<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/NCT01672944</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16448</org_study_id>
    <nct_id>NCT01672944</nct_id>
  </id_info>
  <brief_title>Evaluating Biobanking Educational Tools</brief_title>
  <official_title>Evaluating Biobanking Educational Tools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate English and Spanish language educational materials&#xD;
      that inform the community about a type of cancer research that involves the collection,&#xD;
      storage, and processing of biospecimens. Part A of this study involved creating surveys about&#xD;
      biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to&#xD;
      evaluate education materials about biospecimen donation and research.&#xD;
&#xD;
      Phase II consists of two independent randomized controlled trials. Each trial is being&#xD;
      conducted independently to test English and Spanish language materials (75 subjects each).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project addresses gaps in information by developing and validating English and Spanish&#xD;
      language instruments to measure knowledge of and attitudes towards biospecimen donation and&#xD;
      banking, as well as intention to donate biospecimens to a biobank (Part A). Once developed,&#xD;
      the instruments will be used to evaluate biobanking educational priming tools by conducting&#xD;
      two independent RCTs. Wherein English educational materials will be tested with 75&#xD;
      participants recruited from an urban clinic, and Spanish educational materials will be tested&#xD;
      with 75 participant recruited form a rural community health center network. For each RCT&#xD;
      following baseline assessment, participants will be randomized to either: 1) educational&#xD;
      priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN);&#xD;
      or 2) an NCI-developed brochure entitled &quot;Providing Your Tissue for Research: What You Need&#xD;
      to Know.&quot; Seven to 28 days later participants will be given a telephone follow up interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2010</start_date>
  <completion_date type="Actual">September 17, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BANKS-Knowledge Scale</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BANKS-Attitudes Scale</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 15-item questionnaire measuring attitudes toward biobanking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BANKS-Self-Efficacy Scale</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BANKS-Intentions</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decisional Self-Efficacy</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at follow-up (between 7 and 28 days after enrollment). Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale. 1995; www.ohri.ca/decisionaid).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BANKS-Trust Scale</measure>
    <time_frame>Average of 28 days</time_frame>
    <description>Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">339</enrollment>
  <condition>Neoplasm</condition>
  <arm_group>
    <arm_group_label>TBCCN-developed educational materials</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center. English kit is entitled &quot;Biobanking Hope for a Cancer Cure&quot;, and Spanish kit is entitled &quot;Biobanco: Una esperanza de cura para el cancer.&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Biobanking educational Brochure developed by the National Cancer Institute. English brochure is entitled &quot;Providing your Tissue for Research: What you need to Know&quot;, Spanish brochure is entitled &quot;Lo que usted debe saber antes de dar sus tejidos para investigación médica.&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TBCCN-developed educational materials</intervention_name>
    <description>Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled. These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.</description>
    <arm_group_label>TBCCN-developed educational materials</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NCI-developed educational materials</intervention_name>
    <description>Participants will be asked to view the English biobanking educational Brochure entitled &quot;Providing your Tissue for Research: What you need to Know&quot;, or Spanish brochure entitled &quot;Lo que usted debe saber antes de dar sus tejidos para investigación médica.&quot;</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        English Language RCT Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for an appointment at Lifetime Cancer Screening (LCS)&#xD;
&#xD;
          -  able to read and speak English&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Spanish Language RCT Inclusion Criteria:&#xD;
&#xD;
          -  receiving care at a participating clinic from the Suncoast Community Health Centers&#xD;
             network&#xD;
&#xD;
          -  able to read and speak Spanish&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously diagnosed with cancer&#xD;
&#xD;
          -  previously participated in a biobank&#xD;
&#xD;
          -  participated in another TBCCN-related study entitled &quot;community perceptions on&#xD;
             biobanking&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clement Gwede, PhD, MPH, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>September 17, 2021</last_update_submitted>
  <last_update_submitted_qc>September 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biological specimen banks</keyword>
  <keyword>Health education</keyword>
  <keyword>Tissue banks</keyword>
  <keyword>Health care survey</keyword>
  <keyword>Tissue</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/NCT01672944
org study id: MCC-16448
nct id: NCT01672944
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate English and Spanish language educational materials
      that inform the community about a type of cancer research that involves the collection,
      storage, and processing of biospecimens. Part A of this study involved creating surveys about
      biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to
      evaluate education materials about biospecimen donation and research.

      Phase II consists of two independent randomized controlled trials. Each trial is being
      conducted independently to test English and Spanish language materials (75 subjects each).
The project addresses gaps in information by developing and validating English and Spanish
      language instruments to measure knowledge of and attitudes towards biospecimen donation and
      banking, as well as intention to donate biospecimens to a biobank (Part A). Once developed,
      the instruments will be used to evaluate biobanking educational priming tools by conducting
      two independent RCTs. Wherein English educational materials will be tested with 75
      participants recruited from an urban clinic, and Spanish educational materials will be tested
      with 75 participant recruited form a rural community health center network. For each RCT
      following baseline assessment, participants will be randomized to either: 1) educational
      priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN);
      or 2) an NCI-developed brochure entitled "Providing Your Tissue for Research: What You Need
      to Know." Seven to 28 days later participants will be given a telephone follow up interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: BANKS-Knowledge Scale
time frame: Average of 28 days
description: Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking.
measure: BANKS-Attitudes Scale
time frame: Average of 28 days
description: Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 15-item questionnaire measuring attitudes toward biobanking.
measure: BANKS-Self-Efficacy Scale
time frame: Average of 28 days
description: Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank.
measure: BANKS-Intentions
time frame: Average of 28 days
description: Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.
measure: Decisional Self-Efficacy
time frame: Average of 28 days
description: Administered at follow-up (between 7 and 28 days after enrollment). Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale. 1995; www.ohri.ca/decisionaid).
measure: BANKS-Trust Scale
time frame: Average of 28 days
description: Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research.
arm group label: TBCCN-developed educational materials
arm group type: Experimental
description: Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center. English kit is entitled "Biobanking Hope for a Cancer Cure", and Spanish kit is entitled "Biobanco: Una esperanza de cura para el cancer."
arm group label: Control Group
arm group type: Other
description: Biobanking educational Brochure developed by the National Cancer Institute. English brochure is entitled "Providing your Tissue for Research: What you need to Know", Spanish brochure is entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
intervention type: Other
intervention name: TBCCN-developed educational materials
description: Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled. These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.
arm group label: TBCCN-developed educational materials
intervention type: Other
intervention name: NCI-developed educational materials
description: Participants will be asked to view the English biobanking educational Brochure entitled "Providing your Tissue for Research: What you need to Know", or Spanish brochure entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clement Gwede, PhD, MPH, RN
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
responsible party type: Sponsor