RecruitingPhase 4NCT05215353

A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

368 participants

Start Date

Jan 14, 2022

Study Type

INTERVENTIONAL

Conditions

Survivorship

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria26

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
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
English-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
Access to Zoom and a quiet/private location

Exclusion Criteria19

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
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

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.