Clinical trial NCT05215353: A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Official title: Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Survivorship
Keywords: Music Therapy
Cognitive Behavioral Therapy
Anxiety
21-516
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-01-31
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed MELODY trial is a two-arm, parallel group, randomized clinical trial (RCT) to compare the effectiveness of music therapy (M) versus cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in a diverse, heterogeneous sample of 300 cancer survivors.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: HADS anxiety score changes
timeFrame: 8 weeks
measure: HADS anxiety score changes
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: