<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/NCT03258892</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-16301</org_study_id>
    <secondary_id>NCI-2017-01277</secondary_id>
    <nct_id>NCT03258892</nct_id>
  </id_info>
  <brief_title>Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy</brief_title>
  <official_title>Sarcoma Treatment Guide Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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 randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in&#xD;
      improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The&#xD;
      Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more&#xD;
      engaged with care, encourage communication, and to better manage side effects associated with&#xD;
      chemotherapy treatments in order to improve quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate whether symptom management and communication are improved in patients who are&#xD;
      chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To explore whether patients who have previously undergone chemotherapy benefit from a&#xD;
      Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication&#xD;
      between patient and providers.&#xD;
&#xD;
      II. To assess patient satisfaction with using the STG at the end of the trial.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.&#xD;
&#xD;
      ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG&#xD;
      before completing 2 additional courses of standard of care chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will keep notes of qualitative feedback provided by participants regarding the Sarcoma Treatment Guide (STG) obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the Numeri</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS. Secondary analysis will inc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS (Numeric Ratings Scale). Secondary analysis will inc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Arm A (STG pre-chemotherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive the STG before completing 4 courses of standard of care chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (STG post-chemotherapy initiation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive STG</description>
    <arm_group_label>Arm A (STG pre-chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (STG post-chemotherapy initiation)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (STG pre-chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (STG post-chemotherapy initiation)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (STG pre-chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (STG post-chemotherapy initiation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be able to read, write, and understand English&#xD;
&#xD;
          -  Sarcoma clinic patient&#xD;
&#xD;
          -  About to begin either oral or cytotoxic chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received previous chemotherapy&#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>James Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>James Chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <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/NCT03258892
org study id: OSU-16301
secondary id: NCI-2017-01277
nct id: NCT03258892
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in
      improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The
      Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more
      engaged with care, encourage communication, and to better manage side effects associated with
      chemotherapy treatments in order to improve quality of life.
PRIMARY OBJECTIVES:

      I. To evaluate whether symptom management and communication are improved in patients who are
      chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.

      SECONDARY OBJECTIVES:

      I. To explore whether patients who have previously undergone chemotherapy benefit from a
      Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication
      between patient and providers.

      II. To assess patient satisfaction with using the STG at the end of the trial.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.

      ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG
      before completing 2 additional courses of standard of care chemotherapy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls
time frame: Up to 1 year
description: Will keep notes of qualitative feedback provided by participants regarding the Sarcoma Treatment Guide (STG) obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the Numeri
measure: Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls
time frame: Up to 1 year
description: Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS. Secondary analysis will inc
measure: Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls
time frame: Up to 1 year
description: Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey. Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic. Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain. The calls will be logged to track quantity, reason and outcome of all participants. Symptoms ratings self-reported by patients will be tracked using the NRS (Numeric Ratings Scale). Secondary analysis will inc
arm group label: Arm A (STG pre-chemotherapy)
arm group type: Experimental
description: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
arm group label: Arm B (STG post-chemotherapy initiation)
arm group type: Experimental
description: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
intervention type: Other
intervention name: Educational Intervention
description: Receive STG
arm group label: Arm A (STG pre-chemotherapy)
arm group label: Arm B (STG post-chemotherapy initiation)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (STG pre-chemotherapy)
arm group label: Arm B (STG post-chemotherapy initiation)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Arm A (STG pre-chemotherapy)
arm group label: Arm B (STG post-chemotherapy initiation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Chen, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: James Chen
investigator title: Principal Investigator
mesh term: Sarcoma
sharing ipd: No