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/NCT06008574</url>
    </required_header>
    <id_info>
      <org_study_id>23-114</org_study_id>
      <nct_id>NCT06008574</nct_id>
    </id_info>
    <brief_title>A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer</brief_title>
    <acronym>CALM IT</acronym>
    <official_title>Cancer Anxiety Pilot Mindfulness Interdisciplinary Trial (CALM IT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to find out if it is practical to provide the program contained&#xD;
        within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform&#xD;
        that re-configures according to the specific needs of patients through physician&#xD;
        prescriptions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 11, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>A prospective randomized pilot study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adherence Retention rate</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Retention rates will be calculated separately as the proportion of enrolled participants who complete the 4-week and 3-month follow-up surveys. Adherence: The AmDTx app automatically collects adherence data, including date, time, length, and name of session to which participants listened, and transfers the data to the researchers on a weekly basis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Decrease in anxiety symptoms</measure>
      <time_frame>up to 6 months</time_frame>
      <description>These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to the MBCR group will receive remote AmDTx-PCSP in the perioperative period (initiated at least 2 weeks before surgery). AmDTx-PCSP will be continued after surgery, for a minimum of 6 weeks total. AmDTx-PCSP is a step-by-step program including meditation training and other activities relevant for people living with cancer. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if they choose. The first 3 modules of the program are required, and then the participant will be able to pick 3 additional modules based on topics that are most meaningful to them.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CI (control) group (AmDTx-2048)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to the CI group will use a game called &quot;2048&quot;, a cognitive training app, which is used as an control condition to control for expectancy and daily engagement. The participants will use AmDTx-2048 to engage in cognitive training with a puzzle game. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if you choose. In this puzzle game, the participants will slide numbered tiles around a grid, matching tiles of the same value to combine them into one new tile displaying the sum of the previous two numbers. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AmDTx-PCSP</intervention_name>
      <description>Step-by-step program modules including meditation training and other activities relevant for people living with cancer</description>
      <arm_group_label>MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AmDTx-2048</intervention_name>
      <description>Cognitive training exercise called &quot;2048&quot;.AmDTx-2048 is a modified version of a popular game called &quot;2048. It is a fun and relaxing puzzle game&quot;. Within &quot;2048&quot;, participants slide numbered tiles around a grid, matching tiles of the same value.</description>
      <arm_group_label>CI (control) group (AmDTx-2048)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Distress Thermometer (DT)2, Demographic Information and medical history, Assessment for Contamination, Impact of Event Score (IES-R), Mindfulness Attention Awareness Scale (MAAS), PROMIS Short Form v1.0 - Anxiety - 8a, Depression - 4a, Fatigue 4a, Sleep Disturbance 4a, The Lung Cancer Stigma Inventory (LCSI)</description>
      <arm_group_label>CI (control) group (AmDTx-2048)</arm_group_label>
      <arm_group_label>MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically proven lung cancer&#xD;
  &#xD;
            -  Scheduled for surgery with at least 14 days lead time (to allow the participant to&#xD;
               start the mindfulness practice [intervention group] 14 days preoperatively)&#xD;
  &#xD;
            -  Age ≥18 years of age at time of signing informed consent&#xD;
  &#xD;
            -  Access to a smartphone/tablet with data connection&#xD;
  &#xD;
            -  Willing to give time for mindfulness practice (Patients need to have the motivation to&#xD;
               devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over&#xD;
               the course of 1 month to do the mindfulness meditations and practices)&#xD;
  &#xD;
            -  Willing to be randomized to mindfulness MBCR or CI group and complete all assessments&#xD;
  &#xD;
            -  High distress level (Distress Thermometer score ≥4 at initial visit)&#xD;
  &#xD;
            -  Able to understand the study objectives and procedures, comply with the protocol, and&#xD;
               sign an informed consent&#xD;
  &#xD;
            -  Able to read, speak, and understand English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently engaging in app-based mindfulness or meditation for one or more times per&#xD;
               week&#xD;
  &#xD;
            -  As per self-report or as documented in the medical record, current untreated (e.g., no&#xD;
