<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/NCT03023735</url>
  </required_header>
  <id_info>
    <org_study_id>37046</org_study_id>
    <nct_id>NCT03023735</nct_id>
  </id_info>
  <brief_title>Trial of Strategies to Communicate Genetic Information to Different Ethnic Subpopulations</brief_title>
  <official_title>Trial of Strategies to Communicate Genetic Information to Different Ethnic and Racial Subpopulations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to better understand how clinicians give genetic risk information&#xD;
      to patients from multi-ethnic groups and how patients understand this information and&#xD;
      remember it and act upon it. In addition investigators want to know how to better communicate&#xD;
      with patients about complex health issues across the health literacy divide and communication&#xD;
      gap that exists between doctors and their patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Any patient referred to the breast cancer and genetic risk counseling clinics in either of&#xD;
      the two sites will be eligible to participate as long as they meet the inclusion and&#xD;
      exclusion criteria. The research assistant in each site will meet with the patients and&#xD;
      explain about the study goals and procedures and ask them to participate in the study. Those&#xD;
      interested will be enrolled into the study after obtaining informed consent. For those who&#xD;
      refuse to participate, reasons for refusal will be requested and catalogued. All study&#xD;
      participants will be followed and the study measures will be tracked at Days 0, 30, 180 and&#xD;
      365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits,&#xD;
      screening tests and procedures) will be tracked both through the electronic medical records&#xD;
      and patient interviews (as some patients may seek care in other hospitals for emergencies&#xD;
      etc.). Investigators currently do follow-up phone interviews routinely with our patients.&#xD;
      Study measures will be administered as described above. For those who drop out from the&#xD;
      study, reasons for withdrawal from the study will be explored and catalogued.&#xD;
&#xD;
      Procedures for Treatment Compliance and Treatment Non-completers:&#xD;
&#xD;
      (i) Compliance Procedures: Investigators will monitor degree of compliance with whether study&#xD;
      measures were completed on Days 0,7,30 &amp; 365 intervention. Analyses will be done following&#xD;
      the intent-to-treat principle.&#xD;
&#xD;
      (ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for&#xD;
      withdrawal from the study will be explored and catalogued. They will be asked for feedback&#xD;
      about the study intervention and satisfaction with the experience (or the lack thereof).&#xD;
&#xD;
      Procedures for Data Collection: The participants will have the option of submitting the data&#xD;
      in person or by phone to the project research associate. The PI will meet with the study&#xD;
      personnel at least on a weekly basis to continuously monitor their performance and to ensure&#xD;
      adherence to study methodology.&#xD;
&#xD;
      There are risks, discomforts, and inconveniences associated with any research study. These&#xD;
      deserve careful thought. Participants should talk with the Protocol Director for any&#xD;
      questions. Risks of answering the survey instruments and interview questions are minimal and&#xD;
      may occasionally cause distress.&#xD;
&#xD;
      Audio recording of the patient interviews. Investigators will create verbatim transcripts to&#xD;
      be analyzed using qualitative methods. Recordings will be stored for a period of 20 years and&#xD;
      then erased.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome measure using health decisions and healthcare utilization</measure>
    <time_frame>up to 3 years</time_frame>
    <description>In this observational study, investigators propose to follow patients for a period of one to three years to track their cancer treatment and screening decisions (e.g. if they complete mammograms, MRI, surgery, chemotherapy, radiation therapy) as recommended by the clinical team and also ER visits, hospitalizations, ICU admissions and death.</description>
  </primary_outcome>
  <enrollment type="Actual">597</enrollment>
  <condition>Communication</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None. This is an observational study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient referred to the breast cancer genetic risk counseling clinics in either of the&#xD;
        two sites will be eligible to participate as long as they meet the inclusion and exclusion&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer Patients&#xD;
&#xD;
          -  Over 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18&#xD;
&#xD;
          -  Healthy Volunteers.&#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>VJ Periyakoil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>VJ Periyakoil</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03023735
org study id: 37046
nct id: NCT03023735
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this study is to better understand how clinicians give genetic risk information
      to patients from multi-ethnic groups and how patients understand this information and
      remember it and act upon it. In addition investigators want to know how to better communicate
      with patients about complex health issues across the health literacy divide and communication
      gap that exists between doctors and their patients.
Any patient referred to the breast cancer and genetic risk counseling clinics in either of
      the two sites will be eligible to participate as long as they meet the inclusion and
      exclusion criteria. The research assistant in each site will meet with the patients and
      explain about the study goals and procedures and ask them to participate in the study. Those
      interested will be enrolled into the study after obtaining informed consent. For those who
      refuse to participate, reasons for refusal will be requested and catalogued. All study
      participants will be followed and the study measures will be tracked at Days 0, 30, 180 and
      365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits,
      screening tests and procedures) will be tracked both through the electronic medical records
      and patient interviews (as some patients may seek care in other hospitals for emergencies
      etc.). Investigators currently do follow-up phone interviews routinely with our patients.
      Study measures will be administered as described above. For those who drop out from the
      study, reasons for withdrawal from the study will be explored and catalogued.

      Procedures for Treatment Compliance and Treatment Non-completers:

      (i) Compliance Procedures: Investigators will monitor degree of compliance with whether study
      measures were completed on Days 0,7,30 & 365 intervention. Analyses will be done following
      the intent-to-treat principle.

      (ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for
      withdrawal from the study will be explored and catalogued. They will be asked for feedback
      about the study intervention and satisfaction with the experience (or the lack thereof).

      Procedures for Data Collection: The participants will have the option of submitting the data
      in person or by phone to the project research associate. The PI will meet with the study
      personnel at least on a weekly basis to continuously monitor their performance and to ensure
      adherence to study methodology.

      There are risks, discomforts, and inconveniences associated with any research study. These
      deserve careful thought. Participants should talk with the Protocol Director for any
      questions. Risks of answering the survey instruments and interview questions are minimal and
      may occasionally cause distress.

      Audio recording of the patient interviews. Investigators will create verbatim transcripts to
      be analyzed using qualitative methods. Recordings will be stored for a period of 20 years and
      then erased.
observational model: Family-Based
time perspective: Prospective
measure: Composite outcome measure using health decisions and healthcare utilization
time frame: up to 3 years
description: In this observational study, investigators propose to follow patients for a period of one to three years to track their cancer treatment and screening decisions (e.g. if they complete mammograms, MRI, surgery, chemotherapy, radiation therapy) as recommended by the clinical team and also ER visits, hospitalizations, ICU admissions and death.
intervention type: Other
intervention name: None. This is an observational study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: VJ Periyakoil
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: VJ Periyakoil
investigator title: Clinical Associate Professor
sharing ipd: Undecided