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/NCT05976490</url>
    </required_header>
    <id_info>
      <org_study_id>23-178</org_study_id>
      <nct_id>NCT05976490</nct_id>
    </id_info>
    <brief_title>NeuroPathways Intervention for Brain Tumor Patients</brief_title>
    <official_title>NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</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 goal of this study is to test an information and support intervention for patients with&#xD;
        malignant (or &quot;high-grade&quot;) brain tumors. This study was developed to help patients cope&#xD;
        after a brain tumor diagnosis. The main question this study aims to answer is whether this&#xD;
        intervention (which includes access to an information guide and one-on-one coaching sessions)&#xD;
        is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to&#xD;
        patients. Participants will be asked to take part in the coaching sessions, use the guide as&#xD;
        desired, and complete a small group of short surveys at three different points in time; some&#xD;
        participants will be asked to share feedback via exit interviews.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a prospective pilot randomized controlled trial to examine the feasibility&#xD;
        and acceptability of a novel, population-specific intervention designed to help patients with&#xD;
        recently-diagnosed malignant brain tumors process and cope with their illness.&#xD;
  &#xD;
        The specific aims are to 1) refine the NeuroPathways intervention based on feedback from an&#xD;
        open pilot study (n=up to 10) with exit interviews, 2) evaluate the feasibility and&#xD;
        acceptability of NeuroPathways in a pilot randomized controlled trial (n=40), and 3) explore&#xD;
        preliminary effects of the intervention on psychological, behavioral, and cognitive outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">April 10, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Open pilot to refine the intervention in up to 10 participants, followed by a pilot randomized controlled trial (n=40) in which participants will be randomized 1:1 to the intervention versus usual care</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all four intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 60% of enrolled patients complete all four sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 80% of patients score at least 20 points on the CSQ-8.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Exploratory: Perceived Cognitive Function</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will explore the effect of NeuroPathways on perceived cognitive function using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) between study arms in the pilot RCT phase of this study. The FACT-Cog is a 37-item measure of perceived cognitive impairment in cancer patients with scores from 0-148 and higher scores representing higher perceived cognitive functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory: Distress (Depression and Anxiety Symptoms)</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will explore the effect of NeuroPathways on distress using the Hospital Anxiety and Depression Scale (HADS) between study arms in the pilot RCT phase of this study. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. Used extensively in samples of patients with cancer and their caregivers, the questionnaire consists of a four-point item response format that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with higher scores indicating higher symptom burden, and a cutoff of 8 or greater denoting clinically significant anxiety or depression.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory: Self-Efficacy</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will explore the effect of NeuroPathways on self-efficacy using the Lewis Cancer Self-Efficacy Scale (CASE) between study arms in the pilot RCT phase of this study. The CASE is a 17-item questionnaire with a score range of 0-170. Higher scores reflect higher confidence in managing the impact of one's illness.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory: Loneliness</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will explore the effect of NeuroPathways on loneliness using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Isolation between study arms in the pilot RCT phase of this study. The PROMIS - Social Isolation is a 8-item questionnaire, scored from 4-20, that is used to evaluate feelings of loneliness and social isolation. Higher scores indicate greater feelings of loneliness and social isolation.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory: Coping</measure>
      <time_frame>2 years</time_frame>
      <description>The investigators will explore the effect of NeuroPathways on coping using the Brief Coping Orientation to Problems Experienced (Brief-COPE). The Brief-COPE is a 28-item self-report measure assessing a variety of coping styles with scores ranging from 28-112 and higher scores indicating greater coping ability.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Malignant Brain Tumor</condition>
    <condition>Glioma</condition>
    <condition>Coping Skills</condition>
    <arm_group>
      <arm_group_label>NeuroPathways Open Pilot</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist).&#xD;
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks, as well as an exit interview after the intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NeuroPathways Pilot RCT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist).&#xD;
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual supportive care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive usual supportive care, which includes referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician.&#xD;
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Information and Support Intervention</intervention_name>
      <description>Information guide and four one-on-one coaching sessions</description>
      <arm_group_label>NeuroPathways Open Pilot</arm_group_label>
      <arm_group_label>NeuroPathways Pilot RCT</arm_group_label>
      <other_name>NeuroPathways</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual supportive care</intervention_name>
      <description>Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician</description>
      <arm_group_label>Usual supportive care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18&#xD;
  &#xD;
            -  Massachusetts General Hospital Cancer Center patient&#xD;
  &#xD;
            -  Within 6 weeks of diagnosis with a primary malignant brain tumor&#xD;
  &#xD;
            -  Able to speak and read in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to provide informed consent as assessed by the study team (e.g., due to&#xD;
               neurological impairment such as severe cognitive impairment/dementia or&#xD;
               moderate-to-severe receptive aphasia)&#xD;
  &#xD;
            -  Deemed inappropriate to approach by patient's oncologist or study PI&#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>Deborah A Forst, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Deborah A Forst, MD</last_name>
      <phone>617-724-4000</phone>
      <email>dforst@partners.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Massachusetts General Hospital Cancer Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Deborah A Forst</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>glioma</keyword>
    <keyword>supportive care</keyword>
    <keyword>psychoeducation</keyword>
    <keyword>information</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Deborah Forst, MD.&#xD;
  The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
      <ipd_access_criteria>Only de-identified participant data from the final research dataset used in the published manuscript can be shared. Data shall only be shared upon request with researchers who provide a methodologically sound research proposal, at the discretion of the principal investigator.</ipd_access_criteria>
    </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/NCT05976490
  org study id: 23-178
  nct id: NCT05976490
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This goal of this study is to test an information and support intervention for patients with
        malignant (or "high-grade") brain tumors. This study was developed to help patients cope
        after a brain tumor diagnosis. The main question this study aims to answer is whether this
        intervention (which includes access to an information guide and one-on-one coaching sessions)
        is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to
        patients. Participants will be asked to take part in the coaching sessions, use the guide as
        desired, and complete a small group of short surveys at three different points in time; some
        participants will be asked to share feedback via exit interviews.
