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/NCT05968963</url>
    </required_header>
    <id_info>
      <org_study_id>20230726</org_study_id>
      <secondary_id>1R61CA263335-01A1</secondary_id>
      <nct_id>NCT05968963</nct_id>
    </id_info>
    <brief_title>Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation</brief_title>
    <official_title>Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Miami</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 goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy&#xD;
        Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and&#xD;
        reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Count of Participants Recruited</measure>
      <time_frame>Baseline (T1)</time_frame>
      <description>Recruitment will be measured by the count of participants successfully recruited and randomized into the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants Retained</measure>
      <time_frame>Up to 18 months</time_frame>
      <description>Participant retention will be examined via the number of participants retained in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Number of Intervention Sessions that Participants Completed</measure>
      <time_frame>Up to 100 days post-transplant</time_frame>
      <description>Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction Scores as Measured by Weekly Rating Satisfaction Score</measure>
      <time_frame>Up to 100 days post-transplant</time_frame>
      <description>Scores per item range from 0 to 5. Higher scores indicate more satisfaction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>FACT-BMT score range 0-164, with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores range from 40-160 with higher scores indicating better cognitive function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Days to Engraftment Measured from Infusion to Engraftment.</measure>
      <time_frame>Up to 18 months</time_frame>
      <description>To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Days of Hospitalization Measured from Admission to Engraftment.</measure>
      <time_frame>Up to 18 months</time_frame>
      <description>To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Hospital Readmissions after Hospital Discharge</measure>
      <time_frame>Up to 100 days</time_frame>
      <description>To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Infections from Hospital Admission</measure>
      <time_frame>up to 100 Days Post-Infusion Day</time_frame>
      <description>To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Serum Cortisol as Measured by ELISA</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Immunocompetence as Measured by Cytokines</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Immunocompetence as Measured by Thymic Function</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Immunocompetence as Measured by Regulatory T cells</measure>
      <time_frame>Baseline (T1), up to 18 months</time_frame>
      <description>Regulatory T cells measured as cells/mm^3</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Stem Cell Transplantation</condition>
    <condition>Myelodysplastic Syndromes</condition>
    <condition>Leukemia, Myeloid, Acute</condition>
    <condition>Precursor Cell Lymphoblastic Leukemia-Lymphoma</condition>
    <condition>Lymphoma, Non-Hodgkin</condition>
    <arm_group>
      <arm_group_label>Mindfulness-based Music Therapy (MBMT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be in the MBMT group for 5 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness Meditation (MM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be in the MM group for 5 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-based Music Therapy (MBMT)</intervention_name>
      <description>Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.</description>
      <arm_group_label>Mindfulness-based Music Therapy (MBMT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Meditation (MM)</intervention_name>
      <description>Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.</description>
      <arm_group_label>Mindfulness Meditation (MM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years of age&#xD;
  &#xD;
            -  have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia&#xD;
               (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL)&#xD;
  &#xD;
            -  have a treatment plan for an allogeneic hematopoietic stem cell transplant&#xD;
  &#xD;
            -  Speak English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient&#xD;
               treatment in the past 12 months)&#xD;
  &#xD;
            -  severe cognitive impairment (per the short portable mental status questionnaire)&#xD;
  &#xD;
            -  hearing impairment&#xD;
  &#xD;
            -  active alcohol or substance dependence within the past six months&#xD;
  &#xD;
            -  participated in music therapy or mindfulness programs in the past six months&#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>Frank J. Penedo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Frank J Penedo, PhD</last_name>
      <phone>(305) 284-4290</phone>
      <email>fpenedo@miami.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Fleszar-Pavlovic, PhD</last_name>
      <phone>(305) 243-4009</phone>
      <email>sarafleszarpavlovic@med.miami.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Arianna Brito</last_name>
        <phone>305-243-4009</phone>
        <email>aeb178@med.miami.edu</email>
      </contact>
      <investigator>
        <last_name>Frank Penedo, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Frank Penedo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
      <mesh_term>Leukemia, Myeloid</mesh_term>
      <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
      <mesh_term>Myelodysplastic Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05968963
  org study id: 20230726
  secondary id: 1R61CA263335-01A1
  nct id: NCT05968963
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy
        Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and
        reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Count of Participants Recruited
  time frame: Baseline (T1)
  description: Recruitment will be measured by the count of participants successfully recruited and randomized into the study.
