<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/NCT03244995</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0290</org_study_id>
    <secondary_id>NCI-2018-01099</secondary_id>
    <secondary_id>2017-0290</secondary_id>
    <nct_id>NCT03244995</nct_id>
  </id_info>
  <brief_title>Mind-Body Intervention in Glioma Couples</brief_title>
  <official_title>An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners</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 how well a couple-based mind body program works in improving spiritual,&#xD;
      psychosocial, and physical quality of life in patients with high or low grade glioma or&#xD;
      tumors that have spread to the brain and their partners. A couple-based mind body program may&#xD;
      help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall&#xD;
      quality of life in patients with glioma or tumors that have spread to the brain and their&#xD;
      partners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high&#xD;
      grade glioma (HGG) and their partners.&#xD;
&#xD;
      II. Establish the initial efficacy of the CBMB program in patients and their partners&#xD;
      regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary)&#xD;
      outcomes relative to a waitlist control (WLC) group.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy)&#xD;
      and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the&#xD;
      intervention.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and&#xD;
      meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for&#xD;
      6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits,&#xD;
      relationship, health care, work productivity, and quality of life.&#xD;
&#xD;
      GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may&#xD;
      undergo CBMB program after completion of study.&#xD;
&#xD;
      After completion of study, patients are followed up at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 6, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 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>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>Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of CBMB program as determined by attrition</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of CBMB program as determined by adherence</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of CBMB program as determined by acceptability</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Trial considered feasible if &gt; 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CBMB program efficacy</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.</description>
  </primary_outcome>
  <other_outcome>
    <measure>CBMB program efficacy on quality of life (QOL) outcomes</measure>
    <time_frame>Up to 3 months after completion of study</time_frame>
    <description>Will examine treatment mediators and moderators. Will examine if treatment efficacy on QOL outcomes measured at T3 is potentially achieved through improved mindfulness, self-compassion, holding back and intimacy measured at T2 using linear regression analysis in both a and b paths. Ninety percent bootstrap CIs will be constructed to assess the significance of the indirect effects defined using the product-of-coefficient approach. Linear regression analysis or multi-level modeling will be used to test for the interaction effects between treatment and baseline mindfulness, self-compassion, holding back and intimacy, as well as baseline medical and demographic factors (i.e., sex, age, and Karnofsky performance status), each at a two-sided significance level of 0.1.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Glioblastoma</condition>
  <condition>Low Grade Glioma</condition>
  <condition>Malignant Glioma</condition>
  <condition>Metastatic Malignant Neoplasm in the Brain</condition>
  <condition>Partner</condition>
  <condition>WHO Grade III Glioma</condition>
  <arm_group>
    <arm_group_label>Group I (CBMB program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (waitlist control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mind-Body Intervention Procedure</intervention_name>
    <description>Undergo CBMB program</description>
    <arm_group_label>Group I (CBMB program)</arm_group_label>
    <other_name>Mind-Body Interventions</other_name>
    <other_name>Mind-Body Medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (CBMB program)</arm_group_label>
    <arm_group_label>Group II (waitlist control)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (CBMB program)</arm_group_label>
    <arm_group_label>Group II (waitlist control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on&#xD;
             radiographic or pathologic diagnosis of grade III or IV listed in the medical records,&#xD;
             or patients with a malignancy that has metastasized to the brain&#xD;
&#xD;
          -  PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any&#xD;
             type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)&#xD;
&#xD;
          -  PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above&#xD;
&#xD;
          -  PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing&#xD;
             to participate&#xD;
&#xD;
          -  PATIENT &amp; PARTNER: Able to read and speak English&#xD;
&#xD;
          -  PATIENT &amp; PARTNER: Able to provide informed consent&#xD;
&#xD;
          -  PATIENT &amp; PARTNER: Have access to internet connectivity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal&#xD;
             cancer support group&#xD;
&#xD;
          -  PATIENT ONLY: Cognitive deficits that would impede the completion of self-report&#xD;
             instruments as deemed by the clinical team&#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>Kathrin Milbury</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 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>
    <mesh_term>Neoplasms</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/NCT03244995
org study id: 2017-0290
secondary id: NCI-2018-01099
secondary id: 2017-0290
nct id: NCT03244995
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how well a couple-based mind body program works in improving spiritual,
      psychosocial, and physical quality of life in patients with high or low grade glioma or
      tumors that have spread to the brain and their partners. A couple-based mind body program may
      help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall
      quality of life in patients with glioma or tumors that have spread to the brain and their
      partners.
PRIMARY OBJECTIVES:

      I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high
      grade glioma (HGG) and their partners.

      II. Establish the initial efficacy of the CBMB program in patients and their partners
      regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary)
      outcomes relative to a waitlist control (WLC) group.

      EXPLORATORY OBJECTIVES:

      I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy)
      and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the
      intervention.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and
      meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for
      6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits,
      relationship, health care, work productivity, and quality of life.

      GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may
      undergo CBMB program after completion of study.

      After completion of study, patients are followed up at 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
time frame: Up to 6 weeks
description: Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
measure: Feasibility of CBMB program as determined by attrition
time frame: Up to 6 weeks
description: Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.
measure: Feasibility of CBMB program as determined by adherence
time frame: Up to 6 weeks
description: Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.
measure: Feasibility of CBMB program as determined by acceptability
time frame: Up to 6 weeks
description: Trial considered feasible if > 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.
measure: CBMB program efficacy
time frame: Up to 6 weeks
description: Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.
measure: CBMB program efficacy on quality of life (QOL) outcomes
time frame: Up to 3 months after completion of study
description: Will examine treatment mediators and moderators. Will examine if treatment efficacy on QOL outcomes measured at T3 is potentially achieved through improved mindfulness, self-compassion, holding back and intimacy measured at T2 using linear regression analysis in both a and b paths. Ninety percent bootstrap CIs will be constructed to assess the significance of the indirect effects defined using the product-of-coefficient approach. Linear regression analysis or multi-level modeling will be used to test for the interaction effects between treatment and baseline mindfulness, self-compassion, holding back and intimacy, as well as baseline medical and demographic factors (i.e., sex, age, and Karnofsky performance status), each at a two-sided significance level of 0.1.
arm group label: Group I (CBMB program)
arm group type: Experimental
description: Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
arm group label: Group II (waitlist control)
arm group type: Active Comparator
description: Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
intervention type: Procedure
intervention name: Mind-Body Intervention Procedure
description: Undergo CBMB program
arm group label: Group I (CBMB program)
other name: Mind-Body Interventions
other name: Mind-Body Medicine
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Group I (CBMB program)
arm group label: Group II (waitlist control)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (CBMB program)
arm group label: Group II (waitlist control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathrin Milbury
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma
mesh term: Neoplasms