A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Phase 4
Recruiting
- Conditions
- Survivorship
- Interventions
- Other: Music TherapyOther: Cognitive Behavioral TherapyOther: assessments
- Registration Number
- NCT05215353
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music Therapy (MT) assessments 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. Music Therapy (MT) Music Therapy 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. Cognitive Behavioral Therapy (CBT) assessments 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. Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy 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.
- Primary Outcome Measures
Name Time Method HADS anxiety score changes 26 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Alliance MCI
🇺🇸Miami, Florida, United States