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A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
NCT05215353 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
About this study
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.
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
Study design
Enrollment target: 368 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2022-01-14
Estimated completion: 2027-01
Last updated: 2026-02-02
Interventions
Other: Music TherapyOther: Cognitive Behavioral TherapyOther: assessments
Primary outcomes
- • HADS anxiety score changes (8 weeks)
- • HADS anxiety score changes (26 weeks)
Sponsor
Memorial Sloan Kettering Cancer Center · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactJun Mao, MD, MSCE · contact · maoj@mskcc.org · 646-608-8552
ContactKevin Liou, MD · contact · 646-608-8558
InvestigatorJun Mao, MD, MSCE · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (3)
Baptist Alliance MCIRecruiting
Miami, Florida, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Drexel UniversityRecruiting
Philadelphia, Pennsylvania, United States