<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/NCT03806192</url>
  </required_header>
  <id_info>
    <org_study_id>RG1003619</org_study_id>
    <secondary_id>NCI-2018-03629</secondary_id>
    <secondary_id>10048</secondary_id>
    <nct_id>NCT03806192</nct_id>
  </id_info>
  <brief_title>Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>A Field Test of the Partners in Care Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</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 trial studies the feasibility of delivering the Partners in Care Program to caregivers&#xD;
      of patients with acute myeloid leukemia. Psychological counseling interventions, such as the&#xD;
      Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital&#xD;
      adjustment in the context of the cancer, communication, and support skills to the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Participants are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via&#xD;
      telephone.&#xD;
&#xD;
      GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via&#xD;
      video teleconference.&#xD;
&#xD;
      After completion of study, participants are followed up at 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to insufficient funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 16, 2019</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Site intermediary and referring MD</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of recruitment</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of enrollment</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of completion of 5-session intervention</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])</measure>
    <time_frame>Baseline up to 4 months</time_frame>
    <description>Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])</measure>
    <time_frame>Baseline up to 4 months</time_frame>
    <description>Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist</measure>
    <time_frame>Baseline up to 4 months</time_frame>
    <description>Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)</measure>
    <time_frame>Baseline up to 4 months</time_frame>
    <description>Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Group A (psychoeducational counseling sessions via telephone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (psychoeducational counseling sessions in person)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Attend psychoeducational counseling sessions via telephone</description>
    <arm_group_label>Group A (psychoeducational counseling sessions via telephone)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Behavioral, Psychological or Informational Intervention</intervention_name>
    <description>Attend psychoeducational counseling sessions via video teleconference</description>
    <arm_group_label>Group B (psychoeducational counseling sessions in person)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group A (psychoeducational counseling sessions via telephone)</arm_group_label>
    <arm_group_label>Group B (psychoeducational counseling sessions in person)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AML within the recent 2 months&#xD;
&#xD;
          -  Caregivers and patients need to write, read, and speak English as one of their&#xD;
             languages of choice; and currently sharing a residence at least 50% of the time&#xD;
             together&#xD;
&#xD;
          -  Patient must have no other concurrent cancer diagnosis except for basal or squamous&#xD;
             cell&#xD;
&#xD;
          -  Caregiver must be able to sustain up to 60 minutes of interaction with patient&#xD;
             educator&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if either the patient or the caregiver cannot write,&#xD;
             read, and speak English as one of their languages of choice; are not currently sharing&#xD;
             a residence at least 50% of the time together&#xD;
&#xD;
          -  The patient cannot have another concurrent cancer diagnosis except for basal or&#xD;
             squamous cell&#xD;
&#xD;
          -  Caregiver cannot sustain up to 60 minutes of interaction with the patient educator&#xD;
&#xD;
          -  Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM)&#xD;
             or a cell phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>82 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances Lewis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregiver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03806192
org study id: RG1003619
secondary id: NCI-2018-03629
secondary id: 10048
nct id: NCT03806192
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This trial studies the feasibility of delivering the Partners in Care Program to caregivers
      of patients with acute myeloid leukemia. Psychological counseling interventions, such as the
      Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital
      adjustment in the context of the cancer, communication, and support skills to the patient.
OUTLINE: Participants are randomized to 1 of 2 groups.

      GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via
      telephone.

      GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via
      video teleconference.

      After completion of study, participants are followed up at 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
masking description: Site intermediary and referring MD
measure: Rate of recruitment
time frame: Up to 1 year
measure: Rate of enrollment
time frame: Up to 1 year
measure: Rate of completion of 5-session intervention
time frame: Up to 1 year
measure: Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
time frame: Baseline up to 4 months
description: Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
measure: Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
time frame: Baseline up to 4 months
description: Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
measure: Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
time frame: Baseline up to 4 months
description: Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
measure: Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
time frame: Baseline up to 4 months
description: Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
arm group label: Group A (psychoeducational counseling sessions via telephone)
arm group type: Experimental
description: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
arm group label: Group B (psychoeducational counseling sessions in person)
arm group type: Experimental
description: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Attend psychoeducational counseling sessions via telephone
arm group label: Group A (psychoeducational counseling sessions via telephone)
intervention type: Other
intervention name: Behavioral, Psychological or Informational Intervention
description: Attend psychoeducational counseling sessions via video teleconference
arm group label: Group B (psychoeducational counseling sessions in person)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group A (psychoeducational counseling sessions via telephone)
arm group label: Group B (psychoeducational counseling sessions in person)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 82 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frances Lewis
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No