A Randomized Pilot Study of Yoga Intervention in Patients With Multiple Myeloma on Active Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Compliance rate of weekly yoga intervention
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult of age 18 and above
- •Able to understand basic English
- •Able to provide informed consent
- •Diagnosis of multiple myeloma on active treatment as determined by investigators
- •Good performance status as defined by European Cooperative Oncology Group score 0-1
- •Able to utilize computer/laptop and smart phone
- •Able and willing to travel to the yoga studio for weekly sessions
- •Able to utilized a wearable device, such as Apple Watch or Fitbit (optional)
排除标准
- •Poor performance status with European Cooperative Oncology Group score 2-4
- •Actively participating in another clinical trial
- •Poorly controlled mental health symptoms as determined by treating physician
- •Reported fall or syncope in the last 2 months prior to enrollment
- •Concurrent diagnosis of amyloidosis or other cancer requiring active treatment
研究组 & 干预措施
Immediate yoga group
20 participants randomized to immediate yoga intervention group will participate together in a weekly 40-minute guided mindful yoga intervention for a total of 12 consecutive weeks. After each session, participants will be asked to complete the Edmonton Symptom Assessment System (ESAS-r) through MyDataHelps app. At the end of each session, participants will be asked additional questions via MyDataHelps such as completion of yoga session on-site or remotely, the length of time they participated in the session, any additional yoga sessions during the past week, and comments regarding the session/intervention. These participants will also complete health-related quality of life (HRQOL) assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention.
干预措施: Immediate yoga intervention (Other)
Waitlist yoga group (delayed yoga intervention group)
20 participants randomized to this group will start the yoga intervention at week 13 and participate in 12 consecutive weeks of weekly 40 minute guided mindful yoga. Participants in this group will complete ESAS-r every 3 weeks and EORTC QLQ-C30 every 6 weeks for the first 12 weeks. These participants will also complete HRQOL assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention, weeks 13-24.
干预措施: Delayed yoga intervention (Other)
结局指标
主要结局
Compliance rate of weekly yoga intervention
时间窗: 12 weeks
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring compliance and overall completion rate of the program. Measurement: Compliance will be measured by overall percentage of patients completing 40 minutes of weekly yoga sessions in at least 8 out of 12 weeks of intervention. Completion rate will be measured by overall percentage of patients completing the 12 weeks of intervention without withdrawing or dropping out from the study. Hypothesis: Implementation of a weekly mindful yoga intervention will be feasible in multiple myeloma patients as demonstrated compliance of at least 70% patients completing 40 minutes of weekly yoga sessions in 8 out of 12 weeks of intervention.
Accrual rate of yoga intervention study
时间窗: 12 weeks
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring accrual rate. Measurement: Accrual rate will be measured by overall percentage of participants enrolled in the study at the end of 3-month accrual period compared to goal accrual of total 40 participants. Hypothesis: Implementation of a weekly yoga intervention will be feasible in multiple myeloma patients as demonstrated by accrual of 40 patients (100%) over 3 months.
次要结局
- Short-term impact of yoga intervention on symptom burden(12-weeks)
- Short-term impact of yoga intervention on health-related quality of life (HRQOL)(12-weeks)
- Short-term impact of yoga intervention on total daily activity(12-weeks)
- Short-term impact of yoga intervention on resting heart rate(12-weeks)