               medication, no therapy) major psychotic disorder (schizotypal personality disorder,&#xD;
               schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major&#xD;
               psychiatric disorder will be reviewed by the study PI to determine eligibility before&#xD;
               consent&#xD;
  &#xD;
            -  Individuals with impaired decision-making capacity&#xD;
  &#xD;
            -  Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)&#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>Daniela Molena, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniela Molena, MD</last_name>
      <phone>212-639-3870</phone>
      <email>molenad@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christian Nelson, PhD</last_name>
      <phone>646-888-0030</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Basking Ridge (All Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (All Protocol Activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daneila Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (All protocol activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (All Protocol Activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Molena, MD</last_name>
        <phone>212-639-3870</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>Mindfulness Apps</keyword>
    <keyword>23-114</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </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/NCT06008574
  org study id: 23-114
  nct id: NCT06008574
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out if it is practical to provide the program contained
        within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform
        that re-configures according to the specific needs of patients through physician
        prescriptions.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A prospective randomized pilot study
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Adherence Retention rate
  time frame: up to 3 months
  description: Retention rates will be calculated separately as the proportion of enrolled participants who complete the 4-week and 3-month follow-up surveys. Adherence: The AmDTx app automatically collects adherence data, including date, time, length, and name of session to which participants listened, and transfers the data to the researchers on a weekly basis.
  measure: Decrease in anxiety symptoms
  time frame: up to 6 months
  description: These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI)
  arm group label: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)
  arm group type: Experimental
  description: Patients randomized to the MBCR group will receive remote AmDTx-PCSP in the perioperative period (initiated at least 2 weeks before surgery). AmDTx-PCSP will be continued after surgery, for a minimum of 6 weeks total. AmDTx-PCSP is a step-by-step program including meditation training and other activities relevant for people living with cancer. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if they choose. The first 3 modules of the program are required, and then the participant will be able to pick 3 additional modules based on topics that are most meaningful to them.
  arm group label: CI (control) group (AmDTx-2048)
  arm group type: Active Comparator
  description: Patients randomized to the CI group will use a game called "2048", a cognitive training app, which is used as an control condition to control for expectancy and daily engagement. The participants will use AmDTx-2048 to engage in cognitive training with a puzzle game. The participants are asked to use AmDTx for about 20-30 minutes per day, at least 4 days per week, for 6 weeks. The participants are free to proceed at a faster pace and use AmDTx more than 20-30 per day if you choose. In this puzzle game, the participants will slide numbered tiles around a grid, matching tiles of the same value to combine them into one new tile displaying the sum of the previous two numbers. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit.
  intervention type: Other
  intervention name: AmDTx-PCSP
  description: Step-by-step program modules including meditation training and other activities relevant for people living with cancer
  arm group label: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)
  intervention type: Other
  intervention name: AmDTx-2048
  description: Cognitive training exercise called "2048".AmDTx-2048 is a modified version of a popular game called "2048. It is a fun and relaxing puzzle game". Within "2048", participants slide numbered tiles around a grid, matching tiles of the same value.
  arm group label: CI (control) group (AmDTx-2048)
  intervention type: Other
  intervention name: Questionnaires
  description: Distress Thermometer (DT)2, Demographic Information and medical history, Assessment for Contamination, Impact of Event Score (IES-R), Mindfulness Attention Awareness Scale (MAAS), PROMIS Short Form v1.0 - Anxiety - 8a, Depression - 4a, Fatigue 4a, Sleep Disturbance 4a, The Lung Cancer Stigma Inventory (LCSI)
  arm group label: CI (control) group (AmDTx-2048)
  arm group label: MBCR (mindfulness-based cancer survivorship group) (AmDTx-PCSP)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniela Molena, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Daniela Molena, MD
  phone: 212-639-3870
  email: molenad@mskcc.org
  last name: Christian Nelson, PhD
  phone: 646-888-0030
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.