CClinicalTrials.gg
RecruitingNCT07845422Updated Sep 28, 2026

A Study of Music Therapy for Anxiety in People With Cancer

An interventional study of AI-Assisted Collaborative Songwriting (ARTIST) Intervention and Time and attention matched-music listening (TAME) in Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

Browse trials for

Keywords

  • Music therapy
  • Virtual AI-Assisted Music Therapy
  • 26-214
  • Anxiety management
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    AI-assisted collaborative songwriting (ARTIST)

    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

  • Active comparator
    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.

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

Interventions

  • OtherAI-Assisted Collaborative Songwriting (ARTIST) Intervention

    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.

  • OtherTime 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.

05

What researchers measure

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

    Time frame: 26 weeks

06

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (All protocol activities)
    Basking Ridge, New Jersey 07920, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Monmouth (All protocol activities)
    Middletown, New Jersey 07748, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Bergen (All protocol activities)
    Montvale, New Jersey 07645, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
    Commack, New York 11725, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Westchester (All protocol activities)
    Harrison, New York 10604, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Cancer Center (All protocol activites)
    New York, New York 10065, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
  • Memorial Sloan Kettering Nassau (All protocol activities)
    Uniondale, New York 11553, United States
    • Kevin Liou, MD · Contact · 646-608-8558
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT07845422
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Drexel University
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Sep 4, 2026
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Kevin Liou, MD
Contact
liouk@mskcc.org
646-608-8558
Jun Mao, MD, MSCE
Contact
646-608-8552
Kevin Liou, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion