<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/NCT04407611</url>
  </required_header>
  <id_info>
    <org_study_id>H-40045</org_study_id>
    <secondary_id>R01MD014312</secondary_id>
    <nct_id>NCT04407611</nct_id>
  </id_info>
  <brief_title>Scalable Communication Modalities for Returning Genetic Research Results</brief_title>
  <acronym>BWHS RoR</acronym>
  <official_title>Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MGH Institute of Health Professions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Efforts to examine the utility of alternate modalities for genetic results disclosure has&#xD;
      widespread implications for how precision medicine research might yield direct health&#xD;
      benefits for study participants. This study will examine the efficacy of an online&#xD;
      self-guided program to return genetic results to a racial minority cohort population. Study&#xD;
      results will provide empirical evidence on the effectiveness of alternate modalities for&#xD;
      genetic results return, inform ongoing efforts to establish scalable approaches for effective&#xD;
      return of genetic research results, and increase access to personal health information among&#xD;
      African American women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial (RCT) within the Black Women's Health Study&#xD;
      (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an&#xD;
      ongoing prospective cohort study of 59,000 self-identified black women from across the United&#xD;
      States who have been followed since 1995. Targeted sequencing of over 4000 women within the&#xD;
      cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up&#xD;
      the possibility of returning breast cancer genetic results to BWHS participants and examining&#xD;
      the clinical utility of genetic results return. The primary aim of the proposed research&#xD;
      project is to compare the efficacy of two communication modalities for returning breast&#xD;
      cancer genetic research results to African American women: 1) a conventional modality that&#xD;
      entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided&#xD;
      modality that entails returning results directly to participants, with optional genetic&#xD;
      counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of&#xD;
      the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of&#xD;
      result uptake. This study is uniquely situated to provide critical empirical evidence on the&#xD;
      effectiveness of alternate models for genetic results return and provide further insight into&#xD;
      the factors influencing uptake of genetic information among African American women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2023</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <intervention_model_description>Randomization to 1 of 2 study arms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participant that decide to learn genetic results at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participant that decide to learn genetic results at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Knowledge about breast cancer genetics will be assessed using an investigator derived questionnaire consisting of 16 items. Higher scores out of ten are associated with more genetics knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline depression at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline anxiety at 6 weeks</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant distress from cancer risk assessment (test-specific distress) at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant distress from cancer risk assessment (test-specific distress) at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant distress from cancer risk assessment (test-specific distress) at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant uncertainty from cancer risk assessment at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant uncertainty from cancer risk assessment at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant uncertainty from cancer risk assessment at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2275</enrollment>
  <condition>Hereditary Breast and Ovarian Cancer</condition>
  <condition>Lynch Syndrome</condition>
  <arm_group>
    <arm_group_label>Conventional modality</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online modality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online modality</intervention_name>
    <description>Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to</description>
    <arm_group_label>Online modality</arm_group_label>
    <other_name>Web modality</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Genetic counselor follow-up</intervention_name>
    <description>Optional genetic counselor follow-up over the telephone</description>
    <arm_group_label>Online modality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Women in the BWHS previously included in the targeted breast cancer sequencing project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with known cognitive impairments&#xD;
&#xD;
          -  Women with variant of uncertain significance (VUS) results from the sequencing study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catharine Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BU School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catharine Wang, PhD</last_name>
    <phone>617-358-1475</phone>
    <email>clwang@bu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>BU School of Public Health, the research is being conducted remotely</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catharine Wang, PhD</last_name>
      <email>clwang@bu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRCA testing</keyword>
  <keyword>Return of genetic research results</keyword>
  <keyword>eHealth</keyword>
  <keyword>Digital health</keyword>
  <keyword>Risk communication</keyword>
  <keyword>ELSI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Hereditary Breast and Ovarian Cancer Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04407611
org study id: H-40045
secondary id: R01MD014312
nct id: NCT04407611
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Efforts to examine the utility of alternate modalities for genetic results disclosure has
      widespread implications for how precision medicine research might yield direct health
      benefits for study participants. This study will examine the efficacy of an online
      self-guided program to return genetic results to a racial minority cohort population. Study
      results will provide empirical evidence on the effectiveness of alternate modalities for
      genetic results return, inform ongoing efforts to establish scalable approaches for effective
      return of genetic research results, and increase access to personal health information among
      African American women.
This study is a randomized controlled trial (RCT) within the Black Women's Health Study
      (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an
      ongoing prospective cohort study of 59,000 self-identified black women from across the United
      States who have been followed since 1995. Targeted sequencing of over 4000 women within the
      cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up
      the possibility of returning breast cancer genetic results to BWHS participants and examining
      the clinical utility of genetic results return. The primary aim of the proposed research
      project is to compare the efficacy of two communication modalities for returning breast
      cancer genetic research results to African American women: 1) a conventional modality that
      entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided
      modality that entails returning results directly to participants, with optional genetic
      counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of
      the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of
      result uptake. This study is uniquely situated to provide critical empirical evidence on the
      effectiveness of alternate models for genetic results return and provide further insight into
      the factors influencing uptake of genetic information among African American women.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization to 1 of 2 study arms.
primary purpose: Prevention
masking: Single (Participant)
measure: Number of participant that decide to learn genetic results at 6 weeks
time frame: 6 weeks
description: Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
measure: Number of participant that decide to learn genetic results at 6 months
time frame: 6 months
description: Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
measure: Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks
time frame: Baseline, 6 weeks
description: Knowledge about breast cancer genetics will be assessed using an investigator derived questionnaire consisting of 16 items. Higher scores out of ten are associated with more genetics knowledge.
measure: Change in baseline depression at 6 weeks
time frame: Baseline, 6 weeks
description: Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
measure: Depression at 6 months
time frame: 6 months
description: Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
measure: Depression at 12 months
time frame: 12 months
description: Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
measure: Change in baseline anxiety at 6 weeks
time frame: Baseline, 6 weeks
description: Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
measure: Anxiety at 6 months
time frame: 6 months
description: Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
measure: Anxiety at 12 months
time frame: 12 months
description: Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
measure: Participant distress from cancer risk assessment (test-specific distress) at 6 weeks
time frame: 6 weeks
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
measure: Participant distress from cancer risk assessment (test-specific distress) at 6 months
time frame: 6 months
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
measure: Participant distress from cancer risk assessment (test-specific distress) at 12 months
time frame: 12 months
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
measure: Participant uncertainty from cancer risk assessment at 6 weeks
time frame: 6 weeks
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
measure: Participant uncertainty from cancer risk assessment at 6 months
time frame: 6 months
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
measure: Participant uncertainty from cancer risk assessment at 12 months
time frame: 12 months
description: Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
arm group label: Conventional modality
arm group type: No Intervention
description: Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.
arm group label: Online modality
arm group type: Experimental
description: Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.
intervention type: Behavioral
intervention name: Online modality
description: Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to
arm group label: Online modality
other name: Web modality
intervention type: Behavioral
intervention name: Genetic counselor follow-up
description: Optional genetic counselor follow-up over the telephone
arm group label: Online modality
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Catharine Wang, PhD
role: Principal Investigator
affiliation: BU School of Public Health
last name: Catharine Wang, PhD
phone: 617-358-1475
email: clwang@bu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Hereditary Breast and Ovarian Cancer Syndrome
sharing ipd: No