<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/NCT02250911</url>
  </required_header>
  <id_info>
    <org_study_id>14-208</org_study_id>
    <nct_id>NCT02250911</nct_id>
  </id_info>
  <brief_title>Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden</brief_title>
  <official_title>Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to gather information on how easy it is to implement the&#xD;
      workshop, as well as whether individuals find this workshop helpful. In this study,&#xD;
      participants will be assigned at random to one of the two study groups. Based on the&#xD;
      information we obtain, we hope to develop an easily accessible support service for&#xD;
      caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>feasibility of this novel approach</measure>
    <time_frame>2 years</time_frame>
    <description>which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) methods.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Caregivers</condition>
  <arm_group>
    <arm_group_label>This web-based CCC Workshop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the waitlist control arm will be offered what is considered &quot;usual care&quot; at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>webcasts</intervention_name>
    <arm_group_label>This web-based CCC Workshop</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assessments</intervention_name>
    <arm_group_label>This web-based CCC Workshop</arm_group_label>
    <arm_group_label>Waitlist Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Waitlist Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  As per self report, a current caregiver to a patient with any site or stage of cancer&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  A score of &gt; 4 on the Distress Thermometer (DT) and indication that this distress is&#xD;
             related in some way to the caregiving role&#xD;
&#xD;
          -  In the judgment of the investigators and/or consenting professional, able to&#xD;
             comprehend English to complete study assessments&#xD;
&#xD;
          -  Able to perform informed consent&#xD;
&#xD;
          -  Enrollment is open to caregivers with their own current/past cancer histories&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant psychiatric or cognitive disturbance sufficient, in the investigator's&#xD;
             judgment, to preclude providing informed consent.&#xD;
&#xD;
          -  As per self report, unable to access a computer with Internet or unable to use a&#xD;
             computer with Internet provided by the study&#xD;
&#xD;
          -  Participated in the development and refinement of the CCC Workshop (prospective&#xD;
             exemption X14-006)&#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>Allison Applebaum, 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 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregivers of patients</keyword>
  <keyword>CCC = Care for the Cancer Caregivers</keyword>
  <keyword>MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers</keyword>
  <keyword>14-208</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caregiver Burden</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/NCT02250911
org study id: 14-208
nct id: NCT02250911
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to gather information on how easy it is to implement the
      workshop, as well as whether individuals find this workshop helpful. In this study,
      participants will be assigned at random to one of the two study groups. Based on the
      information we obtain, we hope to develop an easily accessible support service for
      caregivers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: feasibility of this novel approach
time frame: 2 years
description: which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) methods.
arm group label: This web-based CCC Workshop
arm group type: Experimental
description: The Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role.
arm group label: Waitlist Control
arm group type: Active Comparator
description: Participants randomized to the waitlist control arm will be offered what is considered "usual care" at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop.
intervention type: Other
intervention name: webcasts
arm group label: This web-based CCC Workshop
intervention type: Behavioral
intervention name: Assessments
arm group label: This web-based CCC Workshop
arm group label: Waitlist Control
intervention type: Other
intervention name: Usual care
arm group label: Waitlist Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Allison Applebaum, 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: Caregiver Burden