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)
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jun Mao, MD, MSCE
- 电话号码：646-608-8552
研究联系人备份
- 姓名：Kevin Liou, MD
- 电话号码：646-608-8558
- 邮箱：liouk@mskcc.org
学习地点
-
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New Jersey
-
Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (All protocol activities)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (All protocol activities)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (All protocol activities)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
-
New York
-
Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
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接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (All protocol activities)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center (All protocol activites)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering Nassau (All protocol activities)
-
接触：
- Kevin Liou, MD
- 电话号码：646-608-8558
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
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. |
|
有源比较器：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. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
anxiety change
大体时间：26 weeks
|
anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale |
26 weeks
|
合作者和调查者
调查人员
- 首席研究员：Kevin Liou, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 26-214
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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