Comparing music therapy and cognitive behavioral therapy for anxiety in cancer survivors

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

This study tests whether music therapy or cognitive behavioral therapy helps reduce anxiety in cancer survivors who have finished treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 368 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT05215353 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of music therapy and cognitive behavioral therapy (CBT) delivered virtually in reducing anxiety among cancer survivors. Researchers will also investigate how personal characteristics and cognitive factors influence participants' responses to these therapies. Participants will be randomly assigned to either the music therapy or CBT group and will undergo assessments to measure their anxiety levels. The study focuses on individuals who have completed cancer treatment and are currently free of disease or have stable disease.

Who should consider this trial

Good fit: Ideal candidates include English- or Spanish-speaking adults aged 18 and older who have a prior cancer diagnosis and experience anxiety symptoms.

Not a fit: Patients currently undergoing active cancer treatment or those with significant cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective non-pharmacological treatment options for anxiety in cancer survivors.

How similar studies have performed: Other studies have shown promising results in using music therapy and CBT for anxiety, suggesting that this approach may be effective.

Eligibility criteria

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

Where this trial is running

Miami, Florida and 2 other locations

• Baptist Alliance MCI — Miami, Florida, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Drexel University — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jun Mao, MD, MSCE

Conditions: Survivorship, Music Therapy, Cognitive Behavioral Therapy, Anxiety, 21-516