<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/NCT03266276</url>
  </required_header>
  <id_info>
    <org_study_id>267-2016</org_study_id>
    <nct_id>NCT03266276</nct_id>
  </id_info>
  <brief_title>Assessing Impact of CCO's PSO &amp; PC Pathway in Ambulatory HNC Clinics</brief_title>
  <official_title>Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology &amp; Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Rates of depression and anxiety in cancer patients are much higher compared to the general&#xD;
      population. 40% of head and neck cancer patients will develop significant distress along the&#xD;
      cancer journey. Less than half of these patients are able to access support, with factors&#xD;
      such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000&#xD;
      Canadians died of cancer, yet there is limited implementation of routine and integrated&#xD;
      advanced care planning in cancer care.&#xD;
&#xD;
      An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care&#xD;
      Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways.&#xD;
      Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will&#xD;
      impact &gt;16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare&#xD;
      utilization, improve treatment decisions and compliance, enable a better quality of life in&#xD;
      survivorship and improve quality at end of life. There is a need for better developed,&#xD;
      standardized response pathways to address PSO and PC needs throughout the patient's journey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head and neck cancer (HNC) is the sixth most commonly diagnosed cancer worldwide. Individuals&#xD;
      with HNC experience a high burden of symptom-related distress (e.g. emotional, physical,&#xD;
      psychological, spiritual etc.). Additionally, HNC patients may experience facial&#xD;
      disfigurement, communication barriers, social stigma, lack of social support, and/or&#xD;
      self-imposed or experienced disease stigma. The presence of depression, anxiety or social&#xD;
      difficulty is relatively common in HNC patients yet less than half of those with significant&#xD;
      distress access psychosocial (PSO) and palliative care (PC). Few studies have examined a&#xD;
      systematic response to reducing distress, integrating a routine psychosocial and palliative&#xD;
      care approach to oncology, with planning for future care for this population.&#xD;
&#xD;
      Most cancer centres do not have a systematic model of practice geared towards distress&#xD;
      screening, PC and PSO approach to care. Therefore, determining how to best incorporate PSO&#xD;
      and PC (PSOPC) into the interprofessional oncology clinic management of patients with HNC&#xD;
      remains an important and unanswered question. The question remains of how to proactively&#xD;
      identify those at higher risk for distress and greater need for specialized psychosocial or&#xD;
      palliative care. Some oncologists consider the provision of PSOPC as an integral part of&#xD;
      their professional role. Yet increasing the delivery of quality primary PSOPC by busy&#xD;
      oncologists may require targeted training, the use of algorithms to prompt PC and PSO&#xD;
      assessment, incorporating response to distress screening / advanced care planning tools into&#xD;
      routine clinical processes, prompts to document conversations about illness understanding and&#xD;
      consideration of individual factors influencing treatment decisions.&#xD;
&#xD;
      The primary goal of this study is to integrate quality primary level PSO and PC into clinic&#xD;
      care by developing and evaluating a routine response to screening in hopes of increasing&#xD;
      documentation of the following: discussion of response to ESAS, illness understanding,&#xD;
      advanced care planning or goals of care conversations.&#xD;
&#xD;
      Specifically, this study will examine the impact of Cancer Care Ontario's (CCO) PSOPC&#xD;
      Pathway, an expert panel recommended algorithm for assessing and managing symptoms and&#xD;
      initiating a PSOPC approach and timely specialized referral, when necessary.&#xD;
&#xD;
      Phase Two: Randomized Controlled Trial&#xD;
&#xD;
      After completing the needs assessment and interprofessional team training in PSO and PC, an&#xD;
      RCT will be used to examine the impact of using a standardized PSOPC pathway approach,&#xD;
      prompted follow up with patients and documentation. Participants will be recruited and&#xD;
      randomized into care as usual group and &quot;intervention&quot; PSOPC pathway group.&#xD;
&#xD;
      Main Hypothesis:&#xD;
&#xD;
      It is hypothesized that compared to treatment as usual, the PSOPC pathway intervention group&#xD;
      will result in an increase in (larger proportion of):&#xD;
&#xD;
      Rationale and Objective:&#xD;
&#xD;
      Innovation: Model of clinical service delivery Currently, there is no standardized process&#xD;
      for meeting the psychosocial and palliative care needs of HNC. This project promotes&#xD;
      learner,needs-driven professional development, and knowledge translation. It will foster a&#xD;
      person-focused, results-driven, integrated and sustainable model of clinical service&#xD;
      delivery.&#xD;
&#xD;
      Individual clinics and cancer centres have developed their own responses to Edmonton Symptom&#xD;
      Assessment System (ESAS) distress screening. However, we believe this project is a unique&#xD;
      Oncology Team/PC/PSO/Patient Advisor collaboration, where all members will work together to&#xD;
      improve symptom assessment and management, improve discussions and documentation involving&#xD;
      illness understanding and advanced care planning to better meet PSO and PC needs, whilst&#xD;
      assessing the role for the PSOPC Pathway.&#xD;
&#xD;
      An additional innovation for this project is to develop and evaluate a customizable approach&#xD;
      to assessing the needs of an oncology team, thereby shaping both professional development&#xD;
      experiences and determining a model of care delivery that should be acceptable within the&#xD;
      clinic frame.&#xD;
&#xD;
      Improving Healthcare and Patient Experience:&#xD;
&#xD;
      The CCO PSOPC pathway was designed to guide improvements in the provision of primary PSOPC&#xD;
      Care, including symptom response, communication, illness understanding, advanced care&#xD;
      planning, as well as increased identification of those who require access to specialized PSO&#xD;
      and PC beyond the skill set of the oncology team. An inaccurate illness understanding&#xD;
      (whether the cancer is curable or not and whether it is progressing) hinders informed&#xD;
      discussions and decisions and supportive end of life planning. And, while some patients with&#xD;
      moderate to severe ESAS ratings have their symptoms assessed and managed, this is not the&#xD;
      case for all patients. Earlier advanced care planning discussions help patients and their&#xD;
