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/NCT05995860</url>
    </required_header>
    <id_info>
      <org_study_id>CTO-IUSCCC-0827</org_study_id>
      <nct_id>NCT05995860</nct_id>
    </id_info>
    <brief_title>Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery</brief_title>
    <acronym>PRECursOr</acronym>
    <official_title>Pilot Study of a Rapid Triadic Communication Intention Elicitation Intervention (PRECursOr) to Improve Supportive Oncology Care Delivery for Patients With Advanced, Incurable Cancer and Their Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Cancer Society, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Indiana University</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this study is to help test an idea designed to foster more supportive talk&#xD;
        between providers (doctors or nurse practitioners), patients, and caregivers during an&#xD;
        outpatient oncology appointment. A caregiver is the person the patient identifies is&#xD;
        primarily involved in their healthcare. This study is collecting your reaction to this idea&#xD;
        in order to understand needed changes before we introduce the idea to a larger group of&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pilot study focuses on an intervention (freelisting) designed to elicit supportive&#xD;
        oncology communication intentions among the patient-caregiver-provider triad prior to an&#xD;
        outpatient oncology encounter. The goal is to shape communication behaviors during the&#xD;
        encounter to improve outcomes of the encounter.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 14, 2023</start_date>
    <completion_date type="Anticipated">March 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>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>Evaluate overall recruitment rates.</measure>
      <time_frame>Once all surveys in the sample size are completed, 9 months anticipated</time_frame>
      <description>PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate overall participant satisfaction surveys.</measure>
      <time_frame>Once all surveys in the sample size are completed, 9 months anticipated</time_frame>
      <description>PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Explore group differences in communication behaviors during the audio-recorded encounters.</measure>
      <time_frame>Once all encounters in the sample size are completed and transcribed, 9 months anticipated</time_frame>
      <description>The intervention group will demonstrate increased communication behaviors during the encounter (i.e., breadth of supportive oncology domains discussed) and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Explore group differences in exit interview outcomes following the encounters.</measure>
      <time_frame>Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated</time_frame>
      <description>The intervention group will demonstrate increased communication behaviors and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes</measure>
      <time_frame>Once all surveys in the sample size are completed, 9 months anticipated</time_frame>
      <description>Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Stage III Vulvar Cancer</condition>
    <condition>Stage III Ovarian Cancer</condition>
    <condition>Stage III Uterine Cancer</condition>
    <condition>Stage III Vaginal Cancer</condition>
    <condition>Stage IV Vulvar Cancer</condition>
    <condition>Stage IV Ovarian Cancer</condition>
    <condition>Stage IV Uterine Cancer</condition>
    <condition>Stage IV Vaginal Cancer</condition>
    <arm_group>
      <arm_group_label>Control group triads</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group triads</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Intervention group triads</intervention_name>
      <description>The intervention consists of a rapid (less than 10-minute) communication intention elicitation exercise (via Freelisting), which is conducted independently with the patient, caregiver, and provider immediately prior to the outpatient oncology encounter. Patients, caregivers, and providers will not be instructed to endorse the Freelist responses that were generated by the intervention prior to the outpatient encounter-leaving the decision to discuss elicited communication intentions during the encounter up to individuals as the conversation naturally occurs. As with the control group, post-encounter survey data will also be collected independently from the patient, caregiver, and the provider, followed by a post-encounter qualitative interview conducted jointly with the patient and caregiver.</description>
      <arm_group_label>Intervention group triads</arm_group_label>
      <other_name>PRECursOr</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients will:&#xD;
  &#xD;
                 1. be adult women with an advanced, incurable gynecologic cancer (Stage III/IV&#xD;
                    disease at diagnosis combined with evidence of refractory/progressive disease&#xD;
                    after first-line treatment or recurrent disease),&#xD;
  &#xD;
                 2. be at a transition point in the illness (provider confirmed non-response to&#xD;
                    treatment, progressive disease, or a symptomatic hospitalization within the last&#xD;
