<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/NCT03043378</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0901</org_study_id>
    <secondary_id>NCI-2018-01268</secondary_id>
    <nct_id>NCT03043378</nct_id>
  </id_info>
  <brief_title>Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic</brief_title>
  <official_title>Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer 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 research study is to learn how frequently cancer patients in the Supportive&#xD;
      Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is&#xD;
      neither related to cancer nor its treatment and lasts beyond the normal tissue healing time&#xD;
      of 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If participant is found to be eligible and agrees to take part in this study, participant&#xD;
      will be asked to complete 3 questionnaires about participant's pain, pain level, and what&#xD;
      drugs participant takes to treat participant's pain. Participant will also be asked a few&#xD;
      questions about tobacco use. These questionnaires should take about 20 minutes to complete.&#xD;
&#xD;
      Researchers will also collect information from participant's medical record such as&#xD;
      participant's date of birth, sex, race, marital status, economic background, and medical&#xD;
      history.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Participation on this study will be over after participant has completed the last&#xD;
      questionnaire.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2018</start_date>
  <completion_date type="Actual">March 23, 2023</completion_date>
  <primary_completion_date type="Actual">March 23, 2023</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>Frequency of Chronic Non-Malignant Pain Among Cancer Patients</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency assessed by Edmonton Symptom Assessment Scale (ESAS-FS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Chronic Non-Malignant Pain Among Cancer Patients</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency assessed by Brief Pain Inventory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Chronic Non-Malignant Pain Among Cancer Patients</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency assessed by the Charlson Comorbidity Index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Chronic Non-Malignant Pain Among Cancer Patients</measure>
    <time_frame>1 days</time_frame>
    <description>Frequency assessed by Pain Characteristic Survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Chronic Non-Malignant Pain Among Cancer Patients</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency assessed by Karnofsky Performance Scale.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">201</enrollment>
  <condition>Malignant Neoplasms of Independent (Primary) Multiple Sites</condition>
  <arm_group>
    <arm_group_label>Chronic Non-Malignant Pain - Cancer Patients</arm_group_label>
    <description>Chronic non-malignant pain among cancer patients undergoing a consultation at the outpatient Supportive Care Clinic at MD Anderson Cancer Center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants complete three questionnaires at consultation visit.</description>
    <arm_group_label>Chronic Non-Malignant Pain - Cancer Patients</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants undergoing consultation at the Supportive Care Clinic at MD Anderson Cancer&#xD;
        Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of cancer with or without active disease&#xD;
&#xD;
          2. Consultation visit at an outpatient supportive care clinic&#xD;
&#xD;
          3. Age 18 or greater&#xD;
&#xD;
          4. Report of having pain within the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Memorial Delirium Assessment Scale &gt;13&#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>David Hui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant Neoplasms of Independent (Primary) Multiple Sites</keyword>
  <keyword>Non-malignant pain</keyword>
  <keyword>Supportive care</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Chronic non-malignant pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03043378
org study id: 2016-0901
secondary id: NCI-2018-01268
nct id: NCT03043378
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn how frequently cancer patients in the Supportive
      Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is
      neither related to cancer nor its treatment and lasts beyond the normal tissue healing time
      of 3 months.
If participant is found to be eligible and agrees to take part in this study, participant
      will be asked to complete 3 questionnaires about participant's pain, pain level, and what
      drugs participant takes to treat participant's pain. Participant will also be asked a few
      questions about tobacco use. These questionnaires should take about 20 minutes to complete.

      Researchers will also collect information from participant's medical record such as
      participant's date of birth, sex, race, marital status, economic background, and medical
      history.

      Length of Study:

      Participation on this study will be over after participant has completed the last
      questionnaire.

      This is an investigational study.

      Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.
observational model: Cohort
time perspective: Prospective
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
time frame: 1 day
description: Frequency assessed by Edmonton Symptom Assessment Scale (ESAS-FS)
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
time frame: 1 day
description: Frequency assessed by Brief Pain Inventory.
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
time frame: 1 day
description: Frequency assessed by the Charlson Comorbidity Index.
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
time frame: 1 days
description: Frequency assessed by Pain Characteristic Survey.
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
time frame: 1 day
description: Frequency assessed by Karnofsky Performance Scale.
arm group label: Chronic Non-Malignant Pain - Cancer Patients
description: Chronic non-malignant pain among cancer patients undergoing a consultation at the outpatient Supportive Care Clinic at MD Anderson Cancer Center.
intervention type: Behavioral
intervention name: Questionnaires
description: Participants complete three questionnaires at consultation visit.
arm group label: Chronic Non-Malignant Pain - Cancer Patients
other name: Surveys
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Hui, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms