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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 4

Conditions: Survivorship

Treatments: Other: Cognitive Behavioral Therapy; Other: Music Therapy; Other: assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT05215353

21-516

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Music Therapy (MT)

Experimental group

Description:

MT is a non-pharmacological, evidence-based intervention, in which board-certified music therapists engage patients in personally tailored experiences with music to achieve therapeutic goals. Patients will receive a workbook with materials for each session These experiences range from music-guided relaxation to more active forms of musical engagement, including singing and improvising music.

Treatment:

Other: assessments

Other: Music Therapy

Cognitive Behavioral Therapy (CBT)

Active Comparator group

Description:

Cognitive behavioral therapy (CBT) is an evidence-based, nonpharmacological intervention delivered by licensed mental health providers. Informed by the cognitive behavior model of anxiety, CBT focuses on the relationship between thoughts, behaviors, and emotions and how thoughts and behaviors can exacerbate or reduce anxiety.

Treatment:

Other: assessments

Other: Cognitive Behavioral Therapy