A Study of Music Therapy for Anxiety in People With Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Cancer

Treatments: Other: Time and attention matched-music listening (TAME); Other: AI-Assisted Collaborative Songwriting (ARTIST) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07845422

26-214

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

AI-assisted collaborative songwriting (ARTIST)

Experimental group

Description:

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.

Treatment:

Other: AI-Assisted Collaborative Songwriting (ARTIST) Intervention

Time and attention matched-music listening (TAME)

Active Comparator group

Description:

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.

Treatment:

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