xml: <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/NCT06026384</url>
    </required_header>
    <id_info>
      <org_study_id>CLARO Pilot</org_study_id>
      <secondary_id>70114759</secondary_id>
      <nct_id>NCT06026384</nct_id>
    </id_info>
    <brief_title>Evaluation of Text or Animation-based Narrative and Non-narrative Interventions to Enhance Cancer Literacy: a Pilot Study (CLARO)</brief_title>
    <acronym>CLARO</acronym>
    <official_title>Development and Evaluation of Theory Guided Narrative and Non-narrative Interventions to Enhance Cancer Literacy and Cancer Prevention Beliefs in the Population: a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>German Cancer Research Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Music, Drama, and Media Hannover</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>German Cancer Research Center</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 goal of this interventional pilot study is to test and evaluate different information&#xD;
        materials created to heighten participants cancer literacy, cancer prevention beliefs, and&#xD;
        subsequent intention for behavioral changes. Forty individuals, intended to cover a broad&#xD;
        socioeconomic background, will participate in the pilot study. Based on the results of this&#xD;
        pilot study, the information materials will be adapted for the following main study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CLARO aims to answer the question, how information materials should be designed to strengthen&#xD;
        optimistic beliefs on cancer prevention and to indirectly facilitate the acquisition of&#xD;
        cancer literacy.&#xD;
  &#xD;
        Four different information materials were developed and will be tested in this pilot study&#xD;
        (2x2-design: text or animation-based / narrative or non-narrative). Participants will take&#xD;
        part in a 30- to 40-minute survey. As part of the study, they will be randomly assigned to&#xD;
        one of the information materials, and asked to evaluate it in depth, both quantitatively and&#xD;
        qualitatively. The interviews will be conducted individually and face to face.&#xD;
  &#xD;
        By using a mixed method approach the study will combine quantitative and qualitative methods&#xD;
        addressing the following research questions:&#xD;
  &#xD;
        Quantitative:&#xD;
  &#xD;
          -  What is the sample's socio-demographics?&#xD;
  &#xD;
          -  Has there already been personal contact with people with cancer (e.g. through own cancer&#xD;
             or cancer in the family)?&#xD;
  &#xD;
          -  What is the level of engagement in health behaviours (smoking, healthy eating, exercise,&#xD;
             BMI)?&#xD;
  &#xD;
          -  How strongly are Cancer Prevention Beliefs and Cancer Information Overload represented?&#xD;
  &#xD;
          -  How much do the participants like the material shown? (three questions on satisfaction&#xD;
             with the material as well as possible counter-argumentation in order to exclude&#xD;
             distortions due to social desirability)&#xD;
  &#xD;
          -  Can the people in the narrative conditions identify with the characters shown?&#xD;
  &#xD;
        Qualitative:&#xD;
  &#xD;
          -  Do the participants like the materials?&#xD;
  &#xD;
          -  Is there something wrong with the quality of the materials? (e.g., quality of sound &amp;&#xD;
             images, presentation of animated figures, font size, readability...)&#xD;
  &#xD;
          -  Are the materials comprehensible?&#xD;
  &#xD;
          -  Is the amount of information appropriate? If not, is it too less or too much?&#xD;
  &#xD;
          -  Is the information given convincing?&#xD;
  &#xD;
          -  What are the most important insights gained from the materials? Do any of the&#xD;
             information have novelty value?&#xD;
  &#xD;
          -  Are the given recommendations perceived as helpful?&#xD;
  &#xD;
          -  Are there ways to improve the materials?&#xD;
  &#xD;
          -  Might anyone feel excluded or offended by the information?&#xD;
  &#xD;
        An inductive content analysis will be carried out to analyse the qualitative data obtained.&#xD;
  &#xD;
        The results of the CLARO pilot study will help to improve the intervention materials that&#xD;
        will be used for the subsequent main study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Satisfaction with the materials</measure>
      <time_frame>20min</time_frame>
      <description>Participants will be asked questions regarding the material presented (qualitatively and quantitatively) covering general satisfaction, comprehensibility, persuasion, affective reactions and potential ways to improve the material</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cancer Prevention Beliefs &amp; Cancer Information Overload</measure>
