Menu
Recruiting NCT07375992

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

No phase Interventional Glioblastoma (GBM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music intervention.
Who it may be relevant to
Registry conditions: Glioblastoma (GBM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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 week

Primary outcome measures

  • Success rate of Music Therapy intervention for GBM patients [Time frame: 6 months]
Secondary outcome measures (1)
  • Rate of survey completion [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Glioblastoma (Newly Diagnosed)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Oncology- Broadway — Baltimore

Identifiers

NCT: NCT07375992 · J2556 · IRB00493841

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