This trial studies the feasibility of a virtual music therapy program and a passive music listening intervention in managing cancer-related symptoms in patients with glioblastoma that does not have genetic changes in the isocitrate dehydrogenase (IDH) family of genes (i.e., "wildtype"). Music therapy involves the clinical use of music-based interventions within a therapeutic relationship provided by a certified music therapist. It is considered a non-pharmacological (non-drug) approach to help manage side effects related to cancer treatment and symptoms of cancer itself (e.g., nausea or fatigue, depression, anxiety). For the virtual music therapy program, a certified music therapist conducts a personalized session, based on a participant’s unique interests and preferences. Sessions can involve actively participating in music creation or singing/body percussion/movement, passively listening to music played live by music therapists or music assisted relaxation, or combinations of these. The passive music listening intervention involves receiving a personalized, therapist-curated music playlist, but without real-time support from a music therapist. This trial may help researchers determine if a virtual music therapy program or a passive music listening intervention is feasible for patients with IDH-wildtype glioblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07375992.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Contact: Matthias Holdhoff
Phone: 410-955-8837
PRIMARY OBJECTIVES:
I. Determine whether individualized virtual music therapy (MT) is feasible in participants undergoing standard of care treatment for newly diagnosed glioblastoma. (Aim 1)
II. Determine whether individualized virtual music therapy via curated playlist (ML) is feasible in participants undergoing standard of care treatment for newly diagnosed glioblastoma. (Aim 2)
SECONDARY OBJECTIVES:
I. Assess proportion of planned assessments and planned intervention sessions completed for both individualized virtual music therapy and curated playlist interventions. (Aim 1)
II. Determine participant-reported benefit for both individualized virtual music therapy and curated playlist interventions. (Aim 2)
III. Determine participant satisfaction with the intervention for both individualized virtual music therapy and curated playlist interventions. (Aim 2)
EXPLORATORY OBJECTIVES:
I. Assess quality of life level, for participants in both individualized virtual music therapy and curated playlist intervention groups, determined by survey measures on well-being as assessed by the Functional Assessment of Cancer Therapy – Brain (FACT-Br), on anxiety level as assessed by Quality of Life in Neurological Disorders – Anxiety (Neuro-QoLTM Anxiety), on depression level as assessed by Quality of Life in Neurological Disorders – Depression (Neuro-QoLTM Depression), and on fatigue level as assessed by Quality of Life in Neurological Disorders – Fatigue (Neuro-QoLTM Fatigue) at various timepoints (pre, mid, post, one month post, long term post-intervention) and compare between timepoints. (Aim 1)
II. Collect overall survival data for both intervention groups. (Aim 2)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive live synchronous virtual music therapy sessions twice weekly (BIW) over 30 minutes for 8 weeks on study.
ARM II: Patients receive a therapist-curated music playlist and listen for 30 minutes BIW for 8 weeks.
After completion of study intervention, patients are followed up at weeks 12, 26, and 52.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMatthias Holdhoff
