Mindfulness-based Music Therapy for Stem Cell Transplantation

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Overseen ByFrank Penedo, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether mindfulness-based music therapy (Electronic Health Mindfulness-based Music Therapy Intervention) can improve quality of life and reduce symptoms for individuals undergoing stem cell transplants. It includes two groups: one using music therapy and the other practicing mindfulness meditation for five months. Individuals with conditions such as myelodysplastic syndrome, acute leukemia, or non-Hodgkin's lymphoma who are planning for a stem cell transplant may be suitable candidates. Participants should not have severe mental health issues or have recently used similar therapies. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could enhance well-being during challenging treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Electronic Health Mindfulness-based Music Therapy Intervention is safe for patients undergoing allogeneic stem cell transplantation?

Research has shown that mindfulness meditation is generally safe and carries few risks. However, few studies have closely examined potential negative effects, so rare side effects may still be unknown.

Researchers are currently studying electronic health mindfulness-based music therapy for patients undergoing stem cell transplants. These studies aim to determine if the therapy can enhance patients' quality of life and alleviate symptoms. Specific safety information remains limited, but the goal is to ensure the therapy is safe and user-friendly for patients.

In summary, mindfulness meditation is typically safe with minimal risks, while electronic health mindfulness-based music therapy is still under investigation for safety.12345

Why are researchers excited about this trial?

Researchers are excited about mindfulness-based music therapy for stem cell transplantation because it offers a novel, non-pharmacological approach to improving patient outcomes. Unlike traditional treatments that focus on medication and physical recovery, this therapy integrates mindfulness and music to potentially reduce stress and enhance emotional well-being during the challenging post-transplantation period. Similarly, mindfulness meditation provides a complementary method to manage mental health by encouraging relaxation and focus, which can be crucial for recovery. Both interventions emphasize holistic care, aiming to improve quality of life and potentially speed up recovery in ways that standard medical treatments alone might not achieve.

What evidence suggests that this trial's treatments could be effective for improving health-related quality of life in patients undergoing stem cell transplantation?

Research has shown that mindfulness-based music therapy (eMBMT) and mindfulness meditation can improve the quality of life for patients undergoing stem cell transplants. In this trial, participants will join either the eMBMT group or the mindfulness meditation group. Studies have found that eMBMT, an easy-to-use digital tool, can lessen the symptoms these patients experience. Mindfulness meditation also effectively reduces stress and boosts emotional well-being in many patient groups. Both methods aim to help patients manage stress and symptoms better, improving their health-related quality of life. While more research is needed, these therapies seem promising in supporting patients during challenging treatments.12346

Who Is on the Research Team?

Dr. Frank J. Penedo Honored with ISBM ...

Frank Penedo, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers aged 18+ with myelodysplastic syndrome, acute myeloid leukemia, acute lymphoblastic leukemia, or non-Hodgkin's Lymphoma who are planning to undergo allogeneic stem cell transplantation. It excludes those with severe psychiatric issues, cognitive impairments, recent substance dependence, hearing problems, or recent mindfulness/music therapy participation.

Inclusion Criteria

I am scheduled for a stem cell transplant from a donor.
I have been diagnosed with MDS, AML, ALL, or NHL.

Exclusion Criteria

I have participated in music therapy or mindfulness programs recently.
Severe cognitive impairment (per the short portable mental status questionnaire)
History of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-based Music Therapy (MBMT) or Mindfulness Meditation (MM) for 5 months

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive function, anxiety, and quality of life

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic Health Mindfulness-based Music Therapy Intervention
  • Mindfulness Meditation
Trial Overview The study tests an electronic health mindfulness-based music therapy intervention aimed at improving life quality and reducing symptoms in patients undergoing allogeneic stem cell transplants. Participants will receive either Mindfulness Meditation (MM) or Mindfulness-based Music Therapy (MBMT).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Mindfulness-based Music Therapy (MBMT)Experimental Treatment1 Intervention
Group II: Mindfulness Meditation (MM)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).
The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.
The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis.Piet, J., Würtzen, H., Zachariae, R.[2022]
Mindfulness-based music therapy (MBMT) has shown significant benefits in improving attention and reducing negative mood and fatigue in women undergoing adjuvant chemotherapy for breast cancer, as indicated by a pilot study.
The study highlights the potential of integrating music therapy with mindfulness practices to enhance the overall well-being of breast cancer patients, suggesting further exploration of music's role in mindfulness.
The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer.Lesiuk, T.[2020]
Adolescents and young adults undergoing hematopoietic stem cell transplantation (HSCT) experience significant stress, and many expressed a strong interest in mindfulness-based interventions to help manage this stress, especially after being introduced to the concept.
Participants indicated that an online mindfulness program could be particularly beneficial immediately after HSCT to alleviate feelings of isolation and improve their overall quality of life during recovery.
Mindfulness in Adolescent and Young Adult (AYA) Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): A Qualitative Study.Crowder, SL., Sauls, R., Redwine, L., et al.[2023]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40215402/
Development of an eHealth Mindfulness-Based Music ...The eMBMT intervention is a comprehensive, user-friendly eHealth tool tailored to the unique needs of allo-SCT patients.
eHealth mindfulness-based music therapy for patients ...eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38763308/
eHealth mindfulness-based music therapy for patients ...Results will inform a fully powered RCT to establish preliminary efficacy of eMBMT on improvements in HRQOL, symptom burden, and disease ...
Electronic Health Mindfulness-based Music Therapy ...The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve health-related ...
Development of an eHealth Mindfulness-Based Music ...Overview of the 8-session eHealth-based mindfulness-based music therapy (eMBMT) intervention for allogeneic stem cell transplantation. (allo ...
Electronic Health Mindfulness-based Music Therapy ...The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve ...
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