      <time_frame>5 min</time_frame>
      <description>Participans will be assessed asking for agreement with three statements that have been used in previous studies: &quot;It seems like everything causes cancer,&quot; &quot;There's not much you can do to lower your chances of getting cancer,&quot; and &quot;There are so many recommendations about preventing cancer, it's hard to know which ones to follow&quot;</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cancer Prevention</condition>
    <arm_group>
      <arm_group_label>Non-Narrative Text</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A short text (531 words) that deals with the preventability of cancer cases. It shows that lifestyle factors such as smoking, unhealthy diet, obesity and physical inactivity are responsible for about 40% of cancer cases. It also suggests ways to reduce the risk of cancer through behavioural changes in these areas. A special focus is on nutrition and physical activity. The text was developed on the basis of the Protection Motivation Theory.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Narrative Text</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The narrative text contains the same information as the non-narrative text, except that it is built into a story. This makes the text slightly longer at 723 words. The text is about a main character and two work colleagues who share their personal experiences about nutrition and exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-Narrative Animation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The animation is based on the text in non-narrative form and aims to be as fully comparable as possible.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Narrative Animation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The animaion is based on the text in narrative form and aims to be as fully comparable as possible.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>text in non-narrative form</intervention_name>
      <description>Participants will be asked to read a text and give feedback afterwards</description>
      <arm_group_label>Non-Narrative Text</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>text in narrative form</intervention_name>
      <description>Participants will be asked to read a text and give feedback afterwards</description>
      <arm_group_label>Narrative Text</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>animated video in non-narrative form</intervention_name>
      <description>Participants will be asked to watch a video and give feedback afterwards</description>
      <arm_group_label>Non-Narrative Animation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>animated video in narrative form</intervention_name>
      <description>Participants will be asked to watch a video and give feedback afterwards</description>
      <arm_group_label>Narrative Animation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between 18 and 70 years old&#xD;
  &#xD;
            -  Being able to speak and understand german&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Not being able and willing to provide informed consent and complete questionnaires&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Karen Steindorf, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>German Cancer Research Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alexander Haussmann, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>German Cancer Research Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Florian Herbolsheimer, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>German Cancer Research Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mona Illmann, M. Sc.</last_name>
      <phone>06221 422370</phone>
      <email>mona.illmann@dkfz-heidelberg.de</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cancer</keyword>
    <keyword>Cancer Literacy</keyword>
    <keyword>Informational Intervention</keyword>
    <keyword>Health Communication</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026384
  org study id: CLARO Pilot
  secondary id: 70114759
  nct id: NCT06026384
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional pilot study is to test and evaluate different information
        materials created to heighten participants cancer literacy, cancer prevention beliefs, and
        subsequent intention for behavioral changes. Forty individuals, intended to cover a broad
        socioeconomic background, will participate in the pilot study. Based on the results of this
        pilot study, the information materials will be adapted for the following main study.
  CLARO aims to answer the question, how information materials should be designed to strengthen
        optimistic beliefs on cancer prevention and to indirectly facilitate the acquisition of
        cancer literacy.
  
