JMIR Publications

ABSTRACT

Background:

Cancer survivors represent one of the fastest growing populations in the United States. Unfortunately, nearly one in three survivors suffer from anxiety symptoms as a long-term consequence of cancer and its treatment. Characterized by restlessness, muscle tension, and worry, anxiety worsens quality of life, impairs daily functioning, and is associated with poor sleep, depressed mood, and fatigue. Although pharmacological treatment options are available, polypharmacy has become a growing concern for cancer survivors. Music therapy (MT) and cognitive behavioral therapy (CBT) are evidence-based, non-pharmacological treatments that have demonstrated effectiveness for anxiety symptoms in cancer populations and can be adapted for remote delivery to increase access to mental health treatments. However, the comparative effectiveness of these two interventions delivered virtually is unknown.

Objective:

The aims of the Music Therapy vs. Cognitive Behavioral Therapy for Cancer-related Anxiety (MELODY) study are: 1) to determine the comparative effectiveness of virtual MT versus virtual CBT for anxiety and co-morbid symptoms in cancer survivors; and 2) to identify patient-level factors associated with greater anxiety symptom reduction for MT and CBT.

Methods:

The MELODY study is a two-arm, parallel group, randomized clinical trial (RCT) that aims to compare the effectiveness of MT versus CBT for anxiety and co-morbid symptoms. The trial will enroll 300 English- or Spanish-speaking survivors of any cancer type or stage who have experienced anxiety symptoms for at least one month. Participants will receive seven weekly sessions of MT or CBT delivered remotely via Zoom over seven weeks. Validated instruments for anxiety (primary outcome), co-morbid symptoms (fatigue, depression, insomnia, pain, cognitive dysfunction), and health-related quality of life will be administered at baseline, week 4, week 8 (end of treatment), week 16, and week 26. Semi-structured interviews will be conducted at week 8 with a subsample of 60 participants (30 per treatment arm) to understand individual experiences with the treatment sessions and their impact.

Results:

The first study participant was enrolled in February 2022. As of January 2023, a total of 151 participants have been enrolled. The trial is expected to be completed by September 2024.

Conclusions:

This study is the first and largest RCT to compare the short- and long-term effectiveness of MT and CBT delivered remotely for anxiety in cancer survivors. Limitations include lack of usual care or placebo control groups and lack of formal diagnostic assessments for psychiatric disorders among trial participants. The study findings will help guide treatment decisions for two evidence-based, scalable, and accessible interventions to promote mental well-being during cancer survivorship. Clinical Trial: The trial is registered at clinicaltrials.gov (NCT05215353).