      families have a better understanding of the disease to make more personalized, informed&#xD;
      decisions about care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>
    <intervention_model_description>Randomized Controlled Trial&#xD;
After completing HNC staff interprofessional team training in PSO and PC, an RCT will be used to examine the impact of using a standardized PSOPC pathway approach, prompted follow up with patients and documentation. Participants will be recruited and randomized into (1) care as usual group and (2) &quot;intervention&quot; PSOPC pathway group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)</measure>
    <time_frame>baseline</time_frame>
    <description>Documented high ESAS scores (&gt;6) and of all PPS scores, symptom management and conversations about PSO-either distress/management/referral/resources, PC needs, and ACP, illness understanding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>Valid and reliable 30-item questionnaire assessing health related quality of life&#xD;
o 5 functional, 3 symptom, global HRQOL and single item scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>PMH-PSQ 24 taps domains of Interpersonal skills, time spent with physician, information and physician relationship likert-type response scale (strongly agree/agree/disagree/strongly disagree/does not apply) consisting of 24 items (49)&#xD;
o Measures two facets of satisfaction with care: physician disengagement and perceived support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mixed-methods interviews</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Mixed-methods interview questions assess patients' perceptions of their overall treatment experience and care received at OCC&#xD;
10 open-ended questions assessing patients' perceptions of the compassion and empathy received from HCPs&#xD;
10 questions taken from CCO's Person-Centered Care and Patient Experience with Outpatient Cancer Care Index assessing three dimensions of care: communication, self-management and support for shared decision-making&#xD;
31 questions taken the Ambulatory Oncology Patient Satisfaction Survey (AOPSS) assessing patients' perceptions of emotional support; information, communication and education; respect for patient preferences; coordination and continuity of care; physical comfort and access to care&#xD;
3 questions from iLead Champions Conversations With Patients assessing whether patients felt their personal needs were heard and met by HCPs during treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>9 questions corresponding to the 9 diagnostic criteria for major depression DSMV as '0' (not at all) to '3' (nearly every day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI-II)</measure>
    <time_frame>baseline, 1, 3, and 6 mnths</time_frame>
    <description>If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Anxiety Disorder (GAD-7)</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>To measure the severity of anxiety among patients 7-item tool based on DSM-V criteria has a scale similar to PHQ-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences in Close Relationships Inventory</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>Assessing how patients feel in close relationships with other people</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and, if participating, Caregiver Semi-structured interview</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>A series of qualitative and quantitative questions assessing patients' experiences during care and caregivers' perceptions of quality of care, illness understanding and whether patient psychosocial and palliative needs were met during treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edmonton Symptom Assessment System</measure>
    <time_frame>baseline, 1 and 3 months</time_frame>
    <description>9 items designed to assess the severity of the most commonly reported symptoms experienced by cancer patients including pain, fatigue, drowsiness, nausea, dyspnea, depression, anxiety, well-being, and loss of appetite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palliative Performance Scale</measure>
    <time_frame>baseline</time_frame>
    <description>Quantitatively represents a person's performance status and ability to function&#xD;
11 point scale from 100% (healthy) to 0% (death) with 10% decrements&#xD;
The scale is based on five observable parameters: ambulation, ability to do activities, self-care, food/fluid intake, and consciousness level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Understanding Questionnaire</measure>
    <time_frame>1, 3, and 6 months</time_frame>
    <description>A series of questions assessing patients' understanding of the course, nature and treatment of their illness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">81</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Supportive Care</condition>
  <arm_group>
    <arm_group_label>Treatment as Usual Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PSOPC pathway approach</intervention_name>
    <description>The intervention will use a standardized PSOPC pathway approach, prompted follow up with patients and documentation.&#xD;
Additionally, clinicians will be prompted to document conversations about response to emotional or physical ESAS symptom scores, symptom management plan (self/education/monitoring/medication), illness understanding; and, if necessary, an offer of PSO/PC referral.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting ambulatory OCC HNC patients, with baseline ESAS scores of &gt;2 (emotional) or&#xD;
             &gt;3 (physical symptoms) with no active suicidal ideation, cognitive impairment or&#xD;
             significant debilitation such that participation would be burdensome for participants&#xD;
             and/or safety concerns as determined by a research assistant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If participants endorse thoughts of dying at baseline, they will be asked to complete&#xD;
             semi-structured questions to assess suicidal ideation (SI). If there is any active SI&#xD;
             or intent, the oncology team will be informed, a record kept and the participant will&#xD;
             be withdrawn from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet Ellis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2019</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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03266276
org study id: 267-2016
nct id: NCT03266276
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rates of depression and anxiety in cancer patients are much higher compared to the general
      population. 40% of head and neck cancer patients will develop significant distress along the
      cancer journey. Less than half of these patients are able to access support, with factors
      such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000
      Canadians died of cancer, yet there is limited implementation of routine and integrated
      advanced care planning in cancer care.

