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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type OTHER

Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.

assessments

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type OTHER

Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.

assessments

Intervention Type OTHER

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.

Interventions

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Music Therapy

Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.

Intervention Type OTHER

Cognitive Behavioral Therapy

Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No