NCT07375992

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
34mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Jan 2029

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 21, 2026

Last Update Submit

March 25, 2026

Conditions

Feasibility Studies

Keywords

newly diagnosedGlioblastomaMusic Therapy

Outcome Measures

Primary Outcomes (1)

  • Success rate of Music Therapy intervention for GBM patients

    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 Outcomes (1)

  • Rate of survey completion

    2 years

Study Arms (2)

Arm A- with Music Therapists

EXPERIMENTAL

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

Arm B- without Music Therapists

EXPERIMENTAL

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

Interventions

Music interventionOTHER

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.

Arm A- with Music TherapistsArm B- without Music Therapists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

oncology- Broadway

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Matthias Holdhoff, MD

    Johns Hopkins -Sidney Kimmel Cancer Center

    PRINCIPAL INVESTIGATOR

  • Grace Tobin, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator, MD

CONTACT

410-995-8837bcp-iss@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will assess the feasibility of Music Therapy in the high-risk, high-needs population of individuals newly diagnosed with GBM and undergoing standard of care adjuvant chemotherapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 2, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)