<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/NCT04499690</url>
  </required_header>
  <id_info>
    <org_study_id>18-5670</org_study_id>
    <nct_id>NCT04499690</nct_id>
  </id_info>
  <brief_title>Global CALM Implementation Study</brief_title>
  <acronym>Global CALM</acronym>
  <official_title>Managing Cancer and Living Meaningfully (CALM): A Global Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to evaluate the implementation of the Managing Cancer and Living&#xD;
      Meaningfully (CALM) Program in diverse cultural settings, including its feasibility,&#xD;
      fidelity, and acceptability. It will also assess the cross-cultural generalizability of the&#xD;
      CALM intervention with a particular focus on patient-reported outcomes with regard to&#xD;
      psychological well-being and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CALM is a semi-structured, manualized, individual psychotherapy designed for patients with&#xD;
      advanced cancer and their loved ones. Research conducted over the past decade has shown that&#xD;
      CALM is a feasible, acceptable, and effective therapy for patients with advanced or&#xD;
      metastatic cancer.&#xD;
&#xD;
      The CALM Training Program was developed to train oncology clinicians in the delivery of CALM.&#xD;
      The training program consists of: 1) introductory workshops, which provide foundational&#xD;
      training in the intervention; 2) advanced workshops, which support the development of&#xD;
      advanced therapeutic skills; and 3) ongoing case supervision, delivered in small-group&#xD;
      format, either in-person or online, which provides an opportunity for continuing improvement&#xD;
      and refinement in the delivery of CALM.&#xD;
&#xD;
      To evaluate the implementation of the CALM Program at the clinician and organization levels,&#xD;
      we will approach clinicians engaging in the CALM Training Program and invite them to&#xD;
      participate in this research study, which includes completion of quantitative measures at&#xD;
      baseline, 1 year (primary endpoint) and 2 years (study endpoint), participation in&#xD;
      qualitative interviews, and collection of feasibility data. Implementation science frameworks&#xD;
      will be applied to assess participants' perceived individual- and contextual-level barriers&#xD;
      and facilitators to implementing CALM through qualitative interviews.&#xD;
&#xD;
      Sites involved in the Global CALM Program will conduct pilot studies of CALM in their setting&#xD;
      to evaluate CALM at the patient- and caregiver-levels. We will not be involved in the&#xD;
      collection of prospective patient- and caregiver-level data, however data will be pooled and&#xD;
      analyzed to assess the cross-cultural generalizability of the CALM intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Anticipated">June 17, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 17, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Site Feasibility Metrics</measure>
    <time_frame>Throughout study completion, every 12 months</time_frame>
    <description>The Global CALM Program's site lead will complete site feasibility metrics, which include measures of reach (e.g. # clinicians engaged in CALM training, # of CALM-related research projects), effectiveness (e.g. CALM treatment integrity and supervision evaluation ratings), adoption (e.g. # of patients being seen for CALM), implementation (e.g. # of completed CALM cases, # CALM certified therapists), and maintenance. This measure is completed annually throughout the site's engagement in the CALM Program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Confidence in Therapy - Oncology Questionnaire</measure>
    <time_frame>Changes from baseline, 1 Year, and 2 Years</time_frame>
    <description>The Confidence with Therapy - Oncology Questionnaire (CTO) is a 14-item Likert-type questionnaire used to assess a therapists' level of confidence in the delivery of psychotherapy to patients who are living with advanced cancer. This questionnaire will be administered to participating clinicians who partake in case supervision, at baseline, 1 year, and 2 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Supervision Evaluation Questionnaire</measure>
    <time_frame>Changes from baseline, 1 Year and 2 Years</time_frame>
    <description>The CALM Supervision Evaluation Questionnaire is a 30-item questionnaire evaluating CALM supervision meetings. Adapted from the works of Spiegel and Spira (1991), Arcinue (2002), Winstanley (2000), and Cliffe et al. (2016), this questionnaire evaluates the perceived feasibility, acceptability and efficacy of supervision, the extent to which the supervision adhered to CALM therapy protocol, and the overall experience of participating in group supervision. This questionnaire will be administered to clinicians who partake in case supervision, at the 1- and 2-year time points.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Global CALM Training Program Clinicians</arm_group_label>
    <description>Clinicians engaging in the CALM Training Program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Managing Cancer and Living Meaningfully</intervention_name>
    <description>A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer</description>
    <arm_group_label>Global CALM Training Program Clinicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clinicians who are participating in the Global CALM Training Program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The research team will approach clinicians who:&#xD;
&#xD;
          -  have expressed interest in taking part in the Global CALM Program;&#xD;
&#xD;
          -  able to deliver psychotherapeutic care according to the legislation/organizational&#xD;
             policy that regulates their profession;&#xD;
&#xD;
          -  ≥18 years of age;&#xD;
&#xD;
          -  able to provide informed consent;&#xD;
&#xD;
          -  fluent in English (or other language(s) in which training and supervision will be&#xD;
             offered);&#xD;
&#xD;
          -  fluent in the main language spoken in the country where their centre is located (to be&#xD;
             able to deliver CALM sessions); and&#xD;
&#xD;
          -  willing/able to engage with training in the CALM therapy and attend in-person or&#xD;
             online supervision meetings (based on feasibility).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Gary Rodin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Hales, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychosocial</keyword>
  <keyword>Behavioural Intervention</keyword>
  <keyword>Implementation Science</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT04499690
org study id: 18-5670
nct id: NCT04499690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study seeks to evaluate the implementation of the Managing Cancer and Living
      Meaningfully (CALM) Program in diverse cultural settings, including its feasibility,
      fidelity, and acceptability. It will also assess the cross-cultural generalizability of the
      CALM intervention with a particular focus on patient-reported outcomes with regard to
      psychological well-being and quality of life.
CALM is a semi-structured, manualized, individual psychotherapy designed for patients with
      advanced cancer and their loved ones. Research conducted over the past decade has shown that
      CALM is a feasible, acceptable, and effective therapy for patients with advanced or
      metastatic cancer.

