Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 4
- 主要终点
- Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
研究概览
简要总结
This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains.
The study intervention involved in this study is:
-"Jacki" recovery jacket
详细描述
In this research study, the investigators are studying the Jacki, a garment that can be worn post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a cancer survivor who leads A Little Easier Recovery®, a non-profit organization in Massachusetts, and may help participants manage the pain of post-surgical drains to increase comfort and ease of daily living. The jacket has not previously been tested in a research study. The investigators are hoping to learn whether the jacket is effective in reducing pain and discomfort from the time participants leave the hospital until they return to have their drains removed.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are ≥ 18 years old.
- •Patients who speak and understand English.
- •Patients who have had mastectomy with reconstructive surgery in one or both breasts.
排除标准
- •Co-morbid delirium
- •Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.
结局指标
主要结局
Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
时间窗: 1-2 weeks
Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
次要结局
- EORTC QLQ-C30: Role Functioning Scale(1-2 weeks)
- Symptom Distress Scale - Pain Intensity(1-2 weeks)
- EORTC QLQ-C30: Emotional Functioning Scale(1-2 weeks)
- EORTC QLQ-C30: Social Functioning Scale(1-2 weeks)
- EORTC QLQ-BR23: Body Image Subscale(1-2 weeks)
- PROMIS Pain Interference Scale - Short Form 8a(1-2 weeks)
- EORTC QLQ-C30: Global QOL Scale(1-2 weeks)
- EORTC QLQ-C30: Physical Functioning Scale(1-2 weeks)
- Symptom Distress Scale - Pain Frequency(1-2 weeks)
- PROMIS Pain Intensity Scale (Short Form 3a)(1-2 weeks)
- EORTC QLQ-C30: Cognitive Functioning Scale(1-2 weeks)
- EORTC QLQ-BR23: Sexual Functioning Subscale(1-2 weeks)
- EORTC QLQ-BR23: Future Perspective Subscale(1-2 weeks)
- EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale(1-2 weeks)
- EORTC QLQ-BR23: Sexual Enjoyment Subscale(1-2 weeks)
- EORTC QLQ-BR23: Breast Symptoms Subscale(1-2 weeks)
- EORTC QLQ-BR23: Arm Symptoms Subscale(1-2 weeks)
- Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)(1 week)
- Pain Management At Home: Use of Pain Medication (Daily Diary)(1-2 weeks)
- EORTC QLQ-BR23: Upset by Hair Loss Subscale(1-2 weeks)
- Pain Management At Home: Use of Mastectomy Bra (Daily Diary)(1-2 weeks)
- Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)(1-2 weeks)
- Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)(1-2 weeks)
研究者
Donna Berry, PhD, RN, FAAN, AOCN
Donna Berry, PhD, RN
Dana-Farber Cancer Institute