Clinical trial · Interventional
A Study of Music Therapy for Anxiety in People With Cancer
Virtual AI-Assisted Music Therapy for Anxiety Symptoms in People With Advanced Cancer (VIRTUOSO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Assisted Collaborative Songwriting (ARTIST) Intervention | Other | — | UNRESOLVED |
| Time and attention matched-music listening (TAME) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI-assisted collaborative songwriting (ARTIST)
- 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.
- interventionNames
- Other: AI-Assisted Collaborative Songwriting (ARTIST) Intervention
- type
- ACTIVE_COMPARATOR
- label
- Time and attention matched-music listening (TAME)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available