<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/NCT04424758</url>
  </required_header>
  <id_info>
    <org_study_id>2204MDJ</org_study_id>
    <nct_id>NCT04424758</nct_id>
  </id_info>
  <brief_title>Testing Video Information About Mammography Screening</brief_title>
  <official_title>Testing Video Information About Mammography Screening in a Randomized Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</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>
      This study examines how video information about mammography screening effect participants&#xD;
      knowledge opinions and choice about screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial&#xD;
      (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be&#xD;
      randomized to either the intervention group (video information about mammography screening&#xD;
      followed by a survey about mammography screening) or the control group (video information&#xD;
      about energy systems followed by the same survey). The survey computer programme will&#xD;
      randomly assign each respondent to either the intervention arm or the control arm in the&#xD;
      beginning of the survey.&#xD;
&#xD;
      The allocation will be concealed from the researchers. The survey computer programme will&#xD;
      deliver the intervention right after randomization. Participants will be aware of the&#xD;
      allocation. However, they do not know about the study design. Data analysts will be kept&#xD;
      blinded to the allocation.&#xD;
&#xD;
      Choice, knowledge and opinions related to mammography screening will be compared between the&#xD;
      control group and the intervention group at one timepoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</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>
    <intervention_model_description>See protocol</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>See protocol</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Choice: proportion of participants in favor of mammography screening</measure>
    <time_frame>One month</time_frame>
    <description>The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response duration: time</measure>
    <time_frame>One month</time_frame>
    <description>Response duration is registered for all participants in the online survey. Mean response duration will be calculated in both the intervention arm and control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.</measure>
    <time_frame>One month</time_frame>
    <description>Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receives information about energy systems through a video. The video does not contain any information related to mammography screening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video information about mammography screening</intervention_name>
    <description>A video informing about mammography screening</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video information about smart energy systems</intervention_name>
    <description>A video informing about smart energy systems</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants eligible for the study includes all men and women age 18-75.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manja Jensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Section of General Practice, University of Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manja Jensen, MD</last_name>
    <phone>0045-35333123</phone>
    <email>madj@sund.ku.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John Brodersen, MD, PhD</last_name>
    <phone>0045-35333123</phone>
    <email>jobr@sund.ku.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Copenhagen, Section of General Practice</name>
      <address>
        <city>Copenhagen</city>
        <state>Capital</state>
        <zip>1014</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manja D Jensen, MD</last_name>
      <phone>0045-35333123</phone>
      <email>madj@sund.ku.dk</email>
    </contact>
    <contact_backup>
      <last_name>John Brodersen, MD, phd</last_name>
      <email>jobr@sund.ku.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 28, 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>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Manja Dahl Jensen</investigator_full_name>
    <investigator_title>Principal investigator, Medical doctor, PhD-student</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>When the study is completed, access to study data will be provided by the PI on request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be stored until 2050.</ipd_time_frame>
    <ipd_access_criteria>Data will be provided by the PI on request.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04424758/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04424758
org study id: 2204MDJ
nct id: NCT04424758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines how video information about mammography screening effect participants
      knowledge opinions and choice about screening.
This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial
      (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be
      randomized to either the intervention group (video information about mammography screening
      followed by a survey about mammography screening) or the control group (video information
      about energy systems followed by the same survey). The survey computer programme will
      randomly assign each respondent to either the intervention arm or the control arm in the
      beginning of the survey.

      The allocation will be concealed from the researchers. The survey computer programme will
      deliver the intervention right after randomization. Participants will be aware of the
      allocation. However, they do not know about the study design. Data analysts will be kept
      blinded to the allocation.

      Choice, knowledge and opinions related to mammography screening will be compared between the
      control group and the intervention group at one timepoint.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: See protocol
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: See protocol
measure: Choice: proportion of participants in favor of mammography screening
time frame: One month
description: The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.
measure: Response duration: time
time frame: One month
description: Response duration is registered for all participants in the online survey. Mean response duration will be calculated in both the intervention arm and control arm.
measure: Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
time frame: One month
description: Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.
arm group label: Intervention group
arm group type: Experimental
description: Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.
arm group label: Control group
arm group type: Placebo Comparator
description: Receives information about energy systems through a video. The video does not contain any information related to mammography screening.
intervention type: Other
intervention name: Video information about mammography screening
description: A video informing about mammography screening
arm group label: Intervention group
intervention type: Other
intervention name: Video information about smart energy systems
description: A video informing about smart energy systems
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manja Jensen, MD
role: Principal Investigator
affiliation: Section of General Practice, University of Copenhagen
last name: Manja Jensen, MD
phone: 0045-35333123
email: madj@sund.ku.dk
last name: John Brodersen, MD, PhD
phone: 0045-35333123
email: jobr@sund.ku.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Manja Dahl Jensen
investigator title: Principal investigator, Medical doctor, PhD-student
sharing ipd: Yes
ipd description: When the study is completed, access to study data will be provided by the PI on request.
ipd info type: Study Protocol
ipd time frame: Data will be stored until 2050.
ipd access criteria: Data will be provided by the PI on request.
provided document: 