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A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Trial Status: active
This clinical trial compares how music therapy versus cognitive behavioral therapy may be able to reduce anxiety among cancer survivors. Both music therapy and cognitive behavioral therapy are routinely used to treat anxiety. Cognitive behavioral therapy is a therapy based on the idea that a person's thoughts, feelings, and actions are all connected. It’s a type of talk therapy (therapy focusing on conversations between patients and their healthcare provider) that helps patients change their behavior. Music therapy uses music to encourage healing and promote a sense of well being. It can include listening to music to help relax and making music by singing or writing a song. Undergoing music therapy or cognitive behavioral therapy may help reduce anxiety among cancer survivors.
Inclusion Criteria
MAIN STUDY: English- or Spanish-speaking
MAIN STUDY: 18 years or older
MAIN STUDY: Prior cancer diagnosis of any type or stage
MAIN STUDY: Free of oncological disease, or stable disease with no evidence of progression
MAIN STUDY: Score of >= 8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
MAIN STUDY: Report anxiety symptoms lasting at least one month
MAIN STUDY: Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
MAIN STUDY: Access to Zoom and a quiet/private location
ADVANCED CANCER SUB-STUDY: English-speaking
ADVANCED CANCER SUB-STUDY: 18 years or older
ADVANCED CANCER SUB-STUDY: 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
ADVANCED CANCER SUB-STUDY: Currently receiving oncological treatment or on active surveillance
ADVANCED CANCER SUB-STUDY: Karnofsky performance score of ≥ 60
ADVANCED CANCER SUB-STUDY: Score of ≥ 8 on the HADS anxiety subscale
ADVANCED CANCER SUB-STUDY: Anxiety symptoms lasting for at least 1 month
ADVANCED CANCER SUB-STUDY: Greater than 6-month expected survival as judged by the treating oncologist
ADVANCED CANCER SUB-STUDY: Willing to adhere to all study procedures
ADVANCED CANCER SUB-STUDY: Access to Zoom and a quiet/private location
ADVANCED CANCER SUB-STUDY: Initiation or change in anxiety medications within the past 4 weeks
Exclusion Criteria
MAIN STUDY: Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed)
MAIN STUDY: Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
MAIN STUDY: Score of >= 10 indicative of cognitive impairment on the Blessed Orientation-Memory Concentration
MAIN STUDY: Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
MAIN STUDY: Unable to provide informed consent for themselves
ADVANCED CANCER SUB-STUDY: Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
ADVANCED CANCER SUB-STUDY: Score of ≥ 10 on Blessed Orientation-Memory-Concentration
ADVANCED CANCER SUB-STUDY: Prior receipt of MT within the past six months
ADVANCED CANCER SUB-STUDY: Plan to receive any form of psychotherapy in the coming 8 weeks
ADVANCED CANCER SUB-STUDY: Plan to initiate or change anxiety medications in the coming 8 weeks
ADVANCED CANCER SUB-STUDY: Unable to provide informed consent for themselves
Additional locations may be listed on ClinicalTrials.gov for NCT05215353.
I. To determine the comparative effectiveness of virtual music therapy (MT) versus virtual cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in cancer survivors (Main Study).
II. To identify patient-level factors associated with greater anxiety symptom reduction for MT and CBT (Main Study).
EXPLORATORY OBJECTIVES:
I. To explore the association between facial expression analyses and anxiety outcomes in the context of MT (Advanced Cancer Sub-study).
II. To explore the feasibility, acceptability, and preliminary effect of active MT and music-guided relaxation for anxiety symptoms in people living with advanced cancer (Advanced Cancer Sub-study).
III. To explore the feasibility, acceptability, and preliminary effect of a therapist attention-music education group for people living with advanced cancer and anxiety symptoms (Advanced Cancer Sub-study).
OUTLINE: Participants of the main study are randomized to Arm I or II. Participants of the advanced cancer sub-study are randomized to Arm III or IV, or V and VI.
ARM I: Participants undergo MT sessions via Zoom over 60 minutes once weekly for 7 weeks.
ARM II: Participants undergo CBT sessions via Zoom over 60 minutes once weekly for 7 weeks.
ARM III: Participants undergo active MT sessions via Zoom over 60 minutes once weekly for 8 weeks.
ARM IV: Participants undergo music guided relaxation session via Zoom over 60 minutes once weekly for 8 weeks.
ARM V: Participants undergo therapist attention-music education group sessions over 8 sessions on study.
ARM VI: Participants undergo active MT sessions via Zoom over 60 minutes once weekly for 8 weeks on study.
After completion of the study intervention, participants in the main study are followed up to week 26 and participants in the advanced cancer sub-study are followed up to week 16.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
