<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/NCT02974569</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16-12876</org_study_id>
    <secondary_id>HM20007402</secondary_id>
    <nct_id>NCT02974569</nct_id>
  </id_info>
  <brief_title>Improving Symptom Self-management in Adolescents &amp; Young Adults With Cancer</brief_title>
  <acronym>CSCAT2</acronym>
  <official_title>Improving Symptom Self-management in Adolescents &amp; Young Adults With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Baldrick's Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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 evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates&#xD;
      an image of the symptoms the participant is experiencing, for improving symptom&#xD;
      self-management in adolescents and young adults with cancer. In this one-group trial,&#xD;
      participants will complete the C-SCAT and use it during two clinic visits with their oncology&#xD;
      providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs)&#xD;
      with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed&#xD;
      the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs&#xD;
      create a picture of their symptoms using images and text on an iPad app. The resulting image&#xD;
      shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has&#xD;
      potential to support AYA's symptom self-management. Facilitating the self-management process,&#xD;
      including self-efficacy, self-regulation behaviors, and patient-provider communication, is&#xD;
      essential for improving symptom outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">October 25, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.</measure>
    <time_frame>Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.</measure>
    <time_frame>Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.</measure>
    <time_frame>Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)</time_frame>
    <description>Semi-structured interviews to address how using the C-SCAT impacts self-regulation behaviors, such as self-monitoring, reflective thinking, and decision-making</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.</measure>
    <time_frame>After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.</measure>
    <time_frame>After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Symptom Clusters</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>C-SCAT</arm_group_label>
    <description>C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer Symptom Capture Tool</intervention_name>
    <description>C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms &quot;feeling bloated&quot; and &quot;sexual dysfunction&quot; that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.</description>
    <arm_group_label>C-SCAT</arm_group_label>
    <other_name>C-SCAT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pediatric and adult oncology clinics at the Virginia Commonwealth University Health System&#xD;
        (VCUHS). Patients and parents of minor patients will be approached as inpatients or as&#xD;
        outpatients at Massey Cancer Center Fellows Clinic and at the Pediatric Oncology Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  15 to 29 years of age with a diagnosis of cancer (primary, relapsed/recurrent,&#xD;
             refractory, progressive, or secondary malignancy) receiving myelosuppressive&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Completion of at least one cycle of therapy for cancer and anticipated to have at&#xD;
             least two additional cycles of myelosuppressive chemotherapy as part of the treatment&#xD;
             plan.&#xD;
&#xD;
          -  Ability to speak and understand English as required to complete the C-SCAT and study&#xD;
             measures.&#xD;
&#xD;
          -  Ability to use a tablet computer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive and/or physical inabilities to complete the proposed study measures as&#xD;
             determined by self--report, parent report of minor, or medical chart.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne W. Ameringer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Childrens Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 6, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>December 20, 2017</last_update_submitted>
  <last_update_submitted_qc>December 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescents</keyword>
  <keyword>young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02974569
org study id: MCC-16-12876
secondary id: HM20007402
nct id: NCT02974569
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates
      an image of the symptoms the participant is experiencing, for improving symptom
      self-management in adolescents and young adults with cancer. In this one-group trial,
      participants will complete the C-SCAT and use it during two clinic visits with their oncology
      providers.
Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs)
      with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed
      the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs
      create a picture of their symptoms using images and text on an iPad app. The resulting image
      shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has
      potential to support AYA's symptom self-management. Facilitating the self-management process,
      including self-efficacy, self-regulation behaviors, and patient-provider communication, is
      essential for improving symptom outcomes.
observational model: Case-Only
time perspective: Prospective
measure: Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.
time frame: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
measure: Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.
time frame: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
measure: Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.
time frame: Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)
description: Semi-structured interviews to address how using the C-SCAT impacts self-regulation behaviors, such as self-monitoring, reflective thinking, and decision-making
measure: Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.
time frame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
measure: Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.
time frame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
arm group label: C-SCAT
description: C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.
intervention type: Device
intervention name: Computer Symptom Capture Tool
description: C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms "feeling bloated" and "sexual dysfunction" that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.
arm group label: C-SCAT
other name: C-SCAT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 29 Years
healthy volunteers: No
last name: Suzanne W. Ameringer, Ph.D.
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Syndrome