<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/NCT01667965</url>
  </required_header>
  <id_info>
    <org_study_id>12-172</org_study_id>
    <nct_id>NCT01667965</nct_id>
  </id_info>
  <brief_title>Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy</brief_title>
  <official_title>Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness and acceptability of a recently&#xD;
      created informative video geared for patients who have been evaluated by a radiation&#xD;
      oncologist for palliative radiation therapy during a hospitalization at Memorial&#xD;
      Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is&#xD;
      given to patients with the purpose of easing symptoms from cancer. It is not given with the&#xD;
      intent to cure the cancer. The video presents basic information about palliative radiation&#xD;
      and palliative care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>create an effective video decision aid</measure>
    <time_frame>1 year</time_frame>
    <description>Effectiveness of the video tool will be assessed by the following measures before and after watching the video. The pre- and post-assessment design comparing uncertainty, knowledge and preference scores of a video explaining palliative radiation and palliative care.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Metastatic Cancer or Locally Advanced</condition>
  <condition>Patients Receiving Palliative Radiation</condition>
  <arm_group>
    <arm_group_label>pts receiving palliative radiation therapy</arm_group_label>
    <description>The design of the study will be a prospective non-randomized cohort study with structured questionnaires administered to all enrolled patients at two or three time-points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <description>Questionnaires will be given before the patient watches a video educational tool to aid informed consent about palliative radiation therapy; and (2) after the patient watches the video educational tool. (3) If the patient receives PRT, a final questionnaire that assesses the patient's impression of the video will also be administered at the conclusion of radiation therapy.</description>
    <arm_group_label>pts receiving palliative radiation therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients will be approached regarding study enrollment at the time that they are&#xD;
        evaluated by the inpatient radiation oncology team for palliative radiation therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Eligible for palliative radiation to the brain, spine, chest, abdomen, pelvis, skin,&#xD;
             or bone as per the judgment of the radiation oncologist or nurse practitioner&#xD;
&#xD;
          -  Patient is English-speaking and able to give informed consent and fill out study&#xD;
             questionnaires&#xD;
&#xD;
          -  Hospitalized at MSKCC&#xD;
&#xD;
          -  Pathologically confirmed malignancy&#xD;
&#xD;
          -  Cancer is metastatic or locally advanced, and is not curable&#xD;
&#xD;
          -  Patients who may undergo radiation at a satellite facility are still eligible for&#xD;
             protocol enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who have seen the video beforehand&#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>Beryl McCormack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>July 13, 2015</last_update_submitted>
  <last_update_submitted_qc>July 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>palliative radiation</keyword>
  <keyword>12-172</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT01667965
org study id: 12-172
nct id: NCT01667965
lead sponsor: 
The purpose of this study is to assess the effectiveness and acceptability of a recently
      created informative video geared for patients who have been evaluated by a radiation
      oncologist for palliative radiation therapy during a hospitalization at Memorial
      Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is
      given to patients with the purpose of easing symptoms from cancer. It is not given with the
      intent to cure the cancer. The video presents basic information about palliative radiation
      and palliative care.
observational model: Case-Only
time perspective: Prospective
measure: create an effective video decision aid
time frame: 1 year
description: Effectiveness of the video tool will be assessed by the following measures before and after watching the video. The pre- and post-assessment design comparing uncertainty, knowledge and preference scores of a video explaining palliative radiation and palliative care.
arm group label: pts receiving palliative radiation therapy
description: The design of the study will be a prospective non-randomized cohort study with structured questionnaires administered to all enrolled patients at two or three time-points.
intervention type: Behavioral
intervention name: questionnaires
description: Questionnaires will be given before the patient watches a video educational tool to aid informed consent about palliative radiation therapy; and (2) after the patient watches the video educational tool. (3) If the patient receives PRT, a final questionnaire that assesses the patient's impression of the video will also be administered at the conclusion of radiation therapy.
arm group label: pts receiving palliative radiation therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beryl McCormack, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Neoplasm Metastasis