      An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care
      Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways.
      Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will
      impact >16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare
      utilization, improve treatment decisions and compliance, enable a better quality of life in
      survivorship and improve quality at end of life. There is a need for better developed,
      standardized response pathways to address PSO and PC needs throughout the patient's journey.
Head and neck cancer (HNC) is the sixth most commonly diagnosed cancer worldwide. Individuals
      with HNC experience a high burden of symptom-related distress (e.g. emotional, physical,
      psychological, spiritual etc.). Additionally, HNC patients may experience facial
      disfigurement, communication barriers, social stigma, lack of social support, and/or
      self-imposed or experienced disease stigma. The presence of depression, anxiety or social
      difficulty is relatively common in HNC patients yet less than half of those with significant
      distress access psychosocial (PSO) and palliative care (PC). Few studies have examined a
      systematic response to reducing distress, integrating a routine psychosocial and palliative
      care approach to oncology, with planning for future care for this population.

      Most cancer centres do not have a systematic model of practice geared towards distress
      screening, PC and PSO approach to care. Therefore, determining how to best incorporate PSO
      and PC (PSOPC) into the interprofessional oncology clinic management of patients with HNC
      remains an important and unanswered question. The question remains of how to proactively
      identify those at higher risk for distress and greater need for specialized psychosocial or
      palliative care. Some oncologists consider the provision of PSOPC as an integral part of
      their professional role. Yet increasing the delivery of quality primary PSOPC by busy
      oncologists may require targeted training, the use of algorithms to prompt PC and PSO
      assessment, incorporating response to distress screening / advanced care planning tools into
      routine clinical processes, prompts to document conversations about illness understanding and
      consideration of individual factors influencing treatment decisions.

