Back to resultsElectronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
Primary Purpose
Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Music Therapy (MBMT)
Mindfulness Meditation (MM)
Sponsored by
About this trial
This is an interventional supportive care trial for Stem Cell Transplantation
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL) have a treatment plan for an allogeneic hematopoietic stem cell transplant Speak English or Spanish Exclusion Criteria: history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months) severe cognitive impairment (per the short portable mental status questionnaire) hearing impairment active alcohol or substance dependence within the past six months participated in music therapy or mindfulness programs in the past six months
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mindfulness-based Music Therapy (MBMT)
Mindfulness Meditation (MM)
Arm Description
Participants will be in the MBMT group for 5 months.
Participants will be in the MM group for 5 months.
Outcomes
Primary Outcome Measures
Count of Participants Recruited
Recruitment will be measured by the count of participants successfully recruited and randomized into the study.
Number of Participants Retained
Participant retention will be examined via the number of participants retained in the study.
Mean Number of Intervention Sessions that Participants Completed
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.
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
Scores per item range from 0 to 5. Higher scores indicate more satisfaction.
Secondary Outcome Measures
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
FACT-BMT score range 0-164, with higher scores indicating better quality of life.
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores range from 40-160 with higher scores indicating better cognitive function.
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Number of Days to Engraftment Measured from Infusion to Engraftment.
To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Number of Days of Hospitalization Measured from Admission to Engraftment.
To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
Number of Hospital Readmissions after Hospital Discharge
To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
Number of Infections from Hospital Admission
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.
Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)
Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Change in Serum Cortisol as Measured by ELISA
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
Change in Immunocompetence as Measured by Cytokines
Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
Change in Immunocompetence as Measured by Thymic Function
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Change in Immunocompetence as Measured by Regulatory T cells
Regulatory T cells measured as cells/mm^3
Full Information
NCT ID
NCT05968963
First Posted
July 19, 2023
Last Updated
September 14, 2023
Sponsor
University of Miami
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05968963
Brief Title
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
Official Title
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based Music Therapy (MBMT)
Arm Type
Experimental
Arm Description
Participants will be in the MBMT group for 5 months.
Arm Title
Mindfulness Meditation (MM)
Arm Type
Experimental
Arm Description
Participants will be in the MM group for 5 months.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Music Therapy (MBMT)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation (MM)
Intervention Description
Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
Primary Outcome Measure Information:
Title
Count of Participants Recruited
Description
Recruitment will be measured by the count of participants successfully recruited and randomized into the study.
Time Frame
Baseline (T1)
Title
Number of Participants Retained
Description
Participant retention will be examined via the number of participants retained in the study.
Time Frame
Up to 18 months
Title
Mean Number of Intervention Sessions that Participants Completed
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.
Time Frame
Up to 100 days post-transplant
Title
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
Description
Scores per item range from 0 to 5. Higher scores indicate more satisfaction.
Time Frame
Up to 100 days post-transplant
Secondary Outcome Measure Information:
Title
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Description
FACT-BMT score range 0-164, with higher scores indicating better quality of life.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
Description
(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
Description
(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.
Description
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores range from 40-160 with higher scores indicating better cognitive function.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Time Frame
Baseline (T1), up to 18 months
Title
Number of Days to Engraftment Measured from Infusion to Engraftment.
Description
To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Time Frame
Up to 18 months
Title
Number of Days of Hospitalization Measured from Admission to Engraftment.
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.
Time Frame
Up to 18 months
Title
Number of Hospital Readmissions after Hospital Discharge
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.
Time Frame
Up to 100 days
Title
Number of Infections from Hospital Admission
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.
Time Frame
up to 100 Days Post-Infusion Day
Title
Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)
Description
Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.
Time Frame
Baseline (T1), up to 18 months
Title
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
Description
PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Description
Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Serum Cortisol as Measured by ELISA
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
Time Frame
Baseline (T1), up to 18 months
Title
Change in Immunocompetence as Measured by Cytokines
Description
Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
Time Frame
Baseline (T1), up to 18 months
Title
Change in Immunocompetence as Measured by Thymic Function
Description
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Time Frame
Baseline (T1), up to 18 months
Title
Change in Immunocompetence as Measured by Regulatory T cells
Description
Regulatory T cells measured as cells/mm^3
Time Frame
Baseline (T1), up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age
have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL)
have a treatment plan for an allogeneic hematopoietic stem cell transplant
Speak English or Spanish
Exclusion Criteria:
history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
severe cognitive impairment (per the short portable mental status questionnaire)
hearing impairment
active alcohol or substance dependence within the past six months
participated in music therapy or mindfulness programs in the past six months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank J Penedo, PhD
Phone
(305) 284-4290
Email
fpenedo@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Fleszar-Pavlovic, PhD
Phone
(305) 243-4009
Email
sarafleszarpavlovic@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank J. Penedo, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arianna Brito
Phone
305-243-4009
Email
aeb178@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Frank Penedo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
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