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Program Official
Principal Investigator
Frank J Penedo
Awardee Organization

University Of Miami Coral Gables
United States

Fiscal Year
2025
Activity Code
R33
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

eHealth Supported Mindfulness-based Music Therapy Intervention (eMBMT) in Hemopoietic Stem Cell Transplant Patients

Allogeneic hematopoietic stem cell transplantation (allo-SCT) is a potentially curative procedure for many hematologic malignancies. Due to the intensive conditioning regimen (e.g., radiotherapy, chemotherapy) and post-transplant complications, allo-SCT is associated with multiple physical and psychological side effects including symptom burden (e.g., fatigue, pain), and poor psychosocial function and emotional distress (e.g., anxiety, depression) that impair health-related quality of life (HRQoL), and occur within the context of following a strict self-management protocol to prevent treatment-related complications. Novel, integrative, engaging, low-demand and scalable programs to reduce symptom burden and improve health related quality of life (HRQoL) and health outcomes in allo-SCT are needed, yet limited work has addressed the development and implementation music therapy—a therapeutic approach that can favorably impact health outcomes in cancer survivors. Mindfulness-based music therapy (MBMT) blends core elements of mindfulness and tailored music intervention components (e.g., songwriting, instrument playing) delivered by a trained music therapist. Our transdisciplinary team has shown that (a) MBMT reduces negative mood, fatigue, and anxiety in breast cancer survivors, (b) stress management and mindfulness improve physiological adjustment (e.g., reduced inflammation) and HRQoL in various cancer survivorship populations, and (c) that eHealth platforms can facilitate effective delivery of psychosocial interventions in cancer patients and survivors. However, studies implementing the first step in developing and evaluating well-designed, feasible, acceptable, and reproducible eHealth facilitated MBMT (eMBMT) interventions to improve patient outcomes are limited. Further, how specific music therapy components impact psychosocial (e.g., anxiety, depression) and physiological (e.g., inflammation, immunocompetence) mechanisms is not well understood. Using our expertise in mix-methods approaches, eHealth, allo-SCT, and MBMT, we address these gaps and propose to establish acceptability, feasibility and intended effects of a novel eHealth facilitated eMBMT in reducing symptom burden and improving HRQoL (Primary Outcomes), improving psychosocial and physiological adaptation and (e.g., cancer distress, reduced inflammation, T-cell recovery/immune reconstitution) (eMBMT Mechanisms), and ameliorating disease activity (e.g., GVHD) (Secondary Outcomes) in patients undergoing allo-SCT. In the R61 Phase we implement a mixed-methods (e.g., focus groups, small RCT) design to finalize eMBMT and a mindfulness meditation (eMM) control condition, establish feasibility and begin to identify music therapy components that favorably impact our study outcomes/mechanisms. In our R33 Phase we conduct a larger scale pilot RCT informed by the R61 findings to establish intended effects of eMBMT music therapy components on HRQOL, symptom burden and psychosocial and physiologic adaptation. Findings will guide a large-scale RCT with long-term follow-up and additional clinical outcomes.

Publications

  • Goel N, Hernandez AE, Ream M, Clarke ES, Blomberg BB, Cole S, Antoni MH. Effects of neighborhood disadvantage on cortisol and interviewer-rated anxiety symptoms in breast cancer patients initiating treatment. Breast cancer research and treatment. 2023 Nov;202(1):203-211. Epub 2023 Aug 10. PMID: 37561280
  • Goel N, Hernandez A, Kwon D, Antoni MH, Cole S. Impact of Neighborhood Disadvantage on Tumor Biology and Breast Cancer Survival. Annals of surgery. 2024 Feb 1;279(2):346-352. Epub 2023 Aug 28. PMID: 37638386
  • Khorfan R, Vora HP, Namm JP, Solomon NL, Lum SS. Expanded Indications for Neoadjuvant Endocrine Therapy in Early-Stage Breast Cancer During the COVID-19 Pandemic. Annals of surgical oncology. 2024 Oct;31(11):7562-7568. Epub 2024 Aug 12. PMID: 39133445
  • Hernandez AE, Borowsky PA, Lubarsky M, Carroll C, Choi S, Kesmodel S, Antoni M, Goel N. Associations Between Perceived Discrimination, Screening Mammography, and Breast Cancer Stage at Diagnosis: A Prospective Cohort Analysis. Annals of surgical oncology. 2024 Nov;31(12):8012-8020. Epub 2024 Jul 26. PMID: 39060693
  • Hernandez AE, Borowsky PA, Nahodyl L, Pinheiro PS, Kobetz EN, Antoni MH, Goel N. A Neighborhood-Level Hispanic Paradox: The Interaction among Hispanic Density, Neighborhood Disadvantage, and Survival in Patients with Breast Cancer. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2025 Apr 3;34(4):483-490. PMID: 39808183
  • Fleszar-Pavlovic SE, Noriega Esquives B, Lovan P, 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. Development of an eHealth Mindfulness-Based Music Therapy Intervention for Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: Qualitative Study. JMIR formative research. 2025 Apr 11;9:e65188. PMID: 40215402
  • 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. Contemporary clinical trials. 2024 Jul;142:107577. Epub 2024 May 17. PMID: 38763308