Music During Allogeneic Stem Cell Transplant Hospitalization: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up
研究概览
简要总结
The goal of this trial is to develop an Independent Music Listening tool for stem cell transplant patients that have prolonged hospitalizations. The main questions it aims to answer are:
[primary hypothesis or outcome measure 1]? [primary hypothesis or outcome measure 2]?
Participants will use a self-guided music listening intervention of 1-hour daily music listening during their inpatient hsopitalization and delivered via web-based platform.
详细描述
To address this clinical and research need in the current project, the primary aim is to (1) assess the feasibility, acceptability, and appropriateness of a self-guided music listening intervention (i.e. Independent Music Listening or "IML") comprised of 1-hour daily music listening during the inpatient hospitalization (e.g., 3-4 weeks) and delivered via web-based platform/smart phone app (e.g., Spotify or Apple music) among 35 HCT patients. Participants will be randomized to IML (n=23) or usual care control group (n=12). The secondary aims are to (2a) explore whether the IML program is associated with improvements on psychosocial self-report measures of patient quality of life, distress, and mindfulness and (2b) whether preliminary psychosocial effects of the IML program are different from a control group of patients completing usual care. In an exploratory aim, the PI will gather qualitative data on patient perceptions and reactions to daily music listening via a daily music diary and post-intervention open-ended questions. Data produced from the current study will help inform development of future interventions to improve quality of life in HCT patients that are based in arts in medicine or creative arts therapy modalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participate patients need to be (a) diagnosed with a disorder that requires an allogeneic stem cell transplant, (b) scheduled for allogeneic stem cell transplant and expected to be admitted for ~3-4 weeks
- •Aged 18 years or older
- •Score ≥1 on the distress thermometer
- •Have access to a smartphone, tablet, or computer with internet capability in order to complete study surveys via Microsoft Forms and to connect to a music streaming platform via website or app
- •Able to provide informed consent.
排除标准
- •Individuals with significant and active cognitive (e.g., major cognitive impairment), psychiatric (e.g., active psychosis), or medical conditions (e.g., untreated significant hearing impairments) that would prevent the ability to provide informed consent or participate in the music listening intervention
- •Individuals without access to music streaming via smartphone, tablet, or computer and have access to internet.
研究组 & 干预措施
Music Intervention
干预措施: Mindful Music Listening (MML) (Other)
Control
结局指标
主要结局
Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up
时间窗: Post-intervention follow-up at 4 weeks post inpatient admission
Feasibility of Intervention Measure (FIM): The FIM has 4 items ranging from 1 (Completely Disagree) to 5 (Completely Agree). Higher scores indicate greater feasibility. Mindful Music Listening (MML) group mean score \>=4 (reflective of an average response of "Agree") at post-intervention will be considered the benchmark for determining that the intervention was feasible, acceptable, and/or appropriate.
Acceptability of Intervention Measure (AIM): Mindful Music Listening Group mean >=4 at follow-up
时间窗: Post-intervention follow-up at 4 weeks post inpatient admission
Acceptability of Implementation Measure (AIM): The Implementation Appropriateness Measure (IAM) (Weiner et al., 2017) Higher scores indicate greater appropriateness. Mindful Music Listening (MML) group mean score \>=4 (reflective of an average response of "Agree") at post-intervention will be considered the benchmark for determining that the intervention was feasible, acceptable, and/or appropriate.
次要结局
- Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)(Post-intervention follow-up at 4 weeks post inpatient admission)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale (HADS-A total score) and Depression Subscale (HADS-D total score)(Post-intervention follow-up at 4 weeks post inpatient admission)
- Five Facet Mindfulness Questionnaire- 15 item short form (FFMQ-15)(Post-intervention follow-up at 4 weeks post inpatient admission)