      The CALM Training Program was developed to train oncology clinicians in the delivery of CALM.
      The training program consists of: 1) introductory workshops, which provide foundational
      training in the intervention; 2) advanced workshops, which support the development of
      advanced therapeutic skills; and 3) ongoing case supervision, delivered in small-group
      format, either in-person or online, which provides an opportunity for continuing improvement
      and refinement in the delivery of CALM.

      To evaluate the implementation of the CALM Program at the clinician and organization levels,
      we will approach clinicians engaging in the CALM Training Program and invite them to
      participate in this research study, which includes completion of quantitative measures at
      baseline, 1 year (primary endpoint) and 2 years (study endpoint), participation in
      qualitative interviews, and collection of feasibility data. Implementation science frameworks
      will be applied to assess participants' perceived individual- and contextual-level barriers
      and facilitators to implementing CALM through qualitative interviews.

      Sites involved in the Global CALM Program will conduct pilot studies of CALM in their setting
      to evaluate CALM at the patient- and caregiver-levels. We will not be involved in the
      collection of prospective patient- and caregiver-level data, however data will be pooled and
      analyzed to assess the cross-cultural generalizability of the CALM intervention.
observational model: Cohort
time perspective: Prospective
measure: Change in Site Feasibility Metrics
time frame: Throughout study completion, every 12 months
description: The Global CALM Program's site lead will complete site feasibility metrics, which include measures of reach (e.g. # clinicians engaged in CALM training, # of CALM-related research projects), effectiveness (e.g. CALM treatment integrity and supervision evaluation ratings), adoption (e.g. # of patients being seen for CALM), implementation (e.g. # of completed CALM cases, # CALM certified therapists), and maintenance. This measure is completed annually throughout the site's engagement in the CALM Program.
measure: Change in Confidence in Therapy - Oncology Questionnaire
time frame: Changes from baseline, 1 Year, and 2 Years
description: The Confidence with Therapy - Oncology Questionnaire (CTO) is a 14-item Likert-type questionnaire used to assess a therapists' level of confidence in the delivery of psychotherapy to patients who are living with advanced cancer. This questionnaire will be administered to participating clinicians who partake in case supervision, at baseline, 1 year, and 2 years.
measure: Change in Supervision Evaluation Questionnaire
time frame: Changes from baseline, 1 Year and 2 Years
description: The CALM Supervision Evaluation Questionnaire is a 30-item questionnaire evaluating CALM supervision meetings. Adapted from the works of Spiegel and Spira (1991), Arcinue (2002), Winstanley (2000), and Cliffe et al. (2016), this questionnaire evaluates the perceived feasibility, acceptability and efficacy of supervision, the extent to which the supervision adhered to CALM therapy protocol, and the overall experience of participating in group supervision. This questionnaire will be administered to clinicians who partake in case supervision, at the 1- and 2-year time points.
arm group label: Global CALM Training Program Clinicians
description: Clinicians engaging in the CALM Training Program.
intervention type: Behavioral
intervention name: Managing Cancer and Living Meaningfully
description: A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer
arm group label: Global CALM Training Program Clinicians
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gary Rodin, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Sarah Hales, MD PhD
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Depression