  measure: Number of Participants Retained
  time frame: Up to 18 months
  description: Participant retention will be examined via the number of participants retained in the study.
  measure: Mean Number of Intervention Sessions that Participants Completed
  time frame: Up to 100 days post-transplant
  description: Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant.
  measure: Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
  time frame: Up to 100 days post-transplant
  description: Scores per item range from 0 to 5. Higher scores indicate more satisfaction.
  measure: Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
  time frame: Baseline (T1), up to 18 months
  description: FACT-BMT score range 0-164, with higher scores indicating better quality of life.
  measure: Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
  time frame: Baseline (T1), up to 18 months
  description: (PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
  measure: Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
  time frame: Baseline (T1), up to 18 months
  description: (PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
  measure: Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.
  time frame: Baseline (T1), up to 18 months
  description: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores range from 40-160 with higher scores indicating better cognitive function.
  measure: Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
  time frame: Baseline (T1), up to 18 months
  description: Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
  measure: Number of Days to Engraftment Measured from Infusion to Engraftment.
  time frame: Up to 18 months
  description: To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
  measure: Number of Days of Hospitalization Measured from Admission to Engraftment.
  time frame: Up to 18 months
  description: To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
  measure: Number of Hospital Readmissions after Hospital Discharge
  time frame: Up to 100 days
  description: To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
  measure: Number of Infections from Hospital Admission
  time frame: up to 100 Days Post-Infusion Day
  description: To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.
  measure: Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)
  time frame: Baseline (T1), up to 18 months
  description: Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.
  measure: Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
  time frame: Baseline (T1), up to 18 months
  description: PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.
  measure: Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
  time frame: Baseline (T1), up to 18 months
  description: Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
  measure: Change in Serum Cortisol as Measured by ELISA
  time frame: Baseline (T1), up to 18 months
  description: Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation
  measure: Change in Immunocompetence as Measured by Cytokines
  time frame: Baseline (T1), up to 18 months
  description: Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
  measure: Change in Immunocompetence as Measured by Thymic Function
  time frame: Baseline (T1), up to 18 months
  description: Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
  measure: Change in Immunocompetence as Measured by Regulatory T cells
  time frame: Baseline (T1), up to 18 months
  description: Regulatory T cells measured as cells/mm^3
  arm group label: Mindfulness-based Music Therapy (MBMT)
  arm group type: Experimental
  description: Participants will be in the MBMT group for 5 months.
  arm group label: Mindfulness Meditation (MM)
  arm group type: Experimental
  description: Participants will be in the MM group for 5 months.
  intervention type: Behavioral
  intervention name: Mindfulness-based Music Therapy (MBMT)
  description: Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
  arm group label: Mindfulness-based Music Therapy (MBMT)
  intervention type: Behavioral
  intervention name: Mindfulness Meditation (MM)
  description: Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
  arm group label: Mindfulness Meditation (MM)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frank J. Penedo, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Frank J Penedo, PhD
  phone: (305) 284-4290
  email: fpenedo@miami.edu
  last name: Sara Fleszar-Pavlovic, PhD
  phone: (305) 243-4009
  email: sarafleszarpavlovic@med.miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Frank Penedo
  investigator title: Professor
  mesh term: Lymphoma
  mesh term: Leukemia
  mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  mesh term: Lymphoma, Non-Hodgkin
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myeloid, Acute
  mesh term: Myelodysplastic Syndromes
  sharing ipd: No