EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants Confident in the Use of EHealth Format
研究概览
简要总结
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.
详细描述
PRIMARY OBJECTIVES:
I. To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.
OUTLINE:
Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.
After completion of study, participants are followed up at 4 weeks from surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Cognitively able to complete assessments as judged by the study team
- •Able to understand, read and write English
排除标准
- •Have schizophrenia or any other psychotic disorder
- •Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome
结局指标
主要结局
Number of Participants Confident in the Use of EHealth Format
时间窗: Up to 4 weeks
This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
次要结局
- Number of Participants Reporting Adverse Events(Up to 4 weeks)
- Number of Participants Recruited and Completed All Assessments(Up to 4 weeks)
- Percentage of Participants Completing 4-week Visits(Up to 4 weeks)
- Number of Participants That Adhered to Study Interventions(Up to 4 weeks)