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/NCT05984667</url>
    </required_header>
    <id_info>
      <org_study_id>MCC-22-20126</org_study_id>
      <nct_id>NCT05984667</nct_id>
    </id_info>
    <brief_title>Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Glioma</brief_title>
    <acronym>C-SMART</acronym>
    <official_title>Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Glioma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Commonwealth University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Psychological Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Virginia Commonwealth 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 primary aims of this mixed-methods trial are to test the feasibility and acceptability of&#xD;
        the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered&#xD;
        via telehealth to patients with glioma and mild neurocognitive disorder (mNCD).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 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>Determine feasibility of C-SMART recruitment</measure>
      <time_frame>10 months</time_frame>
      <description>As evidenced by rates of participant screening, eligibility, and consent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine feasibility of C-SMART - Data collection procedures</measure>
      <time_frame>10 months</time_frame>
      <description>As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine acceptability of C-SMART intervention - Attendance</measure>
      <time_frame>10 months</time_frame>
      <description>As evidenced by the attendance rate at intervention sessions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine feasibility of C-SMART - Retention Rate</measure>
      <time_frame>11 months</time_frame>
      <description>As evidenced by the number of patients that complete post-intervention measures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine acceptability of C-SMART intervention - Satisfaction</measure>
      <time_frame>10 months</time_frame>
      <description>After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being &quot;Not at all&quot; to 5 being &quot;A great deal&quot;. Higher scores indicate greater satisfaction with the intervention session.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine acceptability of C-SMART intervention - Satisfaction - Recommendation</measure>
      <time_frame>10 months</time_frame>
      <description>As evidenced by the number of patients that would recommend the intervention to others</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Optimization of C-SMART research procedures</measure>
      <time_frame>8 months</time_frame>
      <description>The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa&gt;.80)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine feasibility of C-SMART research procedures - Patient reported outcome completion</measure>
      <time_frame>10 months</time_frame>
      <description>Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Glioma, Mixed</condition>
    <condition>Mild Neurocognitive Disorder</condition>
    <arm_group>
      <arm_group_label>C-SMART</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>C-SMART</intervention_name>
      <description>The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.</description>
      <arm_group_label>C-SMART</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults with a glioma diagnosis confirmed by histology&#xD;
  &#xD;
            -  At least one domain of neurocognitive function ≥ 1.5 SD below estimate premorbid&#xD;
               functioning&#xD;
  &#xD;
            -  Karnofsky' Performance Status (KPS) score ≥ 80&#xD;
  &#xD;
            -  ≥ 1 month out of radiation therapy&#xD;
  &#xD;
            -  Ability to read, speak, and understand English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to attend virtual sessions&#xD;
  &#xD;
            -  Inability to understand and provide informed consent&#xD;
  &#xD;
            -  Presence of clinically significant insomnia&#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>Sarah E Braun, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Virginia Commonwealth University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah E Braun, PhD</last_name>
      <phone>8046287028</phone>
      <email>sarah.braun@vcuhealth.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Giuliana V Zarrella, BA</last_name>
      <phone>8046254910</phone>
      <email>giuliana.zarrella@vcuhealth.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Virginia Commonwealth University</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>23298</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Braun, Ph.D</last_name>
        <phone>804-628-7028</phone>
        <email>sarah.braun@vcuhealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Giuliana Zarrella</last_name>
        <phone>8046254910</phone>
        <email>giuliana.zarrella@vcuhealth.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mindfulness</keyword>
    <keyword>Cognitive rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioma</mesh_term>
      <mesh_term>Neurocognitive Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share individual participant data (IPD) to other researchers at this time.</ipd_description>
    </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/NCT05984667
  org study id: MCC-22-20126
  nct id: NCT05984667
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The primary aims of this mixed-methods trial are to test the feasibility and acceptability of
        the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered
        via telehealth to patients with glioma and mild neurocognitive disorder (mNCD).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Determine feasibility of C-SMART recruitment
  time frame: 10 months
  description: As evidenced by rates of participant screening, eligibility, and consent
  measure: Determine feasibility of C-SMART - Data collection procedures
  time frame: 10 months
  description: As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
  measure: Determine acceptability of C-SMART intervention - Attendance
  time frame: 10 months
  description: As evidenced by the attendance rate at intervention sessions
  measure: Determine feasibility of C-SMART - Retention Rate
  time frame: 11 months
  description: As evidenced by the number of patients that complete post-intervention measures
  measure: Determine acceptability of C-SMART intervention - Satisfaction
  time frame: 10 months
  description: After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.
  measure: Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
  time frame: 10 months
  description: As evidenced by the number of patients that would recommend the intervention to others
  measure: Optimization of C-SMART research procedures
  time frame: 8 months
  description: The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80)
  measure: Determine feasibility of C-SMART research procedures - Patient reported outcome completion
  time frame: 10 months
  description: Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.
  arm group label: C-SMART
  arm group type: Experimental
  description: C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.
  intervention type: Behavioral
  intervention name: C-SMART
  description: The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.
  arm group label: C-SMART
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sarah E Braun, PhD
  role: Principal Investigator
  affiliation: Virginia Commonwealth University
  last name: Sarah E Braun, PhD
  phone: 8046287028
  email: sarah.braun@vcuhealth.org
  last name: Giuliana V Zarrella, BA
  phone: 8046254910
  email: giuliana.zarrella@vcuhealth.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Glioma
  mesh term: Neurocognitive Disorders
  sharing ipd: No
  ipd description: There is no plan to share individual participant data (IPD) to other researchers at this time.