<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/NCT03287492</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0028</org_study_id>
    <secondary_id>NCI-2018-01052</secondary_id>
    <secondary_id>2017-0028</secondary_id>
    <nct_id>NCT03287492</nct_id>
  </id_info>
  <brief_title>RCT of QPS vs General Information Sheet</brief_title>
  <official_title>A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer</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>
      This trial studies how well information materials work in helping communication between&#xD;
      physicians and participants with cancer that has spread to other places in the body and their&#xD;
      caregivers. Approaches that encourage participants to actively participate and ask&#xD;
      appropriate questions during their visit may be important to enhance their understanding of&#xD;
      their illness and empower them to make important decisions regarding their medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare patients' perception of helpfulness in communicating with their physicians&#xD;
      between a question prompt sheet (QPS) and a general information sheet (GIS).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare caregivers' perception of helpfulness in communicating with their physicians&#xD;
      between the QPS and the GIS.&#xD;
&#xD;
      II. To examine the level of patients' and caregivers' overall satisfaction with the&#xD;
      consultation with the use of the QPS versus the GIS.&#xD;
&#xD;
      III. To examine physicians' views about the information material and overall satisfaction&#xD;
      with the use of the QPS versus the GIS.&#xD;
&#xD;
      IV. To explore how the use of QPS affects the average speaking time of patient or physician&#xD;
      during the consultation visit.&#xD;
&#xD;
      V. To establish demographic and clinical predictors of patients' perception of helpfulness of&#xD;
      a QPS.&#xD;
&#xD;
      VI. To examine the overall patients' preference between the QPS and GIS in an open label&#xD;
      phase.&#xD;
&#xD;
      VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.&#xD;
&#xD;
      VIII. To explore the factors underlying patients' preferences for the QPS or GIS.&#xD;
&#xD;
      OUTLINE: Participants are randomized into 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Participants receive QPS and answer questions from physician. At follow up visit,&#xD;
      participants receive both QPS and GIS.&#xD;
&#xD;
      GROUP II: Participants receive GIS and answer questions from physician. At follow up visit,&#xD;
      participants receive both QPS and GIS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Standard statistics including mean, standard deviation, median, range, frequency and percentage will be summarized for variables of interest, such as patients' demographics, clinical characteristics, anxiety state, patients'/caregivers' views about the information material, patients' satisfaction, physicians' views about the information material and consultation, patients' preferences for information, patient preferences for level of involvement in decision-making and patients' overall preference between the question prompt sheet (QPS) and the general information sheet (GIS) at the follow-up visit. Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare continuous variables of interest between the QPS and the GIS. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between categorical variables and helpfulness of information material.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregivers' perception of helpfulness in communicating with their physicians</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients'/caregivers' overall satisfaction with the consultation</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's view/overall satisfaction about the information material</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient anxiety state scores before and after consultation between the QPS and the GIS</measure>
    <time_frame>Baseline up to 6 weeks</time_frame>
    <description>Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average speaking time of patient or physician during the consultation visit affected by QPS</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the average speaking time of patient or physician during the consultation visit. Also, general linear model will be applied to assess the effect of QPS on the average speaking time adjusting for clinically and/or statistically important factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic and clinical predictors of patients' perception of helpfulness of a QPS</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on patients' perception of helpfulness of QPS when dichotomizing the answer to the question 3 in the Patient/Caregiver Assessment Questionnaire (&quot;Agree/Strongly Agree&quot;=Helpful versus the rest).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patients' preference between the QPS and GIS in an open label phase</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will estimate the preference of information material with 95% confidence intervals. Also, univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on overall patients' preference between QPS and GIS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Advanced Malignant Neoplasm</condition>
  <condition>Caregiver</condition>
  <condition>Physician</condition>
  <arm_group>
    <arm_group_label>Group I (QPS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (GIS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational Intervention</intervention_name>
    <description>Receive QPS</description>
    <arm_group_label>Group I (QPS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational Intervention</intervention_name>
    <description>Receive GIS</description>
    <arm_group_label>Group II (GIS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (QPS)</arm_group_label>
    <arm_group_label>Group II (GIS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (Patient participation) First outpatient consultation visit with a palliative care&#xD;
             specialist&#xD;
&#xD;
          -  (Patient participation) Normal cognitive status, defined as a normal state of arousal&#xD;
             and an absence of obvious clinical findings of confusion, memory deficits or&#xD;
             concentration deficits, as determined by the patient's physician&#xD;
&#xD;
          -  (Patient participation) Ability to read and communicate in English&#xD;
&#xD;
          -  (Patient participation) Diagnosis of advanced cancer&#xD;
&#xD;
          -  (Patient participation) Signed written informed consent form&#xD;
&#xD;
          -  (Caregiver participation) accompanied the patient to the clinic visit&#xD;
&#xD;
          -  (Caregiver participation) is identified by the patient as someone who is actively&#xD;
             involved in their overall care&#xD;
&#xD;
          -  (Caregiver participation) is able to read and communicate in English&#xD;
&#xD;
          -  (Caregiver participation) is willing to participate in the study and able to complete&#xD;
             the questionnaires&#xD;
&#xD;
          -  (Physician participation) a palliative medicine specialist&#xD;
&#xD;
          -  (Physician participation) seeing the patient in consultation on the day of the study&#xD;
&#xD;
          -  (Physician participation) willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph A Arthur</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>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</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>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/NCT03287492
org study id: 2017-0028
secondary id: NCI-2018-01052
secondary id: 2017-0028
nct id: NCT03287492
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how well information materials work in helping communication between
      physicians and participants with cancer that has spread to other places in the body and their
      caregivers. Approaches that encourage participants to actively participate and ask
      appropriate questions during their visit may be important to enhance their understanding of
      their illness and empower them to make important decisions regarding their medical care.
PRIMARY OBJECTIVES:

