<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/NCT04426019</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SPH-11-0179</org_study_id>
    <nct_id>NCT04426019</nct_id>
  </id_info>
  <brief_title>Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women</brief_title>
  <official_title>Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Prevention Research Institute of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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 primary purpose of this study is to train community health workers (promotoras) from the&#xD;
      Prosalud promotora program to implement the Cultivando la Salud (CLS) breast and cervical&#xD;
      cancer screening program, to adapt and deliver the CLS intervention program for&#xD;
      Hispanic/Latina women in the Greater Houston Area, and to evaluate the process and effect of&#xD;
      the adapted CLS program on increasing mammography and cervical cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2012</start_date>
  <completion_date type="Actual">May 16, 2014</completion_date>
  <primary_completion_date type="Actual">May 16, 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome of the CLS education program on increasing breast and cervical cancer screening behaviors in Hispanic women will be based on participants' completion of a mammography and/or completion of a Pap test screening measured using self-report.</measure>
    <time_frame>end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).</time_frame>
    <description>Outcomes based on self-report on follow-up survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reach of CLS education program as defined by the number of eligible Hispanic women reached with CLS program</measure>
    <time_frame>end of intervention (18 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reach of CLS education program as defined by the number of cancer specific referrals made</measure>
    <time_frame>end of intervention (18 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose of CLS as defined by the time spent with each woman</measure>
    <time_frame>end of intervention (18 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose of CLS as defined by the types and numbers of referrals and/or recommendations given</measure>
    <time_frame>end of intervention (18 months)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1025</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>CLS intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No CLS intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CLS Intervention</intervention_name>
    <description>Promotoras will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening</description>
    <arm_group_label>CLS intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No CLs intervention</intervention_name>
    <description>This control arm will receive only usual practice care and will not receive the CLS intervention.They may receive the intervention after study has been completed</description>
    <arm_group_label>No CLS intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who identify as Hispanic/Latina ancestry or descent and live in the Greater&#xD;
             Houston Area in Texas&#xD;
&#xD;
          -  no previous diagnosis of breast or cervical cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, and women who are adherent to screening guidelines&#xD;
&#xD;
          -  prior or current cancer diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lara Savas</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Lara Savas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Mammogram</keyword>
  <keyword>Pap test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT04426019
org study id: HSC-SPH-11-0179
nct id: NCT04426019
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to train community health workers (promotoras) from the
      Prosalud promotora program to implement the Cultivando la Salud (CLS) breast and cervical
      cancer screening program, to adapt and deliver the CLS intervention program for
      Hispanic/Latina women in the Greater Houston Area, and to evaluate the process and effect of
      the adapted CLS program on increasing mammography and cervical cancer screening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Primary outcome of the CLS education program on increasing breast and cervical cancer screening behaviors in Hispanic women will be based on participants' completion of a mammography and/or completion of a Pap test screening measured using self-report.
time frame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
description: Outcomes based on self-report on follow-up survey
measure: Reach of CLS education program as defined by the number of eligible Hispanic women reached with CLS program
time frame: end of intervention (18 months)
measure: Reach of CLS education program as defined by the number of cancer specific referrals made
time frame: end of intervention (18 months)
measure: Dose of CLS as defined by the time spent with each woman
time frame: end of intervention (18 months)
measure: Dose of CLS as defined by the types and numbers of referrals and/or recommendations given
time frame: end of intervention (18 months)
arm group label: CLS intervention
arm group type: Experimental
arm group label: No CLS intervention
arm group type: Active Comparator
intervention type: Behavioral
intervention name: CLS Intervention
description: Promotoras will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening
arm group label: CLS intervention
intervention type: Behavioral
intervention name: No CLs intervention
description: This control arm will receive only usual practice care and will not receive the CLS intervention.They may receive the intervention after study has been completed
arm group label: No CLS intervention
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lara Savas
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Lara Savas
investigator title: Assistant Professor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No