                    month),&#xD;
  &#xD;
                 3. not be receiving specialty palliative care or hospice,&#xD;
  &#xD;
                 4. read/speak English, and&#xD;
  &#xD;
                 5. be able to provide written informed consent.&#xD;
  &#xD;
            -  caregivers will:&#xD;
  &#xD;
                 1. identify as the individual who is primarily involved in the patient's care,&#xD;
  &#xD;
                 2. be able to attend the oncology encounter,&#xD;
  &#xD;
                 3. read/speak English, and&#xD;
  &#xD;
                 4. be able to provide written informed consent.&#xD;
  &#xD;
            -  providers will:&#xD;
  &#xD;
                 1. specialize in gynecologic oncology, and&#xD;
  &#xD;
                 2. provide outpatient care at IUSCCC gynecologic oncology clinic.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          patients and/or caregivers will be excluded if either one or both demonstrate:&#xD;
  &#xD;
            1. cognitive impairment, or&#xD;
  &#xD;
            2. speech/hearing difficulties precluding participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Indiana University Melvin and Bren Simon Comprehensive Cancer Center</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indiana University</investigator_affiliation>
      <investigator_full_name>Kristin Levoy</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
      <mesh_term>Vulvar Neoplasms</mesh_term>
      <mesh_term>Vaginal Neoplasms</mesh_term>
      <mesh_term>Uterine Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995860
  org study id: CTO-IUSCCC-0827
  nct id: NCT05995860
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to help test an idea designed to foster more supportive talk
        between providers (doctors or nurse practitioners), patients, and caregivers during an
        outpatient oncology appointment. A caregiver is the person the patient identifies is
        primarily involved in their healthcare. This study is collecting your reaction to this idea
        in order to understand needed changes before we introduce the idea to a larger group of
        patients.
  This pilot study focuses on an intervention (freelisting) designed to elicit supportive
        oncology communication intentions among the patient-caregiver-provider triad prior to an
        outpatient oncology encounter. The goal is to shape communication behaviors during the
        encounter to improve outcomes of the encounter.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Evaluate overall recruitment rates.
  time frame: Once all surveys in the sample size are completed, 9 months anticipated
  description: PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).
  measure: Evaluate overall participant satisfaction surveys.
  time frame: Once all surveys in the sample size are completed, 9 months anticipated
  description: PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.
  measure: Explore group differences in communication behaviors during the audio-recorded encounters.
  time frame: Once all encounters in the sample size are completed and transcribed, 9 months anticipated
  description: The intervention group will demonstrate increased communication behaviors during the encounter (i.e., breadth of supportive oncology domains discussed) and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.
  measure: Explore group differences in exit interview outcomes following the encounters.
  time frame: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated
  description: The intervention group will demonstrate increased communication behaviors and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.
  measure: Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
  time frame: Once all surveys in the sample size are completed, 9 months anticipated
  description: Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.
  arm group label: Control group triads
  arm group type: No Intervention
  arm group label: Intervention group triads
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Intervention group triads
  description: The intervention consists of a rapid (less than 10-minute) communication intention elicitation exercise (via Freelisting), which is conducted independently with the patient, caregiver, and provider immediately prior to the outpatient oncology encounter. Patients, caregivers, and providers will not be instructed to endorse the Freelist responses that were generated by the intervention prior to the outpatient encounter-leaving the decision to discuss elicited communication intentions during the encounter up to individuals as the conversation naturally occurs. As with the control group, post-encounter survey data will also be collected independently from the patient, caregiver, and the provider, followed by a post-encounter qualitative interview conducted jointly with the patient and caregiver.
  arm group label: Intervention group triads
  other name: PRECursOr
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Indiana University
  investigator full name: Kristin Levoy
  investigator title: Assistant Professor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Vulvar Neoplasms
  mesh term: Vaginal Neoplasms
  mesh term: Uterine Neoplasms