xml: <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/NCT06028152</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00023029</org_study_id>
      <nct_id>NCT06028152</nct_id>
    </id_info>
    <brief_title>Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning</brief_title>
    <official_title>Adapting an Advance Care Planning Intervention and Delivery Model for Use With Patients With Cancer and Their Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Milton S. Hershey Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Milton S. Hershey Medical 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>
        The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness&#xD;
        of end-of-life conversation game &quot;Hello&quot; as a tool to help individuals with breast, lung,&#xD;
        and/or genito-urinary cancers treated at Penn State Cancer Institute and their loved ones&#xD;
        perform advance care planning. The main questions it aims to answer are:&#xD;
  &#xD;
          -  What modifications and/or adaptations are necessary to Hello for use in cancer&#xD;
             populations?&#xD;
  &#xD;
          -  How do different delivery models compare for recruitment in terms of feasibility and&#xD;
             efficiency?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Complete pre-game questionnaires&#xD;
  &#xD;
          -  Play the Hello game&#xD;
  &#xD;
          -  Complete post-game questionnaires&#xD;
  &#xD;
          -  Participate in a focus group&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous studies conducted by the investigators have shown that the Hello game demonstrates&#xD;
        successful ACP engagement in general populations, but has yet to be tailored to meet the&#xD;
        unique needs of patients with advanced cancer and their caregivers. Outlining their care&#xD;
        preferences by engaging in ACP is an important aspect of care according to patients with&#xD;
        advanced cancer. However, only 55% of patients with advanced cancer patients have&#xD;
        participated in ACP. These patients have substantial bio-psycho-social stressors that&#xD;
        distinguish their ACP needs from others. Tailoring established interventions that foster high&#xD;
        quality conversations about medical treatment preferences and end-of-life issues (such as the&#xD;
        Hello game) is critically important for this population given its unique needs. As evidenced&#xD;
        by qualitative interviews with &gt;200 participants, the Hello game creates a safe environment&#xD;
        for sensitive conversations about end-of-life issues and inspired sharing of rich&#xD;
        perspectives, with no reported adverse events, excessive burden, or negative emotional&#xD;
        effects. That said, the intervention must be adapted for patients with cancer, particularly&#xD;
        those with advanced cancer and their caregivers.&#xD;
  &#xD;
        Additionally, while several effective ACP interventions exist (including Hello), how best to&#xD;
        disseminate these interventions has not been rigorously or systematically studied. In other&#xD;
        ongoing and previous studies, the investigators have demonstrated success in both engaging&#xD;
        individuals living in underrepresented communities in ACP and successfully enrolling them in&#xD;
        interventional research about ACP. The investigators credit these successes to their unique&#xD;
        intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM&#xD;
        overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to&#xD;
        discuss end-of-life issues) by leveraging established community connections to recruit&#xD;
        participants to participate in ACP interventions as well as research. In the CBDM, trusted&#xD;
        community &quot;hosts&quot; (who are leaders from local hospice organizations, senior centers, health&#xD;
        agencies) invite participants to attend an ACP event. They introduce the research team to the&#xD;
        attendees who may choose to participate in the ACP activity, the research, or both. Hosts are&#xD;
        provided with marketing materials and utilize their community network channels to advertise&#xD;
        the event. This model allows for research to be conducted more easily within hard to reach&#xD;
        and underserved communities such as Black, Hispanic and rural communities- much like the most&#xD;
        remote communities across the PSCI's 28-county catchment area.&#xD;
  &#xD;
        Patients with cancer, however, are unique, and may require an alternative approach that&#xD;
        involves partnering with their oncology care team to introduce the concept of ACP and&#xD;
        encourage participation in ACP and research. Notably, there is evidence that patients are&#xD;
        more likely to engage in ACP when recommended by their physician, so how best to approach ACP&#xD;
        for cancer patients is unknown. A common approach to ACP intervention research is to use a&#xD;
        Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned&#xD;
        within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is&#xD;
        recommended by the patient's clinician (rather than through community-based outreach groups).&#xD;
