Status:
RECRUITING
A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Survivorship
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05215353
Start Date
January 14 2022
End Date
January 1 2026
Last Update
January 13 2025
Active Locations (3)
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1
Baptist Alliance MCI
Miami, Florida, United States, 33143
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Drexel University
Philadelphia, Pennsylvania, United States, 19104