        Four different information materials were developed and will be tested in this pilot study
        (2x2-design: text or animation-based / narrative or non-narrative). Participants will take
        part in a 30- to 40-minute survey. As part of the study, they will be randomly assigned to
        one of the information materials, and asked to evaluate it in depth, both quantitatively and
        qualitatively. The interviews will be conducted individually and face to face.
  
        By using a mixed method approach the study will combine quantitative and qualitative methods
        addressing the following research questions:
  
        Quantitative:
  
          -  What is the sample's socio-demographics?
  
          -  Has there already been personal contact with people with cancer (e.g. through own cancer
             or cancer in the family)?
  
          -  What is the level of engagement in health behaviours (smoking, healthy eating, exercise,
             BMI)?
  
          -  How strongly are Cancer Prevention Beliefs and Cancer Information Overload represented?
  
          -  How much do the participants like the material shown? (three questions on satisfaction
             with the material as well as possible counter-argumentation in order to exclude
             distortions due to social desirability)
  
          -  Can the people in the narrative conditions identify with the characters shown?
  
        Qualitative:
  
          -  Do the participants like the materials?
  
          -  Is there something wrong with the quality of the materials? (e.g., quality of sound &
             images, presentation of animated figures, font size, readability...)
  
          -  Are the materials comprehensible?
  
          -  Is the amount of information appropriate? If not, is it too less or too much?
  
          -  Is the information given convincing?
  
          -  What are the most important insights gained from the materials? Do any of the
             information have novelty value?
  
          -  Are the given recommendations perceived as helpful?
  
          -  Are there ways to improve the materials?
  
          -  Might anyone feel excluded or offended by the information?
  
        An inductive content analysis will be carried out to analyse the qualitative data obtained.
  
        The results of the CLARO pilot study will help to improve the intervention materials that
        will be used for the subsequent main study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Satisfaction with the materials
  time frame: 20min
  description: Participants will be asked questions regarding the material presented (qualitatively and quantitatively) covering general satisfaction, comprehensibility, persuasion, affective reactions and potential ways to improve the material
  measure: Cancer Prevention Beliefs & Cancer Information Overload
  time frame: 5 min
  description: Participans will be assessed asking for agreement with three statements that have been used in previous studies: "It seems like everything causes cancer," "There's not much you can do to lower your chances of getting cancer," and "There are so many recommendations about preventing cancer, it's hard to know which ones to follow"
  arm group label: Non-Narrative Text
  arm group type: Experimental
  description: A short text (531 words) that deals with the preventability of cancer cases. It shows that lifestyle factors such as smoking, unhealthy diet, obesity and physical inactivity are responsible for about 40% of cancer cases. It also suggests ways to reduce the risk of cancer through behavioural changes in these areas. A special focus is on nutrition and physical activity. The text was developed on the basis of the Protection Motivation Theory.
  arm group label: Narrative Text
  arm group type: Experimental
  description: The narrative text contains the same information as the non-narrative text, except that it is built into a story. This makes the text slightly longer at 723 words. The text is about a main character and two work colleagues who share their personal experiences about nutrition and exercise.
  arm group label: Non-Narrative Animation
  arm group type: Experimental
  description: The animation is based on the text in non-narrative form and aims to be as fully comparable as possible.
  arm group label: Narrative Animation
  arm group type: Experimental
  description: The animaion is based on the text in narrative form and aims to be as fully comparable as possible.
  intervention type: Other
  intervention name: text in non-narrative form
  description: Participants will be asked to read a text and give feedback afterwards
  arm group label: Non-Narrative Text
  intervention type: Other
  intervention name: text in narrative form
  description: Participants will be asked to read a text and give feedback afterwards
  arm group label: Narrative Text
  intervention type: Other
  intervention name: animated video in non-narrative form
  description: Participants will be asked to watch a video and give feedback afterwards
  arm group label: Non-Narrative Animation
  intervention type: Other
  intervention name: animated video in narrative form
  description: Participants will be asked to watch a video and give feedback afterwards
  arm group label: Narrative Animation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Karen Steindorf, Prof. Dr.
  role: Principal Investigator
  affiliation: German Cancer Research Center
  last name: Alexander Haussmann, Dr.
  role: Principal Investigator
  affiliation: German Cancer Research Center
  last name: Florian Herbolsheimer, Dr.
  role: Principal Investigator
  affiliation: German Cancer Research Center
  last name: Mona Illmann, M. Sc.
  phone: 06221 422370
  email: mona.illmann@dkfz-heidelberg.de
  responsible party type: Sponsor
  sharing ipd: No