Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Inclusion Criteria for Advanced Cancer Sub-Study (N=50)
Inclusion Criteria for group MT sub-study (N=18)
Exclusion Criteria:
Exclusion Criteria for Advanced Cancer Sub-Study
Exclusion Criteria for group MT sub-study
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Mao, MD, MSCE | Contact | 646-608-8552 | maoj@mskcc.org | |
| Kevin Liou, MD | Contact | 646-608-8558 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Alliance MCI | Recruiting | Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41494146 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D009147 | Music Therapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Cognitive Behavioral Therapy | Other | Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom. |
|
| assessments | Other | 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. |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Drexel University | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001521 | Behavior Therapy |