<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/NCT04476654</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-19-15167</org_study_id>
    <secondary_id>HM20016234</secondary_id>
    <secondary_id>NCI-2019-04689</secondary_id>
    <secondary_id>R21CA236496</secondary_id>
    <nct_id>NCT04476654</nct_id>
  </id_info>
  <brief_title>Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video</brief_title>
  <official_title>Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      Genetic counseling and testing (GCT) provides invaluable information for women who are&#xD;
      at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT&#xD;
      compared to White women. This study will conduct a RCT to test the efficacy of a&#xD;
      culturally-tailored theory-based video intervention aimed to address key psychosocial factors&#xD;
      (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased&#xD;
      risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women&#xD;
      regarding genetic counseling through a multi-center trial and ultimately address the&#xD;
      disparity in genetic counseling uptake that exists between Black and White women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer (BC) is the most frequently diagnosed cancer in African American women&#xD;
      (hereafter referred to as &quot;Black&quot;) and their cancer mortality is higher than other&#xD;
      racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women&#xD;
      are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black&#xD;
      women present more often with triple-negative breast cancer (TNBC) an aggressive disease&#xD;
      defined by the absence of estrogen and progesterone receptors, and human epidermal growth&#xD;
      factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial&#xD;
      disparities also exist for women with ovarian cancer, the most lethal of the gynecologic&#xD;
      cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited&#xD;
      pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA&#xD;
      variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk&#xD;
      of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for&#xD;
      Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at&#xD;
      risk of carrying a BRCA PV. GCT provides women with information needed to make informed&#xD;
      decisions to reduce their cancer risk, yet Black women are less likely to use GCT than&#xD;
      whites. There is a dearth of interventions to address this issue and produced results are&#xD;
      mixed and modest. Awareness of a positive result can inform treatment decisions for cancer&#xD;
      patients and risk management in survivors or women unaffected with cancer.&#xD;
&#xD;
      Reasons for the lower uptake of GCT in Black women are multi-factorial and include access,&#xD;
      knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected).&#xD;
      There are substantial scientific gaps regarding effective interventions to address the&#xD;
      sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be&#xD;
      anchored within the needs and cultural values of their audience. While improving knowledge&#xD;
      about GCT and one's individual risks is important, interventions that only address knowledge&#xD;
      may not enhance uptake, as risk information evokes emotional reactions that are often&#xD;
      stronger predictors of behaviors than cognitive factors.&#xD;
&#xD;
      Notably, this team has identified factors that contribute to Black women's uptake of GCT. In&#xD;
      preliminary studies, researchers found that self-efficacy in making decisions about GCT and&#xD;
      medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at&#xD;
      risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated&#xD;
      with lower uptake. Similar studies suggest that Black women report emotions related to fear&#xD;
      of being singled out, and the fear of being hopeless. Because most interventions have focused&#xD;
      solely on knowledge or access, the proposed study makes a considerable shift in the field by&#xD;
      additionally targeting emotions, ambivalence, and developing a media-based risk communication&#xD;
      tool.&#xD;
&#xD;
      Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed&#xD;
      methods study. In Phase I (months 1-7), formative research and preliminary data will be used&#xD;
      to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and&#xD;
      piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In&#xD;
      Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and&#xD;
      psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen&#xD;
      developed GCT literature (control group) (n=25) or a tailored YouTube video intervention&#xD;
      (n=25) will be conducted . All women will be referred to an appointment scheduler who will&#xD;
      assist them with making an appointment with a genetic counselor. Participants will complete a&#xD;
      baseline survey and follow-up assessment. The primary outcome will be genetic counseling&#xD;
      uptake and receipt testing at 3-months will be explored. Specific aims are to:&#xD;
&#xD;
      Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC.&#xD;
&#xD;
      Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the&#xD;
      YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs&#xD;
      control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention&#xD;
      group (vs control group) will report higher knowledge, higher self-efficacy, higher&#xD;
      endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most&#xD;
      women (≥75%) will be satisfied with the experimental intervention.&#xD;
&#xD;
      Enhancing GCT in at-risk populations is a national priority. Given trends towards panel&#xD;
      testing and other genomic advances, there is potential for existing disparities to widen.&#xD;
      Findings will inform new strategies for behavioral interventions for Black women and a larger&#xD;
      trial. If successful, the intervention could be easily disseminated broadening its reach to&#xD;
      affected and unaffected women.&#xD;
&#xD;
      This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and&#xD;
      the national priorities to increase diversity in genetics research participation and&#xD;
      incorporate emotions into cancer research. Findings will inform new strategies for behavioral&#xD;
      interventions targeting African-Americans in a larger trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of genetic counseling and testing uptake.</measure>
    <time_frame>3 months</time_frame>
    <description>Our primary outcome will be for participants to receive genetic testing and counseling. Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge Scale - Genetic counseling and testing knowledge .</measure>
    <time_frame>Within one hour before the intervention and within one hour post-intervention.</time_frame>
    <description>The investigators will test general knowledge about hereditary breast and ovarian cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy Scale</measure>
    <time_frame>Within one hour before the intervention and within one hour post-intervention.</time_frame>
    <description>The investigators will test self-efficacy in genetic counseling services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Ambivalence Scale</measure>
    <time_frame>Within one hour before the intervention and within one hour post-intervention.</time_frame>
    <description>The investigators will test the emotional ambivalence about participating in genetic counseling services.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Fact Sheet Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Komen print materials about genetic counseling and testing will be given to women.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YouTube Video Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>YouTube Video Arm</intervention_name>
    <description>Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.</description>
    <arm_group_label>YouTube Video Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 18 years of age&#xD;
&#xD;
          -  Must be at high risk for hereditary breast or ovarian cancer&#xD;
&#xD;
          -  Must identify as Black/African American&#xD;
&#xD;
          -  Must be a woman&#xD;
&#xD;
          -  Referred to a genetic counselor for the purpose of being high risk of carrying a&#xD;
             hereditary breast and/or ovarian cancer mutation&#xD;
&#xD;
        Genetic Counselors:&#xD;
&#xD;
          -  Must be at least 18 years of age&#xD;
&#xD;
          -  Must be qualified&#xD;
&#xD;
          -  Must be approved by the PI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Race other than Black/African American&#xD;
&#xD;
          -  Do not gave a high risk for hereditary breast or ovarian cancer&#xD;
&#xD;
        Genetic Counselors:&#xD;
&#xD;
          -  Under 18&#xD;
&#xD;
          -  Not qualified&#xD;
&#xD;
          -  Not approved by the PI&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa Sheppard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genetic counseling and testing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT04476654
org study id: MCC-19-15167
secondary id: HM20016234
secondary id: NCI-2019-04689
secondary id: R21CA236496
nct id: NCT04476654
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Genetic counseling and testing (GCT) provides invaluable information for women who are
      at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT
      compared to White women. This study will conduct a RCT to test the efficacy of a
      culturally-tailored theory-based video intervention aimed to address key psychosocial factors
      (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased
      risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women
      regarding genetic counseling through a multi-center trial and ultimately address the
      disparity in genetic counseling uptake that exists between Black and White women.
Breast cancer (BC) is the most frequently diagnosed cancer in African American women
      (hereafter referred to as "Black") and their cancer mortality is higher than other
      racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women
      are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black
      women present more often with triple-negative breast cancer (TNBC) an aggressive disease
      defined by the absence of estrogen and progesterone receptors, and human epidermal growth
      factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial
      disparities also exist for women with ovarian cancer, the most lethal of the gynecologic
      cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited
      pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA
      variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk
      of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for
      Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at
      risk of carrying a BRCA PV. GCT provides women with information needed to make informed
      decisions to reduce their cancer risk, yet Black women are less likely to use GCT than
      whites. There is a dearth of interventions to address this issue and produced results are
      mixed and modest. Awareness of a positive result can inform treatment decisions for cancer
      patients and risk management in survivors or women unaffected with cancer.

