<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/NCT02988271</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0491</org_study_id>
    <secondary_id>NCI-2018-01295</secondary_id>
    <secondary_id>2016-0491</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT02988271</nct_id>
  </id_info>
  <brief_title>Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress</brief_title>
  <official_title>Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress</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 self-administered meditation therapy works in improving anxiety&#xD;
      and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a&#xD;
      mind-body approach that uses a variety of techniques, such as deep breathing, sound, or&#xD;
      movement, that may help to decrease distress and anxiety and enhance the health and quality&#xD;
      of life of patients with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the feasibility of having patients self-administer meditation recordings&#xD;
      using a portable, computer-based program during a 2-week period.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Assess the effect of self-administered meditation on anxiety, depression and other&#xD;
      symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.&#xD;
&#xD;
      II. Evaluate participant satisfaction with the meditation delivery and tracking program.&#xD;
&#xD;
      III. Examine the association between the frequency of practice (number of sessions a day) and&#xD;
      choice of length of practice (5, 10, or 15 minute sessions) and anxiety, depression and other&#xD;
      patient reported outcomes.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (MEDITATION): Patients watch a pre-recorded instructional meditation video via an&#xD;
      iPod meditation app. Patients then complete meditation exercises using the meditation app&#xD;
      over 5-15 minutes once daily (QD) for up to 2 weeks. Patients also complete questionnaires&#xD;
      before and after meditation sessions and participate in an interview over 10 minutes.&#xD;
&#xD;
      GROUP II (WAITLIST CONTROL): Patients receive supportive care, such as access to social&#xD;
      workers, support groups, spiritual care, or other patient services for up to 2 weeks.&#xD;
      Patients also complete questionnaires over 15-20 minutes and participate in an interview over&#xD;
      10 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 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 self-administered meditation</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Feasibility will be confirmed if at least 50% of the eligible patients approached consent to the study and at least 70% of subjects complete at least two meditation sessions each week during the 2-week period. The study will calculate rates, frequencies, and 90% confidence intervals (CIs) of the rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Summary statistics and 90% CIs will be calculated to assess differences in mean anxiety, depression and other outcomes measured at the end of the study, as well as the change scores from baseline, between subjects randomized to meditation and those randomized to wait-list. Additional analysis may include analysis of covariance (ANCOVA) to control for relevant baseline outcome variables or other patient characteristics. Summary statistics and 90% CIs will also be calculated separately by intervention arm and to examine within-subject differences for those who were randomized to wait-list and then received the meditation intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>The questionnaire purpose is to learn more about meditation's effect on your health over the past two weeks. It asks, how much do you agree or disagree? Options are, strongly disagree, disagree, neutral, agree and strongly agree. The questionnaire asks patients to pick the closest answer for each statement. The first statements asks, 'My well-being has improved', the second, &quot;I am more focused', the third asks, 'I am in a better mood', the fourth asks, 'My energy level had increased', and lastly, 'I am sleeping better'. The exit questionnaire is scored as a sum value for each scale range provided. For each scale range provided, higher values/and or lower values represent whether participants agree or disagree with the statements listed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of meditation and choice of length of meditation</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>The study will explore the association between frequency of meditation and choice of length of meditation and patient reported outcomes using correlation analyses.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Group I (meditation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.</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 receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Participate in interview</description>
    <arm_group_label>Group I (meditation)</arm_group_label>
    <arm_group_label>Group II (waitlist control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Meditation Therapy</intervention_name>
    <description>Complete meditation therapy</description>
    <arm_group_label>Group I (meditation)</arm_group_label>
    <other_name>Meditation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Complete questionnaires</description>
    <arm_group_label>Group I (meditation)</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>Procedure</intervention_type>
    <intervention_name>Supportive Care</intervention_name>
    <description>Receive supportive care</description>
    <arm_group_label>Group II (waitlist control)</arm_group_label>
    <other_name>Supportive Therapy</other_name>
    <other_name>Symptom Management</other_name>
    <other_name>Therapy, Supportive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at MD Anderson with a cancer history who are either undergoing active&#xD;
             treatment or who have completed treatment for their cancer&#xD;
&#xD;
          -  Must understand and read English, sign a written informed consent, and follow protocol&#xD;
             requirements&#xD;
&#xD;
          -  Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment&#xD;
&#xD;
          -  Patient self-reported ESAS psychological scale score (sum of anxiety and depression&#xD;
             scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and&#xD;
             7 on a 0 to 10 numeric scale, where 10 is the worst possible&#xD;
&#xD;
          -  If on medication for anxiety, stable dose of medications for management of anxiety&#xD;
             symptoms for at least six weeks prior to enrollment with no plans to change&#xD;
             meditations in the subsequent four weeks. Increases or decreases allowed within drug&#xD;
             class, but changing drug class will make patient in-evaluable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a formal thought disorder (e.g., schizophrenia)&#xD;
&#xD;
          -  Known history of a neurological and/or psychological disorder that in the physician's&#xD;
             opinion may interfere with the patient's ability to cooperate with study procedures&#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>Gabriel Lopez</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>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 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>Neoplasms</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02988271
org study id: 2016-0491
secondary id: NCI-2018-01295
secondary id: 2016-0491
secondary id: P30CA016672
nct id: NCT02988271
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how well self-administered meditation therapy works in improving anxiety
      and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a
      mind-body approach that uses a variety of techniques, such as deep breathing, sound, or
      movement, that may help to decrease distress and anxiety and enhance the health and quality
      of life of patients with cancer.
PRIMARY OBJECTIVES:

