<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/NCT03840109</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-19957</org_study_id>
    <nct_id>NCT03840109</nct_id>
  </id_info>
  <brief_title>Emotional Support Messages Following a Cancer Diagnosis</brief_title>
  <official_title>Emotional Support Messages Following a Cancer Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</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>
      Cancer patients will be randomly shown one of 18 emotional support messages created by the&#xD;
      research team that differ based on how much of the message consists of positive statements&#xD;
      and how much consists of negative statements. The messages with negative statements also&#xD;
      differ based on whether the negative statements occur at the start or end of the message.&#xD;
      After viewing the message, participants have the opportunity to rate the effectiveness of the&#xD;
      message, to what extent the message made them feel better, and to what extent the message&#xD;
      affects how they view the message provider as a useful source of emotional support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">November 24, 2020</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Message Effectiveness Scale</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceived message effectiveness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Affective Improvement Scale</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of self-reports of emotional improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Supporter Competence Scale</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceptions of supporter competence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likelihood of Seeking Support Scale</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of their likelihood to seek support from the supporter in the future.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">417</enrollment>
  <condition>Psychological Stress</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <description>All participants will take an online questionnaire which includes their evaluation of one of 18 different emotional support messages randomly assigned through the Qualtrics survey system. The participants answer a series of closed ended scales regarding quality of the support message, supporter's competence, amount of emotional improvement they experienced after reading the message, and likelihood to seek support from the person writing the message.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 1a</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the last 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 1b</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the first 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 2a</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the last 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 2b</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the first 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 3a</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the last 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 3b</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the first 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 4a</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the last 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire 4b</intervention_name>
    <description>Participants will be randomly shown two versions of messages in which the first 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be 18 years of age or older&#xD;
&#xD;
          -  Participants with a diagnosis of breast, prostate, thoracic or digestive cancer in the&#xD;
             past 3 years&#xD;
&#xD;
          -  Participants consented to Moffitt's Total Cancer Care (TCC) protocol and indicating a&#xD;
             willingness to be contacted for future research by including an email contact.&#xD;
&#xD;
          -  Ability to read and write fluently in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Maija Reblin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://moffitt.org/clinical-trials-research/clinical-trials/</url>
    <description>Moffitt Cancer Center Clinical Trials Website</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emotional support</keyword>
  <keyword>cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>March 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03840109/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/NCT03840109
org study id: MCC-19957
nct id: NCT03840109
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer patients will be randomly shown one of 18 emotional support messages created by the
      research team that differ based on how much of the message consists of positive statements
      and how much consists of negative statements. The messages with negative statements also
      differ based on whether the negative statements occur at the start or end of the message.
      After viewing the message, participants have the opportunity to rate the effectiveness of the
      message, to what extent the message made them feel better, and to what extent the message
      affects how they view the message provider as a useful source of emotional support.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Message Effectiveness Scale
time frame: Through study completion, up to 1 year
description: Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceived message effectiveness.
measure: Affective Improvement Scale
time frame: Through study completion, up to 1 year
description: Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of self-reports of emotional improvement.
measure: Supporter Competence Scale
time frame: Through study completion, up to 1 year
description: Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceptions of supporter competence.
measure: Likelihood of Seeking Support Scale
time frame: Through study completion, up to 1 year
description: Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of their likelihood to seek support from the supporter in the future.
arm group label: All Participants
description: All participants will take an online questionnaire which includes their evaluation of one of 18 different emotional support messages randomly assigned through the Qualtrics survey system. The participants answer a series of closed ended scales regarding quality of the support message, supporter's competence, amount of emotional improvement they experienced after reading the message, and likelihood to seek support from the person writing the message.
intervention type: Behavioral
intervention name: Questionnaire 1a
description: Participants will be randomly shown two versions of messages in which the last 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 1b
description: Participants will be randomly shown two versions of messages in which the first 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 2a
description: Participants will be randomly shown two versions of messages in which the last 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 2b
description: Participants will be randomly shown two versions of messages in which the first 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 3a
description: Participants will be randomly shown two versions of messages in which the last 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 3b
description: Participants will be randomly shown two versions of messages in which the first 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 4a
description: Participants will be randomly shown two versions of messages in which the last 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
intervention type: Behavioral
intervention name: Questionnaire 4b
description: Participants will be randomly shown two versions of messages in which the first 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
arm group label: All Participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Maija Reblin, PhD
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
url: http://moffitt.org/clinical-trials-research/clinical-trials/
description: Moffitt Cancer Center Clinical Trials Website
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No
provided document: 