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

Survivorship Clinical Trial

Official title:

Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215353
• Other study ID #: 21-516
• Status: Recruiting
• Phase: Phase 4
• Start date: January 14, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jun Mao, MD, MSCE
• Phone: 646-608-8552
• Email: maoj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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=30)
• 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

Related Conditions & MeSH terms

• Survivorship

Intervention

Other:
• Music Therapy
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
• Cognitive Behavioral Therapy
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
• assessments
Participants 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.

Locations

Country	Name	City	State
United States	Baptist Alliance MCI	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HADS anxiety score changes	Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of =8 indicates presence of anxiety symptoms.	8 weeks
Primary	HADS anxiety score changes	Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of =8 indicates presence of anxiety symptoms.	26 weeks

External Links

•   Memorial Sloan Kettering Cancer Center