  This study will be a prospective pilot randomized controlled trial to examine the feasibility
        and acceptability of a novel, population-specific intervention designed to help patients with
        recently-diagnosed malignant brain tumors process and cope with their illness.
  
        The specific aims are to 1) refine the NeuroPathways intervention based on feedback from an
        open pilot study (n=up to 10) with exit interviews, 2) evaluate the feasibility and
        acceptability of NeuroPathways in a pilot randomized controlled trial (n=40), and 3) explore
        preliminary effects of the intervention on psychological, behavioral, and cognitive outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Open pilot to refine the intervention in up to 10 participants, followed by a pilot randomized controlled trial (n=40) in which participants will be randomized 1:1 to the intervention versus usual care
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
  time frame: 2 years
  description: The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all four intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 60% of enrolled patients complete all four sessions.
  measure: Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
  time frame: 2 years
  description: The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 80% of patients score at least 20 points on the CSQ-8.
  measure: Exploratory: Perceived Cognitive Function
  time frame: 2 years
  description: The investigators will explore the effect of NeuroPathways on perceived cognitive function using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) between study arms in the pilot RCT phase of this study. The FACT-Cog is a 37-item measure of perceived cognitive impairment in cancer patients with scores from 0-148 and higher scores representing higher perceived cognitive functioning.
  measure: Exploratory: Distress (Depression and Anxiety Symptoms)
  time frame: 2 years
  description: The investigators will explore the effect of NeuroPathways on distress using the Hospital Anxiety and Depression Scale (HADS) between study arms in the pilot RCT phase of this study. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. Used extensively in samples of patients with cancer and their caregivers, the questionnaire consists of a four-point item response format that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with higher scores indicating higher symptom burden, and a cutoff of 8 or greater denoting clinically significant anxiety or depression.
  measure: Exploratory: Self-Efficacy
  time frame: 2 years
  description: The investigators will explore the effect of NeuroPathways on self-efficacy using the Lewis Cancer Self-Efficacy Scale (CASE) between study arms in the pilot RCT phase of this study. The CASE is a 17-item questionnaire with a score range of 0-170. Higher scores reflect higher confidence in managing the impact of one's illness.
  measure: Exploratory: Loneliness
  time frame: 2 years
  description: The investigators will explore the effect of NeuroPathways on loneliness using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Isolation between study arms in the pilot RCT phase of this study. The PROMIS - Social Isolation is a 8-item questionnaire, scored from 4-20, that is used to evaluate feelings of loneliness and social isolation. Higher scores indicate greater feelings of loneliness and social isolation.
  measure: Exploratory: Coping
  time frame: 2 years
  description: The investigators will explore the effect of NeuroPathways on coping using the Brief Coping Orientation to Problems Experienced (Brief-COPE). The Brief-COPE is a 28-item self-report measure assessing a variety of coping styles with scores ranging from 28-112 and higher scores indicating greater coping ability.
  arm group label: NeuroPathways Open Pilot
  arm group type: Experimental
  description: Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist).
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks, as well as an exit interview after the intervention.
  arm group label: NeuroPathways Pilot RCT
  arm group type: Experimental
  description: Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist).
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks.
  arm group label: Usual supportive care
  arm group type: Active Comparator
  description: Participants will receive usual supportive care, which includes referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician.
  Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks.
  intervention type: Behavioral
  intervention name: Information and Support Intervention
  description: Information guide and four one-on-one coaching sessions
  arm group label: NeuroPathways Open Pilot
  arm group label: NeuroPathways Pilot RCT
  other name: NeuroPathways
  intervention type: Other
  intervention name: Usual supportive care
  description: Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician
  arm group label: Usual supportive care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Deborah A Forst, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Deborah A Forst, MD
  phone: 617-724-4000
  email: dforst@partners.org
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Deborah A Forst
  investigator title: Principal Investigator
  mesh term: Brain Neoplasms
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Deborah Forst, MD.
  The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
  ipd access criteria: Only de-identified participant data from the final research dataset used in the published manuscript can be shared. Data shall only be shared upon request with researchers who provide a methodologically sound research proposal, at the discretion of the principal investigator.