A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
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
- GROUP MT SUB-STUDY: English-speaking
- GROUP MT SUB-STUDY: 18 years or older
- GROUP MT SUB-STUDY: Prior cancer diagnosis of any type or stage
- GROUP MT SUB-STUDY: Free of oncological disease, or stable disease with no evidence of progression
- GROUP MT SUB-STUDY: Score of ≥ 8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- GROUP MT SUB-STUDY: Report anxiety symptoms lasting at least one month
- GROUP MT SUB-STUDY: Willing to adhere to all study-related procedures
- GROUP MT SUB-STUDY: Access to Zoom and a quiet/private location
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
- 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)
- GROUP MT SUB-STUDY: Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
- GROUP MT SUB-STUDY: Score of ≥ 10 on Blessed Orientation-Memory-Concentration
- GROUP MT SUB-STUDY: Prior receipt of MT within the past six months
- GROUP MT SUB-STUDY: Plan to receive any form of psychotherapy in the coming 8 weeks
- GROUP MT SUB-STUDY: Initiation or change in anxiety medications within the past 4 weeks
- GROUP MT SUB-STUDY: Unable to provide informed consent for themselves
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05215353.
Locations matching your search criteria
United States
Florida
Miami
New York
New York
Pennsylvania
Philadelphia
PRIMARY OBJECTIVES:
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 a therapist attention-music education group for people living with advanced cancer and anxiety symptoms. (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).
IV. To explore the feasibility, acceptability, and preliminary effect of a group music therapy for anxiety symptoms in cancer survivors. (Cancer Survivors Pilot Feasibility 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. Participants of the pilot feasibility sub-study are assigned to Arm VII.
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.
ARM VII: Participants undergo virtual MT group sessions over 60 minutes once weekly over 7 weeks.
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
Principal InvestigatorJun J. Mao
- Primary ID21-516
- Secondary IDsNCI-2022-01099
- ClinicalTrials.gov IDNCT05215353