<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/NCT03257007</url>
  </required_header>
  <id_info>
    <org_study_id>1702223546</org_study_id>
    <nct_id>NCT03257007</nct_id>
  </id_info>
  <brief_title>Mindfulness to Enhance Quality of Life and Support Advance Care Planning</brief_title>
  <acronym>MEANING</acronym>
  <official_title>Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana 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 MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel&#xD;
      mindfulness meditation-based intervention (MEANING) to usual care for adults with&#xD;
      advanced-stage solid malignancies and their family caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mindfulness meditation practices have reduced emotional distress, avoidant coping, and&#xD;
      improved spiritual well-being in adult cancer patients. These beneficial effects may occur&#xD;
      through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and&#xD;
      adaptive coping through self-awareness, self-regulation, and self-transcendence. Most&#xD;
      mindfulness trials in cancer have focused on early-stage survivors; however, preliminary&#xD;
      evidence suggests that mindfulness may help reduce distress in patients with advanced cancer&#xD;
      and their family caregivers (FCGs).&#xD;
&#xD;
      Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be&#xD;
      randomized in equal numbers to receive either the 6-week mindfulness intervention or usual&#xD;
      care. Both groups will receive standard cancer care throughout the study period. Dyads&#xD;
      randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body&#xD;
      scan, sitting meditation) and mindful communication practices to enhance quality of life,&#xD;
      support advance care planning engagement, and improve a variety of secondary outcomes.&#xD;
&#xD;
      The study will use a mixed methods 2-arm randomized design to examine the effects of the&#xD;
      mindfulness intervention compared to usual care and seek to explain trial results using&#xD;
      insights gleaned from post-intervention qualitative interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2017</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</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>Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants are blind to study hypotheses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in quality of life (QoL) for Patients</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>QoL for patients will be assessed with the McGill Quality of Life Inventory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in quality of life (QoL) for Family Caregivers</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in advance care planning (ACP) stage of change</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in advance care planning (ACP) engagement</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in caregiver burden</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in avoidant coping</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in avoidant coping</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in depressive symptoms</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Depressive symptoms will be assessed using the PHQ-8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in anxiety</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Anxiety will be assessed using the GAD-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in spiritual well-being</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Spiritual well-being will be measured using the FACIT-SP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in sleep disturbance</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in family communication</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Family communication will be assessed using the Social Constraint Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in interpersonal closeness</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in acceptance of illness</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Acceptance of illness will be assessed using the PEACE Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mindfulness</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer</measure>
    <time_frame>Baseline, 6 weeks, and 10 weeks</time_frame>
    <description>Distress will be assessed using the Distress Thermometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention satisfaction and helpfulness</measure>
    <time_frame>6 weeks</time_frame>
    <description>Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Mindfulness</condition>
  <condition>Meditation</condition>
  <condition>Metastatic Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Advance Care Planning</condition>
  <condition>Palliative Care</condition>
  <condition>Family Caregiver</condition>
  <condition>Supportive Care</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria-Patients&#xD;
&#xD;
          -  Patient is at least 18 years of age.&#xD;
&#xD;
          -  Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or&#xD;
             metastatic) solid malignancy.&#xD;
&#xD;
          -  Patient's attending medical oncologist would not be surprised if the patient died in&#xD;
             the next 12 months.&#xD;
&#xD;
          -  Patient has not completed a POST form.&#xD;
&#xD;
          -  Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance&#xD;
             subscale.&#xD;
&#xD;
          -  Patient is willing and able to consent and travel to the class location for 6 weekly&#xD;
             2-hour sessions.&#xD;
&#xD;
          -  Patient has a family member or close friend eligible and interested in participating&#xD;
             in the study.&#xD;
&#xD;
          -  Patient has adequate English fluency for completion of data collection&#xD;
&#xD;
        Inclusion Criteria-Family Care Givers (FCG)&#xD;
&#xD;
          -  FCG is at least 18 years of age.&#xD;
&#xD;
          -  FCG has been invited to participate in the trial with a patient who meets eligibility&#xD;
             criteria above.&#xD;
&#xD;
          -  FCG is willing and able to consent and travel to the class location for 6 weekly&#xD;
             2-hour sessions.&#xD;
&#xD;
          -  FCG has adequate English fluency for completion of data collection&#xD;
&#xD;
        Exclusion Criteria-Patients&#xD;
&#xD;
          -  Patient reports a score of &gt; 2 on the Activities and Function item from the Patient&#xD;
             Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the&#xD;
             Eastern Cooperative Oncology Group score).&#xD;
&#xD;
          -  Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits&#xD;
             significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation,&#xD;
             active psychosis) that in the judgment of the investigators would preclude providing&#xD;
             informed consent and study participation.&#xD;
&#xD;
          -  Currently receiving hospice care (patients who enroll in hospice during the trial will&#xD;
             have the option of continuing trial participation).&#xD;
&#xD;
        Exclusion Criteria-FCGs&#xD;
&#xD;
        • FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium,&#xD;
        retardation, active psychosis) that in the judgment of the investigators would preclude&#xD;
        providing informed consent and study participation.&#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>Shelley A Johns, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Shelley Johns</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03257007/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03257007
org study id: 1702223546
nct id: NCT03257007
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel
      mindfulness meditation-based intervention (MEANING) to usual care for adults with
      advanced-stage solid malignancies and their family caregivers.
