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Trial Title:
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
NCT ID:
NCT05968963
Condition:
Stem Cell Transplantation
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
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)
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Arianna Brito
Phone:
305-243-4009
Email:
aeb178@med.miami.edu
Investigator:
Last name:
Frank Penedo, PhD
Email:
Principal Investigator
Start date:
November 28, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968963
