Music Therapy Versus Cognitive Behavioral Therapy via Telehealth for Anxiety in Survivors of Cancer: A Randomized Clinical Trial.
Kevin T Liou, Joke Bradt, M Beatriz Currier...
https://pubmed.ncbi.nlm.nih.gov/41494146Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05215353
Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-22
368
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how music therapy and cognitive behavioral therapy (CBT), both delivered virtually, may reduce anxiety in people who have survived cancer. This study also aims to understand if factors like age, sex, race, education, and expectations about therapy affect how well participants respond to these treatments. The trial is a Phase 4 study comparing these two non-drug therapies for cancer-related anxiety. Participants will be randomly assigned to receive either music therapy or cognitive behavioral therapy. Both treatments consist of seven weekly 60-minute group sessions conducted through a secure online platform (Zoom). Music therapy sessions involve personalized musical experiences guided by certified music therapists, including relaxation and musical engagement activities. CBT sessions focus on the connection between thoughts, behaviors, and emotions, led by licensed mental health providers. The study also includes a subgroup completing optional interviews and follows all participants for 26 weeks. Before randomization and at several points up to 26 weeks, participants will complete assessments measuring anxiety using the Hospital Anxiety and Depression Scale (HADS). Researchers will track changes in anxiety scores at 8 and 26 weeks. Participants must have access to Zoom and a private location for sessions. Safety and adherence are monitored throughout, with the study sponsored by Memorial Sloan Kettering Cancer Center.
CONDITIONS
Brief Title
A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- English- or Spanish-speaking
- 18 years or older
- Prior cancer diagnosis of any type or stage
- Free of oncological disease, or stable disease with no evidence of progression
- Score of 68 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- Report anxiety symptoms lasting at least one month
- Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
- Access to Zoom and a quiet/private location
- For advanced cancer sub-study: advanced cancer diagnosis, currently receiving oncological treatment or on active surveillance, Karnofsky performance score of 60, greater than 6-month expected survival as judged by oncologist
- For group MT sub-study: English-speaking, prior cancer diagnosis, free of oncological disease or stable disease, score of 68 on HADS anxiety subscale, anxiety symptoms for at least one month, willing to adhere to procedures, access to Zoom and quiet/private location
You will not qualify if you...
- Completed active cancer treatment less than one month prior to enrollment (except maintenance hormonal or targeted therapies)
- Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
- Score of 610 on the Blessed Orientation-Memory-Concentration test indicating cognitive impairment
- Received seven or more MT or CBT sessions for anxiety within the last six months
- Unable to provide informed consent
- For advanced cancer sub-study: plan to receive psychotherapy in coming 8 weeks, recent or planned changes in anxiety medications
- For group MT sub-study: prior receipt of MT within six months, plan for psychotherapy in coming 8 weeks, recent changes in anxiety medications
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual)
Treatment
Duration - 7 weeks
Participants receive seven weekly 60-minute treatments of either music therapy or cognitive behavioral therapy, delivered virtually through Zoom.
7 weekly virtual visits
Follow-up
Duration - Up to 19 weeks after treatment
Participants complete study assessments at weeks 4, 8, 16, and 26 to monitor anxiety symptoms and treatment effects. A subgroup may participate in optional interviews after treatment.
Assessments at weeks 4, 8, 16, and 26; optional interviews after treatment
Trial Site Locations
Total: 3 locations
1
Baptist Alliance MCI
Miami, Florida, United States, 33143
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
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Research Team
J
Jun Mao, MD, MSCE
K
Kevin Liou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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