      I. To compare patients' perception of helpfulness in communicating with their physicians
      between a question prompt sheet (QPS) and a general information sheet (GIS).

      SECONDARY OBJECTIVES:

      I. To compare caregivers' perception of helpfulness in communicating with their physicians
      between the QPS and the GIS.

      II. To examine the level of patients' and caregivers' overall satisfaction with the
      consultation with the use of the QPS versus the GIS.

      III. To examine physicians' views about the information material and overall satisfaction
      with the use of the QPS versus the GIS.

      IV. To explore how the use of QPS affects the average speaking time of patient or physician
      during the consultation visit.

      V. To establish demographic and clinical predictors of patients' perception of helpfulness of
      a QPS.

      VI. To examine the overall patients' preference between the QPS and GIS in an open label
      phase.

      VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.

      VIII. To explore the factors underlying patients' preferences for the QPS or GIS.

      OUTLINE: Participants are randomized into 1 of 2 groups.

      GROUP I: Participants receive QPS and answer questions from physician. At follow up visit,
      participants receive both QPS and GIS.

      GROUP II: Participants receive GIS and answer questions from physician. At follow up visit,
      participants receive both QPS and GIS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
time frame: Up to 3 years
description: Standard statistics including mean, standard deviation, median, range, frequency and percentage will be summarized for variables of interest, such as patients' demographics, clinical characteristics, anxiety state, patients'/caregivers' views about the information material, patients' satisfaction, physicians' views about the information material and consultation, patients' preferences for information, patient preferences for level of involvement in decision-making and patients' overall preference between the question prompt sheet (QPS) and the general information sheet (GIS) at the follow-up visit. Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare continuous variables of interest between the QPS and the GIS. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between categorical variables and helpfulness of information material.
measure: Caregivers' perception of helpfulness in communicating with their physicians
time frame: Up to 3 years
description: Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
measure: Patients'/caregivers' overall satisfaction with the consultation
time frame: Up to 3 years
description: Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
measure: Physician's view/overall satisfaction about the information material
time frame: Up to 3 years
description: Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
measure: Change in patient anxiety state scores before and after consultation between the QPS and the GIS
time frame: Baseline up to 6 weeks
description: Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
measure: Average speaking time of patient or physician during the consultation visit affected by QPS
time frame: Up to 3 years
description: Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the average speaking time of patient or physician during the consultation visit. Also, general linear model will be applied to assess the effect of QPS on the average speaking time adjusting for clinically and/or statistically important factors.
measure: Demographic and clinical predictors of patients' perception of helpfulness of a QPS
time frame: Up to 3 years
description: Univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on patients' perception of helpfulness of QPS when dichotomizing the answer to the question 3 in the Patient/Caregiver Assessment Questionnaire ("Agree/Strongly Agree"=Helpful versus the rest).
measure: Overall patients' preference between the QPS and GIS in an open label phase
time frame: Up to 3 years
description: Will estimate the preference of information material with 95% confidence intervals. Also, univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on overall patients' preference between QPS and GIS.
arm group label: Group I (QPS)
arm group type: Experimental
description: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
arm group label: Group II (GIS)
arm group type: Active Comparator
description: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
intervention type: Other
intervention name: Informational Intervention
description: Receive QPS
arm group label: Group I (QPS)
intervention type: Other
intervention name: Informational Intervention
description: Receive GIS
arm group label: Group II (GIS)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (QPS)
arm group label: Group II (GIS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph A Arthur
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