Recruiting

AI Music Therapy & Music Listening

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07845422

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AI-Assisted Collaborative Songwriting (ARTIST) Intervention

Time and attention matched-music listening (TAME)

Study Details

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.

Conditions

Cancer

Study ID

NCT07845422

Start date

Sep 4, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

AI-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.

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.

Primary outcome measure

  • anxiety reduction [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Kevin Liou, MD

646-608-8558liouk@mskcc.org

Jun Mao, MD, MSCE

646-608-8552

Locations

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kevin Liou, MD

646-608-8558

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kevin Liou, MD

646-608-8558

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kevin Liou, MD

646-608-8558

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

Recruiting

Commack, New York, United States, 11725

Contacts

Kevin Liou, MD

646-608-8558

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kevin Liou, MD

646-608-8558

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Kevin Liou, MD

646-608-8558

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Kevin Liou, MD

646-608-8558

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.