<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/NCT04479696</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0097</org_study_id>
    <secondary_id>NCI-2020-03698</secondary_id>
    <secondary_id>2018-0097</secondary_id>
    <nct_id>NCT04479696</nct_id>
  </id_info>
  <brief_title>Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors</brief_title>
  <official_title>Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer 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>
      This trial studies whether a customized video intervention can help to reduce anxiety in&#xD;
      brain cancer patients undergoing radiation treatment and their caregivers. A customized&#xD;
      neuro-imaging referenced symptom video that describes symptoms and side effects specific to&#xD;
      the patients' tumor may result in an early and sustained reduction in anxiety and distress&#xD;
      during and after radiation treatment, thereby improving quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine if provision of a neuro-imaging referenced symptom (NIRS) video intervention&#xD;
      for patients starting radiotherapy for newly diagnosed primary brain tumors reduces patient&#xD;
      anxiety during radiation compared to standard of care information.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if provision of a NIRS video intervention for patients starting radiotherapy&#xD;
      for newly diagnosed primary brain tumors reduces caregiver anxiety during radiation compared&#xD;
      to standard of care information.&#xD;
&#xD;
      II. To determine if any changes in patient or caregiver anxiety early during radiation are&#xD;
      sustained after the completion of radiation.&#xD;
&#xD;
      III. To investigate whether changes in anxiety are associated with changes in quality of life&#xD;
      and distress in patients.&#xD;
&#xD;
      IV. To investigate whether patients perceive the NIRS intervention to have been helpful in&#xD;
      understanding possible tumor and treatment symptoms.&#xD;
&#xD;
      OUTLINE: Patients and their caregivers are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I (NIRS VIDEO): Patients receive standard of care verbal and written education materials.&#xD;
      Patients also receive a customized NIRS video which includes a description of each their&#xD;
      tumor, functional areas of the brain affected, and possible symptoms from the tumor and&#xD;
      radiation treatment based on the neuro-imaging features. Patients and their caregivers watch&#xD;
      the video together or separately over 1.5-3 minutes before the end of the first week of&#xD;
      radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an&#xD;
      optional survey over 5-10 minutes.&#xD;
&#xD;
      ARM II (STANDARD OF CARE EDUCATION): Patients receive standard of care verbal and written&#xD;
      education materials.&#xD;
&#xD;
      After completion of radiation treatment, patients are followed up at 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2019</start_date>
  <completion_date type="Anticipated">February 2, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 2, 2027</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)</time_frame>
    <description>Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain [FACT- Br]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score</measure>
    <time_frame>From baseline to 2 and 6 weeks</time_frame>
    <description>Analysis will focus on the between-group comparison of the changes of the caregiver S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores</measure>
    <time_frame>From baseline to 1 month post-RT</time_frame>
    <description>Analysis will be performed by testing for the effects of time, in particular, differences between the average of weeks 2 and 6 during RT and 1 month after RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient Distress Thermometer score and FACT-Br score</measure>
    <time_frame>From baseline to 2 weeks, 6 weeks, and 1 month post-RT</time_frame>
    <description>Evaluates the impact between distress and overall quality of life in patients. LMMs will be used to assess the correlations between change in anxiety and change in quality of life, etc., without including time as an independent variable, yet with within-subject correlations still accounted for. For each fixed time point, simple correlations will also be calculated. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survey</measure>
    <time_frame>Up to 1 month post-RT</time_frame>
    <description>Evaluates whether neuro-imaging referenced symptom intervention was subjectively helpful in understanding their tumor and treatment symptoms and alleviating their anxiety. Relevant summary statistics will be computed. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Glioblastoma</condition>
  <condition>WHO Grade II Glioma</condition>
  <condition>WHO Grade III Glioma</condition>
  <arm_group>
    <arm_group_label>Arm I (NIRS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (standard of care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive standard of care verbal and written education materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive standard of care verbal and written education materials</description>
    <arm_group_label>Arm I (NIRS)</arm_group_label>
    <arm_group_label>Arm II (standard of care)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (NIRS)</arm_group_label>
    <arm_group_label>Arm II (standard of care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete optional survey</description>
    <arm_group_label>Arm I (NIRS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video</intervention_name>
    <description>Watch NIRS video</description>
    <arm_group_label>Arm I (NIRS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA: Adult patients with newly diagnosed glioma (World Health&#xD;
             Organization [WHO] grade 2-4) who are planned for a 6-week course of radiotherapy&#xD;
             after surgery&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA: Able to complete questionnaires in English&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance&#xD;
             imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the&#xD;
             start of radiotherapy&#xD;
&#xD;
          -  CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (&gt;= 18 years) who is accompanying an&#xD;
             eligible patient consented to the study&#xD;
&#xD;
          -  CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is&#xD;
             consented for participation on the study&#xD;
&#xD;
          -  CAREGIVER ELIGIBILITY CRITERIA: Able and willing to complete questionnaires in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that&#xD;
             prevent the ability to complete the questionnaires as determined by the assessing&#xD;
             staff in the pre-intervention evaluation&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status&#xD;
             [KPS] &lt; 60) that prevent the ability to complete the questionnaires&#xD;
&#xD;
          -  CAREGIVER ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that&#xD;
             prevent the ability to complete the questionnaires as determined by the assessing&#xD;
             staff in the pre-intervention evaluation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caroline Chung</last_name>
    <phone>713-745-5422</phone>
    <email>cchung3@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Chung</last_name>
      <phone>713-563-2300</phone>
    </contact>
    <investigator>
      <last_name>Caroline Chung</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 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>
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04479696
org study id: 2018-0097
secondary id: NCI-2020-03698
secondary id: 2018-0097
nct id: NCT04479696
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies whether a customized video intervention can help to reduce anxiety in
      brain cancer patients undergoing radiation treatment and their caregivers. A customized
      neuro-imaging referenced symptom video that describes symptoms and side effects specific to
      the patients' tumor may result in an early and sustained reduction in anxiety and distress
      during and after radiation treatment, thereby improving quality of life.
PRIMARY OBJECTIVE:

