NCT05215353

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Jan 2022

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2022Jan 2027

Study Start

First participant enrolled

January 14, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 18, 2022

Last Update Submit

January 29, 2026

Conditions

Survivorship

Keywords

Music TherapyCognitive Behavioral TherapyAnxiety21-516

Outcome Measures

Primary Outcomes (2)

  • HADS anxiety score changes

    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

    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

Study Arms (3)

Music Therapy (MT)

EXPERIMENTAL

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 TherapyOther: assessments

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

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: Cognitive Behavioral TherapyOther: assessments

Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized)

EXPERIMENTAL

Participants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform.

Other: Music Therapy

Interventions

Music TherapyOTHER

Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.

Music Therapy (MT)Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized)
Cognitive Behavioral TherapyOTHER

Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.

Cognitive Behavioral Therapy (CBT)
assessmentsOTHER

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.

Cognitive Behavioral Therapy (CBT)Music Therapy (MT)

Eligibility Criteria

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

You may qualify if:

  • English- or Spanish-speaking
  • 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
  • English-speaking
  • 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
  • +11 more criteria

You may not qualify if:

  • 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
  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baptist Alliance MCI

Miami, Florida, 33143, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

  • Liou KT, Bradt J, Currier MB, Baser R, Panageas K, MacLeod J, Walker D, Li SQ, Lopez AM, McConnell K, Mao JJ. Music Therapy Versus Cognitive Behavioral Therapy via Telehealth for Anxiety in Survivors of Cancer: A Randomized Clinical Trial. J Clin Oncol. 2026 Feb 10;44(5):375-385. doi: 10.1200/JCO-25-00726. Epub 2026 Jan 6.

    PMID: 41494146DERIVED

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • Jun Mao, MD, MSCE

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Mao, MD, MSCE

CONTACT

646-608-8552maoj@mskcc.org

Kevin Liou, MD

CONTACT

646-608-8558

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The proposed MELODY trial is a two-arm, parallel group, randomized clinical trial (RCT) to compare the effectiveness of music therapy (M) versus cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in a diverse, heterogeneous sample of 300 cancer survivors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

January 14, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Locations

US(3)