      The primary goal of this study is to integrate quality primary level PSO and PC into clinic
      care by developing and evaluating a routine response to screening in hopes of increasing
      documentation of the following: discussion of response to ESAS, illness understanding,
      advanced care planning or goals of care conversations.

      Specifically, this study will examine the impact of Cancer Care Ontario's (CCO) PSOPC
      Pathway, an expert panel recommended algorithm for assessing and managing symptoms and
      initiating a PSOPC approach and timely specialized referral, when necessary.

      Phase Two: Randomized Controlled Trial

      After completing the needs assessment and interprofessional team training in PSO and PC, an
      RCT will be used to examine the impact of using a standardized PSOPC pathway approach,
      prompted follow up with patients and documentation. Participants will be recruited and
      randomized into care as usual group and "intervention" PSOPC pathway group.

      Main Hypothesis:

      It is hypothesized that compared to treatment as usual, the PSOPC pathway intervention group
      will result in an increase in (larger proportion of):

      Rationale and Objective:

      Innovation: Model of clinical service delivery Currently, there is no standardized process
      for meeting the psychosocial and palliative care needs of HNC. This project promotes
      learner,needs-driven professional development, and knowledge translation. It will foster a
      person-focused, results-driven, integrated and sustainable model of clinical service
      delivery.

      Individual clinics and cancer centres have developed their own responses to Edmonton Symptom
      Assessment System (ESAS) distress screening. However, we believe this project is a unique
      Oncology Team/PC/PSO/Patient Advisor collaboration, where all members will work together to
      improve symptom assessment and management, improve discussions and documentation involving
      illness understanding and advanced care planning to better meet PSO and PC needs, whilst
      assessing the role for the PSOPC Pathway.

      An additional innovation for this project is to develop and evaluate a customizable approach
      to assessing the needs of an oncology team, thereby shaping both professional development
      experiences and determining a model of care delivery that should be acceptable within the
      clinic frame.

      Improving Healthcare and Patient Experience:

