<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/NCT02264782</url>
  </required_header>
  <id_info>
    <org_study_id>14988</org_study_id>
    <secondary_id>NCI-2017-00456</secondary_id>
    <secondary_id>14988</secondary_id>
    <secondary_id>R01CA158027</secondary_id>
    <nct_id>NCT02264782</nct_id>
  </id_info>
  <brief_title>PreView: The Preventive Video Education in Waiting Rooms Program</brief_title>
  <official_title>PreView: The Preventive Video Education in Waiting Rooms Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <brief_summary>
    <textblock>
      This clinical trial studies how well PreView, preventive video education, works in increasing&#xD;
      rates of breast, cervical and colorectal cancer screening, improving participants' stage of&#xD;
      change with respect to age appropriate cancer screening and increasing patient-provider&#xD;
      discussions about prostate cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the extent to which PreView increases the likelihood that primary care&#xD;
      patient participants will receive mammograms, pap tests, colon cancer tests or prostate&#xD;
      specific antigen (PSA) testing discussions with primary care physicians compared with&#xD;
      participants who receive usual care.&#xD;
&#xD;
      II. To determine the extent that PreView increases participants' readiness to be screened for&#xD;
      breast cancer, cervical cancer or colorectal cancer (CRC) compared with usual care.&#xD;
&#xD;
      III. To determine the extent that PreView increases the likelihood that PSA testing will be&#xD;
      discussed in primary care physician visits compared with usual care.&#xD;
&#xD;
      OUTLINE: Patients are randomized into 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on&#xD;
      an iPad in the waiting room before a doctor visit.&#xD;
&#xD;
      GROUP II: Patients watch a video about healthy lifestyles including information about&#xD;
      exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor&#xD;
      visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</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>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changing participants' readiness to be screened for breast, cervical and colorectal cancer</measure>
    <time_frame>Up to 3 hours from pre-visit to post-visit interview.</time_frame>
    <description>To determine the extent to which PreView increases the likelihood that primary care patient participants will receive mammograms, Pap tests, colon cancer tests or PSA testing discussions with primary care physicians compared with participants who receive usual care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increasing physician-patient discussions about PSA screening measured by chart review</measure>
    <time_frame>Baseline up to 14 months</time_frame>
    <description>To determine the extent that PreView increases participants' readiness to be screened for breast cancer, cervical cancer or CRC compared with usual care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increasing rates of breast, cervical and colorectal cancer screening</measure>
    <time_frame>From Baseline up to 14 months</time_frame>
    <description>To determine the extent that PreView increases the likelihood that PSA testing will be discussed in primary care physician visits compared with usual care.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">508</enrollment>
  <condition>Health Status Unknown</condition>
  <arm_group>
    <arm_group_label>Group I (PreView)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on an iPad in the waiting room before a doctor visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (educational video)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients watch a video about healthy lifestyles including information about exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computer-Assisted Intervention</intervention_name>
    <description>Complete PreView</description>
    <arm_group_label>Group I (PreView)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computer-Assisted Intervention</intervention_name>
    <description>Watch an educational video</description>
    <arm_group_label>Group II (educational video)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (PreView)</arm_group_label>
    <arm_group_label>Group II (educational video)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Without a history of cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With a history of cancer (for whom subsequent procedures would be surveillance and not&#xD;
             screening)&#xD;
&#xD;
          -  Individuals who do not speak English or Spanish (except for the testimonials)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judith Walsh</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSF Medical Center-Mount Zion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Muir Medical Center-Concord Campus</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mount Zion</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</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/NCT02264782
org study id: 14988
secondary id: NCI-2017-00456
secondary id: 14988
secondary id: R01CA158027
nct id: NCT02264782
lead sponsor: 
collaborator: 
This clinical trial studies how well PreView, preventive video education, works in increasing
      rates of breast, cervical and colorectal cancer screening, improving participants' stage of
      change with respect to age appropriate cancer screening and increasing patient-provider
      discussions about prostate cancer screening.
PRIMARY OBJECTIVES:

      I. To determine the extent to which PreView increases the likelihood that primary care
      patient participants will receive mammograms, pap tests, colon cancer tests or prostate
      specific antigen (PSA) testing discussions with primary care physicians compared with
      participants who receive usual care.

      II. To determine the extent that PreView increases participants' readiness to be screened for
      breast cancer, cervical cancer or colorectal cancer (CRC) compared with usual care.

      III. To determine the extent that PreView increases the likelihood that PSA testing will be
      discussed in primary care physician visits compared with usual care.

      OUTLINE: Patients are randomized into 1 of 2 groups.

      GROUP I: Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on
      an iPad in the waiting room before a doctor visit.

      GROUP II: Patients watch a video about healthy lifestyles including information about
      exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor
      visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Investigator)
measure: Changing participants' readiness to be screened for breast, cervical and colorectal cancer
time frame: Up to 3 hours from pre-visit to post-visit interview.
description: To determine the extent to which PreView increases the likelihood that primary care patient participants will receive mammograms, Pap tests, colon cancer tests or PSA testing discussions with primary care physicians compared with participants who receive usual care
measure: Increasing physician-patient discussions about PSA screening measured by chart review
time frame: Baseline up to 14 months
description: To determine the extent that PreView increases participants' readiness to be screened for breast cancer, cervical cancer or CRC compared with usual care.
measure: Increasing rates of breast, cervical and colorectal cancer screening
time frame: From Baseline up to 14 months
description: To determine the extent that PreView increases the likelihood that PSA testing will be discussed in primary care physician visits compared with usual care.
arm group label: Group I (PreView)
arm group type: Experimental
description: Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on an iPad in the waiting room before a doctor visit.
arm group label: Group II (educational video)
arm group type: Active Comparator
description: Patients watch a video about healthy lifestyles including information about exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor visit.
intervention type: Other
intervention name: Computer-Assisted Intervention
description: Complete PreView
arm group label: Group I (PreView)
intervention type: Other
intervention name: Computer-Assisted Intervention
description: Watch an educational video
arm group label: Group II (educational video)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (PreView)
arm group label: Group II (educational video)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Judith Walsh
role: Principal Investigator
affiliation: UCSF Medical Center-Mount Zion
facility: 
facility: 
country: United States
responsible party type: Sponsor