<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/NCT02205749</url>
  </required_header>
  <id_info>
    <org_study_id>201208079</org_study_id>
    <secondary_id>3U54CA153460-03S1</secondary_id>
    <nct_id>NCT02205749</nct_id>
  </id_info>
  <brief_title>Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women</brief_title>
  <official_title>Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research with stored biospecimens can provide substantial societal benefits, including&#xD;
      greater understanding of cancer etiology and discovery of new cancer therapies, but one&#xD;
      critical social and ethical issue is the use of samples for research unplanned at the time of&#xD;
      biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad&#xD;
      consent, study-specific consent) have been proposed for secondary research use of&#xD;
      biospecimens, but empirical data on individuals' preferences for different consent models are&#xD;
      limited, particularly from those with limited health literacy and from racial and ethnic&#xD;
      minority groups. It is critically important to understand the consent preferences of diverse&#xD;
      individuals, as participation of all population subgroups in biobanks is essential to reach&#xD;
      translational cancer research goals. Based on a social ecological conceptual framework, the&#xD;
      investigators will examine preferences for consent models for secondary research uses of&#xD;
      biospecimens among a racially and socioeconomically diverse sample of women 35 years of age&#xD;
      and older. The investigators aim to compare experimentally the effect of consent model on&#xD;
      intentions to donate biospecimens for future research use among a diverse sample of women.&#xD;
      The investigators hypothesize that women will have stronger intentions to donate based on the&#xD;
      broad model of consent and the study-specific model of consent compared with the notice model&#xD;
      of consent. These findings from groups underrepresented in research will be critical since&#xD;
      the participation of these groups in biobanks is essential to generating findings that will&#xD;
      achieve translational research goals of eliminating cancer disparities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intent to Donate</measure>
    <time_frame>Immediate</time_frame>
    <description>Intention to donate to a biobank.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consent Model Preference</measure>
    <time_frame>Immediate</time_frame>
    <description>Preferred type of consent for secondary use of biospecimens.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Biospecimen Donation</condition>
  <arm_group>
    <arm_group_label>Study-specific consent model</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>• Review plain language brochure describing consent to a biobank based on the study-specific model of consent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Broad consent model</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>• Review plain language brochure describing consent to a biobank based on the broad model of consent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Notice consent model</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>• Review plain language brochure describing consent to a biobank based on the notice model of consent</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Study-specific consent model</intervention_name>
    <description>• Review plain language brochure describing consent to a biobank based on the study-specific model of consent</description>
    <arm_group_label>Broad consent model</arm_group_label>
    <arm_group_label>Notice consent model</arm_group_label>
    <arm_group_label>Study-specific consent model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Broad consent model</intervention_name>
    <description>• Review plain language brochure describing consent to a biobank based on the broad model of consent</description>
    <arm_group_label>Broad consent model</arm_group_label>
    <arm_group_label>Notice consent model</arm_group_label>
    <arm_group_label>Study-specific consent model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Notice consent model</intervention_name>
    <description>• Review plain language brochure describing consent to a biobank based on the notice model of consent</description>
    <arm_group_label>Broad consent model</arm_group_label>
    <arm_group_label>Notice consent model</arm_group_label>
    <arm_group_label>Study-specific consent model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  35 years old or older&#xD;
&#xD;
          -  Proficient in English&#xD;
&#xD;
          -  Identifies as Non-Hispanic&#xD;
&#xD;
          -  Identifies as African-American or Black&#xD;
&#xD;
          -  Identifies as Caucasian or White&#xD;
&#xD;
          -  Identifies as Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 35 years old&#xD;
&#xD;
          -  Not proficient in English&#xD;
&#xD;
          -  Identifies as Hispanic&#xD;
&#xD;
          -  Identifies as a race other than African-American or Black; or Caucasian or White&#xD;
&#xD;
          -  Identifies as more than one race&#xD;
&#xD;
          -  Identifies as Male&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly A Kaphingst, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Utah</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bettina Drake, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biobanks</keyword>
  <keyword>informed consent</keyword>
  <keyword>health literacy</keyword>
  <!-- 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/NCT02205749
org study id: 201208079
secondary id: 3U54CA153460-03S1
nct id: NCT02205749
lead sponsor: 
collaborator: 
has dmc: No
Research with stored biospecimens can provide substantial societal benefits, including
      greater understanding of cancer etiology and discovery of new cancer therapies, but one
      critical social and ethical issue is the use of samples for research unplanned at the time of
      biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad
      consent, study-specific consent) have been proposed for secondary research use of
      biospecimens, but empirical data on individuals' preferences for different consent models are
      limited, particularly from those with limited health literacy and from racial and ethnic
      minority groups. It is critically important to understand the consent preferences of diverse
      individuals, as participation of all population subgroups in biobanks is essential to reach
      translational cancer research goals. Based on a social ecological conceptual framework, the
      investigators will examine preferences for consent models for secondary research uses of
      biospecimens among a racially and socioeconomically diverse sample of women 35 years of age
      and older. The investigators aim to compare experimentally the effect of consent model on
      intentions to donate biospecimens for future research use among a diverse sample of women.
      The investigators hypothesize that women will have stronger intentions to donate based on the
      broad model of consent and the study-specific model of consent compared with the notice model
      of consent. These findings from groups underrepresented in research will be critical since
      the participation of these groups in biobanks is essential to generating findings that will
      achieve translational research goals of eliminating cancer disparities.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Intent to Donate
time frame: Immediate
description: Intention to donate to a biobank.
measure: Consent Model Preference
time frame: Immediate
description: Preferred type of consent for secondary use of biospecimens.
arm group label: Study-specific consent model
arm group type: Other
description: • Review plain language brochure describing consent to a biobank based on the study-specific model of consent
arm group label: Broad consent model
arm group type: Other
description: • Review plain language brochure describing consent to a biobank based on the broad model of consent
arm group label: Notice consent model
arm group type: Other
description: • Review plain language brochure describing consent to a biobank based on the notice model of consent
intervention type: Behavioral
intervention name: Study-specific consent model
description: • Review plain language brochure describing consent to a biobank based on the study-specific model of consent
arm group label: Broad consent model
arm group label: Notice consent model
arm group label: Study-specific consent model
intervention type: Behavioral
intervention name: Broad consent model
description: • Review plain language brochure describing consent to a biobank based on the broad model of consent
arm group label: Broad consent model
arm group label: Notice consent model
arm group label: Study-specific consent model
intervention type: Behavioral
intervention name: Notice consent model
description: • Review plain language brochure describing consent to a biobank based on the notice model of consent
arm group label: Broad consent model
arm group label: Notice consent model
arm group label: Study-specific consent model
criteria: 
gender: Female
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kimberly A Kaphingst, ScD
role: Principal Investigator
affiliation: The University of Utah
last name: Bettina Drake, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor