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

August 17, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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