      Reasons for the lower uptake of GCT in Black women are multi-factorial and include access,
      knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected).
      There are substantial scientific gaps regarding effective interventions to address the
      sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be
      anchored within the needs and cultural values of their audience. While improving knowledge
      about GCT and one's individual risks is important, interventions that only address knowledge
      may not enhance uptake, as risk information evokes emotional reactions that are often
      stronger predictors of behaviors than cognitive factors.

      Notably, this team has identified factors that contribute to Black women's uptake of GCT. In
      preliminary studies, researchers found that self-efficacy in making decisions about GCT and
      medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at
      risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated
      with lower uptake. Similar studies suggest that Black women report emotions related to fear
      of being singled out, and the fear of being hopeless. Because most interventions have focused
      solely on knowledge or access, the proposed study makes a considerable shift in the field by
      additionally targeting emotions, ambivalence, and developing a media-based risk communication
      tool.

      Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed
      methods study. In Phase I (months 1-7), formative research and preliminary data will be used
      to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and
      piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In
      Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and
      psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen
      developed GCT literature (control group) (n=25) or a tailored YouTube video intervention
      (n=25) will be conducted . All women will be referred to an appointment scheduler who will
      assist them with making an appointment with a genetic counselor. Participants will complete a
      baseline survey and follow-up assessment. The primary outcome will be genetic counseling
      uptake and receipt testing at 3-months will be explored. Specific aims are to:

      Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC.

      Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the
      YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs
      control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention
      group (vs control group) will report higher knowledge, higher self-efficacy, higher
      endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most
      women (≥75%) will be satisfied with the experimental intervention.

      Enhancing GCT in at-risk populations is a national priority. Given trends towards panel
      testing and other genomic advances, there is potential for existing disparities to widen.
      Findings will inform new strategies for behavioral interventions for Black women and a larger
      trial. If successful, the intervention could be easily disseminated broadening its reach to
      affected and unaffected women.

      This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and
      the national priorities to increase diversity in genetics research participation and
      incorporate emotions into cancer research. Findings will inform new strategies for behavioral
      interventions targeting African-Americans in a larger trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Rate of genetic counseling and testing uptake.
time frame: 3 months
description: Our primary outcome will be for participants to receive genetic testing and counseling. Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.
measure: Knowledge Scale - Genetic counseling and testing knowledge .
time frame: Within one hour before the intervention and within one hour post-intervention.
description: The investigators will test general knowledge about hereditary breast and ovarian cancer
measure: Self-efficacy Scale
time frame: Within one hour before the intervention and within one hour post-intervention.
description: The investigators will test self-efficacy in genetic counseling services.
measure: Emotional Ambivalence Scale
time frame: Within one hour before the intervention and within one hour post-intervention.
description: The investigators will test the emotional ambivalence about participating in genetic counseling services.
arm group label: Fact Sheet Arm
arm group type: No Intervention
description: Komen print materials about genetic counseling and testing will be given to women.
arm group label: YouTube Video Arm
arm group type: Active Comparator
description: Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.
intervention type: Behavioral
intervention name: YouTube Video Arm
description: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
arm group label: YouTube Video Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Vanessa Sheppard, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers.