A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT05215353
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Survivorship
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Music Therapy — OTHERParticipants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
- Cognitive Behavioral Therapy — OTHERParticipants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
- assessments — OTHERParticipants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.
Study Details
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.
Key Dates
- Start date
- Jan 14, 2022
- Status verified
- May 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 368 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Music Therapy (MT)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.
- Active Comparator: Cognitive Behavioral Therapy (CBT)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.
- Experimental: Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized)Participants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform.
Primary Outcome Measure
HADS anxiety score changes [ Time Frame: 8 weeks ]
Central Contacts
- Jun Mao, MD, MSCE646-608-8552
- Kevin Liou, MD646-608-8558
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baptist Alliance MCI | Miami | Florida | 33143 | Beatriz Currier, MD 786-596-2000 |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Jun Mao, MD, MSCE 646-608-8552 Kevin Liou, MD 646-608-8558 |
| Drexel University | Philadelphia | Pennsylvania | 19104 | - |
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