Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) (MELODY)

June 11, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556

The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Virtually via Zoom, all participants will meet with Music Therapists to create playlists and learn how to complete surveys measuring quality of life.

Participants will be randomly assigned, half to each arm. Arm A will interact with Music Therapists and listen to music twice a week, then independently fill out quality of life questionnaires.

Arm B will listen to music independently twice a week, then independently fill out quality of life questionnaires.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Principal Investigator- Matthias Holdhoff, MD, PhD.
  • Phone Number: 410-955-8837 410-995-8837
  • Email: bcp-iis@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Oncology- Broadway
        • Contact:
          • Matthias Holdhoff, MD. PhD.
          • Phone Number: 410-955--8837
          • Email: bcp-iis@jh.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Glioblastoma
  • Cognitive capacity to respond to surveys
  • Access to computer and web access
  • Ability to attend virtual music therapy sessions
  • Audibly process music
  • Proficient in English

Exclusion Criteria:

  • Not planning to undergo standard of care radiation therapy and concurrent and adjuvant temozolomide.
  • A life expectancy of less than 6 months.
  • Concurrent use of any other standard or investigational agents (excepting tumor treating fields).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit adherence with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A- with Music Therapists
Arm A of the study will involve individuals who are assigned to receive twice weekly music therapy sessions with a Music Therapist. These live sessions will be conducted virtually via a Johns Hopkins Compliance virtual platform (e.g., Zoom) each session will last 30 minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.
Other: Music intervention

Each GBM study participant in Arm A will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be curated by a board-certified music therapist. Arm B participants will receive curated playlists of music created by a music therapist. Participants will then listen to the curated music playlists on the participant's own device twice per week.

All participants will complete a total of 16 music therapy sessions, scheduled twice per week over 8 weeks. Each session will last approximately 30 minutes.
Experimental: Arm B- without Music Therapists
Arm B of the study participants will meet with a music therapist to create a curated playlist. The participant will then listen independently to music therapy sessions twice a week for thirty minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.
Other: Music intervention

Each GBM study participant in Arm A will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be curated by a board-certified music therapist. Arm B participants will receive curated playlists of music created by a music therapist. Participants will then listen to the curated music playlists on the participant's own device twice per week.

All participants will complete a total of 16 music therapy sessions, scheduled twice per week over 8 weeks. Each session will last approximately 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of Music Therapy intervention for GBM patients
Time Frame: 6 months
Determine success rate of the delivery of individualized virtual music therapy (MT) in participants undergoing standard of care treatment for newly diagnosed glioblastoma.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of survey completion
Time Frame: 2 years
Rate of participants completing all surveys.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Keep Punching Foundation

Investigators

  • Principal Investigator: Grace Tobin, MD, Johns Hopkins University
  • Principal Investigator: Matthias Holdhoff, MD, PhD., Johns Hopkins -Sidney Kimmel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

May 26, 2028

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J2556
  • IRB00493841 (Other Identifier: JHU IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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