Survivorship
Conditions
Keywords
Music Therapy, Cognitive Behavioral Therapy, Anxiety, 21-516
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.
Interventions
OTHERMusic Therapy
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
OTHERCognitive Behavioral Therapy
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
OTHERassessments
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HADS anxiety score changes | 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. |
Countries
United States
Contacts
CONTACTJun Mao, MD, MSCE
CONTACTKevin Liou, MD
PRINCIPAL_INVESTIGATORJun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Outcome results
None listed