Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
研究概览
简要总结
The purpose of this study is to find out if it is practical to provide 2 interventions, VMB exercise classes and EUC (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.
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
- •Age ≥ 18 years or older
- •Any pancreas disease (benign, pre-malignant, or malignant) and will be undergoing pancreatectomy
- •Has at least one week to participate in the study prior to the anticipated surgery date
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
- •English-speaking only
排除标准
- •Unable to give informed consent due to cognitive impairment or impaired decisionmaking capacity
- •Cognitive impairment precluding response to study assessments
- •Received neoadjuvant or any chemoradiation in the past 60 days
- •Unwilling to accept random assignment
- •Unwilling to commit to the 12-week study time period
- •Unlikely to be compliant because of social factors that prevent patients from attending classes or doing home practice (e.g., unreliable internet, no access to a computer)
研究组 & 干预措施
Virtual mind-body group exercise classes (VMB)
Will be provided with the schedule and links to the web-based mind-body exercises offered by MSK in real-time via the Zoom video conferencing platform. Each session is led by a licensed clinician (e.g., licensed dance therapist, certified yoga instructor, nurse specialist/physical trainer) with specific expertise in the oncology setting.
干预措施: Virtual mind-body group exercise classes (Other)
Enhanced usual care (EUC)
Pre-recorded self-care videos.
干预措施: Enhanced usual care (Other)
结局指标
主要结局
Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
时间窗: 1 year
total number of patients invited, and the total number of study participants will be recorded
次要结局
- improving patient-reported outcomes (PROs)(1 year)