<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/NCT03035448</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0679</org_study_id>
    <secondary_id>NCI-2018-01285</secondary_id>
    <nct_id>NCT03035448</nct_id>
  </id_info>
  <brief_title>Communication Strategies to Introduce Psychology Services</brief_title>
  <official_title>A Randomized Controlled Trial of Communication Strategies to Introduce Psychology Services in the Palliative Care Setting</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 about advanced cancer patients' preferences about&#xD;
      how psychology services are introduced.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, during an already-scheduled office visit, you will&#xD;
      complete 3 questionnaires about your symptoms, your emotional health, and if you have ever&#xD;
      participated in psychiatric or psychology services. These questionnaires should take about 9&#xD;
      minutes to complete.&#xD;
&#xD;
      All participants will watch 2 short videos. The videos show actors playing a doctor,&#xD;
      counselor, and patient, discussing psychology service options. Each video is about 1 minute&#xD;
      and 30 seconds long and will discuss the same material, but the content of each video will be&#xD;
      different. The order in which they are presented will be randomly assigned (as in the flip of&#xD;
      a coin). You will have an equal chance of seeing either video first.&#xD;
&#xD;
      After you watch the second video, you will complete 3 questionnaires about whether you think&#xD;
      1 of the videos was better than the other, and about your attitude toward psychology&#xD;
      services. These questionnaires should take about 4 minutes to complete.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      It should take about 16 minutes to watch both videos and to complete all questionnaires. Your&#xD;
      participation on this study will be over after you have completed the last questionnaire.&#xD;
&#xD;
      Other Information:&#xD;
&#xD;
      We will ask your caregiver(s) to leave the room while the videos are played. In case they&#xD;
      decide to stay, we will ask them to keep silent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants asked the preference to the introduction of counselor. The possible answers are The First Video, The Second Video, Neither, or No Difference. The actual content of the answers will be decoded by the study team at the end of the study to &quot;Counselor Alone&quot; or &quot;MD + Counselor&quot; depending on each patient's assigned arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Malignant Neoplasms of Independent (Primary) Multiple Sites</condition>
  <arm_group>
    <arm_group_label>Video 1: Counselor Alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete 3 assessment questionnaires during an already-scheduled office visit.&#xD;
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.&#xD;
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video 2: Doctor + Counselor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete 3 assessment questionnaires during an already-scheduled office visit.&#xD;
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.&#xD;
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete.&#xD;
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete.</description>
    <arm_group_label>Video 1: Counselor Alone</arm_group_label>
    <arm_group_label>Video 2: Doctor + Counselor</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Presentation</intervention_name>
    <description>Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.</description>
    <arm_group_label>Video 1: Counselor Alone</arm_group_label>
    <arm_group_label>Video 2: Doctor + Counselor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;/= 18 years-old&#xD;
&#xD;
          2. Can speak, read, and understand English&#xD;
&#xD;
          3. Diagnosis of locally advanced, recurrent, or metastatic disease&#xD;
&#xD;
          4. Patients treated as outpatients by the supportive and palliative care team&#xD;
&#xD;
          5. Normal cognitive status as determined by the interviewer based on the ability to&#xD;
             understand the nature of the study and consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous psychological counseling received in supportive care department&#xD;
&#xD;
          2. Patients with severe symptom distress as assessed by nursing staff&#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>Sujin Ann-Yi, PHD, MA</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>June 2022</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant neoplasms of independent (primary) multiple sites</keyword>
  <keyword>Advanced cancer</keyword>
  <keyword>Recurrent cancer</keyword>
  <keyword>Metastatic disease</keyword>
  <keyword>Palliative care</keyword>
  <keyword>Videos</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</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/NCT03035448
org study id: 2016-0679
secondary id: NCI-2018-01285
nct id: NCT03035448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn about advanced cancer patients' preferences about
      how psychology services are introduced.

      This is an investigational study.

      Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.
If you agree to take part in this study, during an already-scheduled office visit, you will
      complete 3 questionnaires about your symptoms, your emotional health, and if you have ever
      participated in psychiatric or psychology services. These questionnaires should take about 9
      minutes to complete.

      All participants will watch 2 short videos. The videos show actors playing a doctor,
      counselor, and patient, discussing psychology service options. Each video is about 1 minute
      and 30 seconds long and will discuss the same material, but the content of each video will be
      different. The order in which they are presented will be randomly assigned (as in the flip of
      a coin). You will have an equal chance of seeing either video first.

      After you watch the second video, you will complete 3 questionnaires about whether you think
      1 of the videos was better than the other, and about your attitude toward psychology
      services. These questionnaires should take about 4 minutes to complete.

      Length of Study:

      It should take about 16 minutes to watch both videos and to complete all questionnaires. Your
      participation on this study will be over after you have completed the last questionnaire.

      Other Information:

      We will ask your caregiver(s) to leave the room while the videos are played. In case they
      decide to stay, we will ask them to keep silent.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting
time frame: Day 1
description: Participants asked the preference to the introduction of counselor. The possible answers are The First Video, The Second Video, Neither, or No Difference. The actual content of the answers will be decoded by the study team at the end of the study to "Counselor Alone" or "MD + Counselor" depending on each patient's assigned arm.
arm group label: Video 1: Counselor Alone
arm group type: Experimental
description: Participants complete 3 assessment questionnaires during an already-scheduled office visit.
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services.
arm group label: Video 2: Doctor + Counselor
arm group type: Experimental
description: Participants complete 3 assessment questionnaires during an already-scheduled office visit.
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services.
intervention type: Behavioral
intervention name: Questionnaires
description: Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
arm group label: Video 1: Counselor Alone
arm group label: Video 2: Doctor + Counselor
other name: Surveys
intervention type: Other
intervention name: Video Presentation
description: Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
arm group label: Video 1: Counselor Alone
arm group label: Video 2: Doctor + Counselor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sujin Ann-Yi, PHD, MA
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