pre-telephone counseling)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (online education)
arm group label: Arm B (online education, post telephone counseling)
arm group label: Arm C (online education, pre- and post-telephone counselling)
arm group label: Arm D (online education, pre-telephone counseling)
criteria: 
gender: Female
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Karen H Lu
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Karen H. Lu, MD
phone: 713-745-7877
email: magenta@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://magenta.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms