<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/NCT03286192</url>
  </required_header>
  <id_info>
    <org_study_id>20170290</org_study_id>
    <nct_id>NCT03286192</nct_id>
  </id_info>
  <brief_title>Compassion Cultivation Training for Nurses</brief_title>
  <official_title>Compassion Cultivation Training for Nurses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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 purpose of this study is to evaluate the feasibility of implementing a Compassion&#xD;
      Cultivation Training (CCT) program for oncology nurses at Sylvester Comprehensive Cancer&#xD;
      Center. The goal of CCT is to provide a structured and systematic way of cultivating&#xD;
      daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for&#xD;
      oneself and others. CCT typically includes (i) eight weekly 2-hour classes and (ii) daily&#xD;
      practice. The in-class activities include pedagogical instruction and active group&#xD;
      discussion, guided meditation, interactive practical exercises, and sharing of inspiring&#xD;
      readings/stories to prime feelings of open-heartedness or connection to others.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Compassion Cultivation Training (CCT) protocol is a secular course that was developed by&#xD;
      the Center for Compassion &amp; Altruism Research and Education (CCARE) at Stanford University,&#xD;
      School of Medicine (Jinpa, 2013). The course was developed by Thupten Jinpa, PhD, in&#xD;
      collaboration with contemplative scholars, psychologists, and scientist at Stanford. The goal&#xD;
      of CCT is to provide a structured and systematic way of cultivating daily-life skills needed&#xD;
      to strengthen qualities of compassion, empathy, and kindness for oneself and others. CCT&#xD;
      typically includes (i) eight weekly 2-hour classes and (ii) daily practice. The in-class&#xD;
      activities include pedagogical instruction and active group discussion, guided meditation,&#xD;
      interactive practical exercises, and sharing of inspiring readings/stories to prime feelings&#xD;
      of open-heartedness or connection to others. The daily practice includes both formal and&#xD;
      informal practices. Participants are provided with formal guided meditations that are 15 to&#xD;
      30 minutes long in the form of MP3 or cds. Participants may receive practices and&#xD;
      instructions via email with a link to the location of the MP3. They will be provided with&#xD;
      practice logs to report their amount of practice as well as some basic observations to the&#xD;
      research team. In the present study, we will follow the official CCT manual. The training is&#xD;
      composed of 8 sessions, which can be delivered in 7-10 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">August 2, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group feasibility study of a psychosocial intervention</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of individuals who do not drop out of the study prior to completing the post-intervention assessment</measure>
    <time_frame>24 weeks after first session</time_frame>
    <description>Number of individuals who do not drop out of the study prior to completing the post-intervention assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>baseline and 7-10 weeks</time_frame>
    <description>self-report instrument that measures perceptions of stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maslach Burnout Inventory</measure>
    <time_frame>baseline and 7-10 weeks</time_frame>
    <description>self-report instrument that measures emotional exhaustion, depersonalization, and acheivement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Philadelphia Mindfulness Scale</measure>
    <time_frame>baseline and 7-10 weeks</time_frame>
    <description>self-report instrument that measures present moment awareness and acceptance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Tolerance Scale</measure>
    <time_frame>baseline and 7-10 weeks</time_frame>
    <description>self-report instrument that measures feelings of distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>baseline and 7-10 weeks</time_frame>
    <description>self-report measure of health-related quality of life</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Feasibility</condition>
  <arm_group>
    <arm_group_label>Single-Arm Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this arm receive compassion cultivation training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>compassion cultivation training</intervention_name>
    <description>Eight 2-hour group sessions that provide a structured and systematic way of cultivating daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for oneself and others.</description>
    <arm_group_label>Single-Arm Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be 18 years of age or older&#xD;
&#xD;
          2. Be willing and able to give informed consent&#xD;
&#xD;
          3. Be a Registered Nurse (RN)&#xD;
&#xD;
          4. Currently works at Sylvester Comprehensive Cancer Center&#xD;
&#xD;
          5. Currently works at least 20 hours/week&#xD;
&#xD;
          6. Be able to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any participants who are deemed to present an acute safety risk to self or others.&#xD;
&#xD;
          2. Any infants, children, or teenagers under 18 years of age.&#xD;
&#xD;
          3. Prisoners&#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>Debbie Anglade, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>August 2, 2018</last_update_submitted>
  <last_update_submitted_qc>August 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Debbie Anglade</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03286192/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03286192/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03286192
org study id: 20170290
nct id: NCT03286192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility of implementing a Compassion
      Cultivation Training (CCT) program for oncology nurses at Sylvester Comprehensive Cancer
      Center. The goal of CCT is to provide a structured and systematic way of cultivating
      daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for
      oneself and others. CCT typically includes (i) eight weekly 2-hour classes and (ii) daily
      practice. The in-class activities include pedagogical instruction and active group
      discussion, guided meditation, interactive practical exercises, and sharing of inspiring
      readings/stories to prime feelings of open-heartedness or connection to others.
The Compassion Cultivation Training (CCT) protocol is a secular course that was developed by
      the Center for Compassion & Altruism Research and Education (CCARE) at Stanford University,
      School of Medicine (Jinpa, 2013). The course was developed by Thupten Jinpa, PhD, in
      collaboration with contemplative scholars, psychologists, and scientist at Stanford. The goal
      of CCT is to provide a structured and systematic way of cultivating daily-life skills needed
      to strengthen qualities of compassion, empathy, and kindness for oneself and others. CCT
      typically includes (i) eight weekly 2-hour classes and (ii) daily practice. The in-class
      activities include pedagogical instruction and active group discussion, guided meditation,
      interactive practical exercises, and sharing of inspiring readings/stories to prime feelings
      of open-heartedness or connection to others. The daily practice includes both formal and
      informal practices. Participants are provided with formal guided meditations that are 15 to
      30 minutes long in the form of MP3 or cds. Participants may receive practices and
      instructions via email with a link to the location of the MP3. They will be provided with
      practice logs to report their amount of practice as well as some basic observations to the
      research team. In the present study, we will follow the official CCT manual. The training is
      composed of 8 sessions, which can be delivered in 7-10 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group feasibility study of a psychosocial intervention
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of individuals who do not drop out of the study prior to completing the post-intervention assessment
time frame: 24 weeks after first session
description: Number of individuals who do not drop out of the study prior to completing the post-intervention assessment
measure: Perceived Stress Scale
time frame: baseline and 7-10 weeks
description: self-report instrument that measures perceptions of stress
measure: Maslach Burnout Inventory
time frame: baseline and 7-10 weeks
description: self-report instrument that measures emotional exhaustion, depersonalization, and acheivement
measure: Philadelphia Mindfulness Scale
time frame: baseline and 7-10 weeks
description: self-report instrument that measures present moment awareness and acceptance
measure: Distress Tolerance Scale
time frame: baseline and 7-10 weeks
description: self-report instrument that measures feelings of distress
measure: SF-36
time frame: baseline and 7-10 weeks
description: self-report measure of health-related quality of life
arm group label: Single-Arm Intervention
arm group type: Experimental
description: All participants in this arm receive compassion cultivation training
intervention type: Behavioral
intervention name: compassion cultivation training
description: Eight 2-hour group sessions that provide a structured and systematic way of cultivating daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for oneself and others.
arm group label: Single-Arm Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Debbie Anglade, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Debbie Anglade
investigator title: Assistant Professor
sharing ipd: No
provided document: 
provided document: 