NCT07845422

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable cancer

Timeline
35mo left

Started Sep 2026

Typical duration for not_applicable cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

Study Start

First participant enrolled

September 4, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Cancer

Keywords

Music therapyVirtual AI-Assisted Music Therapy26-214Anxiety management

Outcome Measures

Primary Outcomes (1)

  • anxiety reduction

    anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale

    26 weeks

Study Arms (2)

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.

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.

Other: Time and attention matched-music listening (TAME)

Interventions

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.

Time and attention matched-music listening (TAME)
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.

AI-assisted collaborative songwriting (ARTIST)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 or Spanish-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 * No diagnosis of bipolar disorder, schizophrenia, or substance abuse * Score of 10 or higher on Blessed Orientation-Memory-Concentration indicative of dementia * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

MethodsTime

Intervention Hierarchy (Ancestors)

Investigative TechniquesPhysical Phenomena

Study Officials

  • Kevin Liou, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Liou, MD

CONTACT

646-608-8558liouk@mskcc.org

Jun Mao, MD, MSCE

CONTACT

646-608-8552

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: VIRTUOSO is a two-arm, parallel-group, randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 4, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)