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and
      improved spiritual well-being in adult cancer patients. These beneficial effects may occur
      through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and
      adaptive coping through self-awareness, self-regulation, and self-transcendence. Most
      mindfulness trials in cancer have focused on early-stage survivors; however, preliminary
      evidence suggests that mindfulness may help reduce distress in patients with advanced cancer
      and their family caregivers (FCGs).

      Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be
      randomized in equal numbers to receive either the 6-week mindfulness intervention or usual
      care. Both groups will receive standard cancer care throughout the study period. Dyads
      randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body
      scan, sitting meditation) and mindful communication practices to enhance quality of life,
      support advance care planning engagement, and improve a variety of secondary outcomes.

      The study will use a mixed methods 2-arm randomized design to examine the effects of the
      mindfulness intervention compared to usual care and seek to explain trial results using
      insights gleaned from post-intervention qualitative interviews.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Participants are blind to study hypotheses.
measure: Change from baseline in quality of life (QoL) for Patients
time frame: Baseline, 6 weeks, and 10 weeks
description: QoL for patients will be assessed with the McGill Quality of Life Inventory.
measure: Change from baseline in quality of life (QoL) for Family Caregivers
time frame: Baseline, 6 weeks, and 10 weeks
description: QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
measure: Change from baseline in advance care planning (ACP) stage of change
time frame: Baseline, 6 weeks, and 10 weeks
description: ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).
measure: Change from baseline in advance care planning (ACP) engagement
time frame: Baseline, 6 weeks, and 10 weeks
description: ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
measure: Change from baseline in caregiver burden
time frame: Baseline, 6 weeks, and 10 weeks
description: Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
measure: Change from baseline in avoidant coping
time frame: Baseline, 6 weeks, and 10 weeks
description: Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale
measure: Change from baseline in avoidant coping
time frame: Baseline, 6 weeks, and 10 weeks
description: Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
measure: Change from baseline in depressive symptoms
time frame: Baseline, 6 weeks, and 10 weeks
description: Depressive symptoms will be assessed using the PHQ-8
measure: Change from baseline in anxiety
time frame: Baseline, 6 weeks, and 10 weeks
description: Anxiety will be assessed using the GAD-7
measure: Change from baseline in spiritual well-being
time frame: Baseline, 6 weeks, and 10 weeks
description: Spiritual well-being will be measured using the FACIT-SP.
measure: Change from baseline in sleep disturbance
time frame: Baseline, 6 weeks, and 10 weeks
description: Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
measure: Change from baseline in family communication
time frame: Baseline, 6 weeks, and 10 weeks
description: Family communication will be assessed using the Social Constraint Scale
measure: Change from baseline in interpersonal closeness
time frame: Baseline, 6 weeks, and 10 weeks
description: Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
measure: Change from baseline in acceptance of illness
time frame: Baseline, 6 weeks, and 10 weeks
description: Acceptance of illness will be assessed using the PEACE Scale.
measure: Change from baseline in mindfulness
time frame: Baseline, 6 weeks, and 10 weeks
description: Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
measure: Distress Thermometer
time frame: Baseline, 6 weeks, and 10 weeks
description: Distress will be assessed using the Distress Thermometer.
measure: Intervention satisfaction and helpfulness
time frame: 6 weeks
description: Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).
arm group label: Usual Care
arm group type: No Intervention
description: Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.
arm group label: Mindfulness
arm group type: Active Comparator
description: The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
intervention type: Behavioral
intervention name: Mindfulness
description: The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.
arm group label: Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shelley A Johns, PsyD
role: Principal Investigator
affiliation: Indiana University School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Shelley Johns
investigator title: Assistant Professor of Medicine, Research Scientist
mesh term: Neoplasm Metastasis
sharing ipd: Undecided
provided document: 