<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/NCT03037346</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0704</org_study_id>
    <secondary_id>NCI-2018-01745</secondary_id>
    <secondary_id>2016-0704</secondary_id>
    <nct_id>NCT03037346</nct_id>
  </id_info>
  <brief_title>Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes, and Beliefs in Participants With Stage I-IV Gynecological Cancers</brief_title>
  <official_title>Preparing Patients and Family Caregivers for Medical Decision Making: Evaluating the Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes and Beliefs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      This trial evaluates the impact of a systemic social work driven approach on medical power of&#xD;
      attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV&#xD;
      gynecological cancers. Social work counseling and education may help increase the number of&#xD;
      participants who complete medical power of attorney documents. Counseling and education may&#xD;
      also affect attitudes about decision-making and willingness to take part in these&#xD;
      conversations in participants with stage I-IV gynecological cancers and their family members&#xD;
      and/or caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic&#xD;
      social work counseling and education clinical process.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine change in medical power of attorney (MPOA)/primary family caregivers'&#xD;
      knowledge, attitudes and beliefs about conditions for quality surrogate medical&#xD;
      decision-making (MDM).&#xD;
&#xD;
      II. To determine change in MPOA/primary family caregivers' knowledge of patients' values and&#xD;
      goals for MDM.&#xD;
&#xD;
      III. Evaluate patients' and MPOA/primary family caregivers' willingness to participate in&#xD;
      future advance care planning discussions to discuss patients' values and goals important to&#xD;
      MDM.&#xD;
&#xD;
      IV. Evaluate predictors of patient subgroups most likely to respond to the social work&#xD;
      counseling and education clinical process.&#xD;
&#xD;
      V. Explore aspects of the Spanish language version of the advance care planning engagement&#xD;
      survey to inform future validation studies.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge,&#xD;
      attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational&#xD;
      video about the importance of the role of MPOA.&#xD;
&#xD;
      After completion of intervention, participants are followed up at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who decline to participate in the study</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be reported with 95% confidence intervals. Descriptive demographic and disease characteristics for patients who decline study participation but allow collection of demographic and disease characteristics will be compared to those of participating patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who already have medical power of attorney (MPOAD) at consult</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM), in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who completed MPOAD at the first social work counselor visit</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who completed MPOAD after the first educational video</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who completed MPOAD within 3 months after the educational video</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Willingness to participate in future advance care planning discussions</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">734</enrollment>
  <condition>Caregiver</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <arm_group>
    <arm_group_label>Supportive Care (questionnaires, educational video)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete questionnaires about MPOAD</description>
    <arm_group_label>Supportive Care (questionnaires, educational video)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (questionnaires, educational video)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video</intervention_name>
    <description>Watch educational video</description>
    <arm_group_label>Supportive Care (questionnaires, educational video)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENTS&#xD;
&#xD;
          -  Diagnosis of invasive gynecologic malignancy stages 1-4.&#xD;
&#xD;
          -  New patient in the Gynecologic Oncology Center.&#xD;
&#xD;
          -  Adequate capacity to understand and complete MPOAD in the opinion of the study&#xD;
             investigator or research assistant.&#xD;
&#xD;
          -  Able to speak and understand English and/or Spanish.&#xD;
&#xD;
          -  Provision of Institutional Review Board (IRB)-approved informed consent.&#xD;
&#xD;
          -  Available MPOA or primary family caregiver who consents to study participation.&#xD;
&#xD;
          -  FAMILY CAREGIVER/MPOA&#xD;
&#xD;
          -  MPOA or if none documented in electronic health record (EHR), primary family&#xD;
             caregiver, as designated by the patient.&#xD;
&#xD;
          -  Permission to contact provided by patient.&#xD;
&#xD;
          -  Adequate capacity to understand and complete study measures in the opinion of the&#xD;
             study investigator or research assistant.&#xD;
&#xD;
          -  Provision of IRB-approved informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Without a MPOA or available family caregiver.&#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>Donna S Zhukovsky</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Neoplasms, Female</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/NCT03037346
org study id: 2016-0704
secondary id: NCI-2018-01745
secondary id: 2016-0704
nct id: NCT03037346
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial evaluates the impact of a systemic social work driven approach on medical power of
      attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV
      gynecological cancers. Social work counseling and education may help increase the number of
      participants who complete medical power of attorney documents. Counseling and education may
      also affect attitudes about decision-making and willingness to take part in these
      conversations in participants with stage I-IV gynecological cancers and their family members
      and/or caregivers.
PRIMARY OBJECTIVES:

      I. To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic
      social work counseling and education clinical process.

      SECONDARY OBJECTIVES:

      I. To determine change in medical power of attorney (MPOA)/primary family caregivers'
      knowledge, attitudes and beliefs about conditions for quality surrogate medical
      decision-making (MDM).

      II. To determine change in MPOA/primary family caregivers' knowledge of patients' values and
      goals for MDM.

      III. Evaluate patients' and MPOA/primary family caregivers' willingness to participate in
      future advance care planning discussions to discuss patients' values and goals important to
      MDM.

      IV. Evaluate predictors of patient subgroups most likely to respond to the social work
      counseling and education clinical process.

      V. Explore aspects of the Spanish language version of the advance care planning engagement
      survey to inform future validation studies.

      OUTLINE:

      Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge,
      attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational
      video about the importance of the role of MPOA.

      After completion of intervention, participants are followed up at 3 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Proportion of patients who decline to participate in the study
time frame: Up to 3 months
description: Will be reported with 95% confidence intervals. Descriptive demographic and disease characteristics for patients who decline study participation but allow collection of demographic and disease characteristics will be compared to those of participating patients.
measure: Proportion of patients who already have medical power of attorney (MPOAD) at consult
time frame: Up to 3 months
description: Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM), in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.
measure: Proportion of patients who completed MPOAD at the first social work counselor visit
time frame: Up to 3 months
description: Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.
measure: Proportion of participants who completed MPOAD after the first educational video
time frame: Up to 3 months
description: Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.
measure: Proportion of participants who completed MPOAD within 3 months after the educational video
time frame: Up to 3 months
description: Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.
measure: Willingness to participate in future advance care planning discussions
time frame: Up to 3 months
description: Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.
arm group label: Supportive Care (questionnaires, educational video)
arm group type: Experimental
description: Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.
intervention type: Other
intervention name: Questionnaire Administration
description: Complete questionnaires about MPOAD
arm group label: Supportive Care (questionnaires, educational video)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive Care (questionnaires, educational video)
intervention type: Other
intervention name: Video
description: Watch educational video
arm group label: Supportive Care (questionnaires, educational video)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Donna S Zhukovsky
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Genital Neoplasms, Female