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NCT Number: NCT05215353

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baptist Alliance MCI, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

for group MT sub-study (N=18)

  • English-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
  • 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

Exclusion criteria

for group MT sub-study

  • 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 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
  • Unable to provide informed consent for themselves

Treatment and study plan

Music Therapy

Other

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

Cognitive Behavioral Therapy

Other

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

Assessments

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.

Primary outcomes

  1. HADS anxiety score changes

    Time frame: 8 weeks

    Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.

  2. HADS anxiety score changes

    Time frame: 26 weeks

    Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Mao, MD, MSCE

CONTACT

[email protected]

646-608-8552

Kevin Liou, MD

CONTACT

646-608-8558

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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