      I. To determine if provision of a neuro-imaging referenced symptom (NIRS) video intervention
      for patients starting radiotherapy for newly diagnosed primary brain tumors reduces patient
      anxiety during radiation compared to standard of care information.

      SECONDARY OBJECTIVES:

      I. To determine if provision of a NIRS video intervention for patients starting radiotherapy
      for newly diagnosed primary brain tumors reduces caregiver anxiety during radiation compared
      to standard of care information.

      II. To determine if any changes in patient or caregiver anxiety early during radiation are
      sustained after the completion of radiation.

      III. To investigate whether changes in anxiety are associated with changes in quality of life
      and distress in patients.

      IV. To investigate whether patients perceive the NIRS intervention to have been helpful in
      understanding possible tumor and treatment symptoms.

      OUTLINE: Patients and their caregivers are randomized to 1 of 2 arms.

      ARM I (NIRS VIDEO): Patients receive standard of care verbal and written education materials.
      Patients also receive a customized NIRS video which includes a description of each their
      tumor, functional areas of the brain affected, and possible symptoms from the tumor and
      radiation treatment based on the neuro-imaging features. Patients and their caregivers watch
      the video together or separately over 1.5-3 minutes before the end of the first week of
      radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an
      optional survey over 5-10 minutes.

      ARM II (STANDARD OF CARE EDUCATION): Patients receive standard of care verbal and written
      education materials.

      After completion of radiation treatment, patients are followed up at 1 month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)
time frame: From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)
description: Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain [FACT- Br]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.
measure: Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score
time frame: From baseline to 2 and 6 weeks
description: Analysis will focus on the between-group comparison of the changes of the caregiver S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
measure: Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores
time frame: From baseline to 1 month post-RT
description: Analysis will be performed by testing for the effects of time, in particular, differences between the average of weeks 2 and 6 during RT and 1 month after RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
measure: Changes in patient Distress Thermometer score and FACT-Br score
time frame: From baseline to 2 weeks, 6 weeks, and 1 month post-RT
description: Evaluates the impact between distress and overall quality of life in patients. LMMs will be used to assess the correlations between change in anxiety and change in quality of life, etc., without including time as an independent variable, yet with within-subject correlations still accounted for. For each fixed time point, simple correlations will also be calculated. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
measure: Patient survey
time frame: Up to 1 month post-RT
description: Evaluates whether neuro-imaging referenced symptom intervention was subjectively helpful in understanding their tumor and treatment symptoms and alleviating their anxiety. Relevant summary statistics will be computed. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
arm group label: Arm I (NIRS)
arm group type: Experimental
description: Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
arm group label: Arm II (standard of care)
arm group type: Active Comparator
description: Patients receive standard of care verbal and written education materials.
intervention type: Other
intervention name: Educational Intervention
description: Receive standard of care verbal and written education materials
arm group label: Arm I (NIRS)
arm group label: Arm II (standard of care)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (NIRS)
arm group label: Arm II (standard of care)
intervention type: Other
intervention name: Survey Administration
description: Complete optional survey
arm group label: Arm I (NIRS)
intervention type: Other
intervention name: Video
description: Watch NIRS video
arm group label: Arm I (NIRS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Chung
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Caroline Chung
phone: 713-745-5422
email: cchung3@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma