Stem Cell TransplantationNCT07469592
eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
A study testing eHealth Mindfulness-based Music Therapy (eMBMT) and eHealth Mindfulness Meditation (eMM) in people with Stem Cell Transplantation and Myelodysplastic Syndromes, run by University of Miami at 1 site in United States.
Trial summary
The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
- What is being tested?
- eHealth Mindfulness-based Music Therapy (eMBMT) and eHealth Mindfulness Meditation (eMM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome [MDS], acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or non Hodgkin's Lymphoma [NHL])
- have a treatment plan for a hematopoietic stem cell transplant
- Speak English or Spanish
Who cannot join
- 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 the prior pilot MBMT R61 phase
- participated in music therapy or mindfulness programs in the past six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Tea Kostreni, 305-243-4445, txk706@med.miami.edu
Frank J Penedo, PhD
About this study
The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.
- Conditions
- Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
- Being tested
- eHealth Mindfulness-based Music Therapy (eMBMT), eHealth Mindfulness Meditation (eMM)
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth Mindfulness-based Music Therapy (eMBMT)Behavioural
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.
eHealth Mindfulness Meditation (eMM)Behavioural
Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
| Study group | Role | What they receive |
|---|---|---|
| eHealth Mindfulness-based Music Therapy (eMBMT) | Experimental | Participants will be in the MBMT group for 5 months. Receives: Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT) |
| eHealth Mindfulness Meditation (eMM) | Experimental | Participants will be in the MM group for 5 months. Receives: Behavioral: eHealth Mindfulness Meditation (eMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)
Measured: Baseline (T1), up to 18 months
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.
Measured: Baseline (T1), up to 18 months
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.
Measured: Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).
The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.
Measured: Baseline (T1), up to 18 months
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.
Measured: Baseline (T1), up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 18 months
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.
Measured: Up to 100 days
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.
Measured: up to 100 Days Post-Infusion Day
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.
Measured: Baseline (T1), up to 18 months
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).
GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.
Measured: Baseline (T1), up to 18 months
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.
Measured: Baseline (T1), up to 18 months
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
Measured: Baseline (T1), up to 18 months
Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay
Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a >3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.
Measured: Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Thymic Function
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Measured: Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Regulatory T cells
Regulatory T cells measured as cells/mm^3
Measured: Baseline (T1), up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start22 Jul 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank J Penedo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469592
- Sponsor's protocol ID
- 20250732
- Other IDs
- R33CA263335
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07469592
- Acronym / sponsor ID
- 20250732
- Conditions
- Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHealth Mindfulness-based Music Therapy (eMBMT) | Experimental | Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT)Participants will be in the MBMT group for 5 months. |
| eHealth Mindfulness Meditation (eMM) | Experimental | Behavioral: eHealth Mindfulness Meditation (eMM)Participants will be in the MM group for 5 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome [MDS], acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or non Hodgkin's Lymphoma [NHL])
- have a treatment plan for a hematopoietic stem cell transplant
- Speak English or Spanish
Key exclusion criteria (6 listed)
- 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 the prior pilot MBMT R61 phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth Mindfulness-based Music Therapy (eMBMT)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. | Behavioural | eHealth Mindfulness-based Music Therapy (eMBMT) |
| eHealth Mindfulness Meditation (eMM)Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually. | Behavioural | eHealth Mindfulness Meditation (eMM) |
Primary outcome
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
Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
Time frame: Baseline (T1), up to 18 months
(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.
Time frame: Baseline (T1), up to 18 months
(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 Fast Cognitive Evaluation (FaCE).
Time frame: Baseline (T1), up to 18 months
The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Time frame: Baseline (T1), up to 18 months
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.
Time frame: Up to 18 months
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.
Time frame: Up to 18 months
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
Time frame: Up to 100 days
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
Time frame: up to 100 Days Post-Infusion Day
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.
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
Time frame: Baseline (T1), up to 18 months
PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).
Time frame: Baseline (T1), up to 18 months
GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Time frame: Baseline (T1), up to 18 months
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
Time frame: Baseline (T1), up to 18 months
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 Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay
Time frame: Baseline (T1), up to 18 months
Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a >3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.
Change in Immunocompetence as Measured by Thymic Function
Time frame: Baseline (T1), up to 18 months
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Change in Immunocompetence as Measured by Regulatory T cells
Time frame: Baseline (T1), up to 18 months
Regulatory T cells measured as cells/mm^3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank J Penedo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Mindfulness-based Music Therapy (eMBMT) and eHealth Mindfulness Meditation (eMM) in people with Stem Cell Transplantation and Myelodysplastic Syndromes, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank J Penedo, PhD ((305) 284-4290, fpenedo@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.