      I. To determine the feasibility of having patients self-administer meditation recordings
      using a portable, computer-based program during a 2-week period.

      SECONDARY OBJECTIVES:

      I. Assess the effect of self-administered meditation on anxiety, depression and other
      symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.

      II. Evaluate participant satisfaction with the meditation delivery and tracking program.

      III. Examine the association between the frequency of practice (number of sessions a day) and
      choice of length of practice (5, 10, or 15 minute sessions) and anxiety, depression and other
      patient reported outcomes.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (MEDITATION): Patients watch a pre-recorded instructional meditation video via an
      iPod meditation app. Patients then complete meditation exercises using the meditation app
      over 5-15 minutes once daily (QD) for up to 2 weeks. Patients also complete questionnaires
      before and after meditation sessions and participate in an interview over 10 minutes.

      GROUP II (WAITLIST CONTROL): Patients receive supportive care, such as access to social
      workers, support groups, spiritual care, or other patient services for up to 2 weeks.
      Patients also complete questionnaires over 15-20 minutes and participate in an interview over
      10 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of self-administered meditation
time frame: Up to 2 weeks
description: Feasibility will be confirmed if at least 50% of the eligible patients approached consent to the study and at least 70% of subjects complete at least two meditation sessions each week during the 2-week period. The study will calculate rates, frequencies, and 90% confidence intervals (CIs) of the rates.
measure: Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire
time frame: Up to 2 weeks
description: Summary statistics and 90% CIs will be calculated to assess differences in mean anxiety, depression and other outcomes measured at the end of the study, as well as the change scores from baseline, between subjects randomized to meditation and those randomized to wait-list. Additional analysis may include analysis of covariance (ANCOVA) to control for relevant baseline outcome variables or other patient characteristics. Summary statistics and 90% CIs will also be calculated separately by intervention arm and to examine within-subject differences for those who were randomized to wait-list and then received the meditation intervention.
measure: The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.
time frame: Up to 2 weeks
description: The questionnaire purpose is to learn more about meditation's effect on your health over the past two weeks. It asks, how much do you agree or disagree? Options are, strongly disagree, disagree, neutral, agree and strongly agree. The questionnaire asks patients to pick the closest answer for each statement. The first statements asks, 'My well-being has improved', the second, "I am more focused', the third asks, 'I am in a better mood', the fourth asks, 'My energy level had increased', and lastly, 'I am sleeping better'. The exit questionnaire is scored as a sum value for each scale range provided. For each scale range provided, higher values/and or lower values represent whether participants agree or disagree with the statements listed.
measure: Frequency of meditation and choice of length of meditation
time frame: Up to 2 weeks
description: The study will explore the association between frequency of meditation and choice of length of meditation and patient reported outcomes using correlation analyses.
arm group label: Group I (meditation)
arm group type: Experimental
description: Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
arm group label: Group II (waitlist control)
arm group type: Active Comparator
description: Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
intervention type: Other
intervention name: Interview
description: Participate in interview
arm group label: Group I (meditation)
arm group label: Group II (waitlist control)
intervention type: Procedure
intervention name: Meditation Therapy
description: Complete meditation therapy
arm group label: Group I (meditation)
other name: Meditation
intervention type: Procedure
intervention name: Quality-of-Life Assessment
description: Complete questionnaires
arm group label: Group I (meditation)
arm group label: Group II (waitlist control)
other name: Quality of Life Assessment
intervention type: Procedure
intervention name: Supportive Care
description: Receive supportive care
arm group label: Group II (waitlist control)
other name: Supportive Therapy
other name: Symptom Management
other name: Therapy, Supportive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel Lopez
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Depression
mesh term: Depressive Disorder