Mindfulness-based Music Therapy for Stem Cell Transplantation

Overseen By Frank Penedo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Psychiatric illness, Cognitive impairment, Hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mindfulness-based Music Therapy for Stem Cell Transplantation?

Research shows that music therapy, when used alongside conventional cancer treatments, can improve quality of life, help manage stress, and reduce pain and discomfort. Additionally, mindfulness-based music therapy has been found to enhance attention and decrease mood distress in women undergoing chemotherapy for breast cancer. ^{1 2 3 4 5}

Is mindfulness-based music therapy safe for humans?

Mindfulness-based music therapy is generally considered safe for humans. It is a noninvasive treatment that has been used to help reduce anxiety, stress, and pain in various medical settings, including cancer treatment and bone marrow transplantation. ^{5 6 7 8 9}

How is the Mindfulness-based Music Therapy treatment different from other treatments for stem cell transplantation?

This treatment is unique because it combines mindfulness meditation with music therapy to help reduce stress and improve quality of life for patients undergoing stem cell transplantation. Unlike standard treatments, it focuses on reducing psychological stress through relaxation and mindfulness practices, which can be delivered online, making it accessible even during hospital stays. ^{1 5 6 10 11}

What is the purpose of this trial?

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).

Research Team

Frank Penedo, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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)

I have hearing loss.

Timeline

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

Treatment Details

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).

Participant Groups

Group I: Mindfulness-based Music Therapy (MBMT) Experimental Treatment 1 Intervention

Participants will be in the MBMT group for 5 months.

Group II: Mindfulness Meditation (MM) Experimental Treatment 1 Intervention

Participants will be in the MM group for 5 months.

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+

Findings from Research

Music therapy, which has been used since ancient times and incorporated into modern medicine since the 1950s, is now a common practice in cancer care, particularly in large cancer centers in the U.S.

When combined with conventional cancer treatments, music therapy has been shown to improve patients' quality of life, enhance emotional expression, reduce stress, and alleviate physical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. Richardson, MM., Babiak-Vazquez, AE., Frenkel, MA.[2008]

Incorporating music therapy as an adjunct intervention for adult surgical step-down patients led to a significant reduction in both pain (from an average of 6.07 to 3.45) and anxiety (from an average of 56.47 to 46.52) after therapy sessions, based on a study of 42 patients over 3 months.

The results indicate that music therapy is not only statistically significant but also clinically meaningful, effectively reducing pain from moderate to mild levels and anxiety from mild to none.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy for Surgical Patients: Approach for Managing Pain and Anxiety. Bojorquez, GR., Jackson, KE., Andrews, AK.[2021]

Mindfulness-based music therapy (MBMT) significantly improved attention in women with breast cancer undergoing chemotherapy, as shown by a repeated measures analysis of variance.

Participants also experienced notable improvements in mood, particularly a significant reduction in fatigue, highlighting MBMT as a beneficial intervention for managing mood distress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. Lesiuk, T.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Lesiuk, T.[2020]

A case-controlled study on bone marrow transplant patients showed that combined music therapy and relaxation imagery can be feasibly implemented to help manage pain and nausea, which are common side effects of the treatment.

The intervention, consisting of 45-minute sessions twice a week, is hypothesized to reduce stress responses through neuroendocrine pathways, potentially improving patient comfort during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of using music therapy with relaxation imagery in the management of patients undergoing bone marrow transplantation: a pilot feasibility study. Sahler, OJ., Hunter, BC., Liesveld, JL.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Music therapy can significantly help pediatric oncology patients by addressing physical, social, and psychological needs, such as reducing pain and anxiety, and decreasing reliance on pain medication.

It promotes social interaction and emotional expression, enhancing relationships with healthcare providers and family, which is crucial for patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. Standley, JM., Hanser, SB.[2017]

Participants in a mindfulness-based music therapy intervention reported feeling relaxed and connected, with in-person sessions fostering a stronger connection to music and family compared to virtual sessions.

While virtual delivery of the intervention was more feasible, in-person sessions were preferred, highlighting the importance of format in enhancing the therapeutic experience for young adults undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. Phillips, CS., Bockhoff, J., Berry, DL., et al.[2023]

Music therapy is a noninvasive and cost-effective intervention that can effectively reduce heart rate, blood pressure, anxiety, and pain in patients.

The review highlights the historical and theoretical foundations of music therapy, suggesting its potential to improve patient outcomes across various clinical settings and emphasizing the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music as intervention: a notable endeavor to improve patient outcomes. White, JM.[2022]

In a study involving 69 patients undergoing high-dose therapy with autologous stem cell transplantation (HDT/ASCT), music therapy significantly reduced mood disturbances, showing a 37% lower total mood disturbance score compared to standard care.

Music therapy is a noninvasive and cost-effective intervention that may help alleviate psychological distress in patients with hematologic malignancies during their inpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cassileth, BR., Vickers, AJ., Magill, LA.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Music Therapy for Surgical Patients: Approach for Managing Pain and Anxiety. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of using music therapy with relaxation imagery in the management of patients undergoing bone marrow transplantation: a pilot feasibility study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Music as intervention: a notable endeavor to improve patient outcomes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. [2015]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness in Adolescent and Young Adult (AYA) Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): A Qualitative Study. [2023]