Virtual AI-Assisted Music Therapy for Anxiety Symptoms in People With Advanced Cancer (VIRTUOSO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- anxiety reduction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: AI-Assisted Collaborative Songwriting (ARTIST) Intervention (Other)
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.
干预措施: Time and attention matched-music listening (TAME) (Other)
结局指标
主要结局
anxiety reduction
时间窗: 26 weeks
anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
次要结局
未报告次要终点