RecruitingNot Applicable

eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation

United States165 participantsStarted 2026-07-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 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 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 the prior pilot MBMT R61 phase * participated in music therapy or mindfulness programs in the past six months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.

Timeframe: Baseline (T1), up to 18 months

Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.

Timeframe: Baseline (T1), up to 18 months

Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).

Timeframe: Baseline (T1), up to 18 months

Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index

Timeframe: Baseline (T1), up to 18 months

Number of Days to Engraftment Measured from Infusion to Engraftment.

Timeframe: Up to 18 months

Number of Days of Hospitalization Measured from Admission to Engraftment.

Trial details

NCT IDNCT07469592

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-30

Contact for this trial

Frank J Penedo, PhD

(305) 284-4290 fpenedo@miami.edu

View on ClinicalTrials.gov More Stem Cell Transplantation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.

Timeframe: Baseline (T1), up to 18 months

Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.

Timeframe: Baseline (T1), up to 18 months

Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).

Timeframe: Baseline (T1), up to 18 months

Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index

Timeframe: Baseline (T1), up to 18 months

Number of Days to Engraftment Measured from Infusion to Engraftment.

Timeframe: Up to 18 months

Number of Days of Hospitalization Measured from Admission to Engraftment.