<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/NCT01704235</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008709</org_study_id>
    <secondary_id>CPC-12122-L</secondary_id>
    <nct_id>NCT01704235</nct_id>
  </id_info>
  <brief_title>Vietnamese Women's Health Project III</brief_title>
  <official_title>Community Based Participatory Research to Understanding Symptom Perception, Preventive Care-Seeking, and Their Impact on Cervical Cancer Screening Among Vietnamese American Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this protocol is to understand the extent of symptom perception and preventive&#xD;
      care-seeking among Vietnamese American women and their impact on cervical cancer screening&#xD;
      from the perspectives and experiences of key informants including primary health care&#xD;
      providers and Vietnamese American women (VAW, foreign-born and United States-born). With this&#xD;
      information, the investigators can better understand how to promote cervical cancer screening&#xD;
      in the Vietnamese community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No further extensive description.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2012</start_date>
  <completion_date type="Actual">July 25, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The extent of symptom perception</measure>
    <time_frame>Duration of the study; Up to 1 year</time_frame>
    <description>To understand the extent of symptom perception among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The extent of preventive care-seeking</measure>
    <time_frame>Duration of the study; Up to 1 year</time_frame>
    <description>To understand the extent of preventive care-seeking among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Primary health care providers</arm_group_label>
    <description>medical physicians and nurse practitioners</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Demographic Form and Semi-Structured Interview Guide</intervention_name>
    <description>The demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training.&#xD;
A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team.</description>
    <arm_group_label>Primary health care providers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Potential participants will be recruited from the Portland, Oregon Metropolitan area&#xD;
        through referrals and snowball method. Primary health care providers are eligible to&#xD;
        participate in the study if they meet the following criteria: self-identify as currently&#xD;
        practicing as a primary licensed independent practitioner including as a medical physician&#xD;
        or nurse practitioner, whose service populations include Vietnamese American women, and are&#xD;
        able to understand and speak English or Vietnamese. Vietnamese American women are eligible&#xD;
        to participate in the study if they meet the following criteria: self-identify as a&#xD;
        Vietnamese American woman, between ages 21 to 65 years old, have not had a hysterectomy,&#xD;
        and are able to understand and speak English or Vietnamese.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary health care providers are eligible to participate in the study if they meet&#xD;
             the following criteria:&#xD;
&#xD;
               -  self-identify as currently practicing as a primary licensed independent&#xD;
                  practitioner including as a medical physician or nurse practitioner,&#xD;
&#xD;
               -  whose service populations include Vietnamese American women,&#xD;
&#xD;
               -  and are able to understand and speak English or Vietnamese.&#xD;
&#xD;
          -  Vietnamese American women are eligible to participate in the study if they meet the&#xD;
             following criteria:&#xD;
&#xD;
               -  self-identify as a Vietnamese American woman (foreign-born women who have&#xD;
                  immigrated to the United States from other countries or are United States-born),&#xD;
&#xD;
               -  between ages 21 to 65 years old,&#xD;
&#xD;
               -  have not had a hysterectomy,&#xD;
&#xD;
               -  and are able to understand and speak English or Vietnamese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a Vietnamese American woman&#xD;
&#xD;
          -  Not between the ages of 21 to 65 years old&#xD;
&#xD;
          -  Had a hysterectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lillian Nail, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01704235
org study id: IRB00008709
secondary id: CPC-12122-L
nct id: NCT01704235
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this protocol is to understand the extent of symptom perception and preventive
      care-seeking among Vietnamese American women and their impact on cervical cancer screening
      from the perspectives and experiences of key informants including primary health care
      providers and Vietnamese American women (VAW, foreign-born and United States-born). With this
      information, the investigators can better understand how to promote cervical cancer screening
      in the Vietnamese community.
No further extensive description.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: The extent of symptom perception
time frame: Duration of the study; Up to 1 year
description: To understand the extent of symptom perception among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.
measure: The extent of preventive care-seeking
time frame: Duration of the study; Up to 1 year
description: To understand the extent of preventive care-seeking among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.
arm group label: Primary health care providers
description: medical physicians and nurse practitioners
intervention type: Other
intervention name: Demographic Form and Semi-Structured Interview Guide
description: The demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training.
A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team.
arm group label: Primary health care providers
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lillian Nail, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms