<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/NCT03820687</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20180283H</org_study_id>
    <nct_id>NCT03820687</nct_id>
  </id_info>
  <brief_title>Improving Informed Decision Making for Cancer Clinical Trial Participation</brief_title>
  <official_title>Improving Informed Decision Making for Cancer Clinical Trial Participation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</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>
      The goal of this study is to develop and pilot test a multi-communication approach to improve&#xD;
      informed decision-making about cancer Clinical Trials (CTs) participation by increasing&#xD;
      awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation&#xD;
      and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs&#xD;
      as an appropriate treatment option for cancer (intention to participate) among patients&#xD;
      attending the MCC (clinic-based setting) and the general public in selected Bexar County&#xD;
      areas (community-based settings).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed two-year study involves a randomized controlled educational trial featuring a&#xD;
      2-group cohort design with random assignment of 400 cancer patients from the MCC to the&#xD;
      intervention or usual care control group. Intervention participants will receive 3&#xD;
      components: 1) a culturally relevant educational video, 2) a brochure and 3) support from a&#xD;
      patient navigator to empower new cancer patients to make informed decisions about cancer CTs&#xD;
      by increasing awareness of clinical trials and MCC services, positive attitudes and&#xD;
      intentions to consider CTs as an appropriate treatment option for cancer. The usual care&#xD;
      control group will receive a general CT fact sheet.&#xD;
&#xD;
      The community education module will have also 3 components: 1) an educational session&#xD;
      delivered via PowerPoint presentation or flip chart, 2) a brochure, and 3) support from a&#xD;
      community health educator to raise awareness, positive attitudes and intentions to consider&#xD;
      CTs as an appropriate treatment for cancer and promote the MCC services among community&#xD;
      members in Bexar County.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2023</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.</measure>
    <time_frame>Up to 3 months after the index oncology visit</time_frame>
    <description>The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who show increase in knowledge/awareness regarding CT participation.</measure>
    <time_frame>Up to 3 months after the index oncology visit</time_frame>
    <description>The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who show improved attitudes regarding CT participation.</measure>
    <time_frame>Up to 3 months after the index oncology visit</time_frame>
    <description>The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.</measure>
    <time_frame>Up to 3 months after the index oncology visit</time_frame>
    <description>The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the intervention group will receive 3 components: 1) a culturally tailored clinical trial educational video, 2) a brochure and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the usual care control group will receive a general clinical trial fact sheet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Trial Educational Video</intervention_name>
    <description>Culturally tailored educational video, brochure, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Trial Fact Sheet</intervention_name>
    <description>General Clinical Trial fact sheet with usual care information regarding Clinical Trials.</description>
    <arm_group_label>Usual Care Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brochure</intervention_name>
    <description>A brochure with educational material about clinical trials and services offered by Mays Cancer Center.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Navigator</intervention_name>
    <description>Support that will be provided by a patient navigator to empower new cancer patients to make an informed decision about cancer clinical trials by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed cancer patients attending any of the clinics at the MCC&#xD;
&#xD;
          -  Patients who have not participated in a Clinical Trial before&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years&#xD;
&#xD;
          -  Patients who have already had a consultation with their doctor to discuss treatment&#xD;
             options&#xD;
&#xD;
          -  Patients who have participated in a Clinical Trial before&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amelie G Ramirez, DrPH, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Health San Antonio</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia Chalela, DrPH, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Health San Antonio</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sneha Prabhu, MPH</last_name>
    <phone>210-562-6546</phone>
    <email>prabhus@uthscsa.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessica Gutierrez</last_name>
    <phone>210-562-6505</phone>
    <email>gutierrezj4@uthscsa.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Texas Health Science Center San Antonio, MCC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelie G Ramirez, DrPH, MPH</last_name>
      <phone>210-562-6500</phone>
      <email>ramirezag@uthscsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Patricia Chalela, DrPH</last_name>
      <phone>210-562-6500</phone>
      <email>chalela@uthscsa.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03820687
org study id: HSC20180283H
nct id: NCT03820687
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to develop and pilot test a multi-communication approach to improve
      informed decision-making about cancer Clinical Trials (CTs) participation by increasing
      awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation
      and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs
      as an appropriate treatment option for cancer (intention to participate) among patients
      attending the MCC (clinic-based setting) and the general public in selected Bexar County
      areas (community-based settings).
The proposed two-year study involves a randomized controlled educational trial featuring a
      2-group cohort design with random assignment of 400 cancer patients from the MCC to the
      intervention or usual care control group. Intervention participants will receive 3
      components: 1) a culturally relevant educational video, 2) a brochure and 3) support from a
      patient navigator to empower new cancer patients to make informed decisions about cancer CTs
      by increasing awareness of clinical trials and MCC services, positive attitudes and
      intentions to consider CTs as an appropriate treatment option for cancer. The usual care
      control group will receive a general CT fact sheet.

      The community education module will have also 3 components: 1) an educational session
      delivered via PowerPoint presentation or flip chart, 2) a brochure, and 3) support from a
      community health educator to raise awareness, positive attitudes and intentions to consider
      CTs as an appropriate treatment for cancer and promote the MCC services among community
      members in Bexar County.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
time frame: Up to 3 months after the index oncology visit
description: The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.
measure: Proportion of patients who show increase in knowledge/awareness regarding CT participation.
time frame: Up to 3 months after the index oncology visit
description: The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.
measure: Proportion of patients who show improved attitudes regarding CT participation.
time frame: Up to 3 months after the index oncology visit
description: The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.
measure: Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.
time frame: Up to 3 months after the index oncology visit
description: The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.
arm group label: Intervention Group
arm group type: Active Comparator
description: Participants in the intervention group will receive 3 components: 1) a culturally tailored clinical trial educational video, 2) a brochure and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.
arm group label: Usual Care Control Group
arm group type: Active Comparator
description: Participants in the usual care control group will receive a general clinical trial fact sheet.
intervention type: Other
intervention name: Clinical Trial Educational Video
description: Culturally tailored educational video, brochure, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials.
arm group label: Intervention Group
intervention type: Other
intervention name: Clinical Trial Fact Sheet
description: General Clinical Trial fact sheet with usual care information regarding Clinical Trials.
arm group label: Usual Care Control Group
intervention type: Other
intervention name: Brochure
description: A brochure with educational material about clinical trials and services offered by Mays Cancer Center.
arm group label: Intervention Group
intervention type: Other
intervention name: Navigator
description: Support that will be provided by a patient navigator to empower new cancer patients to make an informed decision about cancer clinical trials by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amelie G Ramirez, DrPH, MPH
role: Principal Investigator
affiliation: UT Health San Antonio
last name: Patricia Chalela, DrPH, MPH
role: Principal Investigator
affiliation: UT Health San Antonio
last name: Sneha Prabhu, MPH
phone: 210-562-6546
email: prabhus@uthscsa.edu
last name: Jessica Gutierrez
phone: 210-562-6505
email: gutierrezj4@uthscsa.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor