<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/NCT03794635</url>
  </required_header>
  <id_info>
    <org_study_id>18-530</org_study_id>
    <nct_id>NCT03794635</nct_id>
  </id_info>
  <brief_title>An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer</brief_title>
  <official_title>A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test an intervention to improve patients' and their caregivers' ability to&#xD;
      manage difficult emotions and communicate about the patient's illness. There will be two&#xD;
      versions of the intervention used for this study: a culturally tailored version for Latinx&#xD;
      participants refined during Phase 1 of this study, and a version of the intervention that was&#xD;
      not culturally tailored for Latinx patients and caregivers developed in previous work. The&#xD;
      two interventions differ in minor content areas. We will use the culturally tailored&#xD;
      intervention for Latinx participants and the non-tailored intervention for non-Latinx&#xD;
      participants. This culturally sensitive intervention has the potential to reduce Latino/a&#xD;
      patient and caregiver distress and improve patient and caregiver quality of life, shared&#xD;
      understanding of the patient's illness, and patients' and caregivers' ability to discuss,&#xD;
      identify, and document patients' treatment preferences. The intervention is designed to&#xD;
      minimize burden to patients, caregivers, and healthcare institutions to allow for easy&#xD;
      integration into clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of patient-caregiver communication-based intervention defined by participant enrollment</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of patient-caregiver communication-based intervention defined by participant retention</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Metastatic Cancer</condition>
  <condition>Locally Advanced Cancer</condition>
  <condition>Thoracic Cancer</condition>
  <condition>Gynecologic Cancer</condition>
  <condition>Genitourinary Cancer</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Latino/a advanced cancer patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers of Latino/a advanced cancer patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weekly 45 minute Sessions</intervention_name>
    <description>The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study:&#xD;
A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish)&#xD;
A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window.&#xD;
Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention.</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Patients:&#xD;
&#xD;
          -  Self-identifies as Latino/a&#xD;
&#xD;
          -  Diagnosis of poor prognosis advanced cancer defined as: (1) locally advanced or&#xD;
             metastatic cancer (i.e., thoracic, gynecological, genitourinary cancer, pancreatic or&#xD;
             lymphoma) or (2) disease progression following at least first line treatment&#xD;
&#xD;
          -  Fluent in English or Spanish&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Has a primary informal caregiver (as defined by an unpaid individual who provides the&#xD;
             patient with emotional, physical, and/or practical support) who is willing and able to&#xD;
             participate in the study&#xD;
&#xD;
          -  Score of &lt;/= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)&#xD;
&#xD;
          -  To assess whether a prognostic discussion occurred, the oncologist must answer &quot;Yes&quot;&#xD;
             to the following: &quot;Have you discussed the any of the following with Mr./Mrs./Ms.&#xD;
             [INSERT PATIENT&quot;S NAME]: If his/her cancer is curable, if his/her cancer is terminal,&#xD;
             or his/her life expectancy: Yes/No Note: This question will be included in the email&#xD;
             in which study staff request permission to contact the patient.&#xD;
&#xD;
          -  As per self-report, residency in New York or ability to complete sessions in New York&#xD;
             to ensure that provision of TAC is covered by the professional licenses of TAC&#xD;
             interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3 ONLY&#xD;
&#xD;
          -  Able to communicate over the phone for sessions&#xD;
&#xD;
          -  Willingness to be audio-recorded for assessments and study sessions&#xD;
&#xD;
        For Caregivers:&#xD;
&#xD;
          -  Is a primary informal caregiver (as defined by an unpaid individual who provides the&#xD;
             patient with emotional, physical, and/or practical support) for a MSK patient&#xD;
&#xD;
          -  Fluent in English or Spanish&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Score of &lt;/= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)&#xD;
&#xD;
          -  As per self-report, residency in New York or ability to complete sessions in New York&#xD;
             to ensure that provision of TAC is covered by the professional licenses of TAC&#xD;
             interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3 ONLY&#xD;
&#xD;
          -  Able to communicate over the phone for sessions&#xD;
&#xD;
          -  Willingness to be audio-recorded for assessments and study sessions&#xD;
&#xD;
        Psychosocial expert eligibility requirements:&#xD;
&#xD;
          -  Current clinical practice and/or research with advanced cancer patients&#xD;
&#xD;
          -  A history of 5+ years working with advanced cancer patients. Experts across&#xD;
             disciplines (e.g., social work, psychology) may be enrolled.&#xD;
&#xD;
          -  Fluent in English as self-reported by a fluency of &quot;Very well&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Patients&#xD;
&#xD;
          -  As judged by the consenting professional, treating physician or self-report, too weak&#xD;
             or cognitively impaired to participate in the intervention and complete the&#xD;
             assessments&#xD;
&#xD;
          -  Receiving hospice at the time of enrollment&#xD;
&#xD;
          -  Deemed inappropriate for the study by their treating physician&#xD;
&#xD;
          -  As per medical record or self-report, currently being treated for schizophrenia,&#xD;
             substance use or dependence, and/or bi-polar disorder&#xD;
&#xD;
        For Caregivers:&#xD;
&#xD;
          -  As judged by the consenting professional, treating physician or self-report, too weak&#xD;
             or cognitively impaired to participate in the intervention and complete the&#xD;
             assessments&#xD;
&#xD;
          -  As per self-report, currently being treated for schizophrenia, substance use or&#xD;
             dependence, and/or bi-polar disorder&#xD;
&#xD;
        Patient-Caregiver Dyads:&#xD;
&#xD;
          -  Both dyad members respond &quot;b&quot; or &quot;d&quot; on the item in Appendix K, &quot;How would you&#xD;
             describe your/the patient&quot;s health status: a) Relatively healthy, b) Relatively&#xD;
             healthy and terminally ill, c) Seriously ill but not terminally ill, or d) Seriously&#xD;
             and terminally ill&quot; and respond &quot;months&quot; on the item &quot;When you think about your/the&#xD;
             patient's life expectancy, do you think in terms of months or years.&quot;&#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>Kelly Trevino, PhD</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>August 2023</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Latina</keyword>
  <keyword>Latino</keyword>
  <keyword>Spanish</keyword>
  <keyword>Caregiver</keyword>
  <keyword>18-530</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urogenital 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/NCT03794635
org study id: 18-530
nct id: NCT03794635
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will test an intervention to improve patients' and their caregivers' ability to
      manage difficult emotions and communicate about the patient's illness. There will be two
      versions of the intervention used for this study: a culturally tailored version for Latinx
      participants refined during Phase 1 of this study, and a version of the intervention that was
      not culturally tailored for Latinx patients and caregivers developed in previous work. The
      two interventions differ in minor content areas. We will use the culturally tailored
      intervention for Latinx participants and the non-tailored intervention for non-Latinx
      participants. This culturally sensitive intervention has the potential to reduce Latino/a
      patient and caregiver distress and improve patient and caregiver quality of life, shared
      understanding of the patient's illness, and patients' and caregivers' ability to discuss,
      identify, and document patients' treatment preferences. The intervention is designed to
      minimize burden to patients, caregivers, and healthcare institutions to allow for easy
      integration into clinical practice.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
time frame: 3 months
measure: Feasibility of patient-caregiver communication-based intervention defined by participant retention
time frame: 3 months
arm group label: Patients
arm group type: Experimental
description: Latino/a advanced cancer patients
arm group label: Caregivers
arm group type: Experimental
description: Caregivers of Latino/a advanced cancer patients
intervention type: Behavioral
intervention name: Weekly 45 minute Sessions
description: The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study:
A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish)
A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window.
Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention.
arm group label: Caregivers
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly Trevino, PhD
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: Urogenital Neoplasms
sharing ipd: Undecided