<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/NCT04483349</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0211</org_study_id>
    <secondary_id>NCI-2020-04577</secondary_id>
    <secondary_id>2020-0211</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT04483349</nct_id>
  </id_info>
  <brief_title>Assessment of What Patients and Healthcare Providers Value</brief_title>
  <official_title>&quot;What Do You Value?&quot; A Survey Study Assessing How Patients and Health Care Providers Weigh the Different Components of the Value Equation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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>
      To assess the importance patients place on each of the attributes of value (i.e., outcomes,&#xD;
      quality of life [QOL], cost, experience), and how these patientsâ€™ views differ depending on&#xD;
      the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term&#xD;
      surveillance, recurrence).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To assess the importance patients place on each of the attributes of value (i.e.,&#xD;
      outcomes, quality of life [QOL], cost, experience).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess which attributes of value (i.e., outcomes, QOL, cost, experience) health care&#xD;
      providers (i.e., physicians, nurses, administrators) feel are most important in health care&#xD;
      delivery.&#xD;
&#xD;
      II. To assess how these patients' views differ depending on the stage of their therapy&#xD;
      (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).&#xD;
&#xD;
      III. To assess how patients' view differ to health providers.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients and healthcare providers complete a survey over 10-15 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">August 11, 2022</completion_date>
  <primary_completion_date type="Actual">August 11, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)</measure>
    <time_frame>Survey completion up to 1 year</time_frame>
    <description>We will calculate the mean rank of patients yielding usable data and its corresponding 95% confidence interval. Patient characteristics and survey items will be summarized using descriptive statistics, including means, standard deviations (SDs), proportions, range, and 95% confidence intervals (CIs), etc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Most important attributes of value to healthcare providers</measure>
    <time_frame>Survey completion up to 1 year</time_frame>
    <description>Provider characteristics and survey items will be summarized using descriptive statistics, including means, SDs, proportions, range, and 95% CIs, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Importance care providers (i.e., physicians, nurses, administrators) place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)</measure>
    <time_frame>Survey completion up to 1 year</time_frame>
    <description>Chi-square tests (or Fisher's exact test) will be used to compare the results between patients and providers.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">397</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <condition>Pancreatic Adenocarcinoma</condition>
  <condition>Pancreatic Neuroendocrine Carcinoma</condition>
  <arm_group>
    <arm_group_label>Observational (survey administration)</arm_group_label>
    <description>Patients and healthcare providers complete a survey over 10-15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete survey</description>
    <arm_group_label>Observational (survey administration)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric&#xD;
        adenocarcinoma, and healthcare providers involved in the care of gastric and pancreatic&#xD;
        cancer patients at the MD Anderson Cancer Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who has been treated, or is anticipated to be treated, for potentially&#xD;
             resectable, biopsy-proven pancreatic adenocarcinoma, pancreatic neuroendocrine&#xD;
             malignancy, or gastric adenocarcinoma&#xD;
&#xD;
          -  Providers involved in the care of gastric and pancreatic cancer patients. Providers&#xD;
             will include non-collaborative surgical oncologists, medical oncologists, radiation&#xD;
             oncologists, administrators, nurses, mid-level providers&#xD;
&#xD;
          -  Able to understand the description of the study and willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read and answer questions in English&#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 H Katz</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D 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>Related Info</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
    <mesh_term>Carcinoma, Islet Cell</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/NCT04483349
org study id: 2020-0211
secondary id: NCI-2020-04577
secondary id: 2020-0211
secondary id: P30CA016672
nct id: NCT04483349
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the importance patients place on each of the attributes of value (i.e., outcomes,
      quality of life [QOL], cost, experience), and how these patientsâ€™ views differ depending on
      the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term
      surveillance, recurrence).
PRIMARY OBJECTIVE:

      I. To assess the importance patients place on each of the attributes of value (i.e.,
      outcomes, quality of life [QOL], cost, experience).

      SECONDARY OBJECTIVES:

      I. To assess which attributes of value (i.e., outcomes, QOL, cost, experience) health care
      providers (i.e., physicians, nurses, administrators) feel are most important in health care
      delivery.

      II. To assess how these patients' views differ depending on the stage of their therapy
      (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).

      III. To assess how patients' view differ to health providers.

      OUTLINE:

      Patients and healthcare providers complete a survey over 10-15 minutes.
observational model: Cohort
time perspective: Cross-Sectional
measure: Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
time frame: Survey completion up to 1 year
description: We will calculate the mean rank of patients yielding usable data and its corresponding 95% confidence interval. Patient characteristics and survey items will be summarized using descriptive statistics, including means, standard deviations (SDs), proportions, range, and 95% confidence intervals (CIs), etc.
measure: Most important attributes of value to healthcare providers
time frame: Survey completion up to 1 year
description: Provider characteristics and survey items will be summarized using descriptive statistics, including means, SDs, proportions, range, and 95% CIs, etc.
measure: Importance care providers (i.e., physicians, nurses, administrators) place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
time frame: Survey completion up to 1 year
description: Chi-square tests (or Fisher's exact test) will be used to compare the results between patients and providers.
arm group label: Observational (survey administration)
description: Patients and healthcare providers complete a survey over 10-15 minutes.
intervention type: Other
intervention name: Survey Administration
description: Complete survey
arm group label: Observational (survey administration)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew H Katz
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: Related Info
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Carcinoma, Neuroendocrine
mesh term: Carcinoma, Islet Cell