        For this intervention delivery approach, research assistants support interactions between&#xD;
        clinicians (providers or nurses) to find appropriate patients and garner interest in&#xD;
        performing ACP. This model is commonly used to recruit patients for clinical trials,&#xD;
        including ACP interventions. For patients with cancer, the HBDM may have some advantages over&#xD;
        the CBDM, given the close bonds that form between a patient and clinical care team as they&#xD;
        interact frequently during active treatments such as infusions and radiation that often span&#xD;
        several hours and weeks. Leveraging these therapeutic relationships may support greater&#xD;
        acceptance of opportunities to broach ACP than a community-based model, but this remains&#xD;
        unknown.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Experiences and perceptions of intervention</measure>
      <time_frame>Immediately post-intervention</time_frame>
      <description>Group discussions held with patients with cancer and their caregivers to collect qualitative data on acceptability of the game, necessary modifications for use in patients with cancer and their caregivers, and other feedback and opinions on the game experience.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Advance Care Planning Engagement Measure</measure>
      <time_frame>Baseline</time_frame>
      <description>This 4-item short-version survey measures readiness to perform ACP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Advance Care Planning Surrogate Decision Maker Engagement Measure</measure>
      <time_frame>Baseline</time_frame>
      <description>This 17-item survey measures surrogate decision maker readiness to perform ACP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction of Intervention Measure</measure>
      <time_frame>Immediately post-intervention</time_frame>
      <description>This 8-item survey measures participants' satisfaction with the conversation. Each item is scored on a 1-7 scale with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1-7 with 7 indicating the highest conversation satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention Measure</measure>
      <time_frame>Immediately post-intervention</time_frame>
      <description>This 3-item survey measures participants' perceived acceptability of the intervention.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Lung Cancer</condition>
    <condition>Genito Urinary Cancer</condition>
    <arm_group>
      <arm_group_label>Game participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will engage in playing the end-of-life conversation game called &quot;Hello&quot;, which involves answering open-ended questions about medical decision making and end-of-life issues.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>End-of-life conversation game called &quot;Hello&quot;</intervention_name>
      <description>To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').&#xD;
  Other Name: Previously named &quot;My Gift of Grace&quot;</description>
      <arm_group_label>Game participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria Cancer Patient:&#xD;
  &#xD;
            -  Adults (&gt; 18 years old)&#xD;
  &#xD;
            -  Able to speak and read English&#xD;
  &#xD;
            -  Be an individual diagnosed with breast, lung, or genitourinary/prostate cancer as&#xD;
               verified by primary oncologist or is the chosen caregiver for a participant with those&#xD;
               cancers&#xD;
  &#xD;
            -  Receives care at Penn State Health or is the chosen caregiver for a participant&#xD;
               treated at Penn State Health&#xD;
  &#xD;
          Inclusion Criteria Caregiver/Loved one:&#xD;
  &#xD;
            -  Adults (&gt; 18 years old)&#xD;
  &#xD;
            -  Able to speak and read English and/or Spanish&#xD;
  &#xD;
            -  Be the chosen caregiver for a participant with cancer&#xD;
  &#xD;
          Exclusion Criteria Cancer Patient:&#xD;
  &#xD;
            -  Anyone &lt;18 years of age&#xD;
  &#xD;
            -  Anyone unable to speak and read English&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
  &#xD;
            -  Receives cancer care exclusively outside of Penn State Health&#xD;
  &#xD;
          Exclusion Criteria Caregiver/Loved one:&#xD;
  &#xD;
            -  Anyone &lt;18 years of age&#xD;
  &#xD;
            -  Anyone unable to speak and read English&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
      <investigator_full_name>Lauren Van Scoy</investigator_full_name>
      <investigator_title>Professor of Medicine, Humanities and Public Health Sciences</investigator_title>
    </responsible_party>
    <keyword>Advance Care Planning</keyword>
    <keyword>Advance Directives</keyword>
    <keyword>Terminal Illness</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028152
  org study id: STUDY00023029
  nct id: NCT06028152
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness
        of end-of-life conversation game "Hello" as a tool to help individuals with breast, lung,
        and/or genito-urinary cancers treated at Penn State Cancer Institute and their loved ones
        perform advance care planning. The main questions it aims to answer are:
  
