SurvivorshipPhase 4NCT05215353
A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
A Phase 4 study testing Music Therapy, Cognitive Behavioral Therapy and assessments in people with Survivorship, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship
- What is being tested?
- Music Therapy, Cognitive Behavioral Therapy and assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jan 2022to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin Liou, MD contact
United States3 sites, 2 recruiting
- Recruiting
Baptist Alliance MCI
Miami, Florida, 33143
Beatriz Currier, MD, 786-596-2000
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jun Mao, MD, MSCE, 646-608-8552
Kevin Liou, MD, 646-608-8558
- Active, not recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
About this study
Official title: Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
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
- Being tested
- Music Therapy, Cognitive Behavioral Therapy, assessments
- Keywords
- Music Therapy, Cognitive Behavioral Therapy, Anxiety, 21-516
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
Cognitive Behavioral TherapyOther
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
assessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy (MT) | Experimental | 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. Receives: Other: Music Therapy; Other: assessments |
| Cognitive Behavioral Therapy (CBT) | Active comparator | 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. Receives: Other: Cognitive Behavioral Therapy; Other: assessments |
| Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized) | Experimental | Participants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start14 Jan 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215353
- Sponsor's protocol ID
- 21-516
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Publications
Liou KT, Bradt J, Currier MB, Baser R, Panageas K, MacLeod J, Walker D, Li SQ, Lopez AM, McConnell K, Mao JJ. Music Therapy Versus Cognitive Behavioral Therapy via Telehealth for Anxiety in Survivors of Cancer: A Randomized Clinical Trial. J Clin Oncol. 2026 Feb 10;44(5):375-385. doi: 10.1200/JCO-25-00726. Epub 2026 Jan 6.
PubMed 41494146
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
- ClinicalTrials.gov ID
- NCT05215353
- Acronym / sponsor ID
- 21-516
- Conditions
- Survivorship
- Keywords
- Music Therapy, Cognitive Behavioral Therapy, Anxiety, 21-516
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Therapy (MT) | Experimental | Other: Music Therapy, Other: assessmentsMT 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. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Other: Cognitive Behavioral Therapy, Other: assessmentsCognitive 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. |
| Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized) | Experimental | Other: Music TherapyParticipants will attend seven weekly 60-minute virtual group sessions, delivered through Zoom's HIPAA-compliant, encrypted, passcode-protected videoconferencing platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyParticipants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom. | Other | Music Therapy (MT), Sub-study for N=18 cancer survivors original MELODY protocol for group delivery (non randomized) |
| Cognitive Behavioral TherapyParticipants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom. | Other | Cognitive Behavioral Therapy (CBT) |
| assessmentsParticipants 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. | Other | Cognitive Behavioral Therapy (CBT), Music Therapy (MT) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 41494146Liou KT, Bradt J, Currier MB, Baser R, Panageas K, MacLeod J, Walker D, Li SQ, Lopez AM, McConnell K, Mao JJ. Music Therapy Versus Cognitive Behavioral Therapy via Telehealth for Anxiety in Survivors of Cancer: A Randomized Clinical Trial. J Clin Oncol. 2026 Feb 10;44(5):375-385. doi: 10.1200/JCO-25-00726. Epub 2026 Jan 6.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Liou, MD contact
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Music Therapy, Cognitive Behavioral Therapy and assessments in people with Survivorship, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Mao, MD, MSCE (646-608-8552, maoj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS anxiety score changes (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.