<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/NCT01716780</url>
  </required_header>
  <id_info>
    <org_study_id>CCR3439</org_study_id>
    <nct_id>NCT01716780</nct_id>
  </id_info>
  <brief_title>Pain: Screen and Treat</brief_title>
  <official_title>Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is looking at treating cancer pain in head and neck cancer. Patients are asked in&#xD;
      outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with&#xD;
      a pain score of 4 and above are randomised into the study.&#xD;
&#xD;
      Patients are allocated to continue with their current care (control group) or to be reviewed&#xD;
      by the pain/palliative care team (intervention group). At baseline questionnaires are&#xD;
      completed on level of pain, type of pain, quality of life and anxiety/depression. Information&#xD;
      is also collected on the analgesia they've used in the past month and basic health economics&#xD;
      (GP/hospital visits related to pain management and treatment).&#xD;
&#xD;
      Follow up in the trial is for 3 months and consists of questionnaires as above and further&#xD;
      collection of information on analgesic usage and health economics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>Phase 3</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in pain score summarized from patient reports</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of pain</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>Measured by the brief pain inventory questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequacy of pain treatment</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
    <description>Using Pain Management Index, calculated from BPI and WHO ladder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
    <description>Assessed using the EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
    <description>Assessed using the Hospital anxiety and depression questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment costs</measure>
    <time_frame>1 month, 2 months and 3 months</time_frame>
    <description>Information collected on analgesic usage and contact with healthcare professionals for pain management purposes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients allocated to the &quot;control group&quot; will undergo their 'usual care'; they will be given pain medication when they specifically request it or when their oncology doctor/ nurse or GP considers it appropriate to prescribe it, either at the oncology clinic visit or at any time during the course of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the &quot;intervention group&quot; will be reviewed by the pain/palliative care team and will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Patients allocated to the &quot;intervention group&quot; will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients attending head and neck oncology clinics&#xD;
&#xD;
          -  Patients with a cancer diagnosis who are receiving anti cancer treatment or who have&#xD;
             received anti cancer treatment&#xD;
&#xD;
          -  Patients who score 4 or more on the Brief Pain Inventory numerical rating scale&#xD;
             screening question 'worst pain in past 24 hours'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18 years&#xD;
&#xD;
          -  patients unable to respond to an English written assessment&#xD;
&#xD;
          -  patients with medical conditions that could affect their mental function or level of&#xD;
             consciousness such as stroke, or dementia&#xD;
&#xD;
          -  patients who score &lt;4 on the Brief Pain Inventory numerical rating scale screening&#xD;
             question&#xD;
&#xD;
          -  patients already under the care of a pain/palliative care service&#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>John E Williams</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Marsden NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>RMH R&amp;D</investigator_full_name>
    <investigator_title>Dr John Williams</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT01716780
org study id: CCR3439
nct id: NCT01716780
lead sponsor: 
collaborator: 
has dmc: No
This study is looking at treating cancer pain in head and neck cancer. Patients are asked in
      outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with
      a pain score of 4 and above are randomised into the study.

      Patients are allocated to continue with their current care (control group) or to be reviewed
      by the pain/palliative care team (intervention group). At baseline questionnaires are
      completed on level of pain, type of pain, quality of life and anxiety/depression. Information
      is also collected on the analgesia they've used in the past month and basic health economics
      (GP/hospital visits related to pain management and treatment).

      Follow up in the trial is for 3 months and consists of questionnaires as above and further
      collection of information on analgesic usage and health economics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The change in pain score summarized from patient reports
time frame: 1 month, 2 months and 3 months
measure: Impact of pain
time frame: 1 month, 2 months, 3 months
description: Measured by the brief pain inventory questionnaire
measure: Adequacy of pain treatment
time frame: 1 month, 2 months and 3 months
description: Using Pain Management Index, calculated from BPI and WHO ladder
measure: Quality of life
time frame: 1 month, 2 months and 3 months
description: Assessed using the EQ-5D questionnaire
measure: Patient satisfaction
time frame: 1 month, 2 months and 3 months
description: Likert scale
measure: Anxiety and depression
time frame: 1 month, 2 months and 3 months
description: Assessed using the Hospital anxiety and depression questionnaire
measure: Treatment costs
time frame: 1 month, 2 months and 3 months
description: Information collected on analgesic usage and contact with healthcare professionals for pain management purposes
arm group label: Routine care
arm group type: No Intervention
description: Patients allocated to the "control group" will undergo their 'usual care'; they will be given pain medication when they specifically request it or when their oncology doctor/ nurse or GP considers it appropriate to prescribe it, either at the oncology clinic visit or at any time during the course of the study.
arm group label: Intervention
arm group type: Experimental
description: Patients allocated to the "intervention group" will be reviewed by the pain/palliative care team and will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care.
intervention type: Other
intervention name: Intervention
description: Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John E Williams
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Royal Marsden NHS Foundation Trust
investigator full name: RMH R&D
investigator title: Dr John Williams
mesh term: Head and Neck Neoplasms