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/NCT06038604</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00110738</org_study_id>
      <nct_id>NCT06038604</nct_id>
    </id_info>
    <brief_title>Glioblastoma Psychosocial Support Program</brief_title>
    <official_title>Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Glioblastoma Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke 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 goal of the study is to conduct a pilot test of the psychosocial support intervention&#xD;
        with family caregivers and/or patients coping with glioblastoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The specific aims of this study is to pilot test the psychosocial support program for&#xD;
        patients with glioblastoma and/or their family caregivers. The investigators will recruit&#xD;
        patient-caregiver dyads for the psychosocial support intervention; participants will have the&#xD;
        choice whether to take part in the intervention as a dyad or individually given the&#xD;
        variability of symptoms and progression of glioblastoma. The investigators will examine&#xD;
        acceptability and feasibility of the intervention and examine whether participation in the&#xD;
        program can help reduce distress and improve quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Number of participants who complete study participation</measure>
      <time_frame>End of study (4-months)</time_frame>
      <description>Completion of sessions by 70% of participants across a four-month period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who complete post-intervention assessment</measure>
      <time_frame>End of study (4-months)</time_frame>
      <description>Completion of assessments by 70% of participants across a four-month period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants' satisfaction with treatment</measure>
      <time_frame>End of study (4-months)</time_frame>
      <description>Overall satisfaction rating for the psychosocial intervention with 70% of patients and caregivers reporting satisfaction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)</measure>
      <time_frame>Baseline; Post-intervention follow up (up to 4 months)</time_frame>
      <description>The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General distress as measured by the Distress Thermometer</measure>
      <time_frame>Baseline; Post-intervention follow up (up to 4 months)</time_frame>
      <description>The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)</measure>
      <time_frame>Baseline; Post-intervention follow up (up to 4 months)</time_frame>
      <description>The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiving efficacy as measured by the caregiver inventory</measure>
      <time_frame>Baseline; Post-intervention follow up (up to 4 months)</time_frame>
      <description>The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Glioblastoma</condition>
    <arm_group>
      <arm_group_label>Psychosocial Support Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The psychosocial support intervention includes components such as logistical and practical support and self-care, strategies to manage cognitive changes, as well as strategies for effective communication when coping with glioblastoma.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychosocial Support Intervention</intervention_name>
      <description>Participants will receive six weekly 60-minute sessions conducted by videoconference.</description>
      <arm_group_label>Psychosocial Support Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          For patients:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who self-report a diagnosis of glioblastoma&#xD;
  &#xD;
            -  Age &gt;18 years&#xD;
  &#xD;
            -  English Speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lacks capacity for interview or is unable to provide informed consent&#xD;
  &#xD;
            -  Visual or hearing impairments or severe behavioral problems that preclude&#xD;
               participation&#xD;
  &#xD;
            -  Too sick to participate&#xD;
  &#xD;
          For caregivers:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;18 years&#xD;
  &#xD;
            -  English Speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lacks capacity for interview or is unable to provide informed consent&#xD;
  &#xD;
            -  Visual or hearing impairments or severe behavioral problems that preclude&#xD;
               participation&#xD;
  &#xD;
            -  Too sick to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laura S. Porter, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura S. Porter, PhD</last_name>
      <phone>919-416-3436</phone>
      <email>laura.porter@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katherine Ramos, PhD</last_name>
      <phone>919-416-3434</phone>
      <email>katherine.ramos@duke.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Glioblastoma</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/NCT06038604
  org study id: Pro00110738
  nct id: NCT06038604
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the study is to conduct a pilot test of the psychosocial support intervention
        with family caregivers and/or patients coping with glioblastoma.
  The specific aims of this study is to pilot test the psychosocial support program for
        patients with glioblastoma and/or their family caregivers. The investigators will recruit
        patient-caregiver dyads for the psychosocial support intervention; participants will have the
        choice whether to take part in the intervention as a dyad or individually given the
        variability of symptoms and progression of glioblastoma. The investigators will examine
        acceptability and feasibility of the intervention and examine whether participation in the
        program can help reduce distress and improve quality of life.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Number of participants who complete study participation
  time frame: End of study (4-months)
  description: Completion of sessions by 70% of participants across a four-month period
  measure: Number of participants who complete post-intervention assessment
  time frame: End of study (4-months)
  description: Completion of assessments by 70% of participants across a four-month period
  measure: Participants' satisfaction with treatment
  time frame: End of study (4-months)
  description: Overall satisfaction rating for the psychosocial intervention with 70% of patients and caregivers reporting satisfaction.
  measure: Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)
  time frame: Baseline; Post-intervention follow up (up to 4 months)
  description: The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress).
  measure: General distress as measured by the Distress Thermometer
  time frame: Baseline; Post-intervention follow up (up to 4 months)
  description: The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress).
  measure: Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
  time frame: Baseline; Post-intervention follow up (up to 4 months)
  description: The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being).
  measure: Caregiving efficacy as measured by the caregiver inventory
  time frame: Baseline; Post-intervention follow up (up to 4 months)
  description: The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy).
  arm group label: Psychosocial Support Intervention
  arm group type: Experimental
  description: The psychosocial support intervention includes components such as logistical and practical support and self-care, strategies to manage cognitive changes, as well as strategies for effective communication when coping with glioblastoma.
  intervention type: Behavioral
  intervention name: Psychosocial Support Intervention
  description: Participants will receive six weekly 60-minute sessions conducted by videoconference.
  arm group label: Psychosocial Support Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laura S. Porter, PhD
  role: Principal Investigator
  affiliation: Duke University
  last name: Laura S. Porter, PhD
  phone: 919-416-3436
  email: laura.porter@duke.edu
  last name: Katherine Ramos, PhD
  phone: 919-416-3434
  email: katherine.ramos@duke.edu
  responsible party type: Sponsor
  mesh term: Glioblastoma
  sharing ipd: No