Recruiting

Music Therapy & Cognitive Behavioral Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05215353

Conditions

Survivorship

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Music Therapy

Cognitive Behavioral Therapy

assessments

Study Details

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.

Conditions

Survivorship

Study ID

NCT05215353

Start date

Jan 14, 2022

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

368 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

experimental: Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized)

Participants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform.

Interventions

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.

Primary outcome measure

  • HADS anxiety score changes [ Time Frame: 8 weeks ]
  • HADS anxiety score changes [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Kevin Liou, MD

646-608-8558

Locations

Baptist Alliance MCI

Recruiting

Miami, Florida, United States, 33143

Contacts

Beatriz Currier, MD

786-596-2000

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jun Mao, MD, MSCE

646-608-8552

Kevin Liou, MD

646-608-8558

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Music Therapy
  • Cognitive Behavioral Therapy
  • Anxiety
  • 21-516

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-18.