      The CCO PSOPC pathway was designed to guide improvements in the provision of primary PSOPC
      Care, including symptom response, communication, illness understanding, advanced care
      planning, as well as increased identification of those who require access to specialized PSO
      and PC beyond the skill set of the oncology team. An inaccurate illness understanding
      (whether the cancer is curable or not and whether it is progressing) hinders informed
      discussions and decisions and supportive end of life planning. And, while some patients with
      moderate to severe ESAS ratings have their symptoms assessed and managed, this is not the
      case for all patients. Earlier advanced care planning discussions help patients and their
      families have a better understanding of the disease to make more personalized, informed
      decisions about care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
After completing HNC staff interprofessional team training in PSO and PC, an RCT will be used to examine the impact of using a standardized PSOPC pathway approach, prompted follow up with patients and documentation. Participants will be recruited and randomized into (1) care as usual group and (2) "intervention" PSOPC pathway group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
time frame: baseline
description: Documented high ESAS scores (>6) and of all PPS scores, symptom management and conversations about PSO-either distress/management/referral/resources, PC needs, and ACP, illness understanding
measure: The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)
time frame: baseline, 1, 3, and 6 months
description: Valid and reliable 30-item questionnaire assessing health related quality of life
o 5 functional, 3 symptom, global HRQOL and single item scales
measure: Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)
time frame: baseline, 1, 3, and 6 months
description: PMH-PSQ 24 taps domains of Interpersonal skills, time spent with physician, information and physician relationship likert-type response scale (strongly agree/agree/disagree/strongly disagree/does not apply) consisting of 24 items (49)
o Measures two facets of satisfaction with care: physician disengagement and perceived support.
measure: Mixed-methods interviews
time frame: 1 and 3 months
description: Mixed-methods interview questions assess patients' perceptions of their overall treatment experience and care received at OCC
10 open-ended questions assessing patients' perceptions of the compassion and empathy received from HCPs
10 questions taken from CCO's Person-Centered Care and Patient Experience with Outpatient Cancer Care Index assessing three dimensions of care: communication, self-management and support for shared decision-making
31 questions taken the Ambulatory Oncology Patient Satisfaction Survey (AOPSS) assessing patients' perceptions of emotional support; information, communication and education; respect for patient preferences; coordination and continuity of care; physical comfort and access to care
3 questions from iLead Champions Conversations With Patients assessing whether patients felt their personal needs were heard and met by HCPs during treatment
measure: Patient Health Questionnaire (PHQ-9)
time frame: baseline, 1, 3, and 6 months
description: 9 questions corresponding to the 9 diagnostic criteria for major depression DSMV as '0' (not at all) to '3' (nearly every day)
measure: Beck Depression Inventory (BDI-II)
time frame: baseline, 1, 3, and 6 mnths
description: If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores
measure: General Anxiety Disorder (GAD-7)
time frame: baseline, 1, 3, and 6 months
description: To measure the severity of anxiety among patients 7-item tool based on DSM-V criteria has a scale similar to PHQ-9
measure: Beck Anxiety Inventory (BAI)
time frame: baseline, 1, 3, and 6 months
description: If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores
measure: Experiences in Close Relationships Inventory
time frame: baseline, 1, 3, and 6 months
description: Assessing how patients feel in close relationships with other people
measure: Patient and, if participating, Caregiver Semi-structured interview
time frame: 1 and 3 months
description: A series of qualitative and quantitative questions assessing patients' experiences during care and caregivers' perceptions of quality of care, illness understanding and whether patient psychosocial and palliative needs were met during treatment
measure: Edmonton Symptom Assessment System
time frame: baseline, 1 and 3 months
description: 9 items designed to assess the severity of the most commonly reported symptoms experienced by cancer patients including pain, fatigue, drowsiness, nausea, dyspnea, depression, anxiety, well-being, and loss of appetite
measure: Palliative Performance Scale
time frame: baseline
description: Quantitatively represents a person's performance status and ability to function
11 point scale from 100% (healthy) to 0% (death) with 10% decrements
The scale is based on five observable parameters: ambulation, ability to do activities, self-care, food/fluid intake, and consciousness level
measure: Illness Understanding Questionnaire
time frame: 1, 3, and 6 months
description: A series of questions assessing patients' understanding of the course, nature and treatment of their illness
arm group label: Treatment as Usual Control Group
arm group type: No Intervention
description: Treatment as usual.
arm group label: Intervention Group
arm group type: Experimental
description: Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation.
intervention type: Other
intervention name: PSOPC pathway approach
description: The intervention will use a standardized PSOPC pathway approach, prompted follow up with patients and documentation.
Additionally, clinicians will be prompted to document conversations about response to emotional or physical ESAS symptom scores, symptom management plan (self/education/monitoring/medication), illness understanding; and, if necessary, an offer of PSO/PC referral.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janet Ellis, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
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responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: Undecided