          -  What modifications and/or adaptations are necessary to Hello for use in cancer
             populations?
  
          -  How do different delivery models compare for recruitment in terms of feasibility and
             efficiency?
  
        Participants will:
  
          -  Complete pre-game questionnaires
  
          -  Play the Hello game
  
          -  Complete post-game questionnaires
  
          -  Participate in a focus group
  Previous studies conducted by the investigators have shown that the Hello game demonstrates
        successful ACP engagement in general populations, but has yet to be tailored to meet the
        unique needs of patients with advanced cancer and their caregivers. Outlining their care
        preferences by engaging in ACP is an important aspect of care according to patients with
        advanced cancer. However, only 55% of patients with advanced cancer patients have
        participated in ACP. These patients have substantial bio-psycho-social stressors that
        distinguish their ACP needs from others. Tailoring established interventions that foster high
        quality conversations about medical treatment preferences and end-of-life issues (such as the
        Hello game) is critically important for this population given its unique needs. As evidenced
        by qualitative interviews with >200 participants, the Hello game creates a safe environment
        for sensitive conversations about end-of-life issues and inspired sharing of rich
        perspectives, with no reported adverse events, excessive burden, or negative emotional
        effects. That said, the intervention must be adapted for patients with cancer, particularly
        those with advanced cancer and their caregivers.
  
        Additionally, while several effective ACP interventions exist (including Hello), how best to
        disseminate these interventions has not been rigorously or systematically studied. In other
        ongoing and previous studies, the investigators have demonstrated success in both engaging
        individuals living in underrepresented communities in ACP and successfully enrolling them in
        interventional research about ACP. The investigators credit these successes to their unique
        intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM
        overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to
        discuss end-of-life issues) by leveraging established community connections to recruit
        participants to participate in ACP interventions as well as research. In the CBDM, trusted
        community "hosts" (who are leaders from local hospice organizations, senior centers, health
        agencies) invite participants to attend an ACP event. They introduce the research team to the
        attendees who may choose to participate in the ACP activity, the research, or both. Hosts are
        provided with marketing materials and utilize their community network channels to advertise
        the event. This model allows for research to be conducted more easily within hard to reach
        and underserved communities such as Black, Hispanic and rural communities- much like the most
        remote communities across the PSCI's 28-county catchment area.
  
        Patients with cancer, however, are unique, and may require an alternative approach that
        involves partnering with their oncology care team to introduce the concept of ACP and
        encourage participation in ACP and research. Notably, there is evidence that patients are
        more likely to engage in ACP when recommended by their physician, so how best to approach ACP
        for cancer patients is unknown. A common approach to ACP intervention research is to use a
        Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned
        within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is
        recommended by the patient's clinician (rather than through community-based outreach groups).
        For this intervention delivery approach, research assistants support interactions between
        clinicians (providers or nurses) to find appropriate patients and garner interest in
        performing ACP. This model is commonly used to recruit patients for clinical trials,
        including ACP interventions. For patients with cancer, the HBDM may have some advantages over
        the CBDM, given the close bonds that form between a patient and clinical care team as they
        interact frequently during active treatments such as infusions and radiation that often span
        several hours and weeks. Leveraging these therapeutic relationships may support greater
        acceptance of opportunities to broach ACP than a community-based model, but this remains
        unknown.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Experiences and perceptions of intervention
  time frame: Immediately post-intervention
  description: Group discussions held with patients with cancer and their caregivers to collect qualitative data on acceptability of the game, necessary modifications for use in patients with cancer and their caregivers, and other feedback and opinions on the game experience.
  measure: Advance Care Planning Engagement Measure
  time frame: Baseline
  description: This 4-item short-version survey measures readiness to perform ACP.
  measure: Advance Care Planning Surrogate Decision Maker Engagement Measure
  time frame: Baseline
  description: This 17-item survey measures surrogate decision maker readiness to perform ACP.
  measure: Satisfaction of Intervention Measure
  time frame: Immediately post-intervention
  description: This 8-item survey measures participants' satisfaction with the conversation. Each item is scored on a 1-7 scale with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1-7 with 7 indicating the highest conversation satisfaction.
  measure: Acceptability of Intervention Measure
  time frame: Immediately post-intervention
  description: This 3-item survey measures participants' perceived acceptability of the intervention.
  arm group label: Game participants
  arm group type: Experimental
  description: All participants will engage in playing the end-of-life conversation game called "Hello", which involves answering open-ended questions about medical decision making and end-of-life issues.
  intervention type: Other
  intervention name: End-of-life conversation game called "Hello"
  description: To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').
  Other Name: Previously named "My Gift of Grace"
  arm group label: Game participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Milton S. Hershey Medical Center
  investigator full name: Lauren Van Scoy
  investigator title: Professor of Medicine, Humanities and Public Health Sciences
  mesh term: Urogenital Neoplasms
  sharing ipd: No