<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/NCT04437472</url>
  </required_header>
  <id_info>
    <org_study_id>202005063</org_study_id>
    <nct_id>NCT04437472</nct_id>
  </id_info>
  <brief_title>Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)</brief_title>
  <official_title>Remote Collection of Patient Reported Toxicity Using SMS Text Messaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      CareSignal has developed an application that allows for remote collection of patient-reported&#xD;
      data such as symptoms or outcomes on any device compatible with the short message service&#xD;
      (SMS), otherwise known as &quot;text messaging&quot;. The software can be configured to complete&#xD;
      symptom monitoring by surveying patients about toxicity using the PRO-CTCAE tools. PRO-CTCAE&#xD;
      is the patient reported outcomes version of the CTCAE that was designed by the National&#xD;
      Cancer Institute (NCI) for use in clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2020</start_date>
  <completion_date type="Actual">July 9, 2021</completion_date>
  <primary_completion_date type="Actual">July 9, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of invited symptom reports completed during the study period</measure>
    <time_frame>From treatment through 30 days follow-up (estimated to be 3 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of questions completed within each invited symptom report</measure>
    <time_frame>From treatment through 30 days follow-up (estimated to be 3 months)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>CareSignal</arm_group_label>
    <description>-Participants will undergo a single training session on how to use the CareSignal software no more than 4 weeks before starting standard of care therapy. After the training session, patients will be encouraged by the treatment team to complete the baseline symptom report once they receive the questions via SMS prior to starting any therapy and to complete the weekly reports during therapy and in follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CareSignal</intervention_name>
    <description>The CareSignal software will be programmed to automatically ask a subset of the NCI-PRO-CTCAE questions using SMS depending on patient group as designated by the treating physician: (1) thoracic radiation with chemotherapy, (2) thoracic radiation alone, (3) extremity/body wall sarcoma, and (4) other.</description>
    <arm_group_label>CareSignal</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing radiation therapy at Siteman Cancer Center at Washington University&#xD;
        School of Medicine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently planning to receive radiotherapy for 2 or more fractions with or without&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Ability to understand and willingness to sign an IRB approved written informed consent&#xD;
             document (or that of legally authorized representative, if applicable).&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Unable to reliably access and use a device compatible with CareSignal software.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew B Spraker, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04437472
org study id: 202005063
nct id: NCT04437472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
CareSignal has developed an application that allows for remote collection of patient-reported
      data such as symptoms or outcomes on any device compatible with the short message service
      (SMS), otherwise known as "text messaging". The software can be configured to complete
      symptom monitoring by surveying patients about toxicity using the PRO-CTCAE tools. PRO-CTCAE
      is the patient reported outcomes version of the CTCAE that was designed by the National
      Cancer Institute (NCI) for use in clinical trials.
observational model: Cohort
time perspective: Prospective
measure: Percentage of invited symptom reports completed during the study period
time frame: From treatment through 30 days follow-up (estimated to be 3 months)
measure: Percentage of questions completed within each invited symptom report
time frame: From treatment through 30 days follow-up (estimated to be 3 months)
arm group label: CareSignal
description: -Participants will undergo a single training session on how to use the CareSignal software no more than 4 weeks before starting standard of care therapy. After the training session, patients will be encouraged by the treatment team to complete the baseline symptom report once they receive the questions via SMS prior to starting any therapy and to complete the weekly reports during therapy and in follow up.
intervention type: Other
intervention name: CareSignal
description: The CareSignal software will be programmed to automatically ask a subset of the NCI-PRO-CTCAE questions using SMS depending on patient group as designated by the treating physician: (1) thoracic radiation with chemotherapy, (2) thoracic radiation alone, (3) extremity/body wall sarcoma, and (4) other.
arm group label: CareSignal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew B Spraker, M.D., Ph.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
sharing ipd: No