CancerNCT07845422
A Study of Music Therapy for Anxiety in People With Cancer
A study testing AI-Assisted Collaborative Songwriting (ARTIST) Intervention and Time and attention matched-music listening (TAME) in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to compare two different music-based treatment approaches and see if one may work better to reduce anxiety. The researchers will also study whether these music-based treatment approaches help people feel socially connected and change how they cope with anxiety, and whether these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- AI-Assisted Collaborative Songwriting (ARTIST) Intervention and Time and attention matched-music listening (TAME)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Sep 2026to Sep 2029
- Phase
- Interventional
- 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
Criteria:
- Patients must have a pathologically confirmed 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
- Age ≥ 18; English speaking
- Ambulatory as indicated by a Karnofsky performance score of 60 or higher
- Score of 8 or higher on the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
- Anxiety symptoms lasting for at least 1 month
- Greater than 6-month expected survival as judged by the treating oncologist or clinician on the study team
- No diagnosis of bipolar disorder, schizophrenia, or substance abuse
- Score of 10 or lower on Blessed Orientation-Memory-Concentration
- No prior receipt of music therapy within the past six months
- Not currently receiving any form of psychotherapy
- Concomitant Medications
- No initiation or change in scheduled anxiety medications (e.g., anxiolytics, sedatives, hypnotics, antidepressants) within the past 4 weeks
- Initiation or change in PRN anxiety medications are allowed within the past 4 weeks
- No plan to initiate or change scheduled anxiety medications during the study
- Initiation or change in PRN anxiety medications are allowed during the study
- Access to an internet-connected device
- Able to provide informed consent
- Willing to adhere to study procedures, including randomization, session attendance, and completion of assessments
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jun Mao, MD, MSCE contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
Commack, New York, 11725
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Kevin Liou, MD, 646-608-8558
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
Kevin Liou, MD, 646-608-8558
About this study
Official title: Virtual AI-Assisted Music Therapy for Anxiety Symptoms in People With Advanced Cancer (VIRTUOSO)
The researchers are doing this study to compare two different music-based treatment approaches and see if one may work better to reduce anxiety. The researchers will also study whether these music-based treatment approaches help people feel socially connected and change how they cope with anxiety, and whether these changes are linked to lower anxiety levels. Both approaches use music-based activities to treat anxiety. One of the approaches uses an artificial intelligence (AI)-powered song creation platform to write songs with a music therapist. The other approach involves music listening exercises and music-based discussions with research staff, during which you will learn about music culture and history.
- Conditions
- Cancer
- Being tested
- AI-Assisted Collaborative Songwriting (ARTIST) Intervention, Time and attention matched-music listening (TAME)
- Keywords
- Music therapy, Virtual AI-Assisted Music Therapy, 26-214, Anxiety management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Collaborative Songwriting (ARTIST) InterventionOther
Patients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26.
Time and attention matched-music listening (TAME)Other
TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises. This control group is designed to match therapist attention and contact time of ARTIST, as well as control for music engagement unrelated to the active ingredient of ARTIST. Patients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted collaborative songwriting (ARTIST) | Experimental | ARTIST intervention is designed to reduce anxiety by facilitating social connection and cognitive processing of cancer-related experience. The active "ingredient" of our intervention is collaborative songwriting, during which music therapists work with participants to brainstorm themes, draft lyrics, create melodies and harmonies, and produce an original song with personal meaning. Eight weekly 60-minute sessions. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. Receives: Other: AI-Assisted Collaborative Songwriting (ARTIST) Intervention |
| Time and attention matched-music listening (TAME) | Active comparator | TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises.Research staff will facilitate passive listening experiences of pre-selected songs, with each session focusing on a different genre. These music listening exercises will be purely receptive with no behavioral skill training or active music engagement. Research staff will prepare discussion points for each pre-selected song, focusing on academic topics (e.g., music theory, artist biography, historical context, genre characteristics), designed to minimize personal reflection or cognitive processing of cancer-related experiences. Eight weekly 60-minute sessions and all sessions will be delivered via Zoom. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. Receives: Other: Time and attention matched-music listening (TAME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety change
anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
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 posted28 Sep 2026
- Study start4 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- VIRTUOSO is a two-arm, parallel-group, randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University
- Responsible party
- Sponsor
- Investigators
- Kevin Liou, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845422
- Sponsor's protocol ID
- 26-214
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 14 Oct 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 following one year after publication and for up to 36 months later. 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual AI-Assisted Music Therapy for Anxiety Symptoms in People With Advanced Cancer (VIRTUOSO)
- ClinicalTrials.gov ID
- NCT07845422
- Acronym / sponsor ID
- 26-214
- Conditions
- Cancer
- Keywords
- Music therapy, Virtual AI-Assisted Music Therapy, 26-214, Anxiety management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Drexel University
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 28 Sep 2026 (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 two different music-based treatment approaches and see if one may work better to reduce anxiety. The researchers will also study whether these music-based treatment approaches help people feel socially connected and change how they cope with anxiety, and whether these changes are linked to lower anxiety levels. Both approaches use music-based activities to treat anxiety. One of the approaches uses an artificial intelligence (AI)-powered song creation platform to write songs with a music therapist. The other approach involves music listening exercises and music-based discussions with research staff, during which you will learn about music culture and history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- VIRTUOSO is a two-arm, parallel-group, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| AI-assisted collaborative songwriting (ARTIST) | Experimental | Other: AI-Assisted Collaborative Songwriting (ARTIST) InterventionARTIST intervention is designed to reduce anxiety by facilitating social connection and cognitive processing of cancer-related experience. The active "ingredient" of our intervention is collaborative songwriting, during which music therapists work with participants to brainstorm themes, draft lyrics, create melodies and harmonies, and produce an original song with personal meaning. Eight weekly 60-minute sessions. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
| Time and attention matched-music listening (TAME) | Active comparator | Other: Time and attention matched-music listening (TAME)TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises.Research staff will facilitate passive listening experiences of pre-selected songs, with each session focusing on a different genre. These music listening exercises will be purely receptive with no behavioral skill training or active music engagement. Research staff will prepare discussion points for each pre-selected song, focusing on academic topics (e.g., music theory, artist biography, historical context, genre characteristics), designed to minimize personal reflection or cognitive processing of cancer-related experiences. Eight weekly 60-minute sessions and all sessions will be delivered via Zoom. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AI-Assisted Collaborative Songwriting (ARTIST) InterventionPatients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26. | Other | AI-assisted collaborative songwriting (ARTIST) |
| Time and attention matched-music listening (TAME)TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises. This control group is designed to match therapist attention and contact time of ARTIST, as well as control for music engagement unrelated to the active ingredient of ARTIST. Patients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26. | Other | Time and attention matched-music listening (TAME) |
Primary outcome
anxiety change
Time frame: 26 weeks
anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
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 14 Oct 2026.
- 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 following one year after publication and for up to 36 months later. 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Jun Mao, MD, MSCE contact
Kevin Liou, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Collaborative Songwriting (ARTIST) Intervention and Time and attention matched-music listening (TAME) in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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?
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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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 Kevin Liou, MD (646-608-8558, liouk@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety change (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.