A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

May 20, 2026 updated by: Memorial Sloan Kettering Cancer Center

Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)

The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

368

Phase

  • Phase 4

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: Jun Mao, MD, MSCE
  • Phone Number: 646-608-8552
  • Email: maoj@mskcc.org

Study Contact Backup

  • Name: Kevin Liou, MD
  • Phone Number: 646-608-8558

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Baptist Alliance MCI
        • Contact:
          • Beatriz Currier, MD
          • Phone Number: 786-596-2000
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-608-8552
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8558
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • Drexel University

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 ≥8 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

Inclusion Criteria for Advanced Cancer Sub-Study (N=50)

  • English-speaking
  • 18 years or older
  • Advanced cancer diagnosis: stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or leukemia
  • Currently receiving oncological treatment or on active surveillance
  • Karnofsky performance score of ≥60
  • Score of ≥8 on the HADS anxiety subscale
  • Anxiety symptoms lasting for at least 1 month
  • Greater than 6-month expected survival as judged by the treating oncologist
  • Willing to adhere to all study procedures
  • Access to Zoom and a quiet/private location

Inclusion Criteria for group MT sub-study (N=18)

  • English-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 ≥8 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
  • Access to Zoom and a quiet/private location

Exclusion Criteria:

  • Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
  • Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
  • Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration
  • Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
  • Unable to provide informed consent for themselves

Exclusion Criteria for Advanced Cancer Sub-Study

  • Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
  • Score of ≥10 on Blessed Orientation-Memory-Concentration
  • Prior receipt of MT within the past six months
  • Plan to receive any form of psychotherapy in the coming 8 weeks
  • Initiation or change in anxiety medications within the past 4 weeks
  • Plan to initiate or change anxiety medications in the coming 8 weeks
  • Unable to provide informed consent for themselves

Exclusion Criteria for group MT sub-study

  • Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
  • Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
  • Score of ≥10 on Blessed Orientation-Memory-Concentration
  • Prior receipt of MT within the past six months
  • Plan to receive any form of psychotherapy in the coming 8 weeks
  • Initiation or change in anxiety medications within the past 4 weeks
  • Unable to provide informed consent for themselves

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy (MT)
MT is a non-pharmacological, evidence-based intervention, in which board-certified music therapists engage patients in personally tailored experiences with music to achieve therapeutic goals. Patients will receive a workbook with materials for each session These experiences range from music-guided relaxation to more active forms of musical engagement, including singing and improvising music.
Other: Music Therapy
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
Other: assessments
Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.
Active Comparator: Cognitive Behavioral Therapy (CBT)
Cognitive behavioral therapy (CBT) is an evidence-based, nonpharmacological intervention delivered by licensed mental health providers. Informed by the cognitive behavior model of anxiety, CBT focuses on the relationship between thoughts, behaviors, and emotions and how thoughts and behaviors can exacerbate or reduce anxiety.
Other: assessments
Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.
Other: Cognitive Behavioral Therapy
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
Experimental: Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized)
Participants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform.
Other: Music Therapy
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS anxiety score changes
Time Frame: 8 weeks
Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.
8 weeks
HADS anxiety score changes
Time Frame: 26 weeks
Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.
26 weeks

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 14, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

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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