Stem Cell TransplantationNCT05968963
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
A study testing Mindfulness-based Music Therapy (MBMT) and Mindfulness Meditation (MM) 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 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). 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?
- Mindfulness-based Music Therapy (MBMT) and Mindfulness Meditation (MM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
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 music therapy or mindfulness programs in the past six months
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
- Being tested
- Mindfulness-based Music Therapy (MBMT), Mindfulness Meditation (MM)
- 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.
Mindfulness-based Music Therapy (MBMT)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.
Mindfulness Meditation (MM)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 |
|---|---|---|
| Mindfulness-based Music Therapy (MBMT) | Experimental | Participants will be in the MBMT group for 5 months. Receives: Behavioral: Mindfulness-based Music Therapy (MBMT) |
| Mindfulness Meditation (MM) | Experimental | Participants will be in the MM group for 5 months. Receives: Behavioral: Mindfulness Meditation (MM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Recruited
Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.
Measured: Baseline (T1)
Number of Participants Retained
Participant retention will be examined via the number of participants retained in the study.
Measured: Up to 18 months
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.
Measured: Up to 100 days post-transplant
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
Measured: Up to 100 days post-transplant
Secondary outcomes (14)
Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) assesses health-related quality of life in bone marrow transplant recipients. Scores range from 0-164, with higher scores indicating better quality of life.
Measured: Baseline (T1), up to 18 months
Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.
PROMIS® Pain Interference Short Form 8a is scored as a T-score, ranging from 40.7 to 77.0, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater pain interference.
Measured: Baseline (T1), up to 18 months
Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.
PROMIS® Fatigue Short Form 8a is scored as a T-score, ranging from 33.1 to 77.8, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater fatigue.
Measured: Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation
Fast Cognitive Evaluation (FaCE) score range from 0 to 27. Higher score indicates better cognitive function.
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
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.
Measured: Baseline (T1), up to 18 months
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.
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 Immunocompetence as Measured by Cytokines
Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
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 posted1 Aug 2023
- Study start28 Nov 2023
- Primary completion26 May 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 61 participants (actual)
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
- NCT05968963
- Sponsor's protocol ID
- 20230726
- Other IDs
- 1R61CA263335-01A1
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2023
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fleszar-Pavlovic SE, Esquives BN, Brito AE, Sia AM, Kauffman MA, Lopes M, Moreno PI, Koru-Sengul T, Gong R, Wang T, Wieder ED, Rueda-Lara M, Antoni M, Komanduri K, Lesiuk T, Penedo FJ. eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107577. doi: 10.1016/j.cct.2024.107577. Epub 2024 May 17.
PubMed 38763308
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05968963
- Acronym / sponsor ID
- 20230726
- Conditions
- Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 12 Aug 2026
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 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Music Therapy (MBMT) | Experimental | Behavioral: Mindfulness-based Music Therapy (MBMT)Participants will be in the MBMT group for 5 months. |
| Mindfulness Meditation (MM) | Experimental | Behavioral: Mindfulness Meditation (MM)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 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
Key exclusion criteria (5 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 music therapy or mindfulness programs in the past six months
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 |
|---|---|---|
| Mindfulness-based Music Therapy (MBMT)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 | Mindfulness-based Music Therapy (MBMT) |
| Mindfulness Meditation (MM)Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually. | Behavioural | Mindfulness Meditation (MM) |
Primary outcome
Count of Participants Recruited
Time frame: Baseline (T1)
Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.
Number of Participants Retained
Time frame: Up to 18 months
Participant retention will be examined via the number of participants retained in the study.
Mean Number of Intervention Sessions That Participants Completed
Time frame: Up to 100 days post-transplant
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
Time frame: Up to 100 days post-transplant
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
14 secondary outcomes
Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Time frame: Baseline (T1), up to 18 months
Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.
Time frame: Baseline (T1), up to 18 months
Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.
Time frame: Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation
Time frame: Baseline (T1), up to 18 months
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Time frame: Baseline (T1), up to 18 months
Number of Days to Engraftment Measured From Infusion to Engraftment.
Time frame: Up to 18 months
Number of Days of Hospitalization Measured From Admission to Engraftment.
Time frame: Up to 18 months
Number of Hospital Readmissions After Hospital Discharge
Time frame: Up to 100 days
Number of Infections From Hospital Admission
Time frame: up to 100 Days Post-Infusion Day
Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline (T1), up to 18 months
Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (T1), up to 18 months
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Time frame: Baseline (T1), up to 18 months
Change in Serum Cortisol as Measured by ELISA
Time frame: Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Cytokines
Time frame: Baseline (T1), up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38763308Fleszar-Pavlovic SE, Esquives BN, Brito AE, Sia AM, Kauffman MA, Lopes M, Moreno PI, Koru-Sengul T, Gong R, Wang T, Wieder ED, Rueda-Lara M, Antoni M, Komanduri K, Lesiuk T, Penedo FJ. eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107577. doi: 10.1016/j.cct.2024.107577. Epub 2024 May 17.
- 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. This study is not recruiting at the moment.
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 Mindfulness-based Music Therapy (MBMT) and Mindfulness Meditation (MM) 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 5 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: finished, as of the sponsor's last update on 12 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?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants Recruited (time frame: Baseline (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968963, which also lists 1 linked publication.
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 12 Aug 2026.