Clinical trial NCT05968963: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stem Cell Transplantation
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Count of Participants Recruited
timeFrame: Baseline (T1)
measure: Number of Participants Retained
timeFrame: Up to 18 months
measure: Mean Number of Intervention Sessions that Participants Completed
timeFrame: Up to 100 days post-transplant
measure: Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
timeFrame: Up to 100 days post-transplant
Secondary outcomes:
measure: Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
timeFrame: Baseline (T1), up to 18 months
measure: Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
timeFrame: Baseline (T1), up to 18 months
measure: Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
timeFrame: Baseline (T1), up to 18 months
measure: Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.
timeFrame: Baseline (T1), up to 18 months
measure: Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
timeFrame: Baseline (T1), up to 18 months
measure: Number of Days to Engraftment Measured from Infusion to Engraftment.
timeFrame: Up to 18 months
measure: Number of Days of Hospitalization Measured from Admission to Engraftment.
timeFrame: Up to 18 months
measure: Number of Hospital Readmissions after Hospital Discharge
timeFrame: Up to 100 days
measure: Number of Infections from Hospital Admission
timeFrame: up to 100 Days Post-Infusion Day
measure: Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)
timeFrame: Baseline (T1), up to 18 months
measure: Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
timeFrame: Baseline (T1), up to 18 months
measure: Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
timeFrame: Baseline (T1), up to 18 months
measure: Change in Serum Cortisol as Measured by ELISA
timeFrame: Baseline (T1), up to 18 months
measure: Change in Immunocompetence as Measured by Cytokines
timeFrame: Baseline (T1), up to 18 months
measure: Change in Immunocompetence as Measured by Thymic Function
timeFrame: Baseline (T1), up to 18 months
measure: Change in Immunocompetence as Measured by Regulatory T cells
timeFrame: Baseline (